NCT02606526

Early Versus Late BCG Vaccination in HIV-1 Exposed Infants in Uganda in Uganda

A Randomised Controlled Trial in HIV-1 Exposed Ugandan Infants to Estimate Additional Benefits (Non-specific Effects) of BCG

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 4,500 (actual)
• Sponsor: Makerere University · Academic / Other
• Sex: All
• Age: 1 Day
• Healthy volunteers: Accepted

Summary

BCG vaccination may have non-specific effects (NSE) i.e., additional benefits 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 4,500 HIV exposed infants. The intervention is an intra-dermal administration of 0.05 ml of BCG vaccine within 24 hours of birth while the comparator will be an intra-dermal administration of 0.05ml of BCG vaccine at 14 weeks of age. The main study outcomes include: 1. Severe illness in the first 14 weeks of life, 2. Innate and adaptive immune responses to mycobacterial, non-mycobacterial antigens and TLR-agonists 3. Severe illness in the first 14-52 weeks and 0-52 weeks of life. The study will be carried in two health centers and one district hospital in Uganda. Implications: A well-timed BCG vaccination could have important additional benefits in HE infants. This trial could inform the development of programmatically appropriate timing of BCG vaccination for HE infants.

Conditions

• Severe Illness
• Septicaemia
• Diarrhoea
• Lower Respiratory Infection

Interventions

Type	Name	Description
BIOLOGICAL	BCG at birth	See previous description
BIOLOGICAL	Control arm: Delayed BCG	See previous description

Timeline

• Start date: 2016-07-01
• Primary completion: 2024-06-21
• Completion: 2024-06-21
• First posted: 2015-11-17
• Last updated: 2025-03-04

Locations

1 site across 1 country: Uganda