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1. High Risk of New HPV Infection Acquisition Among Unvaccinated Young Men.

Author

Goldstone, Stephen, Dubin, Brady, Saah, Alfred, Luxembourg, Alain, Velicer, Christine, Tota, Joseph, Giuliano, Anna, and Palefsky, Joel

Subjects
HPV infection, HPV vaccines, human papillomavirus, Humans, Male, Homosexuality, Male, Papillomavirus Infections, Papillomaviridae, Sexual and Gender Minorities, Papillomavirus Vaccines
Abstract

BACKGROUND: International data on anogenital HPV infection incidence among men are limited. METHODS: Incidence of incident-persistent (IP) anogenital HPV infections was evaluated among 295 men who have sex with men (MSM) and 1576 heterosexual men (HM) aged 16-27 years in the placebo arm of a global, multicenter 4-valent (4v) HPV vaccine trial. We estimated IP incidence (penile/scrotal, perineal/perianal, anal) for 4vHPV and 9-valent (9v) HPV vaccine types and cumulative IP incidence over 36 months. RESULTS: IP infection incidence per 100 person-years (95% CI) among HM for 4vHPV and 9vHPV types was 4.1 (3.5-4.9) and 6.8 (5.9-7.6) at penile/scrotal, and 1.2 (.8-1.6) and 1.9 (1.5-2.4) at perineal/perianal sites, respectively; and among MSM, IP infection incidence was 2.3 (1.3-3.8) and 3.2 (2.0-4.9) at penile/scrotal, 6.8 (4.9-9.2) and 9.0 (6.9-11.6) at perineal/perianal, and 12.0 (9.4-15.1) and 16.8 (13.7-20.2) at anal sites, respectively. Cumulative IP incidence over 36 months (excluding anal canal; any 9vHPV type) was higher among MSM versus HM (24.1% vs 18.4%). CONCLUSIONS: A substantial proportion of unvaccinated men of catch-up vaccination age developed IP 9vHPV-related infections. Gender-neutral vaccination could decrease male HPV infection, contribute to herd protection, and reduce disease burden. Clinical Trials Registration. NCT00090285.

Published
2024

3. Efficacy, immunogenicity, and safety of a quadrivalent HPV vaccine in men: results of an open-label, long-term extension of a randomised, placebo-controlled, phase 3 trial

Author

Goldstone, Stephen E, Giuliano, Anna R, Palefsky, Joel M, Lazcano-Ponce, Eduardo, Penny, Mary E, Cabello, Robinson E, Moreira, Edson D, Jr, Baraldi, Ezio, Jessen, Heiko, Ferenczy, Alex, Kurman, Robert, Ronnett, Brigitte M, Stoler, Mark H, Bautista, Oliver, Das, Rituparna, Group, Thomas, Luxembourg, Alain, Zhou, Hao Jin, and Saah, Alfred

Published
2022
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4. Final analysis of a 14-year long-term follow-up study of the effectiveness and immunogenicity of the quadrivalent human papillomavirus vaccine in women from four nordic countries

Author

Kjaer, Susanne K., Nygård, Mari, Sundström, Karin, Dillner, Joakim, Tryggvadottir, Laufey, Munk, Christian, Berger, Sophie, Enerly, Espen, Hortlund, Maria, Ágústsson, Ágúst Ingi, Bjelkenkrantz, Kaj, Fridrich, Katrin, Guðmundsdóttir, Ingibjorg, Sørbye, Sveinung Wergeland, Bautista, Oliver, Group, Thomas, Luxembourg, Alain, Marshall, J. Brooke, Radley, David, Yang, Yi Shen, Badshah, Cyrus, and Saah, Alfred

Published
2020
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7. Immunogenicity and Safety of the Quadrivalent Human Papillomavirus Vaccine in HIV-1–Infected Women

Author

Kojic, Erna Milunka, Kang, Minhee, Cespedes, Michelle S, Umbleja, Triin, Godfrey, Catherine, Allen, Reena T, Firnhaber, Cynthia, Grinsztejn, Beatriz, Palefsky, Joel M, Webster-Cyriaque, Jennifer Y, Saah, Alfred, Aberg, Judith A, and Cu-Uvin, Susan

