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Randomized Controlled Trial
. 2014 Dec 15;210(12):1890-9.
doi: 10.1093/infdis/jiu357. Epub 2014 Jun 23.

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  1 , Paula Gonzalez  2 , Ana Cecilia Rodriguez  3 , Leen-Jan van Doorn  4 , Mark Schiffman  1 , Linda Struijk  4 , Sabrina Chen  5 , Wim Quint  4 , Douglas R Lowy  1 , Carolina Porras  3 , Corey DelVecchio  5 , Silvia Jimenez  3 , Mahboobeh Safaeian  1 , John T Schiller  1 , Sholom Wacholder  1 , Rolando Herrero  6 , Allan Hildesheim  1 , Aimée R Kreimer; Costa Rica Vaccine Trial Group
Collaborators, Affiliations
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 et al. J Infect Dis. .

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-as-married); 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.

Keywords: Costa Rica; HPV; HPV vaccine; vulvar human papillomavirus vaccine.

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Figures

Figure 1.
Figure 1.
Trial profile. Abbreviation: HPV, human papillomavirus. aFour women received discordant vaccines (1 woman was enrolled twice and received 3 doses of each vaccine and 3 women received 2 doses of 1 vaccine and 1 dose of the other vaccine). For the aim of this analysis, the women were assigned to the group for which the first dose was given. bData obtained at the 4-year study visit at which vulvar specimens were obtained were used to create the full analytic cohort.
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