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Nine-valent HPV Vaccine to Prevent Persistent Oral HPV Infection in Men Living With HIV

Active Not RecruitingPhase 3

Sponsor: Weill Medical College of Cornell University

Conditions: HPV Positive Oropharyngeal Squamous Cell Carcinoma, HIV-1-infection, HPV Infection

Interventions: 9 valent human papillomavirus vaccine (Types 6, 11, 16, 18, 31, 33, 45, 52, 58), Saline Placebo

Countries: Brazil, Mexico, Puerto Rico

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 men living with HIV.

Eligibility overview

Sex: MALE

Age: 20 Years to 50 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* HIV-1 infection
* 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.

Exclusion Criteria:

* Have a history of oropharyngeal cancer (OPC) or other HPV-related cancer or have suspected OPC or other HPV-related cancer;
* Have received any doses of a licensed or experimental HPV vaccine or have participated in an HPV vaccine study,
* Have a history of anaphylaxis to vaccines or are allergic to any vaccine component (e.g.aluminum, yeast, benzonase);
* Have received any blood products within six months of enrollment, or are currently taking immune-suppressants.
* Currently have warts/lesions in the oral cavity.
* Plan to relocate during the study period.
* Have AIDS-defining condition within 6 months prior to study entry.

Locations (3)

São Paulo, São Paulo, Brazil
Cuernavaca, Morelos, Mexico
San Juan, Purto Rico, Puerto Rico