Abstract
Background: Vaccine efficacy (VE) against vulvar human papillomavirus (HPV) infection has not been reported and data regarding its epidemiology are sparse. Methods: Women (n = 5404) age 22-29 present at the 4-year study visit of the Costa Rica Vaccine Trial provided vulvar and cervical samples. A subset (n = 1044) was tested for HPV DNA (SPF10/LiPA25 version 1). VE against 1-time detection of vulvar HPV16/18 among HPV vaccinated versus unvaccinated women was calculated and compared to the cervix. Prevalence of and risk factors for HPV were evaluated in the control arm (n = 536). Results: Vulvar HPV16/18 VE (54.1%; 95% confidence interval [CI], 4.9%-79.1%) was comparable to cervix (45.8%; 95% CI, 6.4%-69.4%). Vulvar and cervical HPV16 prevalence within the control arm was 3.0% and 4.7%, respectively. Independent risk factors for vulvar HPV were similar to cervix and included: age (adjusted odds ratio [aOR] 0.5 [95% CI,.3-.9] ≥28 vs 22-23]); marital status (aOR 2.3 [95% CI, 1.5-3.5] single vs married/living-asmarried); and number of sexual partners (aOR 3.6 [95% CI, 1.9-7.0] ≥6 vs 1). Conclusions: In this intention-to-treat analysis, VE against vulvar and cervical HPV16/18 were comparable 4 years following vaccination. Risk factors for HPV were similar by anatomic site. Clinical Trials Registration: NCT00128661.
Original language | English |
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Pages (from-to) | 1890-1899 |
Number of pages | 10 |
Journal | Journal of Infectious Diseases |
Volume | 210 |
Issue number | 12 |
DOIs | |
State | Published - Dec 2014 |
Bibliographical note
Publisher Copyright:© The Author 2014.
Keywords
- Costa Rica
- HPV
- HPV vaccine
- Vulvar human papillomavirus vaccine
ASJC Scopus subject areas
- General Medicine