This phase III trial compares the effect of the nine-valent human papillomavirus (HPV) vaccine to a placebo for the prevention of oral HPV infection in men living with human immunodeficiency virus (HIV). There are over 100 types of HPV that infect humans. Some of these types infect the back of the mouth and throat. HPV infections in the mouth (oral HPV) can damage the skin. Rarely, these damaged areas can turn into cancer of the oropharynx, which is the back part of the mouth and the top of the throat. The main purpose of this study is to determine whether the nine-valent HPV vaccine, Gardasil-9, prevents oral HPV infection in men living with HIV. “Nine-valent” means that the vaccine is directed at nine types of HPV.
Additional locations may be listed on ClinicalTrials.gov for NCT04255849.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. To demonstrate that recombinant human papillomavirus nonavalent vaccine (9-valent HPV [9vHPV]) when given in a 3-dose regimen (day 1, months 2 and 6) reduces the incidence of persistent oral HPV infection with 9vHPV vaccine types 6, 11, 16, 18, 31, 33, 45, 52, and 58, a surrogate for HPV-associated oropharyngeal cancer (OPC), in men living with HIV (MLWH) ages 20-50 years who are oral HPV negative to the relevant HPV type at enrollment, compared with placebo.
SECONDARY OBJECTIVES:
I. To evaluate the vaccine-induced serum anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 responses in a subset of MLWH age 20-50 year-old men.
II. To evaluate the safety and tolerability of 9vHPV in MLWH.
EXPLORATORY OBJECTIVES:
I. To establish a specimen and data repository for future analyses to characterize vaccine-induced serum and oral immune responses and oral HPV natural history.
II. 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.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants receive 9vHPV intramuscularly (IM) at baseline (day 1), and at 2 and 6 months.
ARM II: Participants receive saline placebo IM at baseline (day 1), and at 2 and 6 months.
All patients also undergo collection of blood samples throughout the study. In addition, patients may undergo optional swab of penile head/shaft, scrotum, and/or anal canal throughout the study.
After completion of study, participants are followed up at 7, 12, 18, 24, 30, 36, 42, 48, 54, and 60 months.
Lead OrganizationNYP/Weill Cornell Medical Center
Principal InvestigatorGrant B Ellsworth
