title: The Karonga Prevention Trial: a leprosy and tuberculosis vaccine trial in northern Malaŵi. I. Methods of the vaccination phase.
abstract: In this report the methods of the Karonga Prevention Trial, a double-blind leprosy and tuberculosis vaccine trial in Karonga District, Northern Malaŵi, are described in detail. During a total population house-to-house survey, which lasted from November 1985 until August 1989, 121,008 people (57,892 males and 63,116 females) were vaccinated. A further 5835 people refused vaccination and 5757 were ineligible for vaccination, 2652 of them because they had a history or signs of leprosy, or because they were suspected to have early leprosy. A total of 66,145 individuals, without evidence of prior BCG vaccination, received one of the following: BCG, BCG + 5 x 10(7) killed Mycobacterium leprae, or BCG + 6 x 10(8) killed M. leprae; 54,863 individuals found with a typical or a doubtful BCG scar received either placebo or BCG, or (from mid-1987 onwards) BCG + 6 x 10(8) killed M. leprae. Side-effects were not looked for systematically, but 4 individuals self-reported with glandular abscesses, 9 with large post-vaccination ulcers (> 25 mm in diameter) and 2 with ulcers which persisted for more than 1 year. BCG vials collected from paraffin refrigerators in the field showed satisfactory concentrations of viable BCG throughout the trial. Post-vaccination skin test (RT23 and M. leprae soluble antigen) results and post-vaccination ulcer rates indicate that few mistakes were made in the field when recording the vaccine codes.
authors.affiliation: LEPRA, Chilumba, Malawi.
authors.forename: J M
authors.initials: JM
authors.lastname: Pönnighaus
authors.forename: P E
authors.initials: PE
authors.lastname: Fine
authors.forename: L
authors.initials: L
authors.lastname: Bliss
authors.forename: P J
authors.initials: PJ
authors.lastname: Gruer
authors.forename: B
authors.initials: B
authors.lastname: Kapira-Mwamondwe
authors.forename: E
authors.initials: E
authors.lastname: Msosa
authors.forename: R J
authors.initials: RJ
authors.lastname: Rees
authors.forename: D
authors.initials: D
authors.lastname: Clayton
authors.forename: M C
authors.initials: MC
authors.lastname: Pike
authors.forename: J A
authors.initials: JA
authors.lastname: Sterne
mesh_terms: D000293:Adolescent; D000328:Adult; D001500:BCG Vaccine; D001428:Bacterial Vaccines; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D007918:Leprosy / Q000517:prevention & control*; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D009166:Mycobacterium leprae / Q000276:immunology*; D014376:Tuberculosis / Q000517:prevention & control*; D014611:Vaccination
chemical_list: D001500:BCG Vaccine; D001428:Bacterial Vaccines; C060596:anti-leprosy vaccine