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  • 1. Abu-Elyazeed, R R
    et al.
    Heineman, T
    Dubin, G
    Fourneau, M
    Leroux-Roels, I
    Leroux-Roels, G
    Richardus, J H
    Ostergaard, L
    Diez-Domingo, J
    Poder, A
    Van Damme, P
    Romanowski, B
    Blatter, M
    Silfverdal, S A
    Berglund, J
    Josefsson, Ann
    Linköping University, Department of Clinical and Experimental Medicine, Division of Clinical Sciences. Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Center of Paediatrics and Gynaecology and Obstetrics, Department of Gynaecology and Obstetrics in Linköping.
    Cunningham, A L
    Flodmark, C E
    Tragiannidis, A
    Dobson, S
    Olafsson, J
    Puig-Barbera, J
    Mendez, M
    Barton, S
    Bernstein, D
    Mares, J
    Ratner, P
    Safety and immunogenicity of a glycoprotein D genital herpes vaccine in healthy girls 10-17 years of age: results from a randomised, controlled, double-blind trial.2013In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 31, no 51, p. 6136-6043Article in journal (Refereed)
    Abstract [en]

    OBJECTIVE: The investigational AS04-adjuvanted herpes simplex virus type 2 (HSV-2) glycoprotein D (gD2) subunit prophylactic vaccine ('HSV vaccine'; GlaxoSmithKline Vaccines) has been shown to be well tolerated in adults, but limited data exist for pre-teen and adolescent girls, a likely target population. The primary objective of this study was to compare the occurrence of serious adverse events (SAEs) over 12 months between HSV vaccine recipients and saline recipients (placebo control group) in pre-teen and adolescent girls. The immunogenicity of the HSV vaccine was also assessed.

    METHODS: Healthy girls aged 10-17 years, stratified by age (10-15 years; 16-17 years), were randomised 2:1:1 to receive the HSV vaccine, a hepatitis A vaccine (Havrix™; HAV control) or placebo (saline) according to a 0-, 1-, 6-month schedule. Participants and study personnel not involved in the preparation or administration of vaccines were blinded to treatment. Safety and immunogenicity analyses were performed overall and by age (10-15 years; 16-17 years) and HSV serostatus.

    RESULTS: No statistically significant difference in the percentage of subjects with SAEs was observed between the HSV and saline group, or between the HSV and pooled control (HAV and saline) groups. The HSV vaccine was well tolerated, although a higher incidence of solicited local symptoms was observed in the HSV group than in the control group. Neither age nor HSV serostatus at the time of study entry had an impact on the safety profile of this vaccine. The HSV vaccine was immunogenic regardless of pre-vaccination HSV serostatus. Higher anti-gD geometric mean concentrations were observed in HSV-1 seropositive participants than in HSV-1 seronegative participants.

    CONCLUSION: The HSV vaccine had an acceptable safety profile, and was well tolerated and immunogenic when administered to girls aged 10-17 years regardless of age or HSV pre-vaccination serostatus.

  • 2.
    Bråve, Andreas
    et al.
    Swedish Institute for Infectious Disease Control & Department of Microbiology, Tumor and Cell Biology, Karolinska Institutet, Sweden .
    Johansen, Kari
    Swedish Institute for Infectious Disease Control & Department of Microbiology, Tumor and Cell Biology, Karolinska Institutet, Sweden .
    Palma, Paolo
    Division of Immunology and Infectious Diseases, Ospedale Pediatrico Bambino Gesù and Chair of Paediatrics, Department of Public Health, University of Rome Tor Vergata, Italy .
    Benthin, Reinhold
    Swedish Institute for Infectious Disease Control & Department of Microbiology, Tumor and Cell Biology, Karolinska Institutet, Sweden .
    Hinkula, Jorma
    Linköping University, Department of Clinical and Experimental Medicine, Molecular Virology . Linköping University, Faculty of Health Sciences.
    Maternal immune status influences HIV-specific immune responses in pups after DNA prime protein boost using mucosal adjuvant2008In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 26, no 47, p. 5957-5966Article in journal (Refereed)
    Abstract [en]

    This study was designed to determine the impact of maternal HIV-1 specific immunity on HIV-DNA immunization of 2 weeks old pups during the breast-feeding period.

    Adult female mice received intranasal or intradermal HIV DNA (gp160Env, p37Gag, Nef, Tat and Rev) prime and recombinant protein booster immunizations that induced mucosal and systemic HIV-1 specific B and T cell responses. Intranasal administration of the immunogens induced higher serum IgG titers to HIV antigens than the intradermal immunization. Furthermore, predominantly higher HIV-1 specific fecal IgA titers were obtained in nasally immunized mice. The capacity to respond to one single prime with DNA and one boost with recombinant protein was then compared in pups born to mothers displaying HIV-1-specific immune responses and in pups born to non-vaccinated mothers. Immune responses to the greatest number of antigens were detected in pups born to mothers having the highest HIV-1 specific immune responses. These data suggest that HIV-1 DNA-plasmid immunization during breast-feeding and recombinant protein boosting shortly thereafter enhances the breadth of the humoral HIV-1 specific immune responses.

  • 3. Bråve, Andreas
    et al.
    Hallengärd, David
    Schröder, Ulf
    Blomberg, Pontus
    Wahren, Britta
    Hinkula, Jorma
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Clinical and Experimental Medicine, Molecular Virology .
    Intranasal immunization of young mice with a multigene HIV-1 vaccine in combination with the N3 adjuvant induces mucosal and systemic immune responses2008In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 26, no 40, p. 5075-5078Article in journal (Refereed)
    Abstract [en]

    One of the major challenges for the development of an HIV vaccine is to induce potent virus-specific immune responses at the mucosal surfaces where transmission of virus occurs. Intranasal delivery of classical vaccines has been shown to induce good mucosal antibody responses, but so far for genetic vaccines the success has been limited. This study shows that young individuals are sensitive to nasal immunization with a genetic vaccine delivered in a formulation of a lipid adjuvant, the Eurocine N3. Intranasal delivery of a multiclade/multigene HIV-1 genetic vaccine gave rise to vaginal and rectal IgA responses as well as systemic humoral and cellular responses. As electroporation might become the preferred means of delivering genetic vaccines for systemic HIV immunity, nasal delivery by droplet formulation in a lipid adjuvant might become a means of priming or boosting the mucosal immunity. © 2008 Elsevier Ltd. All rights reserved.

  • 4.
    Buonaguro, L
    et al.
    Viral Oncogenesis and Immunotherapies & AIDS Reference Center, Italy.
    Devito, C
    Linköping University, Department of Molecular and Clinical Medicine, Molecular Virology. Linköping University, Faculty of Health Sciences.
    Tornesello, ML
    Viral Oncogenesis and Immunotherapies & AIDS Reference Center, Italy.
    Schröder, U
    Eurocine Vaccines AB, Sweden.
    Wahren, B
    Karolinska Institute, Sweden.
    Hinkula, Jorma
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Molecular and Clinical Medicine, Molecular Virology.
    Buonaguro, FM
    Viral Oncogenesis and Immunotherapies & AIDS Reference Center, Italy.
    DNA-VLP prime-boost intra-nasal immunization induces cellular and humoral anti-HIV-1 systemic and mucosal immunity with cross-clade neutralizing activity2007In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 25, no 32, p. 5968-5977Article in journal (Refereed)
    Abstract [en]

