Nine-valent HPV Vaccine to Prevent Persistent Oral HPV Infection in Men Living with HIV
This is a randomized, double-blinded, placebo-controlled Phase III interventional trial of the nine-valent HPV vaccine (9vHPV) to prevent persistent oral HPV infection in adult cisgender men and transgender women living with HIV.
1.1 Primary Objectives
1.1.1 To demonstrate that 9vHPV when given in a 3-dose regimen (Day 1, Months 2 and 6) reduces the incidence of persistent oral HPV infection with 9-valent HPV vaccine types 6, 11, 16, 18, 31, 33, 45, 52, and 58, a surrogate for HPV associated oropharyngeal cancer, in men living with HIV ages 20-50 years who are oral HPV negative to the relevant HPV type at enrollment, compared with placebo.
1.2 Secondary Objectives
1.2.1 To evaluate the vaccine-induced serum anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 responses in a subset of men living with HIV age 20-50 year old men.
1.2.2 To evaluate the safety and tolerability of 9vHPV in men living with HIV.
1.3 Exploratory Objectives
1.3.1 To establish a biorepository for future analyses to characterize vaccine-induced serum and oral immune responses and oral HPV natural history.
1.3.2 To archive genital and anal samples for future investigation related to vaccine efficacy for the prevention of genital and anal 9vHPV vaccine types, and oral and genital HPV natural history.
Receipt of antiretroviral therapy for at least 6 months
Sexually active in the past 6 months; sexual activity is defined as insertive penile-vaginal sex, receptive or insertive penile-anal sex, oral-anal sex, or oral-genital sex Willingness to comply with three-dose vaccine schedule and subsequent six-month visits for up to four years after randomization.
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