Co-administration of human papillomavirus-16/18 AS04-adjuvanted vaccine with hepatitis B vaccine: Randomized study in healthy girls.

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Vaccine. 2011 Aug 18. [Epub ahead of print]

Co-administration of human papillomavirus-16/18 AS04-adjuvanted vaccine with

hepatitis B vaccine: Randomized study in healthy girls.

Schmeink CE.

Source

Department of Obstetrics/Gynecology 791, Radboud University Nijmegen Medical

Centre, P.O. Box 9101, 6500 HB Nijmegen, Netherlands.

Abstract

BACKGROUND:

To evaluate co-administration of GlaxoKline 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 endpoints at Month 7. Anti-HBs seroprotection rates ™10mIU/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 ™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.

Copyright ¿ 2011. Published by Elsevier Ltd.

PMID: 21856349 [PubMed - as supplied by publisher]