Immune Reconstitution to Measles Virus of HIV Infected Children in Zambia

University of North Carolina (UNC)

Status: Completed

Conditions: Measles

Treatments: Drug: Measles vaccine

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT02058927

R01AI070018 (U.S. NIH Grant/Contract)

CIDRZ 1204/IRB12-0400

Details and patient eligibility

About

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.

Full 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.

Enrollment: 203 patients

Sex: All

Ages: 9 months to 10 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

203 participants in 3 patient groups

HIV-1 infected children

Description:

HIV-1-infected children initiating ART

HIV-1 uninfected children

Description:

control group of HIV-1 uninfected children matched by age

HIV-1 infected children revaccinated

Description:

nested study of revaccination against measles virus of HIV-1-infected children receiving ART who lack protective antibody titers

Treatment:

Drug: Measles vaccine