Impact of baseline covariates on the immunogenicity of a quadrivalent (types 6, 11, 16, and 18) human papillomavirus virus-like-particle vaccine.
BACKGROUND
The quadrivalent (types 6, 11, 16, and 18) human papillomavirus (HPV) L1 virus-like-particle vaccine was 95%-100% effective in preventing cervical and genital disease related to HPV-6, -11, -16, and -18. Vaccine efficacy is thought to be mediated by humoral immunity. Here, we analyze the effect of the baseline characteristics of subjects on vaccine-induced immune responses.


METHODS
Immunogenicity data from 12,343 subjects 9-26 years old randomized to quadrivalent HPV vaccine or placebo in phase 2/3 studies were analyzed. Covariates examined were day 1 HPV serostatus, age, race/ethnicity, region of residence, lactation status, hormonal contraceptive usage, smoking status, Pap test diagnosis, immunosuppressant or anti-inflammatory agent use, and number of sex partners. Anti-HPV responses were summarized as serum anti-HPV-6, -11, -16, or -18 geometric mean titers 1 month after dose 3.


RESULTS
Age at vaccination initiation was inversely proportional to the vaccine-induced anti-HPV response. Vaccination of subpopulations of subjects who were seropositive at day 1 to a vaccine HPV type resulted in more robust anti-HPV responses to that type, compared with those in subjects who were seronegative at baseline. Anti-HPV responses were comparable among the remaining demographic subgroups.


CONCLUSIONS
The immunogenicity of quadrivalent HPV vaccine was comparable among subjects with differing baseline characteristics. These data support vaccination with quadrivalent HPV vaccine across a broad range of baseline subject characteristics.
Giuliano
Anna R
AR
H. Lee Moffitt Cancer Center, Tampa, FL 33612, USA. Anna.Giuliano@moffitt.org
Lazcano-Ponce
Eduardo
E
Villa
Luisa
L
Nolan
Terry
T
Marchant
Colin
C
Radley
David
D
Golm
Greg
G
McCarroll
Kathleen
K
Yu
Jimmy
J
Esser
Mark T
MT
Vuocolo
Scott C
SC
Barr
Eliav
E
D000293:Adolescent; D000328:Adult; D052685:Alphapapillomavirus / Q000145:classification / Q000276:immunology*; D000917:Antibody Formation; D002648:Child; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D030361:Papillomavirus Infections / Q000276:immunology / Q000517:prevention & control*; D053918:Papillomavirus Vaccines / Q000276:immunology*; D015229:Sexually Transmitted Diseases, Viral / Q000276:immunology / Q000517:prevention & control*; D016896:Treatment Outcome
D053918:Papillomavirus Vaccines