Immune Reconstitution to Measles Virus of HIV Infected Children in Zambia

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Carolyn Bolton Moore, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT02058927
First received: February 6, 2014
Last updated: NA
Last verified: February 2014
History: No changes posted

February 6, 2014
February 6, 2014
May 2011
February 2012   (final data collection date for primary outcome measure)
Memory immune responses to measles virus [ Time Frame: 0, 6, 12, 24, 30 and 36 months from start of ART ] [ Designated as safety issue: No ]
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.
Same as current
No Changes Posted
Humoral and cellular immune responses to measles virus before and after revaccination [ Time Frame: 12, 15, 24, 30 and 36 months from start of ART ] [ Designated as safety issue: No ]
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.
Same as current
Not Provided
Not Provided
 
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

blood samples will be stored in a repository for five years beyond the end of the study period. Some samples may be exported to the Johns Hopkins Bloomberg School of Public Health when assays cannot be performed in Zambia.

Probability Sample

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

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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
203
February 2012
February 2012   (final data collection date for primary outcome measure)

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.
Both
9 Months to 10 Years
No
Contact information is only displayed when the study is recruiting subjects
Zambia
 
NCT02058927
12-0400, R01AI070018
No
Carolyn Bolton Moore, MD, University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: Carolyn B Moore, MD University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP