Pub Date : 2020-12-01DOI: 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.
{"title":"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","authors":"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","doi":"10.1016/j.pvr.2020.100207","DOIUrl":"10.1016/j.pvr.2020.100207","url":null,"abstract":"<div><p>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.</p><p>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.</p><p>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.</p><p>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.</p></div>","PeriodicalId":46835,"journal":{"name":"Papillomavirus Research","volume":"10 ","pages":"Article 100207"},"PeriodicalIF":3.2,"publicationDate":"2020-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.pvr.2020.100207","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38415961","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}
Pub Date : 2020-12-01DOI: 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.
{"title":"CINtec PLUS and cobas HPV testing for triaging Canadian women referred to colposcopy with a history of low-grade squamous intraepithelial lesion: Baseline findings","authors":"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","doi":"10.1016/j.pvr.2020.100206","DOIUrl":"10.1016/j.pvr.2020.100206","url":null,"abstract":"<div><h3>Objective and methods</h3><p>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.</p></div><div><h3>Results</h3><p>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).</p></div><div><h3>Conclusions</h3><p>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.</p></div>","PeriodicalId":46835,"journal":{"name":"Papillomavirus Research","volume":"10 ","pages":"Article 100206"},"PeriodicalIF":3.2,"publicationDate":"2020-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.pvr.2020.100206","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38290620","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}
Pub Date : 2020-12-01DOI: 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.
{"title":"Associations between risk-perception, self-efficacy and vaccine response-efficacy and parent/guardian decision-making regarding adolescent HPV vaccination","authors":"Alicia Myhre, Tiaj Xiong , Rachel I. Vogel, Deanna Teoh","doi":"10.1016/j.pvr.2020.100204","DOIUrl":"10.1016/j.pvr.2020.100204","url":null,"abstract":"<div><h3>Objectives</h3><p>To evaluate associations of risk perception, self-efficacy and response-efficacy with HPV vaccination decisions among parents/guardians of adolescents.</p></div><div><h3>Methods</h3><p>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.</p></div><div><h3>Results</h3><p>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.</p></div><div><h3>Conclusions</h3><p>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.</p></div>","PeriodicalId":46835,"journal":{"name":"Papillomavirus Research","volume":"10 ","pages":"Article 100204"},"PeriodicalIF":3.2,"publicationDate":"2020-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.pvr.2020.100204","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38225871","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}
Pub Date : 2020-12-01DOI: 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.
{"title":"Multiple HPV infections among men who have sex with men engaged in anal cancer screening in Abuja, Nigeria","authors":"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","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 > 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}
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.
{"title":"Post-hoc analysis of injection-site reactions following vaccination with quadrivalent human papillomavirus vaccine in Japanese female clinical trial participants","authors":"Shinya Murata, Masayoshi Shirakawa, Yoshie Sugawara, Michiko Shuto, Miyuki Sawata, Yoshiyuki Tanaka","doi":"10.1016/j.pvr.2020.100205","DOIUrl":"10.1016/j.pvr.2020.100205","url":null,"abstract":"<div><h3>Aim</h3><p>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.</p></div><div><h3>Methods</h3><p>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.</p></div><div><h3>Results</h3><p>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.</p></div><div><h3>Conclusions</h3><p>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.</p></div><div><h3>Trial registration</h3><p>Clinicaltrials. gov: NCT00378560 and NCT00411749.</p></div>","PeriodicalId":46835,"journal":{"name":"Papillomavirus Research","volume":"10 ","pages":"Article 100205"},"PeriodicalIF":3.2,"publicationDate":"2020-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.pvr.2020.100205","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38291457","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}
Pub Date : 2020-12-01DOI: 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.
{"title":"Cross-neutralizing antibody titres against non-vaccine types induced by a recombinant trivalent HPV vaccine (16/18/58) in rhesus macaques","authors":"Yan Wang , Yuying Liu , Shutian Liang , Fei Yin , Haijiang Zhang , Yongjiang Liu","doi":"10.1016/j.pvr.2020.100209","DOIUrl":"10.1016/j.pvr.2020.100209","url":null,"abstract":"<div><p>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.</p></div>","PeriodicalId":46835,"journal":{"name":"Papillomavirus Research","volume":"10 ","pages":"Article 100209"},"PeriodicalIF":3.2,"publicationDate":"2020-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.pvr.2020.100209","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38714277","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}
Pub Date : 2020-12-01DOI: 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.
{"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 , 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","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 >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}
Pub Date : 2020-12-01DOI: 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.
{"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 , 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","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}