Efficacy, efficacy and safety of vaccination against human papillomavirus in males: a systematic review.

Vaccination against human papillomavirus (HPV) is safe and effective in the prevention of cervical cancer in women. As HPV infections can also induce cancers of the anus, penis and oral cavity, men's vaccination is also advocated, but systematic reviews of the efficacy and safety at home men are lacking.

We have conducted a systematic review of the effectiveness, efficacy, and safety of HPV vaccination in men of all ages. MEDLINE, Embase, the Cochrane Central Register of Controlled Trials and ClinicalTrials.gov were searched from early to April 2017.

We identified 5196 articles and seven studies (four randomized controlled trials (RCTs), three nonrandomized studies) included, including a total of 5294 participants. The effectiveness of the vaccine against persistent HPV 16 infections of at least 6 months was 46.9% (95% confidence interval (CI) 28.6-60.8%), while the effectiveness against persistent oral infections was 88% (2-98%). Immunization efficacy of 61.9% (21.4-82.8%) and 46.8% (-20 to -77.9%) was observed against grade 2 and grade 3 intraepithelial neoplasia lesions. 3, respectively. No significant estimates of the efficacy or effectiveness of the Grade 2 or 3 penile intraepithelial neoplasia vaccine were provided, and no data were identified for cancer squamous cells of the anus, penis or head and neck. In participants who were seronegative for HPV and negative for PCR at baseline, the efficacy against all outcomes was higher than in HIV-positive and / or PCR-positive individuals. The risk of bias was low in three RCTs and high in one case, while the three nonrandomized studies presented a risk of serious to critical bias. HPV vaccination in men is moderately effective against persistent anogenital HPV infection and high grade anal intraepithelial lesions in studies where the population is predominantly composed of HPV. infected males. Vaccine efficacy was high in study groups including naive HPV males. This supports a recommendation for vaccination of boys before the onset of sexual activity in order to establish optimal protection induced by the vaccine. Mathematical modeling studies will always be needed to evaluate the effects of adding men to existing HPV vaccination programs in women.

Prospective Registry for Systematic Reviews (PROSPERO) CRD42016038965.

Medicine of BMC. 2018 Jul 18 *** Publication ***

Thomas Harder, Ole Wichmann, Stefanie J Klug, Marianne AB van der Sande, Miriam Wiese-Posselt

Robert Koch Institute, Immunization Unit, Seestrasse 10, 13353, Berlin , Germany. ., Robert Koch Institute, Immunization Unit, Seestrasse 10, 13353, Berlin, Germany, Department of Sports and Health Sciences, Technical University Munich, Chair of Epidemiology, Munich, Germany, Institute of tropical medicine, Antwerp, Belgium

PubMed http://www.ncbi.nlm.nih.gov/pubmed/30016957