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No association between HPV-status in tonsillar tissue and sexual behavior of the patients in a northern German population - Critical view of the link between HPV natural history and HPV-driven carcinogenesis 德国北部人群扁桃体组织中HPV状态与患者性行为之间无关联——HPV自然史与HPV驱动癌变之间联系的关键观点
IF 3.2 Pub Date : 2020-12-01 DOI: 10.1016/j.pvr.2020.100207
Elgar Susanne Quabius , Asita Fazel , Christopher Knieling , Stephan Gebhardt , Martin Laudien , Crystal Moore , André Kühnel , Florian Hoppe , Robert Mlynski , Alessa Heinrichs , Alexander Fabian , Markus Hoffmann

HPV-infection in patients with HNSCC is reportedly correlated with sexual behavior, age, and tobacco/alcohol-consumption. HPV-infections of the oral cavity are regarded as sexually transmitted. Comparable data of patient populations outside the U.S. are sparse or missing.

Questionnaires regarding sexual behavior, education tobacco- and alcohol-consumption, were given to 28 patients with tonsillar hyperplasia (H) and 128 patients with tonsillar carcinomas (CA), all with tissue-typed HPV-DNA-status performing PCR. Answers were correlated among groups and HPV-status.

106 questionnaires were analyzed. Comparisons between H- (n = 25) and CA- (n = 81) patients showed that CA-patients were older (61.1yrs ± 9.3) than H-patients (45.2yrs ± 11.9; p < 0.0001; Student's t-test); had a lower educational level (p = 0.0095); and lower number of sexual partners (p = 0.0222; Fisher's exact test). All groups showed a significant correlation between smoking and lack of HPV-DNA-positivity (p = 0.001). Further Fisher's exact tests and logistic regression analysis revealed in all 106 patients no significant correlations between tissue-HPV-status and the analyzed parameters.

Despite the limited sample size, we were able to confirm the established correlation between smoking and tissue-HPV-status. The correlation between sexual behavior and HPV-infection was not confirmed. No consensus exists in the literature about the latter. Our data does not support the strict classification of oral HPV-infections and HPV-driven HNSCCs as STDs.

据报道,HNSCC患者的hpv感染与性行为、年龄和吸烟/饮酒有关。口腔hpv感染被认为是性传播。美国以外的患者群体的可比数据很少或缺失。对28例扁桃体增生(H)患者和128例扁桃体癌(CA)患者进行了关于性行为、教育、烟草和酒精消费的问卷调查,所有患者都具有组织型hpv - dna状态,并进行了PCR。答案在各组和hpv感染状况之间存在相关性。分析了106份问卷。H-患者(n = 25)与CA-患者(n = 81)的比较表明,CA患者(61.1±9.3岁)比H-患者(45.2±11.9岁)年龄大;p & lt;0.0001;学生的学习任务);受教育程度较低(p = 0.0095);性伴侣数量较低(p = 0.0222;费雪精确检验)。所有组均显示吸烟与缺乏hpv - dna阳性之间存在显著相关性(p = 0.001)。进一步的Fisher精确检验和逻辑回归分析显示,在所有106例患者中,组织hpv状态与分析参数之间没有显著相关性。尽管样本量有限,但我们能够确认吸烟与组织hpv状态之间的既定相关性。性行为与hpv感染之间的相关性尚未得到证实。关于后者,文献中没有共识。我们的数据不支持口腔hpv感染和hpv驱动的HNSCCs作为性病的严格分类。
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引用次数: 7
CINtec PLUS and cobas HPV testing for triaging Canadian women referred to colposcopy with a history of low-grade squamous intraepithelial lesion: Baseline findings CINtec PLUS和cobas HPV检测用于诊断有低级别鳞状上皮内病变史的加拿大妇女的阴道镜检查:基线结果
IF 3.2 Pub Date : 2020-12-01 DOI: 10.1016/j.pvr.2020.100206
Sam Ratnam , Dan Jang , Laura Gilbert , Reza Alaghehbandan , Miranda Schell , Rob Needle , Anne Ecobichon-Morris , Peizhong Peter Wang , Mozibur Rahman , Dustin Costescu , Laurie Elit , George Zahariadis , Max Chernesky

Objective and methods

CINtec PLUS and cobas HPV tests were assessed for triaging women referred to colposcopy with a history of LSIL cytology. Both tests were performed at baseline using ThinPrep cervical specimens and biopsy confirmed cervical intraepithelial neoplasia grade 2 or worse (CIN2+) served as the clinical endpoint.

Results

In all ages, (19–76 years, n = 600), 44.3% (266/600) tested CINtec PLUS positive vs. 55.2% (331/600) HPV positive (p = 0.000). Based on 224 having biopsies, sensitivity to detect CIN2+ (n = 54) was 81.5% (44/54) for CINtec PLUS vs. 94.4% (51/54) for HPV testing (p = 0.039); specificities were, 52.4% (89/170) vs. 44.1% (75/170), respectively (p = 0.129). In women ≥30 years (n = 386), 41.2% (159/386) tested CINtec PLUS positive vs. 50.8% (196/386) HPV positive (p = 0.008). Based on 135 having biopsies, sensitivity to detect CIN2+ (n = 24) was 95.8% (23/24) for both CINtec PLUS and HPV tests; specificities were, 55.0% (61/111) vs. 50.5% (56/111), respectively (p = 0.503).