    The immune response to HIV-1 virus-like particles (VLPs), presenting a clade A Ugandan gp120, has been evaluated in a mouse model by intra-nasal (i.n.) administration by a VLP + VLP homologous or a DNA + VLP heterologous prime-boost immunization protocol, including a HIV-1 DNA gp160/rev plasmid. Furthermore, the effect of the Eurocine lipid-based mucosal L3 adjuvant on the VLP immunogenicity has been assessed as well. The designed heterologous protocol is able to increase the env-specific humoral and cellular immune response, compared to the homologous protocol, which is to some extent increased by the administration of L3-adjuvanted VLP boosting dose. The anti-gag response is statistically increased in both homologous and heterologous protocols, particularly when the VLP boosting dose is adjuvanted. Immune sera from immunized animals exhibit >50% ex vivo neutralizing activity against heterologous A and B-clade viral isolates. An envelope B-cell epitope mapping shows an enhanced response against V3 epitopes all across the C2-V5 region in the heterologous prime-boost immunization strategy. The induction of humoral immunity at mucosal sites, which represents the main port of entry for the HIV-1 infection, is extremely relevant. In this framework, the DNA-VLP heterologous prime-boost protocol appears a promising preventive vaccine approach which can significantly benefit from specific mucosal adjuvants, as the Eurocine L3. © 2007 Elsevier Ltd. All rights reserved.

  • 5.
    Carlsson, R. M.
    et al.
    Public Health Agency Sweden, Sweden; Sahlgrens University Hospital, Sweden; Gothenburg University, Sweden.
    Gustafsson, L.
    Public Health Agency Sweden, Sweden.
    Hallander, H. O.
    Public Health Agency Sweden, Sweden.
    Ljungman, M.
    Public Health Agency Sweden, Sweden.
    Olin, P.
    Public Health Agency Sweden, Sweden.
    Gothefors, L.
    Public Health Agency Sweden, Sweden; Umeå University, Sweden.
    Nilsson, Lennart
    Linköping University, Department of Clinical and Experimental Medicine, Division of Neuro and Inflammation Science. Region Östergötland, Heart and Medicine Center, Allergy Center. Linköping University, Faculty of Medicine and Health Sciences. Public Health Agency Sweden, Sweden.
    Netterlid, E.
    Public Health Agency Sweden, Sweden; Lund University, Sweden; Skåne University Hospital, Sweden.
    Two consecutive randomized controlled pertussis booster trials in children initially vaccinated in infancy with an acellular vaccine: The first with a five-component Tdap vaccine to 5-year olds and the second with five- or monocomponent Tdap vaccines at age 14-15 years2015In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 33, no 31, p. 3717-3725Article in journal (Refereed)
    Abstract [en]

    Prior study children from a DTaP efficacy trial were recruited at ages 5 and 15 years to randomized booster trials addressing immunogenicity and reactogenicity; 475 preschool children received mixed or separate injections of a reduced antigen vaccine (Tdap5, Sanofi Pasteur MSD) and an inactivated polio vaccine, and 230 adolescents received the same or another booster vaccine (Tdap1, SSI, Denmark). Pre-vaccination antibody concentrations against pertussis antigens were significantly higher at 15 than 5 years of age, probably due to natural boosting between the studies. Tdap5 induced comparable anti-PT concentrations at both ages, but antibody responses were significantly higher to filamentous haemagglutinin, pertactin and fimbriae 2/3 in adolescents. As expected, a higher amount of PT (Tdap1, 20 mu g) induced a stronger anti-PT response than a lower amount (Tdap5, 2.5 mu g). The frequency of adverse events was low and there were no serious adverse reactions. All local reactions had an early onset and a short duration. A large swelling or redness of more than half of the upper arm circumference was reported in 8/475 5-year-olds and in 6/230 15-year-olds. Children vaccinated with Tdap5 reported more moderate pain in adolescence than at preschool age, whereas itching was only reported in preschool children. Sweden introduced DTaP vaccines in 1996 after a 17-year hiatus with no general pertussis vaccination and pertussis was still endemic at the time of the studies. The frequency of adverse events was nevertheless low in both preschool children and adolescents and antibody responses were adequate. These studies document immunogenicity and reactogenicity in a trial cohort consecutively vaccinated with acellular pertussis vaccines from infancy to adolescence. (C) 2015 Elsevier Ltd. All rights reserved.

  • 6.
    Clarke, S. C.
    et al.
    Scottish Meningococcus and Pneumococcus Reference Laboratory, North Glasgow University Hospitals NHS Trust, Stobhill Hospital, Scotland, UK and Faculty of Biomedical and Life Sciences, University of Glasgow, Glasgow, Scotland, UK.
    Diggle, M. A.
    Scottish Meningococcus and Pneumococcus Reference Laboratory, North Glasgow University Hospitals NHS Trust, Stobhill Hospital, Scotland, UK.
    Mölling, Paula
    National Reference Laboratory for Pathogenic Neisseria, Örebro University Hospital, Örebro, Sweden.
    Unemo, Magnus
    National Reference Laboratory for Pathogenic Neisseria, Örebro University Hospital, Örebro, Sweden.
    Olcén, Per
    National Reference Laboratory for Pathogenic Neisseria, Örebro University Hospital, Örebro, Sweden.
    Analysis of PorA variable region 3 in meningococci: implications for vaccine policy?2003In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 21, no 19-20, p. 2468-2473Article in journal (Refereed)
    Abstract [en]

    Outer membrane protein (OMP) vaccines are being developed against Neisseria meningitidis serogroup B which may provide protection against common circulating serotypes and serosubtypes in some countries. However, limited data is available in Europe from genosubtyping meningococci. We therefore undertook a retrospective analysis of the three main variable regions, VR1, VR2 as well as VR3, of the porA gene from N. meningitidis isolated from different countries, mainly from Scotland and Sweden. Analysis of this gene showed that, amongst 226 strains studied, there were a total of 78 different strains. No new VR1 or VR2 alleles were found but five new VR3 alleles are described. Our data indicates the importance of analysing the VR3 region of PorA in addition to VR1 and VR2 and also highlights, in general terms, the need for genosubtyping meningococci. Such analyses have major implications for the design of new meningococcal vaccines.

  • 7.
    Dannetun, Eva
    et al.
    Smittskyddsenheten US.
    Tegnell, Anders
    Dept of Epidemiology Smittskyddsinstitutet, Solna.
    Hermansson, Göran
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Molecular and Clinical Medicine, Pediatrics. Östergötlands Läns Landsting, Centre of Paediatrics and Gynecology and Obstetrics, Department of Paediatrics in Linköping.
    Törner, Anna
    Avd för Epidemiologi Smittskyddsinstitutet, Solna.
    Giesecke, Johan
    Avd för Epidemiologi Smittskyddsinstitutet, Solna.
    Timeliness of MMR vaccination - Influence on vaccination coverage2004In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 22, no 31-32, p. 4228-4232Article in journal (Refereed)
    Abstract [en]

    Over the last seven years, and especially in 2001, a declining coverage for MMR vaccination in 2-year-olds has been noted in Sweden. By recording actual date of vaccination in a cohort of almost 4000 children in a county in central Sweden, we found that parents' decision to postpone vaccination by up to 1.5 years beyond the stipulated age of 18 months accounted for about half the reported drop in 2001. Even if coverage thus improves with time, postponed vaccination adds to the pool of unprotected children in the population. The design of the current national surveillance system overestimates coverage at 2 years and fails to record delayed vaccination. To avoid future outbreaks that can appear around imported cases of measles it is crucial to attain high coverage levels by timely vaccination. © 2004 Elsevier Ltd. All rights reserved.

