Lang Kuhs Krystle A, Gonzalez Paula, Rodriguez Ana Cecilia, van Doorn Leen-Jan, Schiffman Mark, Struijk Linda, Chen Sabrina, Quint Wim, Lowy Douglas R, Porras Carolina, DelVecchio Corey, Jimenez Silvia, Safaeian Mahboobeh, Schiller John T, Wacholder Sholom, Herrero Rolando, Hildesheim Allan, Kreimer Aimée R
National Cancer Institute, NIH, Bethesda, Maryland.
Proyecto Epidemiológico Guanacaste, Fundación INCIENSA, Costa Rica Prevention and Implementation Group, International Agency for Research on Cancer, Lyon, France.
J Infect Dis. 2014 Dec 15;210(12):1890-9. doi: 10.1093/infdis/jiu357. Epub 2014 Jun 23.
Vaccine efficacy (VE) against vulvar human papillomavirus (HPV) infection has not been reported and data regarding its epidemiology are sparse.
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).
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).
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.
NCT00128661.
针对外阴人乳头瘤病毒（HPV）感染的疫苗效力（VE）尚未见报道，且其流行病学数据稀少。
在哥斯达黎加疫苗试验4年研究访视时到场的22 - 29岁女性（n = 5404）提供了外阴和宫颈样本。对一个亚组（n = 1044）进行了HPV DNA检测（SPF10/LiPA25第1版）。计算了接种疫苗与未接种疫苗女性中针对1次检测到的外阴HPV16/18的疫苗效力，并与宫颈情况进行比较。在对照组（n = 536）中评估了HPV的患病率及危险因素。
外阴HPV16/18疫苗效力（54.1%；95%置信区间[CI]，4.9% - 79.1%）与宫颈情况（45.8%；95% CI，6.4% - 69.4%）相当。对照组中外阴和宫颈HPV16患病率分别为3.0%和4.7%。外阴HPV的独立危险因素与宫颈相似，包括：年龄（校正优势比[aOR] 0.5 [95% CI，0.3 - 0.9] ≥28岁 vs 22 - 23岁）；婚姻状况（aOR 2.3 [95% CI，1.5 - 3.5] 单身 vs 已婚/同居）；性伴侣数量（aOR 3.6 [95% CI，1.9 - 7.0] ≥6个 vs 1个）。
在这项意向性分析中，接种疫苗4年后针对外阴和宫颈HPV16/18的疫苗效力相当。HPV的危险因素在不同解剖部位相似。
NCT00128661。