Conclusions

For women referred to colposcopy with a history of LSIL cytology, CINtec PLUS or cobas HPV test could serve as a predictor of CIN2+ with high sensitivity, particularly in women ≥30 years. Either test can significantly reduce the number of women requiring further investigations and follow up in colposcopy clinics.

目的和方法评估scintec PLUS和cobas HPV检测对有LSIL细胞学史的妇女进行阴道镜检查的分类。两项试验均在基线时使用ThinPrep宫颈标本进行,活检证实宫颈上皮内瘤变2级或更严重(CIN2+)作为临床终点。结果在所有年龄段(19 ~ 76岁,n = 600), CINtec PLUS阳性的占44.3% (266/600),HPV阳性的占55.2% (331/600)(p = 0.000)。基于224例活检,CINtec PLUS检测CIN2+的敏感性(n = 54)为81.5% (44/54),HPV检测为94.4% (51/54)(p = 0.039);特异性分别为52.4%(89/170)和44.1% (75/170)(p = 0.129)。在≥30岁的女性中(n = 386), 41.2%(159/386)检测CINtec PLUS阳性,50.8%(196/386)检测HPV阳性(p = 0.008)。基于135例活检,CINtec PLUS和HPV检测对CIN2+ (n = 24)的敏感性为95.8% (23/24);特异性分别为55.0%(61/111)和50.5% (56/111)(p = 0.503)。结论:对于有LSIL细胞学史的女性,CINtec PLUS或cobas HPV检测可作为CIN2+的高灵敏度预测因子,特别是在≥30岁的女性中。这两种检查都能显著减少需要在阴道镜诊所进行进一步检查和随访的妇女人数。
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引用次数: 4
Associations between risk-perception, self-efficacy and vaccine response-efficacy and parent/guardian decision-making regarding adolescent HPV vaccination 风险感知、自我效能和疫苗反应效能与父母/监护人关于青少年HPV疫苗接种决策之间的关系
IF 3.2 Pub Date : 2020-12-01 DOI: 10.1016/j.pvr.2020.100204
Alicia Myhre, Tiaj Xiong , Rachel I. Vogel, Deanna Teoh

Objectives

To evaluate associations of risk perception, self-efficacy and response-efficacy with HPV vaccination decisions among parents/guardians of adolescents.

Methods

A cross-sectional survey of parents/guardians of adolescents was conducted at the Minnesota State Fair. Risk perception was measured by participant rankings of HPV infection and vaccine risks against diseases/side-effects for which numerical risks were provided. Response efficacy was measured as perceived ability of the vaccine to prevent HPV infection, and self-efficacy was measured as the perceived ability to prevent infection without vaccination (scale 0–100). Chi-squared and Fisher's exact tests compared risk perception, self-efficacy and response-efficacy of vaccinators to non-vaccinators.

Results

Of 405 eligible participants, 355 completed vaccination questions; 304 (86%) were vaccinators and 51 (14%) were non-vaccinators. Non-vaccinators had lower risk-perception of HPV-related cancers (p < 0.05) and higher risk-perception of vaccine-related side-effects (p < 0.05). Self-efficacy was higher (64 ± 24 vs. 30 ± 29; p < 0.0001) and perceived HPV vaccine response efficacy was lower (52 ± 31 vs. 83 ± 19; p < 0.0001) among non-vaccinators compared to vaccinators.

Conclusions

Lower HPV-related cancer risk perception and higher self-efficacy were associated with the decision not to vaccinate. HPV vaccination decisions were similar to meningococcal vaccination decisions, suggesting reluctance to vaccinate in general rather than resistance to the HPV vaccine specifically drove the results.

目的评价青少年父母/监护人HPV疫苗接种决策与风险感知、自我效能和反应效能的关系。方法对参加明尼苏达州博览会的青少年家长/监护人进行横断面调查。风险感知是通过参与者对HPV感染和疫苗对疾病/副作用的风险的排名来衡量的,这些风险提供了数字风险。反应效能以疫苗预防HPV感染的感知能力来衡量,自我效能以不接种疫苗预防感染的感知能力来衡量(量表0-100)。卡方检验和Fisher精确检验比较了接种者和非接种者的风险感知、自我效能和反应效能。在405名符合条件的参与者中,355人完成了疫苗接种问题;304名接种者(86%)和51名非接种者(14%)。未接种疫苗者对hpv相关癌症的风险认知较低(p <0.05)和对疫苗相关副作用的更高风险认知(p <0.05)。自我效能感较高(64±24∶30±29);p & lt;0.0001),感知HPV疫苗应答有效性较低(52±31∶83±19;p & lt;0.0001),与接种者相比。结论hpv相关癌症风险认知较慢和自我效能感较高与不接种疫苗的决定相关。HPV疫苗接种决定与脑膜炎球菌疫苗接种决定相似,表明一般不愿接种疫苗,而不是对HPV疫苗的抵抗力特别推动了结果。
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引用次数: 13
Multiple HPV infections among men who have sex with men engaged in anal cancer screening in Abuja, Nigeria 在尼日利亚阿布贾,与男性发生性行为从事肛门癌筛查的男性中存在多种HPV感染
IF 3.2 Pub Date : 2020-12-01 DOI: 10.1016/j.pvr.2020.100200
Rebecca G. Nowak , Lisa M. Schumaker , Nicholas P. Ambulos , Nicaise Ndembi , Wuese Dauda , Chinedu H. Nnaji , Andrew Mitchell , Trevor J. Mathias , Paul Jibrin , Teresa M. Darragh , Oluwole Olaomi , Trevor A. Crowell , Stefan D. Baral , Manhattan E. Charurat , Søren M. Bentzen , Joel M. Palefsky , Kevin J. Cullen