Subjects
Clinical Research, HPV and/or Cervical Cancer Vaccines, Clinical Trials and Supportive Activities, Prevention, Sexually Transmitted Infections, Cancer, Infectious Diseases, HIV/AIDS, Immunization, Vaccine Related, Infection, Good Health and Well Being, Adolescent, Adult, Antibodies, Viral, Brazil, CD4 Lymphocyte Count, Drug-Related Side Effects and Adverse Reactions, Female, HIV Infections, HIV-1, Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18, Humans, Middle Aged, Papillomaviridae, Papillomavirus Infections, Papillomavirus Vaccines, South Africa, United States, Vaccination, Viral Load, Young Adult, HPV vaccine, HIV-infected women, immunogenicity, vaccine safety, anogenital disease, Biological Sciences, Medical and Health Sciences, Microbiology
Abstract

BackgroundWomen infected with human immunodeficiency virus (HIV) are disproportionately affected by human papillomavirus (HPV)-related anogenital disease, particularly with increased immunosuppression. AIDS Clinical Trials Group protocol A5240 was a trial of 319 HIV-infected women in the United States, Brazil, and South Africa to determine immunogenicity and safety of the quadrivalent HPV vaccine in 3 strata based on screening CD4 count: >350 (stratum A), 201-350 (stratum B), and ≤200 cells/µL (stratum C).MethodsSafety and serostatus of HPV types 6, 11, 16, and 18 were examined. HPV serological testing was performed using competitive Luminex immunoassay (HPV-4 cLIA). HPV type-specific seroconversion analysis was done for participants who were seronegative for the given type at baseline.ResultsMedian age of patients was 36 years; 11% were white, 56% black, and 31% Hispanic. Median CD4 count was 310 cells/µL, and 40% had undetectable HIV-1 load. No safety issues were identified. Seroconversion proportions among women at week 28 for HPV types 6, 11,16, and 18 were 96%, 98%, 99%, and 91%, respectively, for stratum A; 100%, 98%, 98%, and 85%, respectively, for stratum B, and 84%, 92%, 93%, and 75%, respectively, for stratum C.ConclusionsThe quadrivalent HPV vaccine targeted at types 6, 11, 16, and 18 was safe and immunogenic in HIV-infected women aged 13-45 years. Women with HIV RNA load >10 000 copies/mL and/or CD4 count

Published
2014

8. High Risk of New HPV Infection Acquisition Among Unvaccinated Young Men.

Author

Giuliano, Anna R, Palefsky, Joel M, Goldstone, Stephen E, Dubin, Brady, Saah, Alfred, Luxembourg, Alain, Velicer, Christine, and Tota, Joseph E

Abstract

Background International data on anogenital HPV infection incidence among men are limited. Methods Incidence of incident-persistent (IP) anogenital HPV infections was evaluated among 295 men who have sex with men (MSM) and 1576 heterosexual men (HM) aged 16–27 years in the placebo arm of a global, multicenter 4-valent (4v) HPV vaccine trial. We estimated IP incidence (penile/scrotal, perineal/perianal, anal) for 4vHPV and 9-valent (9v) HPV vaccine types and cumulative IP incidence over 36 months. Results IP infection incidence per 100 person-years (95% CI) among HM for 4vHPV and 9vHPV types was 4.1 (3.5–4.9) and 6.8 (5.9–7.6) at penile/scrotal, and 1.2 (.8–1.6) and 1.9 (1.5–2.4) at perineal/perianal sites, respectively; and among MSM, IP infection incidence was 2.3 (1.3–3.8) and 3.2 (2.0–4.9) at penile/scrotal, 6.8 (4.9–9.2) and 9.0 (6.9–11.6) at perineal/perianal, and 12.0 (9.4–15.1) and 16.8 (13.7–20.2) at anal sites, respectively. Cumulative IP incidence over 36 months (excluding anal canal; any 9vHPV type) was higher among MSM versus HM (24.1% vs 18.4%). Conclusions A substantial proportion of unvaccinated men of catch-up vaccination age developed IP 9vHPV-related infections. Gender-neutral vaccination could decrease male HPV infection, contribute to herd protection, and reduce disease burden. Clinical Trials Registration. NCT00090285. [ABSTRACT FROM AUTHOR]

