Antibody response to the 9vHPV vaccine is the basis for its effectiveness in preventing infection and disease related to vaccine HPV types (HPV 6/11/16/18/31/33/45/52/58). Here we present the combined results of an integrated analysis of immunogenicity from several 9vHPV vaccine clinical trials.
Combined analyses of 5 clinical trials of the 9vHPV vaccine (protocols 001, 002, 005, 007 and 009) were conducted by competitive Luminex immunoassay (cLIA) in females aged 9-26 years and males aged 9-15 years in a per-protocol immunogenicity population (PPI) consisting of subjects seronegative at day 1 and (for those >15 years of age), PCR-negative from day 1 through 1 month post-dose 3 for the tested HPV type. Immunogenicity was summarized in populations defined by age at vaccination (≤15 or >15 years of age) and gender.
Of the randomized subjects, 11,304 (99.8%) received at least 1 injection. At least 99.6% of subjects who received 9vHPV vaccine and were in the PPI population were seropositive to the respective vaccine HPV type at 4 weeks post-dose 3. For all subjects, regardless of gender or age, geometric mean titers for all 9 HPV types were robust across race, ethnicity, or region. In general, the magnitude of anti-HPV response tended to decrease with an increase in enrollment age.
The 9vHPV vaccine was strongly immunogenic as shown by high seroconversion rates (>99%) for all vaccine HPV types and robust anti-HPV antibody responses regardless of race, geographic region, age or gender.