Background

Anal precancers and cancers can be detected during screening with high-resolution anoscopy (HRA). The sensitivity of HRA depends on the burden and duration of human papillomavirus (HPV) among those screened as well as anoscopist proficiency, which is highly correlated with prior screening experience. Our objective was to compare the identification and type of HPV and the likelihood of HRA-detected precancer for men who have sex with men (MSM) undergoing their first HRA-screening in Nigeria.

Methods

MSM were recruited from an HIV test-and-treat cohort, TRUST/RV368, into a new anal cancer screening program. Anal swabs obtained during screening underwent Ion Torrent next-generation sequencing using barcoded HPV PCR broad-spectrum primers 5+/6+ to detect up to 161 HPVs. All high-risk (HR) HPVs and the most abundant low-risk (LR)-HPVs were evaluated as type-specific infections with some categorized as belonging to a multiple infection. HRA screening results included benign, low-grade squamous intraepithelial lesions (LSIL), or HSIL as detected by cytology or histology. Multivariable logistic regression was used to assess the association of HPV and other cofactors with any SIL.

Results

Among 342 MSM, 60% were HIV-infected, 89% were under 35 years of age, and 51% had 8 or more years since anal coital debut. Of those with SIL, 89% had LSIL and only 11% had HSIL. Prevalence of any HPV and high-risk (HR)-HPV was 92% and 74%, respectively. The most prevalent genotypes in rank order were HPV6 (31%), HPV16 (23%), HPV42 (20%), HPV11 (18%), HPV45 (18%), and HPV51 (17%). For multiple HR-HPVs, 31% had a single HR-HPV, 32% had 2-3, and 10% had 4 or more. Low-risk HPVs, type 6 and/or 11, were common (42%) and were significantly associated with SIL (adjusted odds ratio [aOR]:1.8, 95% confidence interval [CI]: 1.1–3.1) together with perianal warts (aOR:6.7, 95% CI: 3.3–13.5). In contrast, HR-HPV and multiple HR-HPVs were not significantly associated with SIL (all p > 0.05).

Conclusions

Detection of HSIL was low. Although HR-HPV was abundant, HSIL development also depends on the duration of HR-HPV infections and the anoscopist's level of experience. As our cohort ages and the anoscopist becomes more skilled, detection of HSIL will likely improve.

