A Randomized, Double-Blinded, Placebo-Controlled, Phase III Trial of the Quadrivalent HPV Vaccine to Prevent Anal Human Papillomavirus Infection in HIV-Infected Men and Women
Anal HPV infection can be a risk factor for anal cancer, which is a common non-AIDS-defining
cancer among HIV-infected MSM. Screening for anal cancer is not widely available and can be
difficult to implement. People who receive the FDA-approved quadrivalent HPV vaccine,
Gardasil, may have a reduced risk of developing anal HPV infection, which may in turn reduce
the risk of developing anal cancer. The purpose of this study is to evaluate the
effectiveness of the quadrivalent HPV vaccine, Gardasil, at reducing the incidence of anal
HPV infections in HIV-infected MSM and HIV-infected women.
This study will enroll HIV-infected MSM and HIV-infected women. Participants will be
randomly assigned to receive the HPV vaccine or a placebo vaccine. At the screening study
visit, participants will undergo a physical examination, blood collection, anal swab
procedure, oral examination, questionnaires, a high-resolution anoscopy (HRA), and if
female, a pregnancy test, vaginal swab, and gynecologic exam. At the entry study visit,
participants will undergo most of the procedures performed at screening (with the exception
of an HRA and a gynecologic exam if female) plus a saliva test. Participants will receive
the HPV vaccine or placebo as an injection into their upper arm or thigh on Day 0 and Weeks
8 and 24. Study staff will call participants 2 to 3 days after each vaccination for
follow-up monitoring. Additional study visits and procedures will occur at Week 28, Week 52,
and every 26 weeks thereafter for at least 3 years and for a maximum of 4 years after the
last participant is enrolled in the study. Female participants will also have a gynecologic
exam at screening, Week 52, and every 52 weeks thereafter; a pregnancy test at screening,
baseline, Week 8, Week 24, and as indicated; and self-collected vaginal swabs at screening,
entry, Week 28, Week 52, and every 26 weeks thereafter. Peripheral blood mononuclear cells
(PBMCs) will be collected from some participants at entry, Week 28, and study exit.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Time to the first new persistent infection of HPV 6, 11, 16, or 18
Measured through participant's last study visit, which will occur 3 to 4 years after the last participant is enrolled in the study
No
Timothy J. Wilkin, MD, MPH
Study Chair
Cornell Clinical Research Site
United States: Food and Drug Administration
A5298
NCT01461096
March 2012
Name | Location |
---|---|
UCLA CARE Center CRS | Los Angeles, California 90095 |
Stanford CRS | Palo Alto, California 94305 |
Ucsd, Avrc Crs | San Diego, California |
Ucsf Aids Crs | San Francisco, California |
University of Colorado Hospital CRS | Aurora, Colorado 80262 |
Northwestern University CRS | Chicago, Illinois 60611 |
Rush Univ. Med. Ctr. ACTG CRS | Chicago, Illinois 60612 |
Johns Hopkins Adult AIDS CRS | Baltimore, Maryland 21287 |
Massachusetts General Hospital ACTG CRS | Boston, Massachusetts 02114 |
Beth Israel Deaconess Med. Ctr., ACTG CRS | Boston, Massachusetts 02215 |
Bmc Actg Crs | Boston, Massachusetts 02118 |
Washington U CRS | St. Louis, Missouri |
NY Univ. HIV/AIDS CRS | New York, New York 10016 |
Univ. of Rochester ACTG CRS | Rochester, New York 14642 |
Unc Aids Crs | Chapel Hill, North Carolina 27599 |
Univ. of Cincinnati CRS | Cincinnati, Ohio 45267 |
MetroHealth CRS | Cleveland, Ohio |
Hosp. of the Univ. of Pennsylvania CRS | Philadelphia, Pennsylvania 19104 |
Pitt CRS | Pittsburgh, Pennsylvania 15213 |
HIV Prevention & Treatment CRS | New York, New York 10032 |
The Ponce de Leon Ctr. CRS | Atlanta, Georgia 30308 |
AIDS Care CRS | Rochester, New York 14607 |
Denver Public Health CRS | Denver, Colorado 80204 |
Cornell CRS | New York, New York 10011 |
The Miriam Hosp. ACTG CRS | Providence, Rhode Island 02906 |
Houston AIDS Research Team CRS | Houston, Texas 77030 |
New Jersey Medical School- Adult Clinical Research Ctr. CRS | Newark, New Jersey 07103 |