Immune Reconstitution to Measles Virus of HIV Infected Children in Zambia

Completed

• Conditions: Measles
• Interventions: Drug: Measles vaccine

• Registration Number: NCT02058927
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Study Timeline

• Study Start: 2011-05
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Study First Submitted: 2014-02-06
• Study First Submitted QC: 2014-02-06
• Study First Posted: 2014-02-10
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-17
• Last Update Posted: 2014-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 203

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HIV-1 infected children revaccinated	Measles vaccine	nested study of revaccination against measles virus of HIV-1-infected children receiving ART who lack protective antibody titers

Primary Outcome Measures

Name	Time	Method
Memory immune responses to measles virus	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 Outcome Measures

Name	Time	Method
Humoral and cellular immune responses to measles virus before and after revaccination	12, 15, 24, 30 and 36 months from start of ART	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.

Trial Locations

Locations (1)

Centre for Infectious Disease Research in Zambia; 🇿🇲 Lusaka, Zambia