Elsevier

Papillomavirus Research

Volume 3, June 2017, Pages 105-115
Papillomavirus Research

Impact of baseline covariates on the immunogenicity of the 9-valent HPV vaccine – A combined analysis of five phase III clinical trials

https://doi.org/10.1016/j.pvr.2017.03.002Get rights and content
Under a Creative Commons license
open access

Abstract

Background

The immunogenicity profile of the 9-valent HPV (9vHPV) vaccine was evaluated across five phase III clinical studies conducted in girls and boys 9–15 years of age and young women 16–26 years of age. The effect of baseline characteristics of subjects on vaccine-induced HPV antibody responses was assessed.

Methods

Immunogenicity data from 11,304 subjects who received ≥1 dose of 9vHPV vaccine in five Phase III studies were analyzed. Vaccine was administered as a 3-dose regimen. HPV antibody titers were assessed 1 month after dose 3 using a competitive Luminex immunoassay and summarized as geometric mean titers (GMTs). Covariates examined were age, gender, race, region of residence, and HPV serostatus and PCR status at day 1.

Results

GMTs to all 9 vaccine HPV types decreased with age at vaccination initiation, and were otherwise generally similar among the demographic subgroups defined by gender, race and region of residence. For all subgroups defined by race or region of residence, GMTs were higher in girls and boys than in young women. Vaccination of subjects who were seropositive at day 1 to a vaccine HPV type resulted in higher GMTs to that type, compared with those in subjects who were seronegative for that type at day 1.

Conclusions

9vHPV vaccine immunogenicity was robust among subjects with differing baseline characteristics. It was generally comparable across subjects of different races and from different regions. Greater immunogenicity in girls and boys versus young women (the population used to establish 9vHPV vaccine efficacy in clinical studies) indicates that the anti-HPV responses generated by the vaccine in adolescents from all races or regions were sufficient to induce high-level protective efficacy. This immunogenicity profile supports a widespread 9vHPV vaccination program and early vaccination.

Abbreviations

HPV
human papillomavirus
VLP
virus-like particle
9vHPV
9-valent human papillomavirus
cLIA
competitive Luminex immunoassay
GMTs
geometric mean titers
CI
confidence interval
mMU/mL
milli-Merck units per milliliter
qHPV
quadrivalent human papillomavirus

Studies in the meta-analysis

V503-001
V503-002
V503-005
V503-007
V503-009/GDS01C

Clinical trials.gov identifier

NCT00543543
NCT00943722
NCT00988884
NCT01073293
NCT01304498

Keywords

Human papillomavirus
9v HPV vaccine
Immunogenicity
Clinical trial

Cited by (0)