Immune Reconstitution to Measles Virus of HIV Infected Children in Zambia

Measles Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02058927
• Other study ID #: CIDRZ 1204/IRB12-0400
• Secondary ID: R01AI070018
• Status: Completed
• Phase: N/A
• First received: February 6, 2014
• Last updated: September 17, 2014
• Start date: May 2011
• Est. completion date: February 2012

Study information

• Verified date: September 2014
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: Zambia: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 9 Months to 10 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Measles

Intervention

Drug:
• Measles vaccine
measles revaccination administered at 12 months from start of ART

Locations

Country	Name	City	State
Zambia	Centre for Infectious Disease Research in Zambia	Lusaka

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

Zambia, 

References & Publications (45)

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* Note: There are 45 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No

External Links

•   University of North Carolina website