Impact of Baseline Covariates on the Immunogenicity of a Quadrivalent (Types 6, 11, 16, and 18) Human Papillomavirus Virus‐Like‐Particle Vaccine

Abstract

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.

Evaluation of safety and immunogenicity of a quadrivalent human papillomavirus vaccine in healthy females between 9 and 26 years of age in Sub-Saharan Africa

“…These findings are similar to our study, where the anti-HPV6, 11, 16, and 18 GMTs were 602, 626, 3786, and 811 mMU/mL, respectively. 24 Our observed safety findings are also similar to that of other studies, whereby vaccine recipients have higher rates of injection site pain, erythema and swelling, but similar rates of systemic AEs. 32 Given the high vaccine efficacy seen in the clinical trials, and the fact that in the 8 y since its original licensure, the qHPV vaccine has been shown to be highly effective at the population level, with marked reductions in the prevalence of HPV vaccine-type related infection and disease in many countries, [33][34][35][36][37][38][39][40][41][42][43][44][45][46][47][48][49][50] our findings suggest the vaccine should be equally effective in sub-Saharan African women.…”

“…[12][13][14][15][16][17] Prior to the current study, all studies of the immunogenicity, safety, and efficacy of the qHPV vaccine had been conducted in North America, Latin America, Europe, Asia, and Oceania. 12,13,[18][19][20][21][22][23][24] The efficacy and/or immunogenicity of vaccines and the pathogenicity of the organisms that they target can differ in subpopulations defined by race/ethnicity, behavior, age, and socioeconomic status. 24 Data from the qHPV vaccine program to date support no clinically relevant impact of these baseline covariates on responses to the qHPV vaccine in a sub-Saharan African population.…”

“…12,13,[18][19][20][21][22][23][24] The efficacy and/or immunogenicity of vaccines and the pathogenicity of the organisms that they target can differ in subpopulations defined by race/ethnicity, behavior, age, and socioeconomic status. 24 Data from the qHPV vaccine program to date support no clinically relevant impact of these baseline covariates on responses to the qHPV vaccine in a sub-Saharan African population. 24 Although these observations suggest a similar immune response and safety profile in sub-Saharan African women, given the high burden of HPV 6/11/16/18-related disease in Africa, the present study was designed to assess the safety and immunogenicity of the qHPV vaccine in women aged 9 to 26 y in Africa.…”

A Pooled Analysis of Continued Prophylactic Efficacy of Quadrivalent Human Papillomavirus (Types 6/11/16/18) Vaccine against High-grade Cervical and External Genital Lesions

“…Differences between vaccine efficacy in the per-protocol and intention-to-treat populations imply that the maximum impact from prophylactic HPV vaccination programs will be achieved in women susceptible to infection and disease related to vaccine HPV types (those not previously exposed), as has previously been suggested (20)(21)(22). The vaccine is prophylactic and is not expected to have a therapeutic effect on current HPV infection (HPV DNA positivity) or high-grade intraepithelial lesions/cancer.…”

The effect of history of abnormal pap smear or preceding HPV infection on the humoral immune response to Quadrivalent Human Papilloma virus (qHPV) vaccine in women with systemic lupus erythematosus

“…Data from a large study in normal subjects age 9–26 years (n = 12,343 males and females) showed a more robust anti HPV response to qHPV vaccine in those who were seropositive at baseline. 36 This was confirmed in a subsequent study showing an anamnestic antibody response in men (age 16–26 years) who were seropositive before HPV vaccination. 37 Both of these studies suggest that in normal individuals of young age, there is an anamnestic response to HPV vaccine after natural infection.…”