BCG and the risk of leprosy in Ciudad del Este, Paraguay, 2016-2017

다국어 초록 (Multilingual Abstract)

OBJECTIVES: Paraguay has experienced a 35% reduction in the detected incidence of leprosy during the last ten years, as the vaccination coverage against tuberculosis (Bacillus of Calmette and Guerin [BCG] vaccine) reached ≥ 95% among infants. The objective of this case-control study was to evaluate the protective effect of BCG on the risk of leprosy.
METHODS: We used a population-based case-control study of 20 leprosy confirmed cases reported among residents of Ciudad del Este, Paraguay, diagnosed in 2016-2017. Three controls were selected from a random sample of households from the city. We assessed vaccine effectiveness using 1- odds ratio [OR], and confounding for age, gender, education, occupation, and marital status using stratified and exact logistic regression, and explored if there was effect modification calculating the synergy factor (SF) and relative excess risk due to interaction (RERI).
RESULTS: After controlling for age, gender, education, occupation and marital status, the OR of BCG scar on the risk of leprosy was 0.10 (95% confidence interval [CI], 0.02 to 0.45), for an estimate of vaccine effectiveness of 89.5% reduced risk of leprosy (95% CI, 55.2 to 98.1). There was evidence of heterogeneity by which the effectiveness of BCG seemed stronger among younger persons (Breslow-Day and Z-test of the SF had a p< 0.05), and both the RERI and SF indicated a less then multiplicative and additive interaction of BCG and younger age.
CONCLUSIONS: BCG vaccination was associated with a decreased risk of leprosy in the study population, particularly in persons born after 1980.

참고문헌 (Reference)

1 Cortina-Borja M, "The synergy factor : a statistic to measure interactions in complex diseases" 2 : 105-, 2009

2 Ajalla ME, "The context of leprosy in Brazil-Paraguay border" 21 : 225-232, 2016

3 World Health Organization, "Strategic Advisory Group of Experts in immunization (SAGE)- October 2017"

4 Breslow NE, "Statistical methods in cancer research. Volume I - the analysis of case-control studies" IARC Sci Publ 5-338, 1980

5 Kerr-Pontes LR, "Socioeconomic, environmental, and behavioural risk factors for leprosy in North-east Brazil : results of a case-control study" 35 : 994-1000, 2006

6 Simionato de Assis I, "Social determinants, their relationship with leprosy risk and temporal trends in a tri-border region in Latin America" 12 : e0006407-, 2018

7 Zodpey SP, "Scar size and effectiveness of Bacillus Calmette Guerin(BCG)vaccination in the prevention of tuberculosis and leprosy : a case-control study" 51 : 184-189, 2007

8 VanderWeele TJ, "Sample size and power calculations for additive interactions" 1 : 159-188, 2012

9 Araujo S, "Risk-benefit assessment of Bacillus Calmette-Guérin vaccination, anti-phenolic glycolipid I serology, and Mitsuda test response : 10-year follow-up of household contacts of leprosy patients" 48 : 739-745, 2015

10 Goulart IM, "Risk and protective factors for leprosy development determined by epidemiological surveillance of household contacts" 15 : 101-105, 2008

11 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" 348 : 17-24, 1996

12 Baker DM, "Protective efficacy of BCG vaccine against leprosy in southern Malaŵi" 111 : 21-25, 1993

13 Lombardi C, "Protective efficacy of BCG against leprosy in São Paulo" 30 : 24-30, 1996

14 Fine PE, "Protective efficacy of BCG against leprosy in Northern Malawi" 2 : 499-502, 1986

15 Rodrigues ML, "Protective effect of intradermal BCG against leprosy; a case-control study in central Brazil" 60 : 335-339, 1992

16 Zodpey SP, "Protective effect of Bacillus Calmette Guerin(BCG)against leprosy : a population-based case-control study in Nagpur, India" 70 : 287-294, 1999