背景:在高分辨率肛门镜检查(HRA)的筛查过程中可以检测到癌前病变和癌症。HRA的敏感性取决于接受筛查的人乳头瘤病毒(HPV)的负担和持续时间,以及内镜医师的熟练程度,这与先前的筛查经验高度相关。我们的目的是比较尼日利亚男男性行为者(MSM)首次进行hra筛查时HPV的鉴定和类型以及hra检测出癌前病变的可能性。方法从HIV检测和治疗队列TRUST/RV368中招募smsm进入新的肛门癌筛查项目。在筛选期间获得的肛门拭子使用条形码HPV PCR广谱引物5+/6+进行Ion Torrent下一代测序,检测多达161种HPV。所有高风险(HR) hpv和最丰富的低风险(LR) hpv被评估为类型特异性感染,其中一些被归类为属于多重感染。HRA筛查结果包括良性,低级别鳞状上皮内病变(LSIL),或细胞学或组织学检测到的HSIL。多变量逻辑回归用于评估HPV和其他辅助因素与任何SIL的关联。结果342例男男性行为者中,hiv感染者占60%,年龄在35岁以下者占89%,初次肛交时间在8年及以上者占51%。在SIL患者中,89%为低级别SIL,只有11%为高级别SIL。任何HPV和高危(HR) HPV的患病率分别为92%和74%。最常见的基因型依次为HPV6(31%)、HPV16(23%)、HPV42(20%)、HPV11(18%)、HPV45(18%)和HPV51(17%)。对于多发HR-HPV, 31%有单一HR-HPV, 32%有2-3个,10%有4个或更多。低风险hpv, 6型和/或11型很常见(42%),并且与SIL(调整优势比[aOR]:1.8, 95%可信区间[CI]: 1.1-3.1)以及肛周疣(aOR:6.7, 95% CI: 3.3-13.5)显著相关。相比之下,HR-HPV和多发性HR-HPV与SIL无显著相关性(p均为 > 0.05)。结论HSIL检出率低。虽然HR-HPV是丰富的,HSIL的发展也取决于HR-HPV感染的持续时间和肛门镜医生的经验水平。随着我们的队列年龄的增长和窥镜医生变得更加熟练,HSIL的检测可能会提高。
{"title":"Multiple HPV infections among men who have sex with men engaged in anal cancer screening in Abuja, Nigeria","authors":"Rebecca G. Nowak ,&nbsp;Lisa M. Schumaker ,&nbsp;Nicholas P. Ambulos ,&nbsp;Nicaise Ndembi ,&nbsp;Wuese Dauda ,&nbsp;Chinedu H. Nnaji ,&nbsp;Andrew Mitchell ,&nbsp;Trevor J. Mathias ,&nbsp;Paul Jibrin ,&nbsp;Teresa M. Darragh ,&nbsp;Oluwole Olaomi ,&nbsp;Trevor A. Crowell ,&nbsp;Stefan D. Baral ,&nbsp;Manhattan E. Charurat ,&nbsp;Søren M. Bentzen ,&nbsp;Joel M. Palefsky ,&nbsp;Kevin J. Cullen","doi":"10.1016/j.pvr.2020.100200","DOIUrl":"10.1016/j.pvr.2020.100200","url":null,"abstract":"<div><h3>Background</h3><p>Anal precancers and cancers can be detected during screening with high-resolution anoscopy (HRA). The sensitivity of HRA depends on the burden and duration of human papillomavirus (HPV) among those screened as well as anoscopist proficiency, which is highly correlated with prior screening experience. Our objective was to compare the identification and type of HPV and the likelihood of HRA-detected precancer for men who have sex with men (MSM) undergoing their first HRA-screening in Nigeria.</p></div><div><h3>Methods</h3><p>MSM were recruited from an HIV test-and-treat cohort, TRUST/RV368, into a new anal cancer screening program. Anal swabs obtained during screening underwent Ion Torrent next-generation sequencing using barcoded HPV PCR broad-spectrum primers 5+/6+ to detect up to 161 HPVs. All high-risk (HR) HPVs and the most abundant low-risk (LR)-HPVs were evaluated as type-specific infections with some categorized as belonging to a multiple infection. HRA screening results included benign, low-grade squamous intraepithelial lesions (LSIL), or HSIL as detected by cytology or histology. Multivariable logistic regression was used to assess the association of HPV and other cofactors with any SIL.</p></div><div><h3>Results</h3><p>Among 342 MSM, 60% were HIV-infected, 89% were under 35 years of age, and 51% had 8 or more years since anal coital debut. Of those with SIL, 89% had LSIL and only 11% had HSIL. Prevalence of any HPV and high-risk (HR)-HPV was 92% and 74%, respectively. The most prevalent genotypes in rank order were HPV6 (31%), HPV16 (23%), HPV42 (20%), HPV11 (18%), HPV45 (18%), and HPV51 (17%). For multiple HR-HPVs, 31% had a single HR-HPV, 32% had 2-3, and 10% had 4 or more. Low-risk HPVs, type 6 and/or 11, were common (42%) and were significantly associated with SIL (adjusted odds ratio [aOR]:1.8, 95% confidence interval [CI]: 1.1–3.1) together with perianal warts (aOR:6.7, 95% CI: 3.3–13.5). In contrast, HR-HPV and multiple HR-HPVs were not significantly associated with SIL (all p &gt; 0.05).</p></div><div><h3>Conclusions</h3><p>Detection of HSIL was low. Although HR-HPV was abundant, HSIL development also depends on the duration of HR-HPV infections and the anoscopist's level of experience. As our cohort ages and the anoscopist becomes more skilled, detection of HSIL will likely improve.</p></div>","PeriodicalId":46835,"journal":{"name":"Papillomavirus Research","volume":"10 ","pages":"Article 100200"},"PeriodicalIF":3.2,"publicationDate":"2020-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.pvr.2020.100200","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38004264","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 12
Post-hoc analysis of injection-site reactions following vaccination with quadrivalent human papillomavirus vaccine in Japanese female clinical trial participants 日本女性临床试验参与者接种四价人乳头瘤病毒疫苗后注射部位反应的事后分析
IF 3.2 Pub Date : 2020-12-01 DOI: 10.1016/j.pvr.2020.100205
Shinya Murata, Masayoshi Shirakawa, Yoshie Sugawara, Michiko Shuto, Miyuki Sawata, Yoshiyuki Tanaka

Aim

The quadrivalent human papillomavirus (4vHPV) vaccine has demonstrated efficacy and immunogenicity and was generally well tolerated in clinical trials conducted in Japan. We report a detailed safety analysis of injection-site reactions in female Japanese 4vHPV clinical trial participants.

Methods

This post-hoc analysis included data from 2 double-blind, placebo-controlled phase II clinical trials of a 3-dose (Day 1, Month 2, Month 6) regimen of 4vHPV vaccine in Japanese young women aged 18–26 years (N = 1021; NCT00378560) and girls aged 9–17 years (N = 107; NCT00411749). Injection-site and systemic adverse events (AEs) were monitored using vaccination report cards for 15 days after each vaccine dose; serious AEs were reported throughout the trials. Post-hoc analyses of data from these trials were performed to examine details of injection-site AEs, including day of onset, time from onset to resolution, and maximum intensity.

