Sponsor study identifier
Secondary identifiers
NIH
observational
97
2 countries
23
Study Start
May 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2012
Actual (reported)Study Completion
August 2013
Actual (reported)This study is being done to evaluate how long the immune response from the Human Papilloma Virus (HPV) vaccine you / your child received persists. The immune response occurred after immunization and is what protects you/your child from HPV disease. You / your child received this vaccine as part of an earlier study (P1047). The vaccine is called Human Papillomavirus Vaccine (QHPV Vaccine, also known as GARDASIL®). The study will check to see if the protective effects (called "antibodies") produced by the vaccine have lasted, and for how long these effects will continue to last. You will not be given any medications or vaccines as part of this follow-up study.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2013
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2010
Date type not reportedThis date has not been verified as actual or estimated.
September 20, 2010
Actual (reported)September 22, 2010
Actual (reported)December 2012
Actual (reported)August 2013
Actual (reported)To determine the HPV-type specific antibody levels at 2, 3.5, and 5 years after completion of the QHPV vaccine schedule for each of the arms in P1047
To determine the HPV-type specific antibody levels at 2, 3.5, and 5 years after completion of the QHPV vaccine schedule for each of the arms in P1047 and compare them to published levels of QHPV-induced antibody levels present in age-similar children IMPAACT P1085 without HIV infection at these time intervals after QHPV vaccination.
208 weeks (4 Years)
Comparing the decline over the study interval in HPV type-specific antibody in subjects who received four doses of QHPV (Arm A) with those who received three doses of vaccine (Arm B) in P1047.
4 years
Determining the magnitude of HPV-specific antibody at different times after QHPV vaccination as a function of immune status (as defined by CD4 count and CD4 percent) and plasma HIV viral load.
4 years
Determining the persistence of HPV-specific CMI at 2, 3.5, and 5 years after completion of the QHPV schedule for each of the arms in P1047.
5 years after completion
Evaluating potential associations of HIV plasma RNA, lymphocyte immunophenotypes, HPV-specific memory B cell lymphocytes and HPV-specific CMI with the decay of anti-HPV antibody titers.
4 years
This will be limited to subjects who were enrolled into IMPAACT P1047 and who completed the scheduled vaccine doses for their designated arm.
Miller Children's Hospital Long Beach (5093)
Long Beach, California, 90806, United States
USC/Los Angeles County Medical Center NICHD CRS (5048)
Los Angeles, California, 90033, United States
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CR (3601)
Los Angeles, California, 90095, United States
Univ of California, San Diego (4601)
San Diego, California, 92103, United States
Univ. of California San Francisco NICHD CRS
San Francisco, California, 94117, United States
Univ. of Colorado Denver NICHD CRS (5052)
Aurora, Colorado, 80045, United States
Levin MJ, Huang S, Moscicki AB, Song LY, Read JS, Meyer WA, Saah AJ, Richardson K, Weinberg A; IMPAACT P1085 Protocol Team. Four-year persistence of type-specific immunity after quadrivalent human papillomavirus vaccination in HIV-infected children: Effect of a fourth dose of vaccine. Vaccine. 2017 Mar 23;35(13):1712-1720. doi: 10.1016/j.vaccine.2017.02.021. Epub 2017 Feb 24.
Myron J Levin, MD
University of Colorado, Denver
97 participants (actual enrollment reported by the registry).
First Submitted
September 20, 2010
First Posted
September 22, 2010
Study Start
May 2010
Date type not reportedThis date has not been verified as actual or estimated.
A Study to Compare the Impact of a School Based HPV Program on Vaccination Uptake and Completion Rates
Contact the study team to confirm eligibility.
Children's National Med. Ctr. Washington DC NICHD CRS (5015)
Washington D.C., District of Columbia, 20010, United States
South Florida CDC Ft. Lauderdale NICHD CRS (5055)
Fort Lauderdale, Florida, 33316, United States
Univ of Miami Pediatric/Perinatal HIV/AIDS (4201)
Miami, Florida, 33136, United States
Rush University Cook County Hospital NICHD CRS (5083)
Chicago, Illinois, 60612, United States
Chicago Children's CRS (4001)
Chicago, Illinois, 60614, United States
Children's Hospital of Boston (5009)
Boston, Massachusetts, 02115, United States
Boston Medical Center Ped. HIV Program NICHD CRS (5011)
Boston, Massachusetts, 02118, United States
WNE Maternal Pediatric Adolescent AIDS CRS (7301)
Worcester, Massachusetts, 01605, United States
Wayne State University/Children's Hospital of Michigan NICHD CRS (5041)
Detroit, Michigan, 48201, United States
New Jersey Medical School (NJ) (2802)
Newark, New Jersey, 07103, United States
New York University NY (5012)
New York, New York, 10016, United States
Strong Memorial Hospital, University of Rochester NICHD CRS (5057)
Rochester, New York, 14642, United States
SUNY Stony Brook (5040)
Stony Brook, New York, 11794-8111, United States
Bronx-Lebanon Hospital (6901)
The Bronx, New York, 10457, United States
Jacobi Medical Center Bronx (5013)
The Bronx, New York, 10461, United States
Texas Children's Hosp / Baylor Univ (3801)
Houston, Texas, 77030, United States
San Juan City Hosp. PR NICHD CRS (5031)
San Juan, 00927, Puerto Rico
Primary Completion
December 2012
Actual (reported)Study Completion
August 2013
Actual (reported)Last Updated
April 1, 2015
Record last verified: 2015-03
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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