Published
2024
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9. High Baseline Anal Human Papillomavirus and Abnormal Anal Cytology in a Phase 3 Trial of the Quadrivalent Human Papillomavirus Vaccine in Human Immunodeficiency Virus–Infected Individuals Older Than 26 Years : ACTG 5298

Author

the ACTG 5298 Study Team, Cranston, Ross D., Cespedes, Michelle S., Paczuski, Pawel, Yang, Ming, Coombs, Robert W., Dragavon, Joan, Saah, Alfred, Godfrey, Catherine, Webster-Cyriaque, Jennifer Y., Chiao, Elizabeth Y., Bastow, Barbara, and Wilkin, Timothy

Published
2018

11. High-Grade Anal Intraepithelial Neoplasia Among HIV-1-Infected Men Screening for a Multicenter Clinical Trial of a Human Papillomavirus Vaccine

Author

Wilkin, Timothy, Lee, Jeannette Y, Lensing, Shelly Y, Stier, Elizabeth A, Goldstone, Stephen E, Berry, Michael J, Jay, Naomi, Aboulafia, David M, Einstein, Mark H, Saah, Alfred, Mitsuyasu, Ronald T, and Palefsky, Joel M

Subjects
HIV/AIDS, Infectious Diseases, Clinical Trials and Supportive Activities, Vaccine Related, Sexually Transmitted Infections, Immunization, Clinical Research, Prevention, Cancer, Cervical Cancer, Digestive Diseases, Infection, Good Health and Well Being, Acquired Immunodeficiency Syndrome, Adult, Anus Neoplasms, CD4 Lymphocyte Count, Carcinoma in Situ, HIV-1, Human papillomavirus 16, Humans, Male, Middle Aged, Papillomavirus Vaccines, Vaccination, anal infection, anal intraepithelial neoplasia, HIV-1 infection, human papillomavirus, male
Abstract

PurposeHigh-grade anal intraepithelial neoplasia (HGAIN) is the precursor lesion to invasive anal cancer. Human papillomavirus (HPV) vaccination holds great promise for preventing anal cancer.MethodsWe examined 235 HIV-1-infected men screening for participation in a multisite clinical trial of a quadrivalent HPV vaccine. All participants had anal swabs obtained for HPV testing and cytology and high-resolution anoscopy with biopsies of visible lesions to assess for HGAIN.ResultsHPV types 16 and 18 were detected in 23% and 10%, respectively; abnormal anal cytology was found in 56% and HGAIN in 30%. HGAIN prevalence was significantly higher in those with HPV16 detection compared to those without (38% vs 17%; P = .01). Use of antiretroviral therapy and nadir and current CD4+ cell count were not associated with abnormal anal cytology or HGAIN.ConclusionHGAIN is highly prevalent in HIV-infected men. Further studies are needed on treatment and prevention of HGAIN.

Published
2013

12. Data from A Pooled Analysis of Continued Prophylactic Efficacy of Quadrivalent Human Papillomavirus (Types 6/11/16/18) Vaccine against High-grade Cervical and External Genital Lesions

Author

Kjaer, Susanne K., primary, Sigurdsson, Kristján, primary, Iversen, Ole-Erik, primary, Hernandez-Avila, Mauricio, primary, Wheeler, Cosette M., primary, Perez, Gonzalo, primary, Brown, Darron R., primary, Koutsky, Laura A., primary, Tay, Eng Hseon, primary, García, Patricia, primary, Ault, Kevin A., primary, Garland, Suzanne M., primary, Leodolter, Sepp, primary, Olsson, Sven-Eric, primary, Tang, Grace W.K., primary, Ferris, Daron G., primary, Paavonen, Jorma, primary, Lehtinen, Matti, primary, Steben, Marc, primary, Bosch, F. Xavier, primary, Dillner, Joakim, primary, Joura, Elmar A., primary, Majewski, Slawomir, primary, Muñoz, Nubia, primary, Myers, Evan R., primary, Villa, Luisa L., primary, Taddeo, Frank J., primary, Roberts, Christine, primary, Tadesse, Amha, primary, Bryan, Janine, primary, Maansson, Roger, primary, Lu, Shuang, primary, Vuocolo, Scott, primary, Hesley, Teresa M., primary, Saah, Alfred, primary, Barr, Eliav, primary, and Haupt, Richard M., primary

