Immunogenicity and Safety of Human Papillomavirus-16/18 AS04-Adjuvanted Cervical Cancer Vaccine Coadministered With Combined Diphtheria-Tetanus-Acellular Pertussis–inactivated Poliovirus Vaccine to Girls and Young Women

• Published in: Journal of adolescent health Vol. 46; no. 2; pp. 142 - 151
• Main Authors: Garcia-Sicilia, José, M.D, Schwarz, Tino F., M.D, Carmona, Alfonso, M.D, Peters, Klaus, M.D, Malkin, Jean-Elie, M.D, Tran, Phu M., M.D, Behre, Ulrich, M.D, Iturbe, Enrique B., M.D, Catteau, Gregory, M.Sc, Thomas, Florence, M.D., D.T.M, Dobbelaere, Kurt, M.D, Descamps, Dominique, M.D, Dubin, Gary, M.D
• Format: Journal Article
• Language: English
• Published: New York, NY Elsevier Inc 01-02-2010; Elsevier
• Subjects: Adjuvants, Immunologic - administration & dosage; Adolescent; Adverse effects; Antibodies; Antibodies, Viral - blood; Bacterial diseases; Bacterial diseases of the nervous system. Bacterial myositis; Biological and medical sciences; Child; Diphtheria-tetanus-acellular pertussis–inactivated poliovirus vaccine; Diphtheria-Tetanus-Pertussis Vaccine - administration & dosage; Diphtheria-Tetanus-Pertussis Vaccine - immunology; Dose-Response Relationship, Drug; Ent and stomatologic bacterial diseases; Enzyme-Linked Immunosorbent Assay; Female; Female genital diseases; Gynecology. Andrology. Obstetrics; Human bacterial diseases; Human papillomaviruses; Humans; Immunology; Infectious diseases; Medical sciences; Papillomavirus Infections - immunology; Papillomavirus Infections - prevention & control; Papillomavirus vaccines; Papillomavirus Vaccines - administration & dosage; Papillomavirus Vaccines - immunology; Pediatrics; Poliovirus Vaccine, Inactivated - administration & dosage; Poliovirus Vaccine, Inactivated - immunology; Prevention and actions; Public health. Hygiene; Public health. Hygiene-occupational medicine; Randomized controlled trial; Safety; Specific populations (family, woman, child, elderly...); Tetanus; Time Factors; Tumors; Uterine Cervical Neoplasms - immunology; Uterine Cervical Neoplasms - prevention & control; Vaccines; Vaccines, Combined - administration & dosage; Young women; Papillomavirus vaccines; Immunology; Diphtheria-tetanus-acellular pertussis–inactivated poliovirus vaccine; Adolescent; Female; Adverse effects; Randomized controlled trial; Picornaviridae; Vaccination; Enterovirus; Papovaviridae; Diphtheria-tetanus-acellular pertussis-inactivated poliovirus vaccine; Human papillomavirus 18; Papillomavirus; Prevention; Human papillomavirus 16; Human papillomavirus; Public health; Human; Respiratory disease; Controlled therapeutic trial; Malignant tumor; Diphtheria; Poliovirus; Female genital diseases; Whooping cough; Infection; Virus; Bacteriosis; Tetanus; Uterine cervix diseases; Cervical cancer; Cancer
• ISSN: 1054-139X; 1879-1972
• DOI: 10.1016/j.jadohealth.2009.11.205

Abstract Purpose Many countries recommend human papillomavirus (HPV) vaccination in female adolescents at an age when other vaccines are routinely administered. This open, randomized, multicenter study (108464/NCT00426361) evaluated coadministration of HPV-16/18 AS04-adjuvanted vaccine with diphtheria-tetanus-acellular pertussis–inactivated poliovirus vaccine (dTpa-IPV). Methods Healthy females aged 10 – 18 years were randomized to receive HPV vaccine at months 0, 1, and 6 (n = 248), HPV vaccine coadministered with dTpa-IPV at month 0 and HPV vaccine at months 1 and 6 (n = 255), or dTpa-IPV at month 0 followed by HPV vaccine at months 1, 2, and 7 (n = 248). Immunogenicity was evaluated at months 0, 1, and 7 or 8 (depending on group). Vaccine reactogenicity and safety were also assessed. Results Coadministered dTpa-IPV and HPV vaccine was noninferior to dTpa-IPV alone in terms of seroprotection against diphtheria (99.2% and 100%), tetanus (100% and 100%) and poliovirus types 1, 2, and 3 (≥99.6%), and geometric mean antibody concentrations (ELISA Units/mL) for pertussis toxoid (84 vs. 75), filamentous hemagglutinin (612 and 615) and pertactin (426 and 360) at month 1. Coadministered dTpa-IPV and HPV vaccine was noninferior to HPV vaccine alone in terms of seroconversion rates for HPV-16 (99.5% and 100%) and HPV-18 (99.5% and 100%) and geometric mean antibody titers (ELISA Units/mL) for HPV-16 (15,608 and 18,965) and HPV-18 (6,597 and 6,902) at month 7. Coadministration was generally well tolerated. The reactogenicity of dTpa-IPV and the first dose of HPV vaccine was similar. Conclusions Results from this study support coadministration of the HPV-16/18 AS04-adjuvanted vaccine with dTpa-IPV vaccine in females aged 10–18 years.