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Co-administration of human papillomavirus-16/18 AS04-adjuvanted vaccine with hepatitis B vaccine: Randomized study in healthy girls
Radboud University of Nijmegen.
Radboud University of Nijmegen.
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.
Municipal Public Health Serv Rotterdam Rijnmond.
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2011 (English)In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 29, no 49, 9276-9283 p.Article in journal (Refereed) Published
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.

Place, publisher, year, edition, pages
Elsevier , 2011. Vol. 29, no 49, 9276-9283 p.
Keyword [en]
Human papillomavirus vaccine; Hepatitis B vaccine; Adolescents; Immunogenicity; Safety
National Category
Medical and Health Sciences
Identifiers
URN: urn:nbn:se:liu:diva-73737DOI: 10.1016/j.vaccine.2011.08.037ISI: 000297525500022OAI: oai:DiVA.org:liu-73737DiVA: diva2:476394
Available from: 2012-01-12 Created: 2012-01-12 Last updated: 2017-12-08

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Josefsson, Ann

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Obstetrics and gynecologyFaculty of Health SciencesDepartment of Gynecology and Obstetrics in Linköping
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