Spots Global Cancer Trial Database for Nine-valent HPV Vaccine to Prevent Persistent Oral HPV Infection in Men Living With HIV

Study Description

Brief Summary: 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.

Detailed Description: Cisgender men and transgender women ages 20-50 years living with HIV will be enrolled at affiliated clinical sites of the University of Puerto Rico, the National Institute of Public Health, Mexico, and University of São Paulo, Brazil. Participants will have a baseline blood draw for serum HPV antibodies and stored plasma, an oral rinse for HPV testing, stored anal and genital samples for HPV testing as well as a baseline questionnaire about risk factors for oral HPV infection and oropharyngeal cancer. Five-hundred participants will be randomized in a 1:1 allocation to receive 9vHPV or placebo at Day 1, Month 2 and Month 6. Randomization will be stratified based on clinical site (Brazil, Mexico, Puerto Rico) and age (20-30, 31-40, 41-50 years). The age range of enrolled participants will be monitored to ensure enrollment of an approximately even distribution of participants across the age range. 700 participants will be enrolled Follow-up testing for oral HPV will be conducted at Months 2, 6, 7, 12 and every 6 months thereafter up to 42 months post-vaccination. The rationale for oral testing at Months 2 and 6 is to identify participants who are oral HPV positive prior to receiving the full 3 doses of vaccine. In addition, collection of anal canal and genital specimens (penile head, shaft, scrotum) will occur at Day 1, Months 7, 12 and every 6 months thereafter up to 60 months post-randomization. These specimens will be stored for future studies of HIV and HPV and as such will not be analyzed as part of this study. Blood will be stored for serum HPV antibody testing at month 7, 12 and every 12 months thereafter. Participants will undergo a follow-up questionnaire on risk factors for oral HPV and oropharyngeal cancer. Participants will be assessed for adverse events at each follow-up visit. This is a 5 year study. Participants who received placebo will be offered 9vHPV vaccine at the end of the study free of charge. The trial analyses will be case driven with case counting commencing at Month 7, one month post-dose 3. The primary analysis will take place when at least 14 cases of the primary endpoint (incident persistent oral HPV infection with HPV types 6, 11, 16, 18, 31, 33, 45, 52, or 58) have been observed.

Keywords

Eligibility

Minimum Age: 20 Years

Eligible Ages: ADULT

Sex: MALE

Healthy Volunteers: No

Locations

Contact Details

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