Randomized Trial: Immunogenicity and Safety of Coadministered Human Papillomavirus-16/18 AS04-Adjuvanted Vaccine and Combined Hepatitis A and B Vaccine in Girls

Document type: Journal Articles
Article type: Original article
Peer reviewed: Yes
Author(s): Court Pedersen, Morten Breindahl, Naresh Aggarwal, Johan Berglund, Gyoergy Oroszlan, Sven Arne Silfverdal, Peter Szuts, Michael O'Mahony, Marie-Pierre David, Kurt Dobbelaere
Title: Randomized Trial: Immunogenicity and Safety of Coadministered Human Papillomavirus-16/18 AS04-Adjuvanted Vaccine and Combined Hepatitis A and B Vaccine in Girls
Journal: Journal of Adoloscent Health
Year: 2012
Volume: 50
Issue: 1
Pagination: 38-46
ISSN: 1054-139X
Publisher: Elsevier
URI/DOI: 10.1016/j.jadohealth.2011.10.009
ISI number: 000298370700006
Organization: Blekinge Institute of Technology
Department: School of Health Science (Sektionen för hälsa)
School of Health Science S-371 79 Karlskrona
+46 455 38 50 00
http://www.bth.se/hal/
Language: English
Abstract: Purpose: This randomized, open, controlled, multicenter study (110886/NCT00578227) evaluated human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine (HPV-16/18 vaccine) coadministered with inactivated hepatitis A and B (HAB) vaccine. Coprimary objectives were to demonstrate noninferiority of hepatitis A, hepatitis B, and HPV-16/18 immune responses at month 7 when vaccines were coadministered, compared with the same vaccines administered alone.

Methods: Healthy girls (9-15 years) were age-stratified (9, 10-12, and 13-15 years) and randomized to receive HPV (n = 270), HAB (n = 271), or HPV + HAB (n = 272). Vaccines were administered at months 0, 1, and 6. Immunogenicity was evaluated at months 0 and 7.

Results: The hepatitis A immune response was noninferior for HPV + HAB, versus HAB, for seroconversion rates (100% in each group) and geometric mean antibody titers (GMTs) (95% CI) (4,504.2 [3,993.0-5,080.8] and 5,288.4 [4,713.3-5,933.7] mIU/mL, respectively). The hepatitis B immune response was noninferior for HPV + HAB, versus HAB, for anti-HBs seroprotection rates (98.3% and 100%); GMTs were 3,136.5 [2,436.0-4,038.4] and 5,646.5 [4,481.3-7,114.6] mIU/mL, respectively. The HPV-16/18 immune response was noninferior for HPV + HAB, versus HPV, for seroconversion rates (99.6% and 100% for both antigens) and GMTs (22,993.5 [20,093.4-26,312.0] and 26,981.9 [23,909.5-30,449.1] EL.U/mL for HPV-16; 8,671.2 [7,651.7-9,826.6] and 11,182.7 [9,924.8-12,600.1] EL.U/mL for HPV-18, respectively). No subject withdrew because of adverse events. No vaccine-related serious adverse events were reported. Immune responses and reactogenicity were similar in girls aged 9 years compared with the entire study population.

Conclusions: Results support coadministration of HPV-16/18 vaccine with HAB vaccine in girls aged 9-15 years. The HPV-16/18 vaccine was immunogenic and generally well tolerated in 9-year-old girls.
Subject: Medical Sciences
Keywords: CERVICAL-CANCER VACCINE, SUSTAINED EFFICACY, PARTICLE VACCINE, YOUNG-WOMEN; FOLLOW-UP; HOMOSEXUAL-MEN; ADOLESCENTS; CHILDREN; TYPE-18; IMMUNIZATION
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