• J. Infect. Dis. · Dec 2014

    Randomized Controlled Trial

    Reduced prevalence of vulvar HPV16/18 infection among women who received the HPV16/18 bivalent vaccine: a nested analysis within the Costa Rica Vaccine Trial.

    • Krystle A Lang Kuhs, Paula Gonzalez, Ana Cecilia Rodriguez, Leen-Jan van Doorn, Mark Schiffman, Linda Struijk, Sabrina Chen, Wim Quint, Douglas R Lowy, Carolina Porras, Corey DelVecchio, Silvia Jimenez, Mahboobeh Safaeian, John T Schiller, Sholom Wacholder, Rolando Herrero, Allan Hildesheim, Aimée R Kreimer, and Costa Rica Vaccine Trial Group.
    • National Cancer Institute, NIH, Bethesda, Maryland.
    • J. Infect. Dis. 2014 Dec 15; 210 (12): 1890-9.

    BackgroundVaccine efficacy (VE) against vulvar human papillomavirus (HPV) infection has not been reported and data regarding its epidemiology are sparse.MethodsWomen (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).ResultsVulvar 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-as-married); and number of sexual partners (aOR 3.6 [95% CI, 1.9-7.0] ≥6 vs 1).ConclusionsIn 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 RegistrationNCT00128661.Published by Oxford University Press on behalf of the Infectious Diseases Society of America 2014. This work is written by (a) US Government employee(s) and is in the public domain in the US.

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