Individual level data on vaccine allocation and outcome (leprosy and tuberculosis incidence) on more than 120,000 recruited into the vaccine trial in 1986-89 and followed up until December 2018.
Additional information
This data submission is currently being prepared - August 2021
Individuals age 3 months to 75 years were recruited in house-to-house surveys in 1986-89 in Karonga District, northern Malawi. Those with a BCG scar were randomised to receive repeat BCG or placebo. Those without a BCG scar were randomised to receive BGG or a combined BCG + killed M leprae vaccine. Surveillance was by a mixture of active and passive surveillance. The original trial methods and results after 5-9 years follow-up are described in detail in:
[1] Ponnighaus JM, Fine PEM, Bliss L, et al. The Karonga Prevention Trial: A leprosy and tuberculosis vaccine trial in Northern Malawi - I: Methods of the vaccination phase. Lepr Rev 1993; 64: 338-56.
[2] Karonga Prevention Trial Group. Randomised controlled trial of single BCG, repeated BCG, or combined BCG and killed Mycobacterium leprae vaccine for prevention of leprosy and tuberculosis in Malawi. Lancet 1996; 348: 17-24.
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