Data for: “BCG revaccination in Malawi: 30-year follow-up of a large, randomised, double-blind placebo-controlled trial” – User Guide

Permanent identifier

https://doi.org/10.17037/DATA.00002443

Description

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.

Data collection method

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.

Geographic regions

Karonga District, northern Malawi

Key dates

• Vaccine trial recruitment: Jan 1986 - Oct 1989
• Follow-up Jan 1986 - Dec 2018
• Final version of the data: Jan 2020

Quality Controls

These are described in detail in the papers listed above.

Population

Individuals aged between 3 months to 75 years in Karonga District, northern Malawi.

Ethics

The trial protocol was approved in 1985 by the Health Sciences Research Committee of the Malawi Ministry of Health, the Standing Committee on Research in Human Subjects of WHO, and the Ethics Committee of the London School of Hygiene & Tropical Medicine. Follow-up of the population has been approved in the context of other studies by the Health Sciences Research Committee of the Malawi Ministry of Health and the Ethics Committee of the London School of Hygiene & Tropical Medicine.

Keywords

BCG, BCG revaccination, vaccine trial, tuberculosis, leprosy, BCG + killed M leprae vaccine, Bacillus Calmette-Guérin

Language of written material

English

Project title

Karonga Prevention Trial

Funder/Sponsor

The recruitment phase of the Karonga Prevention Trial was funded primarily by the British Leprosy Relief Association (LEPRA), with assistance from the International Federation of Anti-Leprosy Organizations (ILEP). The vaccines were provided by Glaxo and by the Immunology of Leprosy component of the UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (IMMLEP/TDR). The follow up post 1995 was funded largely by the Wellcome Trust. The present analysis was funded by the Bill & Melinda Gates Foundation.

Grant number

This 30-year follow up was funded, in part, by the Bill and Melinda Gates Organisation OPP1210686 and The Wellcome Trust (063558/01, 079827/06, 098610/12)

Data creators

Associated Roles

File description