Co-administration of human papillomavirus-16/18 AS04-adjuvanted vaccine with hepatitis B vaccine: Randomized study in healthy girls
2011 (English)In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 29, no 49, 9276-9283 p.Article in journal (Refereed) Published
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.
Human papillomavirus vaccine; Hepatitis B vaccine; Adolescents; Immunogenicity; Safety
Medical and Health Sciences
IdentifiersURN: urn:nbn:se:liu:diva-73737DOI: 10.1016/j.vaccine.2011.08.037ISI: 000297525500022OAI: oai:DiVA.org:liu-73737DiVA: diva2:476394