  • 8.
    Elias, D.
    et al.
    Microbiol. and Tumor Biology Center, Karolinska Institute, Box 280, 17177 Stockholm, Sweden, Swed. Inst. for Infect. Dis. Contr., Stockholm, Sweden, Armauer Hansen Research Institute, Box 1005, Addis Ababa, Ethiopia.
    Akuffo, H.
    Microbiol. and Tumor Biology Center, Karolinska Institute, Box 280, 17177 Stockholm, Sweden.
    Pawlowski, A.
    Swed. Inst. for Infect. Dis. Contr., Stockholm, Sweden.
    Haile, M.
    Swed. Inst. for Infect. Dis. Contr., Stockholm, Sweden.
    Schön, Thomas
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Clinical and Experimental Medicine, Medical Microbiology .
    Britton, S.
    Department of Medicine, Unit of Infectious Diseases, Karolinska Institute, 17176 Stockholm, Sweden.
    Schistosoma mansoni infection reduces the protective efficacy of BCG vaccination against virulent Mycobacterium tuberculosis2005In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 23, no 11, p. 1326-1334Article in journal (Refereed)
    Abstract [en]

    We hypothesized that the ability of BCG vaccination to protect against Mycobacterium tuberculosis is less in hosts exposed to chronic helminthes infection compared to unexposed individuals. To test this hypothesis we evaluated the efficacy of BCG vaccination in protecting against M. tuberculosis challenge in Schistosoma mansoni pre-infected mice by analyzing their ability to limit the replication of TB bacilli in the lung and liver and the histology of lung sections. The results show that BCG vaccinated mice with prior S. mansoni infection show significantly higher number of colony forming units of TB bacilli as well as significant reduction in air exchange area in the lung compared to controls. In addition, spleen cells from S. mansoni infected mice were found to produce significantly less IFN-? and nitric oxide when stimulated in vitro with PPD and several fold higher soluble egg antigen (SEA) and Concanavalin A induced IL-4 and IL-5 secretion. Taken together, our data show that S. mansoni infection reduces the protective efficacy of BCG vaccination against M. tuberculosis possibly by attenuation of protective immune responses to mycobacterial antigens and/or by polarizing the general immune responses to the Th2 profile. © 2004 Published by Elsevier Ltd.

  • 9.
    Fernando, Germain J. P.
    et al.
    Vaxxas Pty Ltd, Australia.
    Hickling, Julian
    Working Tandem Ltd, England.
    Flores, Cesar M. Jayashi
    Vaxxas Pty Ltd, Australia.
    Griffin, Paul
    QIMR Berghofer Med Res Inst, Australia; Q Pharm Pry Ltd, Australia; Mater Hosp, Australia; Mater Res Inst, Australia; Univ Queensland, Australia.
    Anderson, Chris D
    Linköping University, Department of Clinical and Experimental Medicine, Division of Cell Biology. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Heart and Medicine Center, Department of Dermatology and Venerology.
    Skinner, S. Rachel
    Univ Sydney, Australia; Childrens Hosp Westmead, Australia.
    Davies, Cristyn
    Univ Sydney, Australia; Childrens Hosp Westmead, Australia.
    Witham, Katey
    Vaxxas Pty Ltd, Australia.
    Pryor, Melinda
    360Biolabs Pry Ltd, Australia.
    Bodle, Jesse
    Seqirus Pty Ltd, Australia.
    Rockman, Steve
    Seqirus Pty Ltd, Australia; Univ Melbourne, Australia.
    Frazer, Ian H.
    Not Found:[Fernando, Germain J. P.; Flores, Cesar M. Jayashi; Witham, Katey; Forster, Angus H.] Vaxxas Pty Ltd, Translat Res Inst, 37 Kent St, Brisbane, Qld 4102, Australia; [Hickling, Julian] Working Tandem Ltd, Cambridge, England; [Griffin, Paul] QIMR Berghofer Med Res Inst, Brisbane, Qld, Australia; [Griffin, Paul] Q Pharm Pry Ltd, Brisbane, Qld, Australia; [Griffin, Paul] Mater Hosp, Dept Med and Infect Dieases, Brisbane, Qld, Australia; [Griffin, Paul] Mater Res Inst, Brisbane, Qld, Australia; [Griffin, Paul] Univ Queensland, Brisbane, Qld, Australia; [Anderson, Christopher D.] Linkoping Univ, Dept Clin and Expt Med, Fac Hlth Sci, Linkoping, Sweden; [Anderson, Christopher D.] Heart and Med Ctr, Dept Dermatol and Venereol, Region Ostergotland, Sweden; [Skinner, S. Rachel; Davies, Cristyn] Univ Sydney, Sydney Med Sch, Discipline Child and Adolescent Hlth, Sydney, NSW, Australia; [Skinner, S. Rachel; Davies, Cristyn] Childrens Hosp Westmead, Sydney, NSW, Australia; [Pryor, Melinda] 360Biolabs Pry Ltd, Burnet Inst, Melbourne, Vic, Australia; [Bodle, Jesse; Rockman, Steve] Seqirus Pty Ltd, Melbourne, Vic, Australia; [Rockman, Steve] Univ Melbourne, Melbourne, Vic, Australia;.
    Forster, Angus H.
    Vaxxas Pty Ltd, Australia.
    Safety, tolerability, acceptability and immunogenicity of an influenza vaccine delivered to human skin by a novel high-density microprojection array patch (Nanopatch (TM))2018In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 36, no 26, p. 3779-3788Article in journal (Refereed)
    Abstract [en]

    Background: Injection using needle and syringe (Namp;S) is the most widely used method for vaccination, but requires trained healthcare workers. Fear of needles, risk of needle-stick injury, and the need to reconstitute lyophilised vaccines, are also drawbacks. The Nanopatch (NP) is a microarray skin patch comprised of a high-density array of microprojections dry-coated with vaccine that is being developed to address these shortcomings. Here we report a randomised, partly-blinded, placebo-controlled trial that represents the first use in humans of the NP to deliver a vaccine. Methods: Healthy volunteers were vaccinated once with one of the following: (1) NPs coated with split inactivated influenza virus (A/California/07/2009 [H1N1], 15 mu g haemagglutinin (HA) per dose), applied to the volar forearm (NP-HAIFA), n = 15; (2) NPs coated with split inactivated influenza virus (A/California/07/2009 11-11N1 I, 15 mu g HA per dose), applied to the upper arm (NP-HA/UA), n = 15; (3) Fluvaxe (R) 2016 containing 15 mu g of the same H1N1 HA antigen injected intramuscularly (IM) into the deltoid (IM-HA/D), n = 15; (4) NPs coated with excipients only, applied to the volar forearm (NP-placebo/FA), n = 5; (5) NPs coated with excipients only applied to the upper arm (NP-placebo/UA), n = 5; or (6) Saline injected IM into the deltoid (IM-placebo/D), n = 5. Antibody responses at days 0, 7, and 21 were measured by haemagglutination inhibition (HAI) and microneutralisation (MN) assays. Findings: NP vaccination was safe and acceptable; all adverse events were mild or moderate. Most subjects (55%) receiving patch vaccinations (HA or placebo) preferred the NP compared with their past experience of IM injection with Namp;S (preferred by 24%). The antigen-vaccinated groups had statistically higher HAI titres at day 7 and 21 compared with baseline (p amp;lt; 0.0001), with no statistical differences between the treatment groups (p amp;gt; 0.05), although the group sizes were small. The geometric mean HAI titres at day 21 for the NP-HA/FA, NP-HA/UA and IM-HA/D groups were: 335 (189-593 95% CI), 160 (74-345 95% CI), and 221 (129-380 95% CI) respectively. A similar pattern of responses was seen with the MN assays. Application site reactions were mild or moderate, and more marked with the influenza vaccine NPs than with the placebo or IM injection. Interpretation: Influenza vaccination using the NP appeared to be safe, and acceptable in this first time in humans study, and induced similar immune responses to vaccination by IM injection. (C) 2018 The Author(s). Published by Elsevier Ltd.

