Predictors of Immune Response and Progression to TB Disease in Infants Vaccinated at Birth with BCG
Information:
| Type of Study | Prospective observational study |
|---|---|
| Design | Case control study |
| Project Site | Western Cape, South Africa |
| Sample Size | total 12,700 subjects Infants were assigned to 1 of 3 groups |
| Population |
Objective 1: BCG vaccinated newborns and adolescents Objective 2: 33 BCG vaccinated newborns per time point (3, 6, 10, 14, 27 and 40 weeks) Objective 3: 11,680 BCG vaccinated newborns, followed to identify children with active TB (cases) and exposed children who did not develop disease (controls) Objective 4: 900 BCG vaccinated newborns, followed to identify 300 children with active TB (cases) and 600 exposed children who did not develop disease (controls) Objective 5: All pediatric Mtb isolates from site over past 2 years |
| Study Period | 2008-2012 |
Goal of Study:
We aim to identify immune correlates of vaccination-induced resistance to subsequent TB disease.
Objectives of Study:
- Validate newly identified vaccination-induced immune correlate(s) of protection against TB disease, following vaccination of newborns with BCG.
- Determine the longitudinal kinetics of the immune response to BCG, in infants vaccinated at birth.
- Determine the kinetics of BCG induced T cell responses over the first year of life.
- Determine when to boost BCG-specific immunity.
- Characterize BCG-specific T cell functional capacity, effector mechanisms and memory subsets over the first year of life.
- Determine whether innate immune gene polymorphisms are associated with differences in ex vivo measured immune responses to BCG, in infants vaccinated at birth.
- Determine whether innate immune gene polymorphisms are associated with lack of BCG-induced protection against TB, in infants vaccinated at birth.
- Determine whether infection with certain Mtb strains is preferentially associated with TB disease in BCG-vaccinated neonates not protected against disease by the vaccine.