Results

Injection-site AEs were reported by 85.6% of 4vHPV vaccine recipients and 72.4% of placebo recipients, most commonly erythema, pain, pruritus, and swelling (each >5% of 4vHPV vaccine recipients). The majority of injection-site AEs had an onset within 3 days of vaccination and were mild to moderate in intensity; few 4vHPV vaccine recipients reported severe injection-site AEs (2.0% overall). All injection-site AEs resolved, and most (4vHPV: 87.5%; placebo: 92.7%) resolved within 5 days of onset.

Conclusions

Most injection-site reactions are mild or moderate in intensity and of short duration. The 3-dose regimen of 4vHPV vaccine is well tolerated in Japanese female clinical trial participants based on this post-hoc analysis. These results will further support safety communication between healthcare providers and vaccine recipients regarding the HPV vaccine.

Trial registration

Clinicaltrials. gov: NCT00378560 and NCT00411749.

目的:在日本进行的临床试验中,四价人乳头瘤病毒(4vHPV)疫苗已显示出有效性和免疫原性,并且普遍耐受良好。我们报告了日本女性4vHPV临床试验参与者注射部位反应的详细安全性分析。方法:这项事后分析纳入了2项双盲、安慰剂对照的II期临床试验的数据,这些试验在18-26岁的日本年轻女性中进行,分别为3剂(第1天、第2个月、第6个月)4vHPV疫苗方案(N = 1021;NCT00378560)和9-17岁的女孩(N = 107;NCT00411749)。每次接种疫苗后15天,使用接种报告卡监测注射部位和全身不良事件(ae);在整个试验过程中都报告了严重的不良反应。对这些试验的数据进行事后分析,以检查注射部位ae的细节,包括发病日期、从发病到消退的时间和最大强度。结果85.6%的4vHPV疫苗接种者和72.4%的安慰剂接种者报告了注射部位不良反应,最常见的是红斑、疼痛、瘙痒和肿胀(各占4vHPV疫苗接种者的5%)。大多数注射部位ae在接种疫苗后3天内发病,强度为轻度至中度;很少有4vHPV疫苗接种者报告严重的注射部位不良反应(总体为2.0%)。所有注射部位的ae都得到了解决,大多数(4vHPV: 87.5%;安慰剂组:92.7%)在发病5天内消退。结论注射部位反应多为轻度或中度,持续时间短。基于这一事后分析,日本女性临床试验参与者对3剂4vHPV疫苗的耐受性良好。这些结果将进一步支持卫生保健提供者和疫苗接受者之间关于HPV疫苗的安全沟通。registrationClinicaltrials审判。网址:NCT00378560和NCT00411749。
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引用次数: 3
Cross-neutralizing antibody titres against non-vaccine types induced by a recombinant trivalent HPV vaccine (16/18/58) in rhesus macaques 重组三价HPV疫苗(16/18/58)诱导的恒河猴非疫苗型交叉中和抗体滴度
IF 3.2 Pub Date : 2020-12-01 DOI: 10.1016/j.pvr.2020.100209
Yan Wang , Yuying Liu , Shutian Liang , Fei Yin , Haijiang Zhang , Yongjiang Liu

Human papillomavirus (HPV) causes not only most cervical cancers but also cancers of the vagina, vulva, penis, anus, rectum, and oropharynx. Every year, 200,000 women die of cervical cancer in the world, and China accounts for about 10%. HPV vaccines are effective in preventing HPV infections thus HPV-related cancers worldwide. Studies on the clinical trials of the 2v Cervarix™ and the 4v Gardasil® have suggested that immunization with either of these vaccines provided some level of protection against other HPV types that are closely related to the types contained in the vaccines. Here we conducted a preliminary evaluation on the ability to induce cross-neutralizing antibodies in rhesus monkeys by a 3v HPV vaccine that targets HPV16, 18, and 58 and it is specifically designed for Chinese women. We found that this vaccine is no less than Gardasil® in terms of the ability to induce NAbs against non-vaccine types of HPV in rhesus macaques. These results provided evidence from the immunogenicity point of view that the KLWS 3v HPV vaccine is a strong competitor to the imported 2v and 4v HPV vaccines currently available on the market.

人乳头瘤病毒(HPV)不仅会导致大多数宫颈癌,还会导致阴道、外阴、阴茎、肛门、直肠和口咽部的癌症。全球每年有20万女性死于宫颈癌,其中中国约占10%。人乳头瘤病毒疫苗可有效预防人乳头瘤病毒感染,从而在世界范围内预防与人乳头瘤病毒有关的癌症。对2v Cervarix™和4v Gardasil®的临床试验研究表明,接种这两种疫苗中的任何一种都能提供一定程度的保护,防止与疫苗中所含类型密切相关的其他HPV类型。在这里,我们对针对HPV16、18和58的3v HPV疫苗在恒河猴中诱导交叉中和抗体的能力进行了初步评估,该疫苗是专门为中国女性设计的。我们发现该疫苗在恒河猴体内诱导抗非疫苗型HPV抗体的能力不低于Gardasil®。这些结果从免疫原性的角度提供了证据,证明KLWS 3v HPV疫苗是目前市场上进口的2v和4v HPV疫苗的有力竞争对手。
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引用次数: 0
Erratum regarding missing Declaration of Competing Interest statements in previously published articles 关于先前发表的文章中缺少竞争利益声明的勘误表
IF 3.2 Pub Date : 2020-12-01 DOI: 10.1016/j.pvr.2020.100210
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引用次数: 0
Long-term immunogenicity, effectiveness, and safety of nine-valent human papillomavirus vaccine in girls and boys 9 to 15 years of age: Interim analysis after 8 years of follow-up 九价人乳头瘤病毒疫苗在9至15岁女孩和男孩中的长期免疫原性、有效性和安全性:8年随访后的中期分析
IF 3.2 Pub Date : 2020-12-01 DOI: 10.1016/j.pvr.2020.100203
Sven-Eric Olsson , Jaime Alberto Restrepo , Julio Cesar Reina , Punnee Pitisuttithum , Angels Ulied , Meera Varman , Pierre Van Damme , Edson Duarte Moreira Jr. , Daron Ferris , Stanley Block , Oliver Bautista , Nancy Gallagher , Jennifer McCauley , Alain Luxembourg

