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      High Risk of New HPV Infection Acquisition Among Unvaccinated Young Men

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          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

          This analysis of men from the placebo arm of a global 4-valent HPV vaccine trial indicates that young adult men in the age range targeted for catch-up vaccination (≤26 years) are at substantial risk of acquiring new HPV persistent anogenital infections.

          Clinical Trials Registration. NCT00090285.

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          Most cited references26

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          Worldwide burden of cancer attributable to HPV by site, country and HPV type

          HPV is the cause of almost all cervical cancer and is responsible for a substantial fraction of other anogenital cancers and oropharyngeal cancers. Understanding the HPV‐attributable cancer burden can boost programs of HPV vaccination and HPV‐based cervical screening. Attributable fractions (AFs) and the relative contributions of different HPV types were derived from published studies reporting on the prevalence of transforming HPV infection in cancer tissue. Maps of age‐standardized incidence rates of HPV‐attributable cancers by country from GLOBOCAN 2012 data are shown separately for the cervix, other anogenital tract and head and neck cancers. The relative contribution of HPV16/18 and HPV6/11/16/18/31/33/45/52/58 was also estimated. 4.5% of all cancers worldwide (630,000 new cancer cases per year) are attributable to HPV: 8.6% in women and 0.8% in men. AF in women ranges from 20% in India and sub‐Saharan Africa. Cervix accounts for 83% of HPV‐attributable cancer, two‐thirds of which occur in less developed countries. Other HPV‐attributable anogenital cancer includes 8,500 vulva; 12,000 vagina; 35,000 anus (half occurring in men) and 13,000 penis. In the head and neck, HPV‐attributable cancers represent 38,000 cases of which 21,000 are oropharyngeal cancers occurring in more developed countries. The relative contributions of HPV16/18 and HPV6/11/16/18/31/33/45/52/58 are 73% and 90%, respectively. Universal access to vaccination is the key to avoiding most cases of HPV‐attributable cancer. The preponderant burden of HPV16/18 and the possibility of cross‐protection emphasize the importance of the introduction of more affordable vaccines in less developed countries.
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            Human papillomavirus vaccination: recommendations of the Advisory Committee on Immunization Practices (ACIP).

            This report summarizes the epidemiology of human papillomavirus (HPV) and associated diseases, describes the licensed HPV vaccines, provides updated data from clinical trials and postlicensure safety studies, and compiles recommendations from CDC's Advisory Committee on Immunization Practices (ACIP) for use of HPV vaccines. Persistent infection with oncogenic HPV types can cause cervical cancer in women as well as other anogenital and oropharyngeal cancers in women and men. HPV also causes genital warts. Two HPV vaccines are licensed in the United States. Both are composed of type-specific HPV L1 protein, the major capsid protein of HPV. Expression of the L1 protein using recombinant DNA technology produces noninfectious virus-like particles (VLPs). Quadrivalent HPV vaccine (HPV4) contains four HPV type-specific VLPs prepared from the L1 proteins of HPV 6, 11, 16, and 18. Bivalent HPV vaccine (HPV2) contains two HPV type-specific VLPs prepared from the L1 proteins of HPV 16 and 18. Both vaccines are administered in a 3-dose series. ACIP recommends routine vaccination with HPV4 or HPV2 for females aged 11 or 12 years and with HPV4 for males aged 11 or 12 years. Vaccination also is recommended for females aged 13 through 26 years and for males aged 13 through 21 years who were not vaccinated previously. Males aged 22 through 26 years may be vaccinated. ACIP recommends vaccination of men who have sex with men and immunocompromised persons (including those with HIV infection) through age 26 years if not previously vaccinated. As a compendium of all current recommendations for use of HPV vaccines, information in this report is intended for use by clinicians, vaccination providers, public health officials, and immunization program personnel as a resource. ACIP recommendations are reviewed periodically and are revised as indicated when new information and data become available.
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              Efficacy of quadrivalent HPV vaccine against HPV Infection and disease in males.