  • 10. Fierabracci, A
    et al.
    Biro, PA
    Yiangou, Y
    Mennuni, C
    Luzzago, A
    Ludvigsson, Johnny
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Molecular and Clinical Medicine, Pediatrics. Östergötlands Läns Landsting, Centre of Paediatrics and Gynecology and Obstetrics, Barn.
    Cortese, R
    Bottazzo, GF
    Osteopontin is an autoantigen of the somatostatin cells in human islets: identification by screening random peptide libraries with sera of patients with insulin-dependent diabetes mellitus.1999In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 18, p. 342-354Article in journal (Refereed)
  • 11.
    Griffin, Paul
    et al.
    QIMR Berghofer Medical Research Institute, Australia; Q Pharm Pty Ltd, Australia; Mater Hospital and Mater Research, Australia; University of Queensland, Australia.
    Elliott, Suzanne
    Q Pharm Pty Ltd, Australia.
    Krauer, Kenia
    Q Pharm Pty Ltd, Australia.
    Davies, Cristyn
    University of Sydney, Australia; Childrens Hospital Westmead, Australia.
    Rachel Skinner, S.
    University of Sydney, Australia; Childrens Hospital Westmead, Australia.
    Anderson, Chris
    Linköping University, Department of Clinical and Experimental Medicine, Division of Cell Biology. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Heart and Medicine Center, Department of Dermatology and Venerology.
    Forster, Angus
    Vaxxas Pty Ltd, Australia.
    Safety, acceptability and tolerability of uncoated and excipient-coated high density silicon micro-projection array patches in human subjects2017In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 35, no 48, p. 6676-6684Article in journal (Refereed)
    Abstract [en]

    Most vaccinations are performed by intramuscular injection with a needle and syringe. However, this method is not ideal due to limitations, such as the risk of needle-stick injury, the requirement for trained personnel to give injections and the need to reconstitute lyophilized vaccines. Therefore, we tested an alternative delivery technology that overcomes the problems with needle and syringe. The Nanopatch (TM) is an array of 10,000 silicon micro-projections per cm(2) that can be dry-coated with vaccine for skin delivery. The high number and density of micro-projections means that high velocity application is required to achieve consistent skin penetration. Before clinically testing a vaccine Nanopatch, this study tests the safety, tolerability and acceptability/utility of uncoated and excipient-coated Nanopatches in healthy adults. Nanopatches were applied to skin of the upper arm and volar forearm and left in contact with the skin for two minutes before removal. The application sites were assessed for local skin response over 28 days. Acceptability interviews were also performed. No unexpected adverse events directly related to the Nanopatch application were reported, All applications of the Nanopatch resulted in an expected erythema response which faded between days 3 and 7. In some subjects, some skin discolouration was visible for several days or up to 3 weeks after application. The majority (83%) of subjects reported a preference for the Nanopatch compared to the needle and syringe and found the application process to be simple and acceptable. On a pain scale from 0 to 10, 78% of applications were scored "0" (no pain) with the average scores for less than 1. The results from this study demonstrate the feasibility of the Nanopatch to improve vaccination by showing that application of the product without vaccine to human skin is safe, tolerable and preferred to needle and syringe administration. (C) 2017 The Authors. Published by Elsevier Ltd.

  • 12.
    Hinkula, Jorma
    et al.
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Clinical and Experimental Medicine, Molecular Virology .
    Hagbom, Marie
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Clinical and Experimental Medicine, Molecular Virology .
    Wahren, Britta
    Swedish Institute for Infectious Disease Control Microbiology and Tumorbiology Center Karolinska Institute, Solna.
    Schröder, Ulf
    Eurocine AB Karolinska Science Park, Stockholm.
    Safety and immunogenicity, after nasal application of HIV-1 DNA gagp37 plasmid vaccine in young mice2008In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 26, no 40, p. 5101-5106Article in journal (Refereed)
    Abstract [en]

    Background: There is a need for safe and potent adjuvants capable of delivering vaccine candidates over the mucosal barrier, with good capacity to stimulate both mucosal and systemic cell-mediated and humoral immunity. An adjuvant aimed for intranasal delivery should preferably deliver the antigen and minimize the transfer into the close proximity of the central nervous system, thus avoiding damage on the olfactory tissues. Advantages with a mucosal delivery route would be to provide mucosal and systemic immunity, requiring lower vaccine doses then when given parentally. The aim of this study was to study if the N3 adjuvant intranasally administered with HIV DNA plasmids would be transferred into the olfactory tissues and cause local inflammation and tissue damage. Results: The N3 adjuvant alone and when combined with HIV-1 DNA gag plasmid and delivered intranasally did not cause detectable damage to the nasal epithelium or the olfactory epithelium or bulb over a period of 3 days after delivery. The intranasal administration of HIV-1 gagp37 DNA induced both a humoral and a cell-mediated immunity against the gag antigen. Significantly higher HIV-1-specific humoral, but not cell-mediated immune responses were seen in DNA/N3-immunized mice in comparison with HIV-1 DNA/saline-immunized animals. Conclusions: A safe and convenient intranasal mode of HIV-1 DNA plasmid and adjuvant delivery was shown not to interfere with the tissues in close proximity to the central nervous system. The N3 adjuvant combined with HIV-1 plasmids enhances the HIV-1-specific immunogenicity and merits to be clinically tested. © 2008 Elsevier Ltd. All rights reserved.

  • 13.
    Istrate, Claudia
    et al.
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Clinical and Experimental Medicine.
    Hinkula, Jorma
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Clinical and Experimental Medicine, Molecular Virology .
    Charpilienne, Annie
    Poncet, Didier
    Cohen, Jean
    Svensson, Lennart
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Clinical and Experimental Medicine, Molecular Virology .
    Johansen, Kari
    Parenteral administration of RF 8-2/6/7 rotavirus-like particles in a one-dose regimen induce protective immunity in mice2008In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 26, no 35, p. 4594-4601Article in journal (Refereed)
    Abstract [en]

    Rotavirus virus-like particles (RV-VLPs) represent a novel strategy for development of a rotavirus subunit vaccine. In this study, RF 8-2/6/7-VLPs with rotavirus VP8 protein (amino acid 1-241 of VP4) fused to the amino terminal end of a truncated VP2, were evaluated for their immunogenic and protective properties. A single intramuscular dose of, either 2 or 20 μg, RF 8-2/6/7-VLPs alone or combined with a potent adjuvant poly[di(carboxylatophenoxy)]phosphazene] (PCPP) induced rotavirus-specific serum IgG and IgA, fecal IgG titers that were enhanced 5-90-fold by adjuvant. Passive protective immunity was achieved in offspring to dams vaccinated with 2 and 20 μg RV-VLPs in presence of adjuvant and 20 μg RV-VLP without adjuvant. © 2008 Elsevier Ltd. All rights reserved.

