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

September 20, 2010
May 16, 2014
May 2010
December 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01206556 on ClinicalTrials.gov Archive Site
  • 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.
  • To compare the decline over the study interval in HPV typespecific antibody in subjects who received four doses of QHPV [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • To determine the magnitude of HPV-specific antibody at different times after QHPV vaccination [ Time Frame: 4 years ] [ 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. [ 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. [ Time Frame: 4 years ] [ Designated as safety issue: No ]
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Human Papilloma Virus (HPV) Type-Specific Antibody
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

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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

Papilloma Virus, Human
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
97
August 2013
December 2012   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT01206556
IMPAACT P1085, U01AI068632
Yes
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Merck Sharp & Dohme Corp.
Study Chair: Myron J Levin, MD University of Colorado, Denver
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP