Early Verus Late BCG Vaccination in HIV-1 Exposed Infants

The Bacillus Calmette–Guérin (BCG) vaccine may have beneficial, so-called non-specific effects, i.e. it may protect babies from serious infections and death, a protection beyond its ability to protect them against tuberculosis (TB).

However, most of the studies that indicate that BCG may have such additional non-specific effects are observational in nature and are fraught with controversy. This makes it difficult to ascertain from them whether the babies who get BCG are truly less prone to severe illness because they received the vaccine or because they had a lower risk of severe illness for other reasons.

Moreover, a different set of studies indicates that giving BCG later in infancy, for example at 10 weeks of age, may enhance immune responses against the vaccine and perhaps even to non-mycobacterial antigens. This may even enhance any non-specific effects of BCG. This enhanced immunity by a deferred BCG vaccine would be particularly useful among HIV-1 exposed (HE) children who show signs of impaired immunity in early infancy and in whom the appropriate timing of BCG vaccination that maximizes protection is uncertain. This study randomizes 2,200 HE Ugandan infants to receive BCG within 24 hours of being born or at 14 weeks of age.

Our main study outcomes are severe illness in the first 14 weeks of life and several immunological responses to mycobacterial and non-mycobacterial antigens. The trial is conducted in three health centers in or close to Kampala. A well-timed BCG vaccination could have important additional effects in HE infants. This study could inform the development of programmatically appropriate timing of BCG vaccination for HE infants.

Project Management Team

Principal Investigator
VICTORIA NANKABIRWA is a senior lecturer in the Department of Epidemiology & Biostatistics, School of Public Health, Makerere University and a researcher at the Center for International Health, University of Bergen. She holds a doctorate degree (PhD) from the University of Bergen. In the past, she has worked at the Norwegian Institute of Public Health (NIPH) as a researcher, at ICAP, Columbia University, New York as an analyst, at Nsambya hospital as a medical doctor and at Mulago national referral hospital. Her research and interests lie in the fields of maternal and child health, perinatal epidemiology, vaccination, core epidemiologic methods, randomized controlled trials and implementation research. Victoria Nankabirwa, Makerere University
Co-Principal Investigator
HALVOR SOMMERFELT is Professor in epidemiology and global health at the University of Bergen, Director of CISMAC, and senior consultant at the Norwegian Institute of Public Health. Through international collaborative ventures with research groups in South Asia, sub-Saharan Africa, Europe and the U.S. he has participated in or coordinated front-line research aimed at improving management and prevention of important childhood illnesses and promoting childhood nutrition. Sommerfelt has (co-)authored more than 100 scientific papers, holds lectures at research institutions in Norway, elsewhere in Europe, India, South Africa, and the US, and he has organized international scientific meetings on maternal and child health and vaccination research. Sommerfelt is also member of the Independent Assessment Committee of Advance Market Commitment for vaccines






Grace Ndeezi


Olive Namugga



James K Tumwine





Thorkild Tylleskär




Country: Uganda