  • 14.
    Jacobsson, Susanne
    et al.
    National Reference Laboratory for Pathogenic Neisseria, Department of Clinical Microbiology, Örebro University Hospital, Örebro, Sweden.
    Thulin, Sara
    National Reference Laboratory for Pathogenic Neisseria, Department of Clinical Microbiology, Örebro University Hospital, Örebro, Sweden.
    Mölling, Paula
    National Reference Laboratory for Pathogenic Neisseria, Department of Clinical Microbiology, Örebro University Hospital, Örebro, Sweden.
    Unemo, Magnus
    National Reference Laboratory for Pathogenic Neisseria, Department of Clinical Microbiology, Örebro University Hospital, Örebro, Sweden.
    Comanducci, Maurizio
    IRIS, Chiron srl, Siena, Italy.
    Rappuoli, Rino
    IRIS, Chiron srl, Siena, Italy.
    Olcén, Per
    National Reference Laboratory for Pathogenic Neisseria, Department of Clinical Microbiology, Örebro University Hospital, Örebro, Sweden.
    Sequence constancies and variations in genes encoding three new meningococcal vaccine candidate antigens2006In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 24, no 12, p. 2161-2168Article in journal (Refereed)
    Abstract [en]

    By the strategy “reverse vaccinology” a number of new antigens have been identified in Neisseria meningitidis, which are potential candidates for a highly needed broad-spectrum meningococcal vaccine. In the present study we examined the prevalence, sequence constancies and variations of the genes encoding three of these new antigens designated, genome-derived neisserial antigen (GNA) 1870, GNA1946 and GNA2132. All three genes were present in all N. meningitidis isolates tested. Concerning gna1870, three major variants of the gene sequences and deduced amino acid sequences were identified and 56% of the deduced amino acids were conserved in all isolates. In gna1946, 98% of the deduced amino acids were conserved and in gna2132, 54% of the deduced amino acids were conserved. Based on gene prevalence and conservation, all three antigens are promising candidates for an effective meningococcal vaccine against all N. meningitidis irrespective of serogroup.

  • 15. Johansson, E.
    et al.
    Istrate, Claudia
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Clinical and Experimental Medicine.
    Charpilienne, A.
    Cohen, J.
    Hinkula, Jorma
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Clinical and Experimental Medicine, Molecular Virology .
    Poncet, D.
    Svensson, Lennart
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Clinical and Experimental Medicine, Molecular Virology .
    Johansen, K.
    Amount of maternal rotavirus-specific antibodies influence the outcome of rotavirus vaccination of newborn mice with virus-like particles2008In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 26, no 6, p. 778-785Article in journal (Refereed)
    Abstract [en]

    In presence of low or high levels of rotavirus-specific maternal antibodies, the ability of newborn mice to respond to immunization with rotavirus RF 8*-2/6/7 VLPs, was evaluated. After parenteral vaccination, 100% of offspring born to low-antibody-titer dams developed rotavirus-specific IgG antibodies (n = 7). In contrast, only 25% of offsprings born to high-antibody-titer dams responded to parenteral immunization (n = 12). When comparing parenteral versus oral immunization in offspring to low-antibody-titer dams only 45% responded after oral immunization (n = 6). In conclusion, the response to parenteral immunization was not hampered by the presence of low levels of maternal antibodies induced by a natural infection while oral immunization was impaired. However, high levels of maternal antibodies impaired the response to parenteral immunization. © 2008 Elsevier Ltd. All rights reserved.

  • 16.
    Lahdenperä, Anne
    et al.
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Clinical and Experimental Medicine, Pediatrics .
    Nilsson, Lennart
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Clinical and Experimental Medicine, Pediatrics . Östergötlands Läns Landsting, Centre of Paediatrics and Gynecology and Obstetrics, Department of Paediatrics in Linköping.
    Regnström, Karin
    Farmakologen Uppsala.
    Kinetics of asthma- and allergy-associated immune response gene expression in peripheral blood mononuclear cells from vaccinated infants after in vitro re-stimulation with vaccine antigen2008In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 26, no 14, p. 1725-1730Article in journal (Refereed)
    Abstract [en]

    The global expression of immune response genes in infants after vaccination and their role in asthma and allergy is not clearly understood. Pharmacogenomics is ideally suited to study the involved cellular responses, since the expression of thousands of genes can be assessed simultaneously. Here, array technology was used to assess the expression kinetics of immune response genes with association to asthma and allergy in peripheral blood mononuclear cells (PBMC) of five healthy infants after vaccination with Infanrix-Polio + Hib. At 12 h after in vitro re-stimulation of the PBMC with pertussis toxin (PT) antigen, 14 immune response pathways, 33 allergy-related and 66 asthma-related genes were found activated. © 2008 Elsevier Ltd. All rights reserved.

  • 17.
    Maltais, Anna-Karin
    et al.
    Eurocine Vaccines AB, Karolinska Institutet Science Park, 171 65 Solna, Sweden.
    Stittelaar, Koert J
    Viroclinics Biosciences B.V., 3029 AK Rotterdam, The Netherlands.
    Veldhuis Kroeze, Edwin J B
    Viroclinics Biosciences B.V., 3029 AK Rotterdam, The Netherlands.
    van Amerongen, Geert
    Viroclinics Biosciences B.V., 3029 AK Rotterdam, The Netherlands.
    Dijkshoorn, Marcel L
    Department of Radiology, Erasmus Medical Center, 3000 DR Rotterdam, The Netherlands.
    Krestin, Gabriel P
    Department of Radiology, Erasmus Medical Center, 3000 DR Rotterdam, The Netherlands.
    Hinkula, Jorma
    Eurocine Vaccines AB, Karolinska Institutet Science Park, 171 65 Solna, Sweden.
    Arwidsson, Hans
    Eurocine Vaccines AB, Karolinska Institutet Science Park, 171 65 Solna, Sweden.
    Lindberg, Alf
    Eurocine Vaccines AB, Karolinska Institutet Science Park, 171 65 Solna, Sweden.
    Osterhaus, Albert D M E
    Viroclinics Biosciences B.V., 3029 AK Rotterdam, The Netherlands / Department of Viroscience, Erasmus Medical Center, 3000 DR Rotterdam, The Netherlands.
    Intranasally administered Endocine™ formulated 2009 pandemic influenza H1N1 vaccine induces broad specific antibody responses and confers protection in ferrets2014In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 32, no 26, p. 3307-15Article in journal (Refereed)
    Abstract [en]

    Influenza is a contagious respiratory disease caused by an influenza virus. Due to continuous antigenic drift of seasonal influenza viruses, influenza vaccines need to be adjusted before every influenza season. This allows annual vaccination with multivalent seasonal influenza vaccines, recommended especially for high-risk groups. There is a need for a seasonal influenza vaccine that induces broader and longer lasting protection upon easy administration. Endocine™ is a lipid-based mucosal adjuvant composed of endogenous lipids found ubiquitously in the human body. Intranasal administration of influenza antigens mixed with this adjuvant has been shown to induce local and systemic immunity as well as protective efficacy against homologous influenza virus challenge in mice. Here we used ferrets, an established animal model for human influenza virus infections, to further investigate the potential of Endocine™ as an adjuvant. Intranasal administration of inactivated pandemic H1N1/California/2009 split antigen or whole virus antigen mixed with Endocine™ induced high levels of serum hemagglutination inhibition (HI) and virus neutralization (VN) antibody titers that were also cross reactive against distant swine viruses of the same subtype. HI and VN antibody titers were already demonstrated after a single nasal immunization. Upon intratracheal challenge with a homologous challenge virus (influenza virus H1N1/The Netherlands/602/2009) immunized ferrets were fully protected from virus replication in the lungs and largely protected against body weight loss, virus replication in the upper respiratory tract and pathological changes in the respiratory tract. Endocine™ formulated vaccines containing split antigen induced higher HI and VN antibody responses and better protection from body weight loss and virus shedding in the upper respiratory tract than the Endocine™ formulated vaccine containing whole virus antigen.

