Human Papilloma Virus (HPV) Type-Specific Antibody

This study has been completed.
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT01206556
First received: September 20, 2010
Last updated: May 16, 2014
Last verified: May 2014
  Purpose

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.


Condition
Papilloma Virus, Human

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Duration of Human Papilloma Virus (HPV) Type-Specific Antibody After Administration of Quadrivalent HPV Vaccine (QHPV) to HIV-1 Infected Children Previously Enrolled in IMPAACT P1047

Resource links provided by NLM:


Further study details as provided by International Maternal Pediatric Adolescent AIDS Clinical Trials Group:

Primary Outcome Measures:
  • 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 [ Time Frame: 208 weeks (4 Years) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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. [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    To compare 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.

  • 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. [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    To determine 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%) and plasma HIV viral load.

  • 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. [ Time Frame: 5 years after completion ] [ Designated as safety issue: No ]
    To determine 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.

  • 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. [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    To evaluate 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.


Enrollment: 97
Study Start Date: May 2010
Study Completion Date: August 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Detailed Description:

Genital Human Papilloma Virus (HPV) infection is the most common sexually transmitted infection (STI) in the United States and worldwide. Over 50% of sexually active adolescents will become infected with HPV. HPV infection is strongly associated with the development of anogenital dysplasias and invasive cancers. Because HPV is a STI, optimal prevention in women will depend on prevention in their partners as well. Males remain a significant reservoir of HPV and vaccinating them will be essential for rapidly preventing transmission of HPV in the community.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

This will be limited to subjects who were enrolled into IMPAACT P1047 and who completed the scheduled vaccine doses for their designated arm.

Criteria

Inclusion Criteria:

  • Previous enrollment in P1047
  • 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:

  • Any clinically significant diseases (other than HIV infection) or clinically significant findings during the screening medical history or physical examination that, in the investigator's opinion, would compromise the outcome of this study.
  • 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.
  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: NCT01206556

Locations
United States, California
Miller Children's Hospital Long Beach (5093)
Long Beach, California, United States, 90806
USC/Los Angeles County Medical Center NICHD CRS (5048)
Los Angeles, California, United States, 90033
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CR (3601)
Los Angeles, California, United States, 90095
Univ of California, San Diego (4601)
San Diego, California, United States, 92103
Univ. of California San Francisco NICHD CRS
San Francisco,, California, United States, 94117
United States, Colorado
Univ. of Colorado Denver NICHD CRS (5052)
Aurora, Colorado, United States, 80045
United States, District of Columbia
Children's National Med. Ctr. Washington DC NICHD CRS (5015)
Washington, District of Columbia, United States, 20010
United States, Florida
South Florida CDC Ft. Lauderdale NICHD CRS (5055)
Ft. Lauderdale, Florida, United States, 33316
Univ of Miami Pediatric/Perinatal HIV/AIDS (4201)
Miami, Florida, United States, 33136
United States, Illinois
Chicago Children's CRS (4001)
Chicago, Illinois, United States, 60614
Rush University Cook County Hospital NICHD CRS (5083)
Chicago, Illinois, United States, 60612
United States, Massachusetts
Boston Medical Center Ped. HIV Program NICHD CRS (5011)
Boston, Massachusetts, United States, 02118
Children's Hospital of Boston (5009)
Boston, Massachusetts, United States, 02115
WNE Maternal Pediatric Adolescent AIDS CRS (7301)
Worcester, Massachusetts, United States, 01605
United States, Michigan
Wayne State University/Children's Hospital of Michigan NICHD CRS (5041)
Detroit, Michigan, United States, 48201
United States, New Jersey
New Jersey Medical School (NJ) (2802)
Newark, New Jersey, United States, 07103
United States, New York
Bronx-Lebanon Hospital (6901)
Bronx, New York, United States, 10457
Jacobi Medical Center Bronx (5013)
Bronx, New York, United States, 10461
New York University NY (5012)
New York, New York, United States, 10016
Strong Memorial Hospital, University of Rochester NICHD CRS (5057)
Rochester, New York, United States, 14642
SUNY Stony Brook (5040)
Stony Brook, New York, United States, 11794-8111
United States, Texas
Texas Children's Hosp / Baylor Univ (3801)
Houston, Texas, United States, 77030
Puerto Rico
San Juan City Hosp. PR NICHD CRS (5031)
San Juan, Puerto Rico, 00927
Sponsors and Collaborators
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Merck Sharp & Dohme Corp.
Investigators
Study Chair: Myron J Levin, MD University of Colorado, Denver
  More Information

Additional Information:
No publications provided

Responsible Party: International Maternal Pediatric Adolescent AIDS Clinical Trials Group
ClinicalTrials.gov Identifier: NCT01206556     History of Changes
Other Study ID Numbers: IMPAACT P1085, U01AI068632
Study First Received: September 20, 2010
Last Updated: May 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by International Maternal Pediatric Adolescent AIDS Clinical Trials Group:
HUMAN PAPILLOMA VIRUS
HPV

Additional relevant MeSH terms:
Virus Diseases
Papilloma
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on September 30, 2014