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.
OBJECTIVE
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 (> or = 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.
Garcia-Sicilia
José
J
Hospital Infantil Universitario La Paz, Madrid, Spain. jgarcia-sicilia@telefonica.net
Schwarz
Tino F
TF
Carmona
Alfonso
A
Peters
Klaus
K
Malkin
Jean-Elie
JE
Tran
Phu M
PM
Behre
Ulrich
U
Iturbe
Enrique B
EB
Catteau
Gregory
G
Thomas
Florence
F
Dobbelaere
Kurt
K
Descamps
Dominique
D
Dubin
Gary
G
D000276:Adjuvants, Immunologic / Q000008:administration & dosage; D000293:Adolescent; D000914:Antibodies, Viral / Q000097:blood; D002648:Child; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000008:administration & dosage* / Q000276:immunology; D004305:Dose-Response Relationship, Drug; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D006801:Humans; D030361:Papillomavirus Infections / Q000276:immunology / Q000517:prevention & control*; D053918:Papillomavirus Vaccines / Q000008:administration & dosage* / Q000276:immunology; D011054:Poliovirus Vaccine, Inactivated / Q000008:administration & dosage* / Q000276:immunology; D013997:Time Factors; D002583:Uterine Cervical Neoplasms / Q000276:immunology / Q000517:prevention & control*; D017778:Vaccines, Combined / Q000008:administration & dosage
D000276:Adjuvants, Immunologic; D000914:Antibodies, Viral; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D053918:Papillomavirus Vaccines; D011054:Poliovirus Vaccine, Inactivated; D017778:Vaccines, Combined; C510352:human papillomavirus vaccine, L1 type 16, 18