  • 18.
    Mousavi-Jazi, Mehrdad
    et al.
    Swedish Institute Communicable Disease Control, Sweden .
    Karlberg, Helen
    Swedish Institute Communicable Disease Control, Sweden Karolinska Institute, Sweden .
    Papa, Anna
    Aristotle University of Thessaloniki, Greece .
    Christova, Iva
    National Centre Infect and Parasit Disease, Bulgaria .
    Mirazimi, Ali
    Linköping University, Department of Clinical and Experimental Medicine. Linköping University, Faculty of Health Sciences.
    Healthy individuals immune response to the Bulgarian Crimean-Congo hemorrhagic fever virus vaccine2012In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 30, no 44, p. 6225-6229Article in journal (Refereed)
    Abstract [en]

    Crimean-Congo hemorrhagic fever virus (CCHFV) poses a great threat to public health due to its high mortality and transmission rate and wide geographical distribution. There is currently no specific antiviral therapy for CCHF. This study provides the first in-depth analysis of the cellular and humoral immune response in healthy individuals following injection of inactivated Bulgarian vaccine, the only CCHFV vaccine available at present. Vaccinated individuals developed robust, anti-CCHFV-specific T-cell activity as measured by IFN-gamma ELISpot assay. The frequency of IFN-gamma secreting T-cells was 10-fold higher in individuals after vaccination with four doses than after one single dose. High levels of CCHFV antibodies were observed following the first dose, but repeated doses were required to achieve antibodies with neutralizing activity against CCHFV. However, the neutralizing activity in these groups was low.

  • 19.
    Nilsson, Lennart
    et al.
    Linköping University, Department of Clinical and Experimental Medicine, Allergy Centre. Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Heart and Medicine Centre, Allergy Centre UHL.
    Lepp, Tiia
    Swedish Institute Communicable Disease Control.
    von Segebaden, Kerstin
    Swedish Institute Communicable Disease Control.
    Hallander, Hans
    Swedish Institute Communicable Disease Control.
    Gustafsson, Lennart
    Swedish Institute Communicable Disease Control.
    Pertussis vaccination in infancy lowers the incidence of pertussis disease and the rate of hospitalisation after one and two doses: Analyses of 10 years of pertussis surveillance2012In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 30, no 21, p. 3239-3247Article in journal (Refereed)
    Abstract [en]

    Objectives: Shortly after pertussis vaccination was reintroduced in Sweden in 1996, an intensified pertussis disease surveillance programme was set up. In this study, we report on in-depth analyses of age-dose-number-specific incidences and the rate of pertussis hospitalisation for children with no, 1 or 2 doses of an acellular pertussis vaccine before pertussis disease. Vaccine coverage, the timeliness of childhood vaccination and the effect of later than scheduled pertussis vaccination(s) are also examined. less thanbrgreater than less thanbrgreater thanStudy design: Children with notified laboratory-confirmed (culture or PCR) pertussis disease were evaluated among the surveillance population of about 1 million infants, born between 1996 and 2007 and followed for pertussis disease from October 1997 to December 2007, for nearly 6 million person-years. Birth and vaccination dates of the diseased children are known from the surveillance programme. To estimate denominators of the age-dose-number-specific pertussis incidences, we used birth and vaccination dates from a vaccine trial with more than 72,000 infants combined with national pertussis vaccine coverage data for children in the surveillance population. less thanbrgreater than less thanbrgreater thanResults: For infants from 3 to andlt;5 months of age, the incidence of pertussis disease with at least 14 days of cough decreased from 264/100,000 for unvaccinated infants to 155/100,000 for infants with one dose of a pertussis vaccine prior to onset of the disease. In the age range 5 to andlt;12 months, the age-dose specific incidences were 526, 95, and 24/100,000 for infants with no, 1 and 2 doses, respectively. The rate of hospitalisation for infants with 1 dose of a pertussis vaccine prior to onset of the disease was significantly lower than for unvaccinated infants of the same age. less thanbrgreater than less thanbrgreater thanFor many infants, there is a delay in administration of the vaccine doses according to the regular 3-5-12 month schedule (which has been the case for many years). Hypothetically, if all infants had been vaccinated exactly on schedule, we would expect about 28% fewer pertussis cases with at least 14 days of cough and 38% fewer hospitalisations due to pertussis, of cases possible to influence by vaccinations on schedule. less thanbrgreater than less thanbrgreater thanConclusion: Pertussis vaccination had a significant effect among infants already after the first dose. This is particularly important for premature infants and infants with severe respiratory and cardiac diseases. A moderate decrease in the incidence of pertussis disease in infants and rate of hospitalisation could be expected if primary vaccinations were carried out closer to the scheduled time than is currently the practice in Sweden.

  • 20.
    Nyström, Jessica
    et al.
    Karolinska University Hospital.
    Cardell, Kristina
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Clinical and Experimental Medicine, Infectious Diseases . Östergötlands Läns Landsting, Centre for Medicine, Department of Infectious Diseases in Östergötland.
    Bjorg Bjornsdottir, Thora
    Karolinska University Hospital.
    Frydén, Aril
    Linköping University, Department of Clinical and Experimental Medicine, Infectious Diseases . Linköping University, Faculty of Health Sciences.
    Hultgren, Catharina
    Karolinska University Hospital.
    Sallberg, Matti
    Karolinska University Hospital.
    Improved cell mediated immune responses after successful re-vaccination of non-responders to the hepatitis B virus surface antigen (HBsAg) vaccine using the combined hepatitis A and B vaccine2008In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 26, no 47, p. 5967-5972Article in journal (Refereed)
    Abstract [en]

    We Successfully re-vaccinated hepatitis B Virus (HBV) vaccine non-responders Using a double dose of the combined hepatitis A virus (HAV) and HBV vaccine. The hope was to improve priming of hepatitis B surface antigen (HBsAg)-specific cell mediated immune response (CMI) by an increased antigen dose and a theoretical adjuvant-effect from the local presence of a HAV-specific CMI. A few non-responders had a detectable HBsAg-specific CMI before re-vaccination. An in vitro detectable HBsAg-specific CMI was primed equally effective in non-responders (58%) as in first time vaccine recipients (68%). After the third dose a weak, albeit significant, association was observed between the magnitude of HBsAg-specific proliferation and anti-HBs levels. This regimen improves the priming of HBsAg-specific CMIs and antibodies.