Background

The nine-valent human papillomavirus (9vHPV) vaccine protects against infection and disease related to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58. The pivotal 36-month Phase III immunogenicity study of 9vHPV vaccine in 9- to 15-year-old girls and boys was extended to assess long-term immunogenicity and effectiveness through approximately 10 years after vaccination. We describe results of an interim analysis based on approximately 8 years of follow-up after vaccination.

Methods

Participants aged 9–15 years who received three doses of 9vHPV vaccine (at day 1, month 2, and month 6) in the base study and consented to follow-up were enrolled in the long-term follow-up study extension (N = 1272 [females, n = 971; males, n = 301]). Serum was collected at months 66 and 90 to assess antibody responses. For effectiveness analysis, genital swabs were collected (to assess HPV DNA by polymerase chain reaction [PCR]) and external genital examination was conducted (to detect external genital lesions) every 6 months starting when the participant reached 16 years of age. Cervical cytology tests were conducted annually when female participants reached 21 years of age; participants with cytological abnormalities were triaged to colposcopy based on a protocol-specified algorithm. External genital and cervical biopsies of abnormal lesions were performed, and histological diagnoses were adjudicated by a pathology panel. Specimens were tested by PCR to detect HPV DNA.

Results

Geometric mean titers for each 9vHPV vaccine HPV type peaked around month 7 and gradually decreased through month 90. Seropositivity rates remained >90% through month 90 for each of the 9vHPV vaccine types by HPV immunoglobulin Luminex Immunoassay. No cases of HPV6/11/16/18/31/33/45/52/58-related high-grade intraepithelial neoplasia or genital warts were observed in the per-protocol population (n = 1107) based on a maximum follow-up of 8.2 years (median 7.6 years) post-Dose 3. Incidence rates of HPV6/11/16/18/31/33/45/52/58-related 6-month persistent infection in females and males were 49.2 and 37.3 per 10,000 person-years, respectively, which were within ranges expected in vaccinated cohorts. There were no vaccine-related SAEs or deaths during the period covered by this interim analysis.

Conclusions

The 9vHPV vaccine provided sustained immunogenicity and durable effectiveness through approximately 7 and 8 years, respectively, following vaccination of girls and boys aged 9–15 years.

