Immune Reconstitution to Measles Virus of HIV-1-Infected Zambian Children Initiating Antiretroviral Therapy
Overview
- Phase
- Not Applicable
- Intervention
- Measles vaccine
- Conditions
- Measles
- Sponsor
- University of North Carolina, Chapel Hill
- Enrollment
- 203
- Locations
- 1
- Primary Endpoint
- Memory immune responses to measles virus
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
This is an observational study of HIV-1 infected children starting antiretroviral therapy to measure the magnitude and quality of general immune reconstitution and pathogen-specific immune reconstitution to measles virus.
Detailed Description
This is a prospective, observational cohort study of 230 HIV-1-infected children initiating ART at public clinics in Lusaka, Zambia to measure the magnitude and quality of general immune reconstitution and pathogen-specific immune reconstitution to measles virus. Non-specific immune reconstitution will be assessed by serial measurements of the number and percentages of CD4+ and CD8+ T-lymphocytes, number and percentages of activated CD4+ and CD8+ T-lymphocytes (using cell surface staining for HLA-DR and CD38), changes in the proportions of naïve and memory CD4+ and CD8+ T-lymphocyte subsets (using cell surface staining for CD45RA and CCR7), and changes in thymic output as determined by TREC levels. Virologic responses to ART will be assessed by serial measurements of plasma HIV-1 RNA levels. Within the observational study, there is a nested study of revaccination against measles virus of HIV-1-infected children receiving ART who lack protective antibody titers to assess the proportion of revaccinated children who develop protective immunity and the duration of protective immunity. Anti-measles virus IgG antibodies will be measured 9 months after initiation of ART. The results will be available at the 12-month follow-up visit and measles revaccination will be recommended to those children lacking protective antibody levels to measles virus.
Investigators
Carolyn Bolton Moore, MD
Assistant Professor
University of North Carolina, Chapel Hill
Eligibility Criteria
Inclusion Criteria
- •Boys and girls 9 months to 10 years of age residing in Lusaka, Zambia are eligible for enrolment.
- •initiating ART
- •history of measles vaccination confirmed by examination of the Immunization Card.
Exclusion Criteria
- Not provided
Arms & Interventions
HIV-1 infected children revaccinated
nested study of revaccination against measles virus of HIV-1-infected children receiving ART who lack protective antibody titers
Intervention: Measles vaccine
Outcomes
Primary Outcomes
Memory immune responses to measles virus
Time Frame: 0, 6, 12, 24, 30 and 36 months from start of ART
Memory immune responses to measles virus will be measured to characterize the magnitude and quality of immune reconstitution in HIV-1 infected Zambian children initiating ART and determine pathogen-specific immune reconstitution.
Secondary Outcomes
- Humoral and cellular immune responses to measles virus before and after revaccination(12, 15, 24, 30 and 36 months from start of ART)