02586nas a2200445   4500000000100000008004100001260001300042653001500055653001000070653001600080653002300096653001000119653002100129653001100150653001100161653001200172653002500184653000900209653001600218653002500234653001700259653001600276100001900292700001200311700001200323700001400335700002300349700001200372700001300384700001400397700001300411700001500424245013300439856005900572300001100631490000700642050003200649520144500681022001402126       1993                            d  c1993 Dec10aAdolescent10aAdult10aBCG Vaccine10aBacterial Vaccines10aChild10aChild, Preschool10aFemale10aHumans10aleprosy10aLongitudinal studies10aMale10aMiddle Aged10aMycobacterium leprae10aTuberculosis10aVaccination1 aPonnighaus J M1 aFine PE1 aBliss L1 aGruer P J1 aKapira-Mwamondwe B1 aMsosa E1 aRees R J1 aClayton D1 aPike M C1 aSterne J A00aThe Karonga Prevention Trial: a leprosy and tuberculosis vaccine trial in northern Malaŵi. I. Methods of the vaccination phase.  uhttp://leprev.ilsl.br/pdfs/1993/v64n4/pdf/v64n4a08.pdf  a338-560 v64  aInfolep Library - available3 a<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>  a0305-7518