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Clinical Trials/NCT02058927
NCT02058927
Completed
Not Applicable

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

University of North Carolina, Chapel Hill1 site in 1 country203 target enrollmentMay 2011
ConditionsMeasles
InterventionsMeasles vaccine

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.

Registry
clinicaltrials.gov
Start Date
May 2011
End Date
February 2012
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

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)

Study Sites (1)

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