Clinical Inquiries

Does qHPV vaccine prevent anal intraepithelial neoplasia and condylomata in men?

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Yes. Quadrivalent human papillomavirus (qHPV) vaccine reduces rates of anal intraepithelial neoplasia (AIN) by 50% to 54%, and persistent anal infection by 59%, associated with the 4 types of HPV in the vaccine (6, 11, 16, and 18) in young men who have sex with men (MSM); it also reduces external genital lesions by 66%, and persistent HPV infection associated with the same 4 HPV types by 48 to 59% in all young men, heterosexual men,and MSM (strength of recommendation [SOR]: B, randomized, placebo-controlled trials [RCTs]).

In addition, the vaccine is associated with a 50% to 55% decrease in recurrent high-grade AIN and anogenital condylomatain older MSM (SOR: B, cohort studies).


Two RCTs that evaluated qHPV in young men for preventing outcomes associated with the 4 HPV subtypes in the vaccine (6, 11, 16, and 18) found that it reduced them by 50% to 66% using an intention-to-treat protocol (TABLE1-4).

Vaccination reduces AIN and persistent infection in MSM

The first RCT evaluated a subset of 602 MSM from the second, larger RCT for preventing AIN and persistent HPV infection.1 The intention-to-treat population included men with 5 or fewer lifetime sexual partners who had engaged in insertive or receptive anal intercourse or oral sex within the last year, were not necessarily HPV-negative at enrollment, and received at least one dose of vaccine (or placebo).

The vaccine reduced AIN associated with the 4 HPV types (6.3 vs 12.6 events per 100 person-years; relative risk reduction [RRR]=50.3%; 95% confidence interval [CI], 25.7-67.2; number needed to treat [NNT]=16 to prevent one AIN case per year) and with HPV of any type (13 vs 17.5 events per 100 person-years; RRR=25.7%; 95% CI, -1.1 to 45.6). It also reduced the rate of persistent HPV infection with the 4 HPV vaccine subtypes (8.8 vs 21.6 events per 100 person-years; RRR=59.4%; 95% CI, 43%-71%; NNT=8 to prevent one persistent HPV infection per year).

Investigators in the study also evaluated vaccine efficacy in a smaller subset (194 men) using per-protocol analysis and found higher prevention rates (78% for AIN due to HPV types 6, 11, 16, and 18). Investigators followed these subjects every 6 months for 36 months with polymerase chain reaction testing for HPV DNA, high-resolution anoscopy with anal cytology, and anal biopsy and histology if there were atypia.


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