A Phase II Study to Evaluate the Immunogenicity and Safety of a Quadrivalent Human Papillomavirus Vaccine in HIV-1-Infected Females
HPV is a DNA virus that affects both men and women. Approximately 90 types of HPV have been
identified, 30 of which are sexually transmitted. The most common forms of HPV are types 6,
11, 16, and 18. The quadrivalent HPV vaccine that will be tested in this study has been
shown in previous studies to be effective in preventing infection with HPV 6, 11, 16, and 18
in healthy young women. According to a report by the Centers for Disease Control and
Prevention (CDC), 80% of women will have acquired HPV by the age of 50. HIV infected women
have been reported to have a higher prevalence and persistence of HPV infection, as well as
an increased risk for abnormal Pap smears and cervical cancer. HPV types 16 and 18 cause the
majority of cervical cancers worldwide, and types 6 and 11 are responsible for the majority
of cases of genital warts. Vaccinations for preventable infections are particularly
important among HIV infected people because people with HIV have compromised immune systems;
therefore, any infection is very serious and can potentially be fatal. However, standard
vaccination series have not been very successful because a compromised immune system may not
produce the desired immune response to a vaccine. The HPV vaccine is designed to protect
against infection with HPV types 6, 11, 16, and 18 and has been approved by the FDA for use
in women between the ages of 9 and 26. The purpose of this study is to determine whether the
quadrivalent HPV vaccine is safe, tolerable, and effective in producing antibodies to HPV in
HIV infected females.
This study will last 72 weeks. Participants will receive their first dose of the HPV vaccine
by intramuscular injection. The HPV vaccine will be administered again at Weeks 8 and 24.
Following each injection, participants will remain at the clinic for 30 minutes of
observation for adverse events. A phone call from or a home visit by study staff will occur
within 2 days following each injection.
Participants will return to the clinic for visits at Weeks 4, 8, 12, 24, 28, 52, and 72.
Most study visits will include a physical exam, medication review, blood and urine
collection, and answering questions about signs and symptoms since study screening. Some
visits will include measurement of HIV viral load in the cervix, a cervical brush, an anal
swab, and an oral exam. Some participants will be asked to provide additional blood samples.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Type-specific HPV antibody development from the seronegative status at baseline to seropositive status a month after the completion of HPV vaccination series (Week 28) for HPV types 6, 11, 16, and 18
At Week 32
No
Erna Milunka Kojic, MD
Study Chair
Department of Immunology/Infectious Disease, The Miriam Hospital, Brown University
United States: Food and Drug Administration
A5240
NCT00604175
February 2008
November 2012
Name | Location |
---|---|
Alabama Therapeutics CRS | Birmingham, Alabama 35294 |
UCLA CARE Center CRS | Los Angeles, California 90095 |
USC CRS | Los Angeles, California 90033 |
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 |
Univ. of Miami AIDS CRS | Miami, Florida 33136 |
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 |
Duke Univ. Med. Ctr. Adult CRS | Durham, North Carolina 27710 |
Regional Center for Infectious Disease, Wendover Medical Center CRS | Greensboro, North Carolina 27401 |
Univ. of Cincinnati CRS | Cincinnati, Ohio 45267 |
Case CRS | Cleveland, Ohio 44106 |
MetroHealth CRS | Cleveland, Ohio |
Hosp. of the Univ. of Pennsylvania CRS | Philadelphia, Pennsylvania 19104 |
University of Washington AIDS CRS | Seattle, Washington 98122 |
Pitt CRS | Pittsburgh, Pennsylvania 15213 |
Usc La Nichd Crs | Los Angeles, California 90033 |
Univ. of Florida Jacksonville NICHD CRS | Jacksonville, Florida |
HIV Prevention & Treatment CRS | New York, New York 10032 |
The Ohio State University Medical Center | Columbus, Ohio 43210 |
The Ponce de Leon Ctr. CRS | Atlanta, Georgia 30308 |
IHV Baltimore Treatment CRS | Baltimore, Maryland 21201 |
AIDS Care CRS | Rochester, New York 14607 |
Vanderbilt Therapeutics CRS | Nashville, Tennessee 37204 |
Miller Children's Hosp. Long Beach CA NICHD CRS | Long Beach, California 90806 |
Denver Public Health CRS | Denver, Colorado 80204 |
Georgetown University CRS (GU CRS) | Washington, District of Columbia 20007 |
Howard Univ. Washington DC NICHD CRS | Washington, District of Columbia 20060 |
Univ. of Miami Ped. Perinatal HIV/AIDS CRS | Miami, Florida 33136 |
Mt. Sinai Hosp. Med. Ctr. - Chicago, Womens & Childrens HIV Program | Chicago, Illinois 60608 |
Rush Univ. Cook County Hosp. Chicago NICHD CRS | Chicago, Illinois 60612 |
Tulane Univ. New Orleans NICHD CRS | New Orleans, Louisiana 70112 |
Henry Ford Hosp. CRS | Detroit, Michigan 48202 |
Cooper Univ. Hosp. CRS | Camden, New Jersey 08103 |
Columbia IMPAACT CRS | New York, New York 10032 |
Cornell CRS | New York, New York 10011 |
The Research & Education Group-Portland CRS | Portland, Oregon 97210 |
Thomas Jefferson Univ. Med. Ctr. CRS | Philadelphia, Pennsylvania 19107 |
The Miriam Hosp. ACTG CRS | Providence, Rhode Island 02906 |
Trinity Health and Wellness Center CRS | Dallas, Texas 75208 |
Houston AIDS Research Team CRS | Houston, Texas 77030 |
Virginia Commonwealth Univ. Medical Ctr. CRS | Richmond, Virginia 23298 |
New Jersey Medical School- Adult Clinical Research Ctr. CRS | Newark, New Jersey 07103 |
UCSD Mother-Child-Adolescent Program CRS | San Diego, California 92103 |
South Florida CDTC Ft Lauderdale NICHD CRS | Fort Lauderdale, Florida 33316 |
Texas Children's Hosp. CRS | Houston, Texas 77030 |