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 |