Published
2023
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13. Supplementary Tables 1-2 from A Pooled Analysis of Continued Prophylactic Efficacy of Quadrivalent Human Papillomavirus (Types 6/11/16/18) Vaccine against High-grade Cervical and External Genital Lesions

Author

Kjaer, Susanne K., primary, Sigurdsson, Kristján, primary, Iversen, Ole-Erik, primary, Hernandez-Avila, Mauricio, primary, Wheeler, Cosette M., primary, Perez, Gonzalo, primary, Brown, Darron R., primary, Koutsky, Laura A., primary, Tay, Eng Hseon, primary, García, Patricia, primary, Ault, Kevin A., primary, Garland, Suzanne M., primary, Leodolter, Sepp, primary, Olsson, Sven-Eric, primary, Tang, Grace W.K., primary, Ferris, Daron G., primary, Paavonen, Jorma, primary, Lehtinen, Matti, primary, Steben, Marc, primary, Bosch, F. Xavier, primary, Dillner, Joakim, primary, Joura, Elmar A., primary, Majewski, Slawomir, primary, Muñoz, Nubia, primary, Myers, Evan R., primary, Villa, Luisa L., primary, Taddeo, Frank J., primary, Roberts, Christine, primary, Tadesse, Amha, primary, Bryan, Janine, primary, Maansson, Roger, primary, Lu, Shuang, primary, Vuocolo, Scott, primary, Hesley, Teresa M., primary, Saah, Alfred, primary, Barr, Eliav, primary, and Haupt, Richard M., primary

Published
2023
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17. Supplementary Tables 1-2 from Attribution of 12 High-Risk Human Papillomavirus Genotypes to Infection and Cervical Disease

Author

Joura, Elmar A., primary, Ault, Kevin A., primary, Bosch, F. Xavier, primary, Brown, Darron, primary, Cuzick, Jack, primary, Ferris, Daron, primary, Garland, Suzanne M., primary, Giuliano, Anna R., primary, Hernandez-Avila, Mauricio, primary, Huh, Warner, primary, Iversen, Ole-Erik, primary, Kjaer, Susanne K., primary, Luna, Joaquin, primary, Miller, Dianne, primary, Monsonego, Joseph, primary, Munoz, Nubia, primary, Myers, Evan, primary, Paavonen, Jorma, primary, Pitisuttithum, Punnee, primary, Steben, Marc, primary, Wheeler, Cosette M., primary, Perez, Gonzalo, primary, Saah, Alfred, primary, Luxembourg, Alain, primary, Sings, Heather L., primary, and Velicer, Christine, primary

Published
2023
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18. Supplementary Material from Attribution of 12 High-Risk Human Papillomavirus Genotypes to Infection and Cervical Disease

Author

Joura, Elmar A., primary, Ault, Kevin A., primary, Bosch, F. Xavier, primary, Brown, Darron, primary, Cuzick, Jack, primary, Ferris, Daron, primary, Garland, Suzanne M., primary, Giuliano, Anna R., primary, Hernandez-Avila, Mauricio, primary, Huh, Warner, primary, Iversen, Ole-Erik, primary, Kjaer, Susanne K., primary, Luna, Joaquin, primary, Miller, Dianne, primary, Monsonego, Joseph, primary, Munoz, Nubia, primary, Myers, Evan, primary, Paavonen, Jorma, primary, Pitisuttithum, Punnee, primary, Steben, Marc, primary, Wheeler, Cosette M., primary, Perez, Gonzalo, primary, Saah, Alfred, primary, Luxembourg, Alain, primary, Sings, Heather L., primary, and Velicer, Christine, primary