背景:九价人乳头瘤病毒(9vHPV)疫苗可预防与HPV 6、11、16、18、31、33、45、52和58型相关的感染和疾病。在9- 15岁的女孩和男孩中进行的为期36个月的9vHPV疫苗的三期免疫原性研究被扩展到评估接种后大约10年的长期免疫原性和有效性。我们描述了一项基于疫苗接种后约8年随访的中期分析结果。在基础研究中接受三剂9vHPV疫苗(分别在第1天、第2个月和第6个月)并同意随访的9-15岁参与者被纳入长期随访研究扩展(N = 1272[女性,N = 971;男性,n = 301])。在第66个月和第90个月采集血清以评估抗体反应。为了进行有效性分析,从参与者年满16岁开始,每6个月收集生殖器拭子(通过聚合酶链反应[PCR]评估HPV DNA)并进行外生殖器检查(检测外生殖器病变)。当女性参与者达到21岁时,每年进行宫颈细胞学检查;细胞学异常的参与者根据协议指定的算法进行阴道镜检查。外部生殖器和宫颈活检异常病变进行,组织学诊断裁定病理小组。采用PCR检测标本的HPV DNA。结果每种9vHPV疫苗的几何平均滴度在第7个月左右达到峰值,并在第90个月逐渐下降。通过人乳头瘤病毒免疫球蛋白Luminex免疫测定,到第90个月,每种9vHPV疫苗类型的血清阳性率保持在90%。根据3剂后最长8.2年(中位7.6年)的随访,在按方案人群(n = 1107)中未观察到hpv6 /11/16/18/31/33/45/52/58相关的高级别上皮内瘤变或生殖器疣病例。hpv6 /11/16/18/31/33/45/52/58相关的6个月持续感染在女性和男性中的发病率分别为49.2 / 10000人-年和37.3 / 10000人-年,这在接种疫苗队列的预期范围内。在本中期分析所涵盖的期间内,没有发生与疫苗有关的急性呼吸道感染或死亡。结论9vHPV疫苗在9-15岁的女孩和男孩接种后分别提供了大约7年和8年的持续免疫原性和持久有效性。
{"title":"Long-term immunogenicity, effectiveness, and safety of nine-valent human papillomavirus vaccine in girls and boys 9 to 15 years of age: Interim analysis after 8 years of follow-up","authors":"Sven-Eric Olsson ,&nbsp;Jaime Alberto Restrepo ,&nbsp;Julio Cesar Reina ,&nbsp;Punnee Pitisuttithum ,&nbsp;Angels Ulied ,&nbsp;Meera Varman ,&nbsp;Pierre Van Damme ,&nbsp;Edson Duarte Moreira Jr. ,&nbsp;Daron Ferris ,&nbsp;Stanley Block ,&nbsp;Oliver Bautista ,&nbsp;Nancy Gallagher ,&nbsp;Jennifer McCauley ,&nbsp;Alain Luxembourg","doi":"10.1016/j.pvr.2020.100203","DOIUrl":"10.1016/j.pvr.2020.100203","url":null,"abstract":"<div><h3>Background</h3><p>The nine-valent human papillomavirus (9vHPV) vaccine protects against infection and disease related to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58. The pivotal 36-month Phase III immunogenicity study of 9vHPV vaccine in 9- to 15-year-old girls and boys was extended to assess long-term immunogenicity and effectiveness through approximately 10 years after vaccination. We describe results of an interim analysis based on approximately 8 years of follow-up after vaccination.</p></div><div><h3>Methods</h3><p>Participants aged 9–15 years who received three doses of 9vHPV vaccine (at day 1, month 2, and month 6) in the base study and consented to follow-up were enrolled in the long-term follow-up study extension (N = 1272 [females, n = 971; males, n = 301]). Serum was collected at months 66 and 90 to assess antibody responses. For effectiveness analysis, genital swabs were collected (to assess HPV DNA by polymerase chain reaction [PCR]) and external genital examination was conducted (to detect external genital lesions) every 6 months starting when the participant reached 16 years of age. Cervical cytology tests were conducted annually when female participants reached 21 years of age; participants with cytological abnormalities were triaged to colposcopy based on a protocol-specified algorithm. External genital and cervical biopsies of abnormal lesions were performed, and histological diagnoses were adjudicated by a pathology panel. Specimens were tested by PCR to detect HPV DNA.</p></div><div><h3>Results</h3><p>Geometric mean titers for each 9vHPV vaccine HPV type peaked around month 7 and gradually decreased through month 90. Seropositivity rates remained &gt;90% through month 90 for each of the 9vHPV vaccine types by HPV immunoglobulin Luminex Immunoassay. No cases of HPV6/11/16/18/31/33/45/52/58-related high-grade intraepithelial neoplasia or genital warts were observed in the per-protocol population (n = 1107) based on a maximum follow-up of 8.2 years (median 7.6 years) post-Dose 3. Incidence rates of HPV6/11/16/18/31/33/45/52/58-related 6-month persistent infection in females and males were 49.2 and 37.3 per 10,000 person-years, respectively, which were within ranges expected in vaccinated cohorts. There were no vaccine-related SAEs or deaths during the period covered by this interim analysis.</p></div><div><h3>Conclusions</h3><p>The 9vHPV vaccine provided sustained immunogenicity and durable effectiveness through approximately 7 and 8 years, respectively, following vaccination of girls and boys aged 9–15 years.</p></div>","PeriodicalId":46835,"journal":{"name":"Papillomavirus Research","volume":"10 ","pages":"Article 100203"},"PeriodicalIF":3.2,"publicationDate":"2020-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.pvr.2020.100203","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38155089","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 29
Strong reduction in prevalence of HPV16/18 and closely related HPV types in sexually active adolescent women following the introduction of HPV vaccination in Argentina 在阿根廷引入HPV疫苗接种后,性活跃的青春期妇女中HPV16/18和密切相关的HPV类型的患病率大幅下降
IF 3.2 Pub Date : 2020-12-01 DOI: 10.1016/j.pvr.2020.100208
Joaquín Víctor González , Gerardo Daniel Deluca , Rita Mariel Correa , Domingo Javier Liotta , Jorge Alejandro Basiletti , María Dolores Fellner , María Celeste Colucci , Olga Gabriela Alzogaray , Nathalia Katz , Juan José Carmona , Néstor Fabián Tappari , Enrique Berner , Viviana Cramer , Paula Real , Carlota Viviana López Kaufman , Gabriela Judit Kosoy , Lucía Katabian , María Silvia Severino , Ricardo Enrique Aboslaiman , Cecilia Chami , María Alejandra Picconi
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引用次数: 5
Prevalence, incidence, and natural history of HPV infection in adult women ages 24 to 45 participating in a vaccine trial 参与疫苗试验的24至45岁成年女性HPV感染的患病率、发病率和自然史
IF 3.2 Pub Date : 2020-12-01 DOI: 10.1016/j.pvr.2020.100202
Daron G. Ferris , Darron R. Brown , Anna R. Giuliano , Evan Myers , Elmar A. Joura , Suzanne M. Garland , Susanne K. Kjaer , Gonzalo Perez , Alfred Saah , Alain Luxembourg , Christine Velicer

Objectives

The natural history of human papillomavirus (HPV) infection has been studied extensively in young women; this study investigated HPV infection in adult women.