  • 21. Rollman, Erik
    et al.
    Mathy, Nathalie
    Bråve, Andreas
    Boberg, Andreas
    Kjerrström, Anne
    van Wely, Cathy
    Engström, Gunnel
    Johansson, Susanne
    Aperia, Kajsa
    Eriksson, Lars E
    Benthin, Reinhold
    Ertl, Peter
    Heeney, Jonathan
    Hinkula, Jorma
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Molecular and Clinical Medicine, Molecular Virology.
    Voss, Gerald
    Wahren, Britta
    Evaluation of immunogenicity and efficacy of combined DNA and adjuvanted protein vaccination in a human immunodeficiency virus type 1/murine leukemia virus pseudotype challenge model2007In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 25, no 11, p. 2145-2154Article in journal (Refereed)
    Abstract [en]

    A DNA plasmid encoding human immunodeficiency virus type 1 (HIV-1) env, nef and tat genes was used in mice in a prime-boost immunization regimen with the corresponding recombinant proteins. The genetic immunogen was delivered with a gene gun and the proteins were injected intramuscularly together with the adjuvant AS02A. Immunizations were followed by experimental challenge with pseudotyped HIV-1 subtype A or B virus. In an initial experiment in which animals were challenged four weeks after the final immunization, all single modality and prime-boost vaccinations resulted in a significant level of protection as compared to control animals. There was a trend for DNA-alone immunization yielding the highest protection. In a subsequent study, a late challenge was performed 19 weeks after the final immunization. All groups having received the DNA vaccine, either alone or in combination with adjuvanted protein, exhibited strong protection against HIV replication. The subtype-specific protection against the experimental HIV challenge was significantly stronger than the cross-protection. Cellular and humoral immune responses were assessed during immunization and after challenge, but without clear correlation to protection against HIV replication. The data suggest that either DNA or protein antigens alone provide partial protection against an HIV-1/MuLV challenge and that DNA immunization is essential for achieving very high levels of efficacy in this murine HIV-1 challenge model. While prime-boost combinations were more immunogenic than DNA alone, they did not appear to provide any further enhancement over DNA vaccine mediated efficacy. The DNA immunogen might prime low levels of CD8+ T cells responsible for virus clearance or possibly a yet unidentified mechanism of protection. © 2006 Elsevier Ltd. All rights reserved.

  • 22.
    Schmeink, Channa E.
    et al.
    Radboud University of Nijmegen.
    Bekkers, Ruud L. M.
    Radboud University of Nijmegen.
    Josefsson, Ann
    Linköping University, Department of Clinical and Experimental Medicine, Obstetrics and gynecology. Linköping University, Faculty of Health Sciences. Östergötlands Läns Landsting, Centre of Paediatrics and Gynecology and Obstetrics, Department of Gynecology and Obstetrics in Linköping.
    Richardus, Jan H.
    Municipal Public Health Serv Rotterdam Rijnmond.
    Berndtsson Blom, Katarina
    Ladulaas Kliniska Studier.
    David, Marie-Pierre
    GlaxoSmithKline Biol.
    Dobbelaere, Kurt
    GlaxoSmithKline Biol.
    Descamps, Dominique
    GlaxoSmithKline Biol.
    Co-administration of human papillomavirus-16/18 AS04-adjuvanted vaccine with hepatitis B vaccine: Randomized study in healthy girls2011In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 29, no 49, p. 9276-9283Article in journal (Refereed)
    Abstract [en]

    Background: To evaluate co-administration of GlaxoSmithKline Biologicals human papillomavirus-16/18 AS04-adjuvanted vaccine (HPV) and hepatitis B vaccine (HepB). Methods: This was a randomized, controlled, open, multicenter study. Healthy girls, aged 9-15 years, were randomized to receive HPV (n = 247), HepB (n = 247) or HPV co-administered with HepB (HPV+ HepB: n=247) at Months 0,1 and 6. Antibodies against hepatitis B surface antigen (HBs), HPV-16 and HPV-18 were measured, and reactogenicity and safety monitored. Co-primary objectives were to demonstrate non-inferiority of hepatitis B and HPV-16/18 immune responses at Month 7 for co-administered vaccines, compared with vaccines administered alone, in the according-to-protocol cohort. Results: The pre-defined criteria for non-inferiority were met for all co-primary immunogenicity end-points at Month 7. Anti-HBs seroprotection rates greater than= 10 mIU/mL were achieved by 97.9% and 100% of girls, respectively, following co-administration or HepB alone. Anti-HBs geometric mean titers (GMTs) (95% confidence interval) were 1280.9 (973.3-1685.7) and 3107.7 (2473.1-3905.1) milli-international units/mL, respectively. Anti-HPV-16 and -18 seroconversion rates were achieved by greater than= 99% of girls following co-administration or HPV alone. Anti-HPV-16 GMTs were 19819.8 (16856.9-23303.6) and 21712.6 (19460.2-24225.6) ELISA units (ELU)/mL, respectively. Anti-HPV-18 GMTs were 8835.1 (7636.3-10222.1) and 8838.6 (7948.5-9828.4) ELU/mL, respectively. Co-administration was generally well tolerated. Conclusions: The study results support the co-administration of HPV-16/18 AS04-adjuvanted vaccine with hepatitis B vaccine in adolescent girls aged 9-15 years. Clinical trials registration: ClinicalTrials.gov registration number NCT00652938.

  • 23.
    Shedrawy, Jad
    et al.
    Karolinska Inst, Sweden.
    Henriksson, Martin
    Linköping University, Department of Medical and Health Sciences, Division of Health Care Analysis. Linköping University, Faculty of Medicine and Health Sciences.
    Hergens, Maria-Pia
    Karolinska Inst, Sweden; Dept Communicable Dis Control and Prevent, Sweden.
    Askling, H. Helena
    Karolinska Inst, Sweden; Dept Communicable Dis Control and Prevent, Sweden.
    Estimating costs and health outcomes of publicly funded tick-born encephalitis vaccination: A cost-effectiveness analysis2018In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 36, no 50, p. 7659-7665Article in journal (Refereed)
    Abstract [en]

    Background: The number of notified cases of Tick-Borne Encephalitis (TBE) in Sweden has been increasing the past years despite the increased use of TBE-vaccine not subsidized by the healthcare system. Stockholm County is a high endemic area and an earlier study has shown that low-income households have lower vaccination coverage even when they are at high risk. This paper aims to determine the cost-effectiveness of a publicly funded TBE vaccination program in Stockholm. Methods: In three different cohorts with individuals aged 3, 40 or 50 years, long-term costs and health outcomes of an out-of-pocket strategy (53% of the cohort is vaccinated on their own expenses) and a structured vaccination program (full cohort is vaccinated covered by the publicly funded health care system), were estimated using a Markov model. The Markov model predicts the costs and effects in term of Quality-adjusted Life Years (QALYs) over a lifetime horizon using a third-party healthcare payer perspective. The primary results are presented as an incremental cost effectiveness ratio (ICER) indicating the additional cost required to achieve one additional QALY with the structured vaccination program. Results: The results show that the structured vaccination program is associated with a gain in QALYs and increased costs compared with an out-of-pocket strategy. The calculated ICERs were 27 761, 99 527 and 160 827 SEK/QALY in cohorts of age 3, 40 and 50, respectively. The sensitivity analyses showed that the results are robust when varying different parameters. Conclusion: Given the setting of Stockholm county, this analysis shows a cost per QALY of a free vaccinations program, especially for children of 3 years old, below generally acceptable cost-effectiveness thresholds in Sweden. 

  • 24.
    van der Vaart, JM
    et al.
    Unilever R&D Vlaardingen.
    Pant, N
    Centre for Oral Biology, Novum.
    Wolvers, D
    Unilever R&D Vlaardingen.
    Bezemer, S
    Unilever R&D Vlaardingen.
    Hermans, PW
    Unilever R&D Vlaardingen.
    Bellamy, K
    Unilever R&D Colworth House.
    Sarker, SA
    Centre for Oral Biology, Novum.
    van der Logt, CPE
    Unilever R&D Vlaardingen.
    Svensson, Lennart
    Swedish Institute for Infectious Disease Control.
    Verrips, CT
    Unilever R&D Vlaardingen.
    Hammarström, L
    Centre for Oral Biology, Novum.
    van Klinken, BJW
    Unilever R&D Vlaardingen.
    Reduction in morbidity of rotavirus induced diarrhoea in mice by yeast produced monovalent llama-derived antibody fragments.2006In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 24, no 41, p. 4130-4137Article in journal (Refereed)
    Abstract [en]

    Apart from the use of oral rehydration solution, there are currently no treatment modalities for rotavirus induced diarrhoea, which is particularly relevant to developing countries. Fragments derived from llama heavy chain antibodies were previously shown to be highly stable, efficiently produced in yeast and exhibiting high epitope specific affinity. We now aim to demonstrate that these antibody fragments are capable of reducing morbidity of rotavirus induced diarrhoea. Here we show the isolation of rotavirus specific antibody fragments and their capability of reducing the morbidity of rotavirus induced diarrhoea in vivo in mice. They could provide a treatment modality for the moderation of human rotavirus infections having a significant impact on the course of an often fatal childhood disease.

