03834nas a2200577 4500000000100000008004100001260001300042653001500055653001000070653000900080653002300089653001000112653002100122653003700143653003700180653002400217653002700241653001100268653002200279653001100301653001000312653001200322653000900334653001600343653001600359653002100375653002000396653001700416653001600433100001300449700001600462700001500478700002200493700001200515700001500527700001500542700001100557700001100568700001600579700001300595700001500608700001200623700001200635245015900647856005100806300001100857490000700868050003200875520233500907022001403242 2005 d c2005 Jun10aAdolescent10aAdult10aAged10aBacterial Vaccines10aChild10aChild, Preschool10aDisease Transmission, Infectious10aDose-Response Relationship, Drug10aDouble-Blind Method10aFamily Characteristics10aFemale10aFollow-Up Studies10aHumans10aIndia10aleprosy10aMale10aMiddle Aged10aProbability10aReference Values10aRisk Assessment10aTime Factors10aVaccination1 aSharma P1 aMukherjee R1 aTalwar G P1 aSarathchandra K G1 aWalia R1 aParida S K1 aPandey R M1 aRani R1 aKar HK1 aMukherjee A1 aKatoch K1 aBenara S K1 aSingh T1 aSingh P00aImmunoprophylactic effects of the anti-leprosy Mw vaccine in household contacts of leprosy patients: clinical field trials with a follow up of 8-10 years. uhttps://leprosyreview.org/article/76/2/12-7143 a127-430 v76 aInfolep Library - available3 a

We report here a large scale, double blind immunoprophylactic trial of a leprosy vaccine based on Mycobacterium w (Mw) in an endemic area of Kanpur Dehat, Uttar Pradesh, India. A population of 420,823 spread over 272 villages was screened where 1226 multibacillary (MB) and 3757 paucibacillary (PB) cases of leprosy were detected. A total of 29,420 household contacts (HHC) of these patients were screened for evidence of active or inactive leprosy. After exclusion of 1622 contacts for any of the different exclusion criteria, a total of 24,060 HHC could be vaccinated for vaccine or placebo under coding (20,194 administered two doses and 3866 received single dose). The vaccine consisted of 1 x 10(9) heat killed bacilli (Mw) in normal saline for the first dose and half of the first dose, i.e. 5 x 10(8) bacilli for the second dose, given 6 months after the first dose. The placebo consisted of 1/8th dose of the normal dose of tetanous toxoid. Both placebo and vaccine were given under double-blind coding, The contacts were followed up during three surveys at 3, 6 and 9 years after the initial vaccination, for detection of post-vaccination cases (PVCs) and observing any side-effects caused as a result of vaccination. The codes were opened on 24th January 2001, after the analysis of the data following completion of the third and final follow-up survey. When only contacts received the vaccine, Mw vaccine showed a protective efficacy (PE) of 68-6% at the end of first, 59% at the end of the second and 39.3% at the end of the third follow-up survey. When both patients and contacts received the vaccine, the protective efficacy observed was 68%, 60% and 28% at the end of the first, second and third surveys, respectively. When patients, and not the contacts, received the vaccine, a PE of 42.9% in the first, 31% in the second and 3% in the third survey was shown. These results suggest that the vaccination of the contacts is more valuable in achieving the objective of immunoprophylaxis than that of patients, and the vaccine effects are noted maximally in children (as compared to adolescents and adults) who constitute the most responsive group The effect of vaccine is sustained for a period of about 7-8 years, following which there is a need to provide a booster vaccination for the sustained protection.

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