@article{18111,
  keywords = {Adolescent, Adult, BCG Vaccine, Bacterial Vaccines, Child, Child, Preschool, Female, Humans, leprosy, Longitudinal studies, Male, Middle Aged, Mycobacterium leprae, Tuberculosis, Vaccination},
  author = {Ponnighaus J M and Fine PE and Bliss L and Gruer P J and Kapira-Mwamondwe B and Msosa E and Rees R J and Clayton D and Pike M C and Sterne J A},
  title = {The Karonga Prevention Trial: a leprosy and tuberculosis vaccine trial in northern Malaŵi. I. Methods of the vaccination phase.},
  abstract = {<p>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.</p>},
  year = {1993},
  journal = {Leprosy review},
  volume = {64},
  pages = {338-56},
  month = {1993 Dec},
  issn = {0305-7518},
  url = {http://leprev.ilsl.br/pdfs/1993/v64n4/pdf/v64n4a08.pdf},
  doi = {10.5935/0305-7518.19930039},
  language = {eng},
}