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
  Purpose

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.


Condition Intervention
Measles
Drug: Measles vaccine

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Immune Reconstitution to Measles Virus of HIV-1-Infected Zambian Children Initiating Antiretroviral Therapy

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Biospecimen Retention:   Samples With DNA

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.


Enrollment: 203
Study Start Date: May 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   9 Months to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02058927

Locations
Zambia
Centre for Infectious Disease Research in Zambia
Lusaka, Zambia
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Carolyn B Moore, MD University of North Carolina, Chapel Hill
  More Information

Additional Information:
Publications:

Responsible Party: Carolyn Bolton Moore, MD, Assistant Professor, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02058927     History of Changes
Other Study ID Numbers: 12-0400, R01AI070018
Study First Received: February 6, 2014
Last Updated: February 6, 2014
Health Authority: Zambia: Research Ethics Committee

Keywords provided by University of North Carolina, Chapel Hill:
HIV
ART
children

Additional relevant MeSH terms:
Measles
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on September 16, 2014