Methods

Data from 3817 women aged 24–45 years in a global trial of the 4-valent HPV (6/11/16/18) vaccine were used to calculate prevalence of anogenital infections containing 9-valent (9v) HPV vaccine types (6/11/16/18/31/33/45/52/58) and five non-vaccine types (35/39/51/56/59). Incidence of infections and persistent infections was estimated for 989 placebo recipients naive to all 14 HPV types at baseline. Age-adjusted hazard ratios were calculated for various sociodemographic factors.

Results

Prevalence of anogenital infection was highest in France at 29.2% (9vHPV types) and 21.7% (non-vaccine types) and lowest in the Philippines at 7.6% (9vHPV types) and 5.1% (non-vaccine types). Overall, HPV incidence (per 100 person-years) was 5.2 (9vHPV types) and 4.7 (non-vaccine types), and incidence of persistent infection was 2.7 (9vHPV types) and 2.1 (non-vaccine types). Factors associated with new HPV infections included younger age, younger age at first intercourse, being single, current use of tobacco, and higher number of past and recent sex partners.

Conclusions

Because mid-adult women acquire new HPV infections, administration of the 9vHPV vaccine could reduce HPV-related morbidity and mortality in this population.

目的广泛研究年轻女性人乳头瘤病毒(HPV)感染的自然病史;本研究调查了成年女性的HPV感染情况。方法在一项全球4价HPV(6/11/16/18)疫苗试验中,使用3817名24-45岁女性的数据,计算9价(9v) HPV疫苗类型(6/11/16/18/31/33/45/52/58)和5种非疫苗类型(35/39/51/56/59)的肛门生殖器感染患病率。在基线时,对所有14种HPV类型的989名安慰剂接受者的感染和持续感染发生率进行了估计。计算了各种社会人口因素的年龄校正风险比。结果法国肛门生殖器感染的患病率最高,为29.2% (9vHPV型)和21.7%(非疫苗型),菲律宾最低,为7.6% (9vHPV型)和5.1%(非疫苗型)。总体而言,HPV发病率(每100人年)为5.2 (9vHPV型)和4.7(非疫苗型),持续感染的发病率为2.7 (9vHPV型)和2.1(非疫苗型)。与新发HPV感染相关的因素包括年龄更小、初次性行为年龄更小、单身、目前使用烟草以及过去和最近的性伴侣数量更多。结论由于中年妇女出现新的HPV感染,接种9vHPV疫苗可降低该人群中HPV相关的发病率和死亡率。
{"title":"Prevalence, incidence, and natural history of HPV infection in adult women ages 24 to 45 participating in a vaccine trial","authors":"Daron G. Ferris ,&nbsp;Darron R. Brown ,&nbsp;Anna R. Giuliano ,&nbsp;Evan Myers ,&nbsp;Elmar A. Joura ,&nbsp;Suzanne M. Garland ,&nbsp;Susanne K. Kjaer ,&nbsp;Gonzalo Perez ,&nbsp;Alfred Saah ,&nbsp;Alain Luxembourg ,&nbsp;Christine Velicer","doi":"10.1016/j.pvr.2020.100202","DOIUrl":"10.1016/j.pvr.2020.100202","url":null,"abstract":"<div><h3>Objectives</h3><p>The natural history of human papillomavirus (HPV) infection has been studied extensively in young women; this study investigated HPV infection in adult women.</p></div><div><h3>Methods</h3><p>Data from 3817 women aged 24–45 years in a global trial of the 4-valent HPV (6/11/16/18) vaccine were used to calculate prevalence of anogenital infections containing 9-valent (9v) HPV vaccine types (6/11/16/18/31/33/45/52/58) and five non-vaccine types (35/39/51/56/59). Incidence of infections and persistent infections was estimated for 989 placebo recipients naive to all 14 HPV types at baseline. Age-adjusted hazard ratios were calculated for various sociodemographic factors.</p></div><div><h3>Results</h3><p>Prevalence of anogenital infection was highest in France at 29.2% (9vHPV types) and 21.7% (non-vaccine types) and lowest in the Philippines at 7.6% (9vHPV types) and 5.1% (non-vaccine types). Overall, HPV incidence (per 100 person-years) was 5.2 (9vHPV types) and 4.7 (non-vaccine types), and incidence of persistent infection was 2.7 (9vHPV types) and 2.1 (non-vaccine types). Factors associated with new HPV infections included younger age, younger age at first intercourse, being single, current use of tobacco, and higher number of past and recent sex partners.</p></div><div><h3>Conclusions</h3><p>Because mid-adult women acquire new HPV infections, administration of the 9vHPV vaccine could reduce HPV-related morbidity and mortality in this population.</p></div>","PeriodicalId":46835,"journal":{"name":"Papillomavirus Research","volume":"10 ","pages":"Article 100202"},"PeriodicalIF":3.2,"publicationDate":"2020-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.pvr.2020.100202","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"37982420","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 20
期刊
Papillomavirus Research
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