Published
2023
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21. Real-world impact and effectiveness of the quadrivalent HPV vaccine: an updated systematic literature review

Author

Wang, Wei (Vivian), primary, Kothari, Smita, additional, Skufca, Jozica, additional, Giuliano, Anna R., additional, Sundström, Karin, additional, Nygård, Mari, additional, Koro, Carol, additional, Baay, Marc, additional, Verstraeten, Thomas, additional, Luxembourg, Alain, additional, Saah, Alfred J., additional, and Garland, Suzanne M., additional

Published
2022
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24. Effectiveness, immunogenicity, and safety of the quadrivalent HPV vaccine in women and men aged 27–45 years

Author

Maldonado, Ivette, primary, Plata, Manuel, additional, Gonzalez, Mauricio, additional, Correa, Alfonso, additional, Nossa, Claudia, additional, Giuliano, Anna R., additional, Joura, Elmar A., additional, Ferenczy, Alex, additional, Ronnett, Brigitte M., additional, Stoler, Mark H., additional, Jin Zhou, Hao, additional, Joshi, Amita, additional, Das, Rituparna, additional, Bautista, Oliver, additional, Group, Thomas, additional, Luxembourg, Alain, additional, Saah, Alfred, additional, and Buchwald, Ulrike Kirsten, additional

Published
2022
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25. Human Papillomavirus Genotypes From Vaginal and Vulvar Intraepithelial Neoplasia in Females 15–26 Years of Age

Author

Garland, Suzanne M., Joura, Elmar A., Ault, Kevin A., Bosch, F. Xavier, Brown, Darron R., Castellsagué, Xavier, Ferenczy, Alex, Ferris, Daron G., Giuliano, Anna R., Hernandez-Avila, Mauricio, Huh, Warner K., Iversen, Ole-Erik, Kjaer, Susanne K., Kurman, Robert J., Luna, Joaquin, Monsonego, Joseph, Muñoz, Nubia, Paavonen, Jorma, Pitisuttihum, Punnee, Ronnett, Brigitte M., Steben, Marc, Stoler, Mark H., Wheeler, Cosette M., Wiley, Dorothy J., Perez, Gonzalo, Saah, Alfred J., Luxembourg, Alain, Li, Se, DiNubile, Mark J., Wagner, Monika, and Velicer, Christine

Published
2018
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26. Human papillomavirus seroprevalence and seroconversion following baseline detection of nine human papillomavirus types in young women

Author

Brown, Darron R., primary, Castellsagué, Xavier, additional, Ferris, Daron, additional, Garland, Suzanne M., additional, Huh, Warner, additional, Steben, Marc, additional, Wheeler, Cosette M., additional, Saah, Alfred, additional, Luxembourg, Alain, additional, Li, Se, additional, and Velicer, Christine, additional

Published
2022
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31. Modeling the health and economic implications of adopting a 1-dose 9-valent human papillomavirus vaccination regimen in a high-income country setting: An analysis in the United Kingdom

Author

Daniels, Vincent, primary, Saxena, Kunal, additional, Patterson-Lomba, Oscar, additional, Gomez-Lievano, Andres, additional, Saah, Alfred, additional, Luxembourg, Alain, additional, Velicer, Christine, additional, Chen, Ya-Ting, additional, and Elbasha, Elamin, additional

Published
2022
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37. Safety, immunogenicity, and efficacy of quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine in women aged 24–45 years: a randomised, double-blind trial

Author

Muñoz, Nubia, Manalastas, Ricardo, Jr, Pitisuttithum, Punee, Tresukosol, Damrong, Monsonego, Joseph, Ault, Kevin, Clavel, Christine, Luna, Joaquin, Myers, Evan, Hood, Sara, Bautista, Oliver, Bryan, Janine, Taddeo, Frank J, Esser, Mark T, Vuocolo, Scott, Haupt, Richard M, Barr, Eliav, and Saah, Alfred

Published
2009
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39. The Discipline of Epidemiology

