Immune Reconstitution to Measles Virus of HIV Infected Children in Zambia
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Immune Reconstitution to Measles Virus of HIV-1-Infected Zambian Children Initiating Antiretroviral Therapy|
- Memory immune responses to measles virus [ Time Frame: 0, 6, 12, 24, 30 and 36 months from start of ART ] [ Designated as safety issue: No ]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.
- Humoral and cellular immune responses to measles virus before and after revaccination [ Time Frame: 12, 15, 24, 30 and 36 months from start of ART ] [ Designated as safety issue: No ]Humoral and cellular immune responses to measles virus before and after revaccination of HIV-1-infected Zambian children receiving ART who lack protective antibody titers will be measured.
Biospecimen Retention: Samples With DNA
blood samples will be stored in a repository for five years beyond the end of the study period. Some samples may be exported to the Johns Hopkins Bloomberg School of Public Health when assays cannot be performed in Zambia.
|Study Start Date:||May 2011|
|Study Completion Date:||February 2012|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
HIV-1 infected children
HIV-1-infected children initiating ART
HIV-1 uninfected children
control group of HIV-1 uninfected children matched by age
HIV-1 infected children revaccinated
nested study of revaccination against measles virus of HIV-1-infected children receiving ART who lack protective antibody titers
Drug: Measles vaccine
measles revaccination administered at 12 months from start of ART
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02058927
|Centre for Infectious Disease Research in Zambia|
|Principal Investigator:||Carolyn B Moore, MD||University of North Carolina, Chapel Hill|