IMPAACT P1085: Human Papilloma Virus (HPV) Type-Specific Antibody
NCT ID: NCT01206556
Last Updated: 2015-04-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
97 participants
OBSERVATIONAL
2010-05-31
2013-08-31
Brief Summary
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Detailed Description
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P1085 is a sub study of P1047, which investigated the safety and immunogenicity of Quadrivalent HPV (QHPV) in HIV-infected girls and boys, age 7 to \<12 years of age. This study was a placebo-controlled trial that compared a recommended three dose schedule of QHPV in one study arm (Arm A) with an arm that received placebo (Arm B). P1047 has thus far demonstrated that QHPV can be safely administered to human immunodeficiency virus (HIV)-infected boys and girls and will stimulate seroconversion in more than 95% of vaccinees. However, these antibody levels were 30-50% lower than those achieved in children without HIV infection. Since levels of vaccine-induced antibodies decline with time after vaccination, it is uncertain if vaccine-induced immunity will be life-long. This concern is supported by some evidence that naturally acquired HPV-specific antibody might decline to a level that will permit re-infection. Comparative persistence data for HPV-specific antibody is available for 5-6 years after vaccination of almost 1000 children without HIV infection (manufacturer's data, unpublished), but there is no such information available from HIV-infected vaccinees.
We seek to determine the long-term durability and kinetics of the vaccine-induced HPV-type-specific antibody and CMI responses in HIV-infected children that were, and are being, immunized in P1047. These subjects are a unique cohort that will allow us to approach this specific clinical issue.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Completion of the P1047 scheduled vaccine doses for their designated arm.
* Parent or legal guardian able and willing to provide signed informed consent
* Subjects should be between 1 and 2 years following their last HPV vaccination.
Exclusion Criteria
* Administration of a globulin-containing product within 90 days prior to enrollment.
* Receipt of an additional dose of Merck HPV vaccine other than that administered for the P1047 study.
* Receipt of GSK HPV vaccine.
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Merck Sharp & Dohme LLC
INDUSTRY
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
NETWORK
Responsible Party
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Principal Investigators
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Myron J Levin, MD
Role: STUDY_CHAIR
University of Colorado, Denver
Locations
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Miller Children's Hospital Long Beach (5093)
Long Beach, California, United States
USC/Los Angeles County Medical Center NICHD CRS (5048)
Los Angeles, California, United States
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CR (3601)
Los Angeles, California, United States
Univ of California, San Diego (4601)
San Diego, California, United States
Univ. of California San Francisco NICHD CRS
San Francisco, California, United States
Univ. of Colorado Denver NICHD CRS (5052)
Aurora, Colorado, United States
Children's National Med. Ctr. Washington DC NICHD CRS (5015)
Washington D.C., District of Columbia, United States
South Florida CDC Ft. Lauderdale NICHD CRS (5055)
Fort Lauderdale, Florida, United States
Univ of Miami Pediatric/Perinatal HIV/AIDS (4201)
Miami, Florida, United States
Rush University Cook County Hospital NICHD CRS (5083)
Chicago, Illinois, United States
Chicago Children's CRS (4001)
Chicago, Illinois, United States
Children's Hospital of Boston (5009)
Boston, Massachusetts, United States
Boston Medical Center Ped. HIV Program NICHD CRS (5011)
Boston, Massachusetts, United States
WNE Maternal Pediatric Adolescent AIDS CRS (7301)
Worcester, Massachusetts, United States
Wayne State University/Children's Hospital of Michigan NICHD CRS (5041)
Detroit, Michigan, United States
New Jersey Medical School (NJ) (2802)
Newark, New Jersey, United States
New York University NY (5012)
New York, New York, United States
Strong Memorial Hospital, University of Rochester NICHD CRS (5057)
Rochester, New York, United States
SUNY Stony Brook (5040)
Stony Brook, New York, United States
Bronx-Lebanon Hospital (6901)
The Bronx, New York, United States
Jacobi Medical Center Bronx (5013)
The Bronx, New York, United States
Texas Children's Hosp / Baylor Univ (3801)
Houston, Texas, United States
San Juan City Hosp. PR NICHD CRS (5031)
San Juan, , Puerto Rico
Countries
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References
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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.
Related Links
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IMPAACT Network Web Site
Other Identifiers
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IMPAACT P1085
Identifier Type: -
Identifier Source: org_study_id
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