Randomized trial of the immunogenicity and safety of the hepatitis B vaccine given in an accelerated schedule coadministered with the human papillomavirus type 16/18 AS04-adjuvanted cervical cancer vaccine
| Autor: | Fien De Boever, Dominique Descamps, Cathy Maes, Edwige Haelterman, Laurent Licini, Kurt Dobbelaere, Marie Pierre David, Geert Leroux-Roels, Jack Levy |
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| Jazyk: | angličtina |
| Rok vydání: | 2011 |
| Předmět: |
IMPACT
(HPV)-16/18 AS04-ADJUVANTED VACCINE Clinical Biochemistry Uterine Cervical Neoplasms Aluminum Hydroxide Antibodies Viral INFECTION NONVACCINE HPV TYPES Immunologie Immunology and Allergy Human papillomavirus 16 Médecine clinique [chimie clinique] Human papillomavirus 18 Immunogenicity Antibody titer YOUNG-WOMEN Hepatitis B Vaccine Research IMMUNIZATION Microbiologie et protistologie [entomologie phytoparasitolog.] Titer Lipid A Treatment Outcome Female Adult Microbiology (medical) Microbiologie et protistologie [parasitologie hum. et anim.] Hepatitis B virus medicine.medical_specialty Allergie et immunopathologie Hepatitis B vaccine Immunology AGED 16-26 YEARS Cancer Vaccines Young Adult Adjuvants Immunologic Internal medicine medicine Humans Hepatitis B Vaccines Papillomavirus Vaccines Hepatitis B Antibodies Hepatitis PARTICLE VACCINE Reactogenicity business.industry Papillomavirus Infections Biology and Life Sciences ADULTS medicine.disease EFFICACY Immunization business Microbiologie et protistologie [bacteriol.virolog.mycolog.] |
| Zdroj: | Clinical and Vaccine Immunology (Print), 18 (9 CLINICAL AND VACCINE IMMUNOLOGY |
| ISSN: | 1556-6811 |
| Popis: | The human papillomavirus type 16/18 (HPV-16/18) AS04-adjuvanted cervical cancer vaccine is licensed for females aged 10 years and above and is therefore likely to be coadministered with other licensed vaccines, such as hepatitis B. In this randomized, open-label study, we compared the immunogenicity of the hepatitis B vaccine administered alone (HepB group) or with the HPV-16/18 AS04-adjuvanted vaccine (HepB+HPV group) in healthy women aged 20 to 25 years (clinical trial NCT00637195). The hepatitis B vaccine was given at 0, 1, 2, and 12 months (an accelerated schedule which may be required by women at high risk), and the HPV-16/18 vaccine was given at 0, 1, and 6 months. One month after the third dose of hepatitis B vaccine, in the according-to-protocol cohort (n = 72 HepB+HPV; n = 76 HepB), hepatitis B seroprotection rates (titer of ≥10 mIU/ml) were 96.4% (95% confidence interval [CI], 87.5 to 99.6) and 96.9% (CI, 89.2 to 99.6) in the HepB+HPV and HepB groups, respectively, in women initially seronegative for anti-hepatitis B surface antigen (HBs) and anti-hepatitis B core antigen (HBc). Corresponding geometric mean titers of anti-HBs antibodies were 60.2 mIU/ml (CI, 40.0 to 90.5) and 71.3 mIU/ml (CI, 53.9 to 94.3). Anti-HBs antibody titers rose substantially after the fourth dose of hepatitis B vaccine. All women initially seronegative for anti-HPV-16 and anti-HPV-18 antibodies seroconverted after the second HPV-16/18 vaccine dose and remained seropositive up to 1 month after the third dose. Both vaccines were generally well tolerated, with no difference in reactogenicity between groups. In conclusion, coadministration of the HPV-16/18 AS04-adjuvanted vaccine did not affect the immunogenicity or safety of the hepatitis B vaccine administered in an accelerated schedule in young women. Copyright © 2011, American Society for Microbiology. All Rights Reserved. SCOPUS: ar.j info:eu-repo/semantics/published |
| Databáze: | OpenAIRE |
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