Reduced prevalence of oral human papillomavirus (HPV) 4 years after bivalent HPV vaccination in a randomized clinical trial in Costa Rica.
Reduced prevalence of oral human papillomavirus (HPV) 4 years after bivalent HPV vaccination in a randomized clinical trial in Costa Rica.
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DOI：
10.1371/journal.pone.0068329
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发表时间：
2013
期刊：
影响因子：
3.7
通讯作者：
CVT Vaccine Group
中科院分区：
文献类型：
--
作者：
Herrero R;Quint W;Hildesheim A;Gonzalez P;Struijk L;Katki HA;Porras C;Schiffman M;Rodriguez AC;Solomon D;Jimenez S;Schiller JT;Lowy DR;van Doorn LJ;Wacholder S;Kreimer AR;CVT Vaccine Group
人乳头瘤病毒（HPV）感染，特别是16型感染，导致越来越多的口咽癌，其发病率正在增加，主要是在发达国家。在一项双盲对照试验中，研究了二价HPV 16/18疫苗对宫颈感染和病变的疫苗效力（VE），我们估计了疫苗接种4年后对流行的口腔HPV感染的VE。随机选择7,466名18 ~ 25岁女性（1∶1）接种HPV16/18疫苗或甲型肝炎疫苗作为对照。在最后一次为期4年的盲法研究访问中，5840名参与者提供了口腔标本（占符合条件的女性的90.9%）来评估VE对口腔感染的影响。我们的初步分析评估了所有接种过口腔和宫颈HPV疫苗的妇女中流行的口腔HPV感染。计算流行宫颈HPV16/18感染的相应VE进行比较。口腔可识别的粘膜HPV患病率相对较低（1.7%）。接种疫苗约4年后，对照组和疫苗组分别发生15例和1例HPV16/18流行感染，估计VE为93.3% （95% CI = 63% ~ 100%）。同一队列在同一次就诊时对流行的宫颈HPV16/18感染的相应疗效为72.5% (95% CI = 63%至79%)（p与口服VE = 0.04）。虽然这些分析的能力有限，但对其他口腔HPV感染没有统计学上显著的保护作用。与对照组相比，接种aso4佐剂HPV16/18疫苗4年后，疫苗组妇女的HPV患病率要低得多，这表明疫苗对口服HPV16/18感染提供了强有力的保护，对预防日益常见的HPV相关口咽癌具有潜在的重要意义。ClinicalTrials.gov，注册号NCT00128661
Human papillomavirus (HPV) infection, particularly with type 16, causes a growing fraction of oropharyngeal cancers, whose incidence is increasing, mainly in developed countries. In a double-blind controlled trial conducted to investigate vaccine efficacy (VE) of the bivalent HPV 16/18 vaccine against cervical infections and lesions, we estimated VE against prevalent oral HPV infections 4 years after vaccination. A total of 7,466 women 18–25 years old were randomized (1∶1) to receive the HPV16/18 vaccine or hepatitis A vaccine as control. At the final blinded 4-year study visit, 5,840 participants provided oral specimens (91·9% of eligible women) to evaluate VE against oral infections. Our primary analysis evaluated prevalent oral HPV infection among all vaccinated women with oral and cervical HPV results. Corresponding VE against prevalent cervical HPV16/18 infection was calculated for comparison. Oral prevalence of identifiable mucosal HPV was relatively low (1·7%). Approximately four years after vaccination, there were 15 prevalent HPV16/18 infections in the control group and one in the vaccine group, for an estimated VE of 93·3% (95% CI = 63% to 100%). Corresponding efficacy against prevalent cervical HPV16/18 infection for the same cohort at the same visit was 72·0% (95% CI = 63% to 79%) (p versus oral VE = 0·04). There was no statistically significant protection against other oral HPV infections, though power was limited for these analyses. HPV prevalence four years after vaccination with the ASO4-adjuvanted HPV16/18 vaccine was much lower among women in the vaccine arm compared to the control arm, suggesting that the vaccine affords strong protection against oral HPV16/18 infection, with potentially important implications for prevention of increasingly common HPV-associated oropharyngeal cancer. ClinicalTrials.gov, Registry number NCT00128661
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影响因子：
10.3
作者：
Nardelli-Haefliger, D;Wirthner, D;De Grandi, P
通讯作者：
De Grandi, P
影响因子：
51.1
作者：
Cogliano, V;Baan, R;El Ghissassi, F
通讯作者：
El Ghissassi, F
DOI：
10.1056/nejmoa0909537
发表时间：
2011-02-03
期刊：
The New England journal of medicine
影响因子：
--
作者：
Giuliano AR;Palefsky JM;Goldstone S;Moreira ED Jr;Penny ME;Aranda C;Vardas E;Moi H;Jessen H;Hillman R;Chang YH;Ferris D;Rouleau D;Bryan J;Marshall JB;Vuocolo S;Barr E;Radley D;Haupt RM;Guris D
通讯作者：
Guris D
影响因子：
10.3
作者：
Munoz, Nubia;Kjaer, Susanne K.;Haupt, Richard M.
通讯作者：
Haupt, Richard M.
影响因子：
51.1
作者：
Kreimer, Aimee R.;Gonzalez, Paula;Herrero, Rolando
通讯作者：
Herrero, Rolando