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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02058927

Enrollment

203

Registered

2014-02-10

Start date

2011-05-31

Completion date

2012-02-29

Last updated

2014-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Measles

Keywords

HIV, ART, children

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.

Interventions

DRUGMeasles vaccine

measles revaccination administered at 12 months from start of ART

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

9 Months to 10 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Zambia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026