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BCG vaccination may have non-specific effects (NSE) i.e., effects on childhood morbidity and mortality that are separate the vaccine's effect on the incidence of disseminated tuberculosis. Though the available literature is mostly from observational study designs, and is fraught with controversy, BCG vaccination at birth, in a high risk population of HIV exposed children, may protect infants against serious infections other than TB. Yet, other studies indicate that giving BCG later in infancy, when the immune system is more mature, may offer even greater protection. The appropriate timing of BCG vaccination could therefore be up for revision. This study will therefore compare BCG vaccination at birth with BCG vaccination at 14 weeks of age in HIV exposed (HE) babies.
Methods: This is an individually randomized clinical trial in 2,192 HIV exposed infants. The intervention is an intra-dermal administration of 0.05 ml of BCG vaccine at 14 weeks of age while the comparator will be an intra-dermal administration of 0.05ml of BCG vaccine within 24 hours of birth (standard of care).
The main study outcomes include:
1. Severe illness in the first 14 weeks of life,
2. TNF, IL‑1b, IL-6 and IFN-γ in response to mycobacterial and non-mycobacterial pathogens and
3. Severe illness in the first 14-52 weeks and 0-52 weeks of life.
The study will be carried in health Center IIIs and health center IVs in Uganda.
Implications: A well-timed BCG vaccination could have important NSEs in HE infants. This trial could inform the development of programmatically appropriate timing of BCG vaccination for HE infants.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Lower Respiratory Tract Infections
Delayed BCG, Control arm: BCG at birth
Not yet recruiting
Published on BioPortfolio: 2015-11-17T21:08:23-0500
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