Adaptive Immunity to Mtb-infection and TB Disease Among Young Ugandan Children (PA21)
Information:
Sponsor - U. S. National Institutes of Health
Principal Investigators – Christine Lancioni, MD, OHSU; Catherine Stein, PhD, ÐÇ¿Õ´«Ã½; Ezekiel Mupere, MBChB, PhD, Uganda-ÐÇ¿Õ´«Ã½ Research Collaboration
| Type of Study | Non-Interventional, Prospective Observational Study Household Contact |
|---|---|
| Design | Household Contact |
| Project Site | Kampala, Uganda |
| Population | |
| Sample Size | 300 children less than 5 years old (less than 60 months) who are household contacts of an index case with active TB
Children will be grouped into two baseline cohorts: Cohort 1:Asymptomatic, TB exposed and no signs and symptoms of Active TB PedAS) Cohort2: Signs and symptoms of Active TB and/or diagnosed with TB Disease (PedTB) |
| Study Period |
2021 - Present Overall study duration: It may take up to 4 years to enroll cohorts Follow up duration: Household Contacts without active TB: 12 Months Household Contacts with active TB: 12 months |
Goal of Study:
The goal of this study is to define the spectrum of adaptive immune responses to primary MTB exposure, and create immune biosignatures that reflect pediatric TB disease, and asymptomatic MTB-exposure with and without evidence of immune sensitization. This study will also determine if HIV-exposure or infection impact a young child’s MTB-specific immune response.
Objectives of Study:
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To recruit Ugandan children 5 years and younger (60 months), with and without perinatal HIV-exposure and/or infection, who are household contacts of an adult
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To identify immunologic phenotypes that correlate with TB disease, versus >remaining asymptomatic following TB household contact, in young children with and without perinatal HIV-exposure and/or infection
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To determine if MTB-specific T cell and/or antibody profiles can be used to distinguish TB disease from asymptomatic MTB infection, in young children with and without perinatal HIV-exposure and/or infection
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To determine how perinatal HIV exposure/infection alters MTB-specific adaptive immune profiles
Research Activities:
Immunology