Clinical Trials

MainTitle

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

This study is not yet open for participant recruitment. (see Contacts and Locations)

Verified February 2020 by Weill Medical College of Cornell University

Sponsor
Weill Medical College of Cornell University

Collaborator
H. Lee Moffitt Cancer Center and Research Institute
University of Sao Paulo
University of Puerto Rico
Mexican National Institute of Public Health
National Cancer Institute (NCI)

Information provided by (Responsible Party)
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier
NCT04255849

First received: January 31, 2020
Last updated: February 3, 2020
Last Verified: February 2020
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
HPV Positive Oropharyngeal Squamous Cell Carcinoma
HIV-1-infection
HPV Infection

Biological : 9 valent human papillomavirus vaccine (Types 6, 11, 16, 18, 31, 33, 45, 52, 58)
Other : Saline Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Nine-valent HPV Vaccine to Prevent Persistent Oral HPV Infection in Men Living With HIV

Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures

  • Number of participants with new persistent oral HPV infections with one or more of the following types: 6, 11, 16, 18, 31, 33, 45, 52, or 58 [ Time Frame: From Month 7 up to Month 42 ]
    The primary endpoint is incident persistent oral HPV infection with HPV types 6, 11, 16, 18, 31, 33, 45, 52, or 58 occurring among participants who remain oral HPV negative to the relevant HPV type through the vaccination period (Day 1-Month 6). Newly acquired oral HPV infections that persist for two or more consecutive oral HPV assessments at least 16 weeks apart with the same 9vHPV detected are defined as "persistent". Case counting will commence with the Month 7 clinical visit and may occur at any timepoint through the final visit, which may be as along as Month 42 for some participants.
Secondary Outcome Measures:
  • Immunogenicity of 9-valent HPV vaccine as measured by proportion of participants experiencing seroconversion for vaccine type. [ Time Frame: Month 7 ]
    To evaluate our secondary immunogenicity endpoint, we will assess the proportion of men who seroconvert to the HPV vaccine types 6, 11, 16, 18, 31, 33, 45, 52, or 58 (both in grouped and type-specific analyses) in serum one month post-dose three (Month 7) using the Wilson's method. Men who enter the study seronegative for a particular HPV vaccine type will be monitored for seroconversion following three doses of 9vHPV.
  • Safety and tolerability of 9-valent HPV vaccine as measured by proportion of participants with >= grade 3 adverse events related to study vaccination or Grade 1 or 2 events leading to premature discontinuation of vaccination, or serious adverse events. [ Time Frame: Baseline through Month 7 ]
    To evaluate the secondary safety and tolerability endpoint, we will report the proportion of participants experiencing a grade 3 or 4 adverse event at least possibly related to study vaccine, grade 1 or 2 adverse events leading to premature discontinuation of vaccine or placebo, and serious adverse events.

Estimated Enrollment: 500
Study Start Date: April 2020
Estimated Study Completion Date: April 2024
Estimated Primary Completion Date: April 2024 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: 9-valent HPV vaccine
Participants receive 9-valent HPV vaccine 0.5mL at entry, Month 2 and Month 6
Biological: 9 valent human papillomavirus vaccine (Types 6, 11, 16, 18, 31, 33, 45, 52, 58)

Gardasil-9 HPV vaccine

Placebo Comparator: Saline Placebo
Participants receive 0.9% NaCl 0.5 mL at entry, Month 2 and Month 6
Other: Saline Placebo

Saline Placebo

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. Each of the three clinical sites will enroll approximately 167 men during the first 18 months of this study.
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 42 months post-vaccination. 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 4 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 29 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.

Eligibility

Eligibility

Ages Eligible for Study: 20 Years to 50 Years  
Sexes Eligible for Study: Male  
Accepts Healthy Volunteers: No  

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.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT04255849

Contacts

Contact:   Maysha Phillips 212-746-7204 map2109@med.cornell.edu

Locations

Brazil
University of São Paulo
São Paulo, Brazil
Contact: Maria Biaggio    55-11- 2661-7554    iza.baggio@hc.fm.usp.br
Mexico
National Institute of Public Health, Mexico
Cuernavaca, Morelos, Mexico, 62209
Contact: Aurelio Cruz, MD    52-777-329-3060    acruz@insp.mx
Puerto Rico
Puerto Rico AIDS Clinical Trials Unit
San Juan, Puerto Rico, 00935
Contact: Sylvia I Davila Nieves, M.Sc.    787-767-9192    sylvia.davila1@upr.edu

Sponsors and Collaborators

Weill Medical College of Cornell University
H. Lee Moffitt Cancer Center and Research Institute
University of Sao Paulo
University of Puerto Rico
Mexican National Institute of Public Health
National Cancer Institute (NCI)

Investigators

Principal Investigator: Timothy Wilkin, MD Weill Medical College of Cornell University
More Information

More Information


Responsible Party: Weill Medical College of Cornell University  
ClinicalTrials.gov Identifier: NCT04255849   History of Changes  
Other Study ID Numbers: 19-11021038  
  U54CA242639  
Study First Received: January 31, 2020  
Last Updated: February 3, 2020  
Individual Participant Data    
Plan to Share IPD: Yes  

Studies a U.S. FDA-regulated Drug Product: Yes  
Studies a U.S. FDA-regulated Device Product: No  
Product Manufactured in and Exported from the U.S.: Yes  

Additional relevant MeSH terms:
Infection
Communicable Diseases
Papillomavirus Infections

ClinicalTrials.gov processed this data on June 02, 2020
This information is provided by ClinicalTrials.gov.