              Infection with human papillomavirus (HPV) and diseases caused by HPV are common in boys and men. We report on the safety of a quadrivalent vaccine (active against HPV types 6, 11, 16, and 18) and on its efficacy in preventing the development of external genital lesions and anogenital HPV infection in boys and men. We enrolled 4065 healthy boys and men 16 to 26 years of age, from 18 countries in a randomized, placebo-controlled, double-blind trial. The primary efficacy objective was to show that the quadrivalent HPV vaccine reduced the incidence of external genital lesions related to HPV-6, 11, 16, or 18. Efficacy analyses were conducted in a per-protocol population, in which subjects received all three vaccinations and were negative for relevant HPV types at enrollment, and in an intention-to-treat population, in which subjects received vaccine or placebo, regardless of baseline HPV status. In the intention-to-treat population, 36 external genital lesions were seen in the vaccine group as compared with 89 in the placebo group, for an observed efficacy of 60.2% (95% confidence interval [CI], 40.8 to 73.8); the efficacy was 65.5% (95% CI, 45.8 to 78.6) for lesions related to HPV-6, 11, 16, or 18. In the per-protocol population, efficacy against lesions related to HPV-6, 11, 16, or 18 was 90.4% (95% CI, 69.2 to 98.1). Efficacy with respect to persistent infection with HPV-6, 11, 16, or 18 and detection of related DNA at any time was 47.8% (95% CI, 36.0 to 57.6) and 27.1% (95% CI, 16.6 to 36.3), respectively, in the intention-to-treat population and 85.6% (97.5% CI, 73.4 to 92.9) and 44.7% (95% CI, 31.5 to 55.6) in the per-protocol population. Injection-site pain was significantly more frequent among subjects receiving quadrivalent HPV vaccine than among those receiving placebo (57% vs. 51%, P<0.001). Quadrivalent HPV vaccine prevents infection with HPV-6, 11, 16, and 18 and the development of related external genital lesions in males 16 to 26 years of age. (Funded by Merck and others; ClinicalTrials.gov number, NCT00090285.).
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                Author and article information

                Contributors
                Journal
                J Infect Dis
                J Infect Dis
                jid
                The Journal of Infectious Diseases
                Oxford University Press
                0022-1899
                1537-6613
                15 March 2024
                28 November 2023
                28 November 2023
                : 229
                : 3
                : 707-718
                Affiliations
                Center for Immunization and Infection Research in Cancer, Moffitt Cancer Center , Tampa, Florida, USA
                University of California SanFrancisco , San Francisco, California, USA
                Icahn School of Medicine at Mount Sinai , NewYork, New York, USA
                Merck & Co, Inc , Rahway, New Jersey, USA
                Merck & Co, Inc , Rahway, New Jersey, USA
                Merck & Co, Inc , Rahway, New Jersey, USA
                Merck & Co, Inc , Rahway, New Jersey, USA
                Merck & Co, Inc , Rahway, New Jersey, USA
                Author notes
                Correspondence: Anna R. Giuliano, PhD, Center for Immunization and Infection Research in Cancer, Moffitt Cancer Center and Research Institute, 12902 Magnolia Drive, Tampa, FL 33612 ( Anna.Giuliano@ 123456moffitt.org ).

                Potential conflicts of interest. A. R. G. reports receipt of support in the form of medical writing for the current manuscript, grants, and consulting fees from Merck Sharp & Dohme LLC. J. M. P. reports receipt of consulting fees from Merck Sharp & Dohme, LLC, Vir Biotechnologies, Antiva Biosciences, and Roche Diagnostics; has received payment from Merck Sharp & Dohme LLC, for lectures, presentations, speakers’ bureaus, and manuscript writing or educational events; is an honorary board member of the International Papillomavirus Society; and holds stock or stock options in Virion Therapeutics. S. G. has received grants from Inovio and Franz Viral Technologies; consulting fees from THD America; and payment or honoraria from Merck Sharp & Dohme, LLC, for speakers’ bureaus. S. G. and J. E. T. have received support from Merck Sharp & Dohme, LLC, for the present manuscript. A. L., B. D., A. S., C. V., and J. E. T. are employees of Merck Sharp & Dohme, LLC. A. L., B. D., A. S., and J. E. T. hold stock in Merck & Co, Inc, Rahway, NJ, USA.

                All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.

                Article
                jiad485
                10.1093/infdis/jiad485
                10938197
                38012959
                d66c8345-1c81-40ae-947f-98ff653e1f39
                © The Author(s) 2023. Published by Oxford University Press on behalf of Infectious Diseases Society of America.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence ( https://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contact journals.permissions@oup.com

                History
                : 03 July 2023
                : 28 October 2023
                : 28 November 2023
                Page count
                Pages: 12
                Funding
                Funded by: Merck Sharp & Dohme, LLC;
                Funded by: Merck & Co, Inc, DOI 10.13039/100004334;
                Categories
                Major Article
                Viruses
                AcademicSubjects/MED00290

                Infectious disease & Microbiology
                human papillomavirus,hpv vaccines,hpv infection
                Infectious disease & Microbiology
                human papillomavirus, hpv vaccines, hpv infection

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