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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01206556 |
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Date of registration:
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20/09/2010 |
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Primary sponsor: |
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Public title:
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Human Papilloma Virus (HPV) Type-Specific Antibody
HPV |
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Scientific title:
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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 |
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Date of first enrolment:
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May 2010 |
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Target sample size:
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110 |
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Recruitment status: |
Enrolling by invitation |
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URL:
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http://clinicaltrials.gov/show/NCT01206556 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Countries of recruitment
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Puerto Rico
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United States
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Contacts
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Name:
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Myron J Levin, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Colorado, Denver |
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Key inclusion & exclusion criteria
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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.
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Papilloma Virus, Human
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Primary Outcome(s)
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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)]
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Secondary Outcome(s)
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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]
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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]
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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]
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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]
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Secondary ID(s)
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IMPAACT P1085
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U01AI068632
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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