Immune Reconstitution to Measles Virus of HIV Infected Children in Zambia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Immune Reconstitution to Measles Virus of HIV-1-Infected Zambian Children Initiating Antiretroviral Therapy

Conditions
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Measles

Intervention / Treatment
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* Drug: Measles vaccine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 9 Months
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HIV-1 infected children<br>HIV-1-infected children initiating ART | |
| HIV-1 uninfected children<br>control group of HIV-1 uninfected children matched by age | |
| HIV-1 infected children revaccinated<br>nested study of revaccination against measles virus of HIV-1-infected children receiving ART who lack protective antibody titers | Drug: Measles vaccine<br>* measles revaccination administered at 12 months from start of ART<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Memory immune responses to measles virus | 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. | 0, 6, 12, 24, 30 and 36 months from start of ART | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Humoral and cellular immune responses to measles virus before and after revaccination | 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. | 12, 15, 24, 30 and 36 months from start of ART | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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children, HIV, ART