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Table 1 Characteristics of included studies

From: Efficacy, effectiveness and safety of vaccination against human papillomavirus in males: a systematic review

Study Location Design Study period Inclusion criteria Exclusion criteria Age at enrolment (median (range)) Duration of follow-up (median) Vaccine/comparator Study sponsorship Conflict of interest Number of participants Outcomes
Giuliano et al. 2011 [32] Multicentre (18 countries) RCT 2004–ongoing (enrolled until 08/2008) Heterosexual men 16–23 years of age who had 1–5 life-time sex partners or MSM 16–26 years. of age who had 1–5 male or female life-time sex partners Men with clinically detectable anogenital warts or genital lesions or history of such findings 20 years. (16–26 years) 2.9 yrs Gardasil/placebo Merck; National Institutes of Health Merck, GlaxoSmith-Kline (GSK), Qiagen, AstraZeneca Vaccinated: 2032; placebo: 2033 PIN grade 2 or 3; penile, perineal or perianal cancer; persistent anogenital infection; incident anogenital infection; genital condyloma acuminatum; severe adverse events
Palefsky et al. 2011 [33] Multicentre (7 countries) RCT (substudy of Giuliano et al. 2011 [32]) 2004– ongoing (enrolled until 08/2008) MSM 16–26 years. of age who had 1–5 male or female life-time sex partners and were engaged in insertive or receptive anal intercourse with another man in the past year Men with history or presence of clinically detectable anogenital warts or genital lesions or intra-anal lesion on anoscopy consistent with AIN or condyloma 22 years. (16–26 years) 2.2 years Gardasil/placebo Merck; National Institutes of Health Merck, GSK, Qiagen, Pharmajet, Aura Biosciences, Roche, GenProbe Vaccinated: 301; placebo: 301 AIN grade 2; AIN grade 3; anal cancer; persistent anal infection; incident anal infection; anal condyloma accuminatum; severe adverse events
Swedish et al. 2012 [25] USA Cohort study 2007–2011 MSM 18 years. or older with a history of biopsy-proven and treated high-grade AIN Less than three vaccine doses; high-grade AIN at study start 40.4 years. (20.3–72.3 years) Vaccinated: 489 days; unvaccinated: 722 days Gardasil/unvaccinated NR Merck, Qiagen, Asha Vaccinated: 88; unvaccin-ated: 114 Recurrent high-grade AIN (AIN grade 2 or 3)
Coskuner et al. 2014 [31] Turkey RCT (not placebo-controlled) 2009–2013 Men with new onset genital warts living in the same area for at least 1 year Previous treatment for preexisting warts; medical disorders that needed chronic treatment; immune suppression (incl. HIV) Mean: 34 years. (+/−  7.6) 4 years after first dose Gardasil/unvaccinated NR NR Vaccinated: 91; unvaccinated: 80 Recurrent condyloma acuminatum
Swedish and Goldstone 2014 [34] USA Cohort study 2007–2013 (vaccinated until 2010) Self-identified MSM, HIV-negative, no prior history of anal condyloma or previously treated anal condyloma but recurrence-free for at least 12 months prior to study entry Men with anal or penile condyloma at study start 42.2 years. (range 26.1–76 years) Up to 4 years. (vacc: median 880 days; unvacc: median 1039 days) Gardasil/unvaccinated None Merck Vaccinated: 116; unvaccinated: 197 Anal condyloma
Kahn et al. 2015 [24] USA (5 centres) Cross-sectional study 2011–2012 Youth with behaviorally acquired HIV Serious psychiatric illness, intoxication with alcohol or drugs 21.5 years. (range 12–24 years) NA Gardasil/unvaccinated National Institutes of Health Merck Vaccinated: 23; unvaccinated: 48 (Incident) oral infection (HPV 16 and/or HPV 18)
NCT01461096 [26, 47] USA, Brazil RCT 2012–2015 (stopped due to futility) HIV-infected adults History of cancer, history of AIN, previous HPV vaccination, anticoagulation, allergies, drug/alcohol dependence, serious illness, immunomodulatory treatment; hepatitis B/C treatment 47 years (intraquartile range: 41–53) 2.1 years. (median) Gardasil/placebo National Institute of Allergy and Infectious Diseases Gilead, Bristol Meyer Squibb, GSK Vaccinated: 236; placebo: 236 Persisting oral infectiona
  1. AIN anal intraepithelial neoplasia, MSM men who have sex with men, NA not applicable, NR not reported, PIN penile, perineal or perianal neoplasia, RCT randomized controlled trial
  2. aData on other outcomes available for combined analysis of males and females