Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2026-01-21 @ 1:50 PM
Study NCT ID:
NCT02058927
Status:
COMPLETED
Last Update Posted:
2014-09-18
First Post:
2014-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immune Reconstitution to Measles Virus of HIV Infected Children in Zambia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008457', 'term': 'Measles'}], 'ancestors': [{'id': 'D018185', 'term': 'Morbillivirus Infections'}, {'id': 'D018184', 'term': 'Paramyxoviridae Infections'}, {'id': 'D018701', 'term': 'Mononegavirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008458', 'term': 'Measles Vaccine'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'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.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 203}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-17', 'studyFirstSubmitDate': '2014-02-06', 'studyFirstSubmitQcDate': '2014-02-06', 'lastUpdatePostDateStruct': {'date': '2014-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Memory immune responses to measles virus', 'timeFrame': '0, 6, 12, 24, 30 and 36 months from start of ART', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Humoral and cellular immune responses to measles virus before and after revaccination', 'timeFrame': '12, 15, 24, 30 and 36 months from start of ART', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV', 'ART', 'children'], 'conditions': ['Measles']}, 'referencesModule': {'references': [{'pmid': '15319741', 'type': 'BACKGROUND', 'citation': 'Newell ML, Brahmbhatt H, Ghys PD. 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Clin Infect Dis. 2001 Apr 1;32(7):1090-4. doi: 10.1086/319591. Epub 2001 Mar 19.'}, {'pmid': '12777579', 'type': 'BACKGROUND', 'citation': 'Melvin AJ, Mohan KM. Response to immunization with measles, tetanus, and Haemophilus influenzae type b vaccines in children who have human immunodeficiency virus type 1 infection and are treated with highly active antiretroviral therapy. Pediatrics. 2003 Jun;111(6 Pt 1):e641-4. doi: 10.1542/peds.111.6.e641.'}, {'pmid': '11528592', 'type': 'BACKGROUND', 'citation': 'Gans H, Yasukawa L, Rinki M, DeHovitz R, Forghani B, Beeler J, Audet S, Maldonado Y, Arvin AM. Immune responses to measles and mumps vaccination of infants at 6, 9, and 12 months. J Infect Dis. 2001 Oct 1;184(7):817-26. doi: 10.1086/323346. Epub 2001 Aug 22.'}, {'pmid': '9669968', 'type': 'BACKGROUND', 'citation': 'Angel JB, Walpita P, Lerch RA, Sidhu MS, Masurekar M, DeLellis RA, Noble JT, Snydman DR, Udem SA. Vaccine-associated measles pneumonitis in an adult with AIDS. Ann Intern Med. 1998 Jul 15;129(2):104-6. doi: 10.7326/0003-4819-129-2-199807150-00007. No abstract available.'}, {'pmid': '12640478', 'type': 'BACKGROUND', 'citation': 'Moss WJ, Clements CJ, Halsey NA. Immunization of children at risk of infection with human immunodeficiency virus. Bull World Health Organ. 2003;81(1):61-70. Epub 2003 Mar 11.'}], 'seeAlsoLinks': [{'url': 'http://www.unc.edu', 'label': 'University of North Carolina website'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nWithin 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '9 Months', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'HIV-1 infected children initiating ART in public clinics within Lusaka, Zambia.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Boys and girls 9 months to 10 years of age residing in Lusaka, Zambia are eligible for enrolment.\n* initiating ART\n* history of measles vaccination confirmed by examination of the Immunization Card.'}, 'identificationModule': {'nctId': 'NCT02058927', 'briefTitle': 'Immune Reconstitution to Measles Virus of HIV Infected Children in Zambia', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'Immune Reconstitution to Measles Virus of HIV-1-Infected Zambian Children Initiating Antiretroviral Therapy', 'orgStudyIdInfo': {'id': 'CIDRZ 1204/IRB12-0400'}, 'secondaryIdInfos': [{'id': 'R01AI070018', 'link': 'https://reporter.nih.gov/quickSearch/R01AI070018', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'HIV-1 infected children', 'description': 'HIV-1-infected children initiating ART'}, {'label': 'HIV-1 uninfected children', 'description': 'control group of HIV-1 uninfected children matched by age'}, {'label': 'HIV-1 infected children revaccinated', 'description': 'nested study of revaccination against measles virus of HIV-1-infected children receiving ART who lack protective antibody titers', 'interventionNames': ['Drug: Measles vaccine']}], 'interventions': [{'name': 'Measles vaccine', 'type': 'DRUG', 'description': 'measles revaccination administered at 12 months from start of ART', 'armGroupLabels': ['HIV-1 infected children revaccinated']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lusaka', 'country': 'Zambia', 'facility': 'Centre for Infectious Disease Research in Zambia', 'geoPoint': {'lat': -15.40669, 'lon': 28.28713}}], 'overallOfficials': [{'name': 'Carolyn B Moore, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Carolyn Bolton Moore, MD', 'investigatorAffiliation': 'University of North Carolina, Chapel Hill'}}}}