  • 25.
    Veldhuis Kroeze, Edwin J. B.
    et al.
    ViroClinics Biosciences BV, Rotterdam, The Netherlands.
    Stittelaar, Koert J.
    ViroClinics Biosciences BV, Rotterdam, The Netherlands.
    Teeuwsen, Vera J.
    ViroClinics Biosciences BV, Rotterdam, The Netherlands.
    Dijkshoorn, Marcel L
    Erasmus Medical Center, Rotterdam, The Netherlands.
    van Amerongen, Geert
    ViroClinics Biosciences BV, Rotterdam, The Netherlands.
    de Waal, Leon
    ViroClinics Biosciences BV, Rotterdam, The Netherlands.
    Kuiken, Thijs
    Erasmus Medical Center, Rotterdam, The Netherlands.
    Krestin, Gabriel P.
    Erasmus Medical Center, Rotterdam, The Netherlands.
    Hinkula, Jorma
    Linköping University, Department of Clinical and Experimental Medicine, Molecular Virology. Linköping University, Faculty of Health Sciences.
    Osterhaus, Albert D. M. E
    ViroClinics Biosciences BV, Rotterdam, The Netherlands.
    Consecutive CT in vivo lung imaging as quantitative parameter of influenza vaccine efficacy in the ferret model2012In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 30, no 51, p. 7391-7394Article in journal (Refereed)
    Abstract [en]

    Preclinical vaccine efficacy studies are generally limited to certain read out parameters such as assessment of virus titers in swabs and organs, clinical signs, serum antibody titers, and pathological changes. These parameters are not always routinely applied and not always scheduled in a logical standardized way. We used computed tomography (CT) imaging as additional and novel read out parameter in a vaccine efficacy study by quantifying alterations in aerated lung volumes in ferrets challenged with the 2009 pandemic A/H1N1 influenza virus.

    Vaccination protected from marked variations in aerated lung volumes compared to naive controls. The vaccinated group showed a daily gradual mean reduction with a maximum of 7.8%, whereas the controls showed a maximum of 14.3% reduction. The pulmonary opacities evident on CT images were most pronounced in the placebo-treated controls, and corresponded to significantly increased relative lung weights at necropsy.

    This study shows that consecutive in vivo CT imaging allows for a day to day read out of vaccine efficacy by quantification of altered aerated lung volumes. 

  • 26.
    Venkata Ramanarao, Parasa
    et al.
    Linköping University, Department of Clinical and Experimental Medicine, Division of Microbiology and Molecular Medicine. Linköping University, Faculty of Medicine and Health Sciences.
    Rose, Jeronimo
    Linköping University, Department of Clinical and Experimental Medicine, Division of Microbiology and Molecular Medicine. Linköping University, Faculty of Medicine and Health Sciences.
    Castillo-Diaz, Luis Alberto
    Ctr Invest and Asistencia Tecnol and Diseno Estado Ja, Mexico.
    de Jesus Aceves-Sanchez, Michel
    Ctr Invest and Asistencia Tecnol and Diseno Estado Ja, Mexico.
    Jazmin Vega-Dominguez, Perla
    Ctr Invest and Asistencia Tecnol and Diseno Estado Ja, Mexico.
    Lerm, Maria
    Linköping University, Department of Clinical and Experimental Medicine, Division of Microbiology and Molecular Medicine. Linköping University, Faculty of Medicine and Health Sciences.
    Alberto Flores-Valdez, Mario
    Ctr Invest and Asistencia Tecnol and Diseno Estado Ja, Mexico.
    Evaluation of the immunogenic capability of the BCG strains BCG Delta BCG1419c and BCG Delta BCG1416c in a three-dimensional human lung tissue model2018In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 36, no 14, p. 1811-1815Article in journal (Refereed)
    Abstract [en]

    Tuberculosis (TB) still remains as an unmet global threat. The current vaccine is not fully effective and novel alternatives are needed. Here, two vaccine candidate strains derived from BCG carrying deletions in the BCG1416c or BCG1419c genes were analysed for their capacity to modulate the cytoldne/chemokine profile and granuloma formation in a human lung tissue model (LTM). We show that the clustering of monocytes, reminiscent of early granuloma formation, in LTMs infected with BCG strains was similar for all of them. However, BCG Delta BCG1419c, like M. tuberculosis, was capable of inducing the production of IL-6 in contrast to the other BCG strains. This work suggests that LTM could be a useful ex vivo assay to evaluate the potential immunogenicity of novel TB vaccine candidates.

  • 27.
    Wallensten, Anders
    et al.
    Linköping University, Faculty of Health Sciences. Linköping University, Department of Clinical and Experimental Medicine, Molecular Virology .
    Munster, V.J.
    Department of Virology, National Influenza Center, Erasmus Medical Center, Dr. Molewaterplein 50, NL-3015 GE Rotterdam, Netherlands.
    Karlsson, M.
    Centre for Microbiological Preparedness (KCB), Swedish Institute for Infectious Disease Control (SMI), SE-171 82 Solna, Sweden.
    Lundkvist, A.
    Centre for Microbiological Preparedness (KCB), Swedish Institute for Infectious Disease Control (SMI), SE-171 82 Solna, Sweden.
    Brytting, M.
    Department of Virology, Swedish Institute for Infectious Disease Control (SMI), SE-171 82 Solna, Sweden.
    Stervander, M.
    Ottenby Bird Observatory, P.O. Box 1500, SE-380 65 Degerhamn, Sweden.
    Osterhaus, A.D.M.E.
    Department of Virology, National Influenza Center, Erasmus Medical Center, Dr. Molewaterplein 50, NL-3015 GE Rotterdam, Netherlands.
    Fouchier, R.A.M.
    Department of Virology, National Influenza Center, Erasmus Medical Center, Dr. Molewaterplein 50, NL-3015 GE Rotterdam, Netherlands.
    Olsen, B.
    Department of Infectious Diseases, Umeå University, SE-901 87 Umeå, Sweden, Department of Biology and Environmental Science, Section for Zoonotic Ecology and Epidemiology, Kalmar University, SE-391 82 Kalmar, Sweden.
    High prevalence of influenza A virus in ducks caught during spring migration through Sweden2006In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 24, no 44-46, p. 6734-6735Article in journal (Refereed)
    Abstract [en]

    As part of our ongoing screening of wild birds in Northern Europe, 358 mallards (Anas platyrhynchos) and 203 shelducks (Tadorna tadorna) were caught in southern Sweden during the spring 2003. Faecal samples were analyzed by real time RT-PCR for the presence of influenza A virus. In contrast to what has been found in North American studies, Eurasian spring migrating ducks passing through Sweden had a relatively high prevalence of influenza A virus. © 2006 Elsevier Ltd. All rights reserved.

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