Immune Reconstitution to Measles Virus of HIV Infected Children in Zambia

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

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 Overview

• Status: Completed
• Conditions: Measles
• Intervention / Treatment: Drug: Measles vaccine

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 Type: Observational
• Enrollment (Actual): 203

Contacts and Locations

Study Locations

• Zambia
  • Lusaka, Zambia
    • Centre for Infectious Disease Research in Zambia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 months to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

HIV-1 infected children initiating ART in public clinics within Lusaka, Zambia.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Principal Investigator: Carolyn B Moore, MD, University of North Carolina, Chapel Hill

Publications and helpful links

General Publications

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Helpful Links

• University of North Carolina website

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: February 6, 2014
• First Submitted That Met QC Criteria: February 6, 2014
• First Posted (Estimate): February 10, 2014

Study Record Updates

• Last Update Posted (Estimate): September 18, 2014
• Last Update Submitted That Met QC Criteria: September 17, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: HIV; children; ART
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Morbillivirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; Measles
• Other Study ID Numbers: CIDRZ 1204/IRB12-0400; R01AI070018 (U.S. NIH Grant/Contract)