Author

Willett, Walter, Greenland, Sander, MacMahon, Brian, Trichopoulos, Dimitrios, Rothman, Ken, Thomas, David, Thun, Michael, Weiss, Noel, Rapp, Jerry, Miller, Robert W., Saah, Alfred J., and Gori, Gio Batta

Published
1995

42. Systematic literature review of cross-protective effect of HPV vaccines based on data from randomized clinical trials and real-world evidence

Author

Brown, Darron R., primary, Joura, Elmar A., additional, Yen, Glorian P., additional, Kothari, Smita, additional, Luxembourg, Alain, additional, Saah, Alfred, additional, Walia, Anuj, additional, Perez, Gonzalo, additional, Khoury, Hanane, additional, Badgley, Danielle, additional, and Stanley, Margaret, additional

Published
2021
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43. Systematic literature review of neutralizing antibody immune responses to non-vaccine targeted high-risk HPV types induced by the bivalent and the quadrivalent vaccines

Author

Stanley, Margaret, primary, Joura, Elmar, additional, Yen, Glorian P., additional, Kothari, Smita, additional, Luxembourg, Alain, additional, Saah, Alfred, additional, Walia, Anuj, additional, Perez, Gonzalo, additional, Khoury, Hanane, additional, Badgley, Danielle, additional, and Brown, Darron R., additional

Published
2021
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50. Anogenital Human Papillomavirus (HPV) Infection, Seroprevalence, and Risk Factors for HPV Seropositivity Among Sexually Active Men Enrolled in a Global HPV Vaccine Trial.

Author

Tota, Joseph E, Giuliano, Anna R, Goldstone, Stephen E, Dubin, Brady, Saah, Alfred, Luxembourg, Alain, Velicer, Christine, and Palefsky, Joel M

Subjects
EPIDEMIOLOGY of sexually transmitted diseases, SEXUALLY transmitted disease risk factors, RESEARCH, SEROPREVALENCE, MEN'S health, CONFIDENCE intervals, PAPILLOMAVIRUS diseases, HUMAN papillomavirus vaccines, VIRUS diseases, DISEASE prevalence, ANAL diseases, MEN who have sex with men, ODDS ratio, SEXUAL partners, DISEASE risk factors
Abstract

Background In men, the incidence of human papillomavirus (HPV)–related cancer is rising, but data regarding male HPV infection and seroprevalence are available from only a few countries. Methods This analysis of a global HPV vaccine trial evaluated baseline data from 1399 human immunodeficiency virus–negative heterosexual men (HM) and men who have sex with men (MSM). Key objectives included assessment of HPV prevalence and risk factors for seropositivity to 9-valent HPV (9vHPV) vaccine types (6, 11, 16, 18, 31, 33, 45, 52, and 58), and concordance between seropositivity and prevalent HPV type. Results Overall, 455 of 3463 HM (13.1%) and 228 of 602 MSM (37.9%) were HPV DNA positive for any 9vHPV vaccine type at baseline. Infection prevalence and seroprevalence (≥1 9vHPV vaccine type) were 13.2% and 8.1%, respectively, among 333 HM from Europe, and 37.9% and 29.9%, respectively, among 335 MSM from Europe or North America. Among men with baseline infection, MSM had higher seroprevalence for concordant HPV types (39.5% vs 10.8% in HM). The seropositivity risk (irrespective of baseline infection status) was higher among MSM versus HM (age-adjusted odds ratio, 3.0 [95% confidence interval, 2.4–6.4]). Among MSM, statistically significant seropositivity risk factors included younger age at sexual debut, higher number of receptive anal sex partners, and less frequent condom use. No factors assessed were associated with seropositivity in HM. Conclusions Higher proportions of MSM than HM were HPV DNA positive and seropositive, and concordance between HPV DNA positivity and seropositivity, a potential marker of true infection versus carriage, was higher in MSM. Most MSM and HM were seronegative for all 9vHPV vaccine types, suggesting the potential benefit of catch-up vaccination after sexual debut. Clinical Trials Registration. NCT00090285. [ABSTRACT FROM AUTHOR]

Published
2022
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