Clinical Trial Experience With Prophylactic Human Papillomavirus 6/11/16/18 Vaccine in Young Black Women

Distribution of Vaccine-Type Human Papillomavirus Does Not Differ by Race or Ethnicity Among Unvaccinated Young Women

“…Survey and HPV DNA data from the four studies were merged. The three primary outcome variables were infection with at least one of the HPV types found in the 2-valent vaccine (HPV16, 18), the 4-valent vaccine (HPV6, 11,16,18), and the 9-valent vaccine (HPV6, 11, 16, 18, 31, 33, 45, 52, 58). Additional outcome variables were infection with at least one HPV type and at least one high-risk HPV type included in one of the three HPV vaccines; the latter was not included in multivariable analyses.…”

“…Black women were more likely than white women to be positive for ‡1 HPV type (odds ratio [OR] 1.83, 95% CI 1.30-2.58) and Hispanic women were less likely than non-Hispanic women to be positive for ‡1 HPV type (OR 0.47, 95% CI 0.24-0.92). However, among all young women and HPV-infected women, neither race nor ethnicity was associated with positivity for HPV types targeted by the following vaccines: 2-valent (HPV16 and/or 18), 11,16,and/or 18),11,16,18, 31, 33, 45, 52, and/or 58). Conclusion: The prevalence of HPV types targeted by the 2-valent, 4-valent, and 9-valent vaccines did not differ by race or ethnicity among all and among HPV-infected women in this sample.…”

“…Previous studies have shown that HPV vaccines have comparable immunogenicity and efficacy in individuals of different race and ethnicity. 11,12 However, a recent study demonstrated that the most common HPV types detected in African American women with cervical intraepithelial neoplasia (CIN) differed from those found in non-Hispanic white women. 13 14 Similarly, a multisite vaccine impact monitoring project demonstrated that HPV16/18-associated high-grade cervical lesions were less common in non-Hispanic blacks and Hispanics compared with non-Hispanic Whites.…”

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

“…Though vaccine efficacy was not an endpoint, in this study a prior sub-analysis of the black women who were enrolled in the large phase 3 efficacy trials of the qHPV vaccine showed vaccine efficacy against disease caused by HPV6, 11, 16, and 18 was 100% for cervical, vulvar, and vaginal intraepithelial neoplasia, and condylomata accuminata, among women who were negative to the vaccine types at study entry. 31 When subjects aged 15 to 26 who were enrolled in the clinical trials of the qHPV vaccine were stratified by race/ethnicity (White, Black, Asian, Hispanic, and other), anti-HPV GMTs for HPV6, 11, 16, and 18 ranged from 540-617, 720-890, 2702-3499, and 549-663 mMU/ML, respectively, and for women who self-identified themselves as Black, the corresponding GMTs were 598, 887, 3499, and 637 mMU/mL, respectively. 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.…”

Attend to the “Small p” Stuff: State Policy Issues Affecting Cervical Cancer Efforts

“…Prophylactic vaccines against human papillomavirus (HPV) infection are safe and effective [1]- [3]. Diagnostic and screening tools for HPV detection are now available and have been recommended for women > 30 years [4] [5], and there are treatment options for early stages of cervical precancer or invasive disease.…”