17 Boelens JJ, "Protective effect of BCG against leprosy in South Sulawesi, Indonesia" 63 : 456-457, 1995

18 Thuc NV, "Protective effect of BCG against leprosy and its subtypes : a case-control study in southern Vietnam" 62 : 532-538, 1994

19 Ministerio de Salud Pública y Bienestar Social, "Programa Nacional de Enfermedades Inmunoprevenibles y PAI. Normas Nacionales de Vacunación, Técnico Administrativas y de Vigilancia del Programa Nacional De Enfermedades Inmunoprevenibles y PAI. Asunción, Paraguay, Enero del 2016"

20 Zou GY, "On the estimation of additive interaction by use of the four-by-two table and beyond" 168 : 212-224, 2008

21 Cunha SS, "Neonatal BCG protection against leprosy : a study in Manaus, Brazilian Amazon" 75 : 357-366, 2004

22 Rothman KJ, "Modern epidemiology" Lippincott Williams & Wilkins 2008

23 Rodrigues LC, "Long lasting BCG protection against leprosy" 25 : 6842-6844, 2007

24 Ajalla ME, "Leprosy in Brazilian counties bordering Paraguay : Mato Grosso do Sul State, 2001-2011" 87 : 32-41, 2016

25 Convit J, "Immunoprophylactic trial with combined Mycobacterium leprae/BCG vaccine against leprosy : preliminary results" 339 : 446-450, 1992

26 Gimenez-León P, "History of public health planning in Paraguay 1956-2015"

27 Gillini L, "Global practices in regard to implementation of preventive measures for leprosy" 11 : e0005399-, 2017

28 World Health Organization, "Global health observatory data. Universal Health Coverage. Data on Full child immunization"

29 World Health Organization, "Global health observatory data. Leprosy - number of reported cases by country"

30 Orenstein WA, "Further observations" Epidemiol Rev 212-241, 1988

31 Institute for Resource Development, "Encuesta Nacional de Demografía y Salud, 1990. Columbia MD, 1991"

32 Pönnighaus JM, "Efficacy of BCG vaccine against leprosy and tuberculosis in northern Malawi" 339 : 636-639, 1992

33 Zodpey SP, "Effectiveness of bacillus Calmette-Guerin(BCG)vaccination in the prevention of leprosy; a case-finding control study in Nagpur, India" 66 : 309-315, 1998

34 Zodpey SP, "Effectiveness of Bacillus Calmette Guerin(BCG)vaccination in the prevention of leprosy : a population-based case-control study in Yavatmal District, India" 119 : 209-216, 2005

35 Rahete NP, "Effectiveness of Bacillus Calmette Guerin(BCG)vaccination in the prevention of leprosy : a population-based case-control study in Raipur, India" 51 : 86-90, 2007

36 Düppre NC, "Effectiveness of BCG vaccination among leprosy contacts : a cohort study" 102 : 631-638, 2008

37 Muliyil J, "Effect of BCG on the risk of leprosy in an endemic area : a case control study" 59 : 229-236, 1991

38 Gupte MD, "Comparative leprosy vaccine trial in south India" 70 : 369-388, 1998

39 Richardus RA, "Clinical manifestations of leprosy after BCG vaccination : an observational study in Bangladesh" 33 : 1562-1567, 2015

40 Orege PA, "Casecontrol study of BCG vaccination as a risk factor for leprosy and tuberculosis in western Kenya" 61 : 542-549, 1993

41 Gomes RR, "BCG vaccine and leprosy household contacts : protective effect and probability to becoming sick during follow-up" 37 : 6510-6517, 2019

42 Convit J, "BCG vaccination protects against leprosy in Venezuela : a casecontrol study" 61 : 185-191, 1993

43 Stanley SJ, "BCG vaccination of children against leprosy in Uganda: final results" 87 : 233-248, 1981

44 Lwin K, "BCG vaccination of children against leprosy : fourteen-year findings of the trial in Burma" 63 : 1069-1078, 1985

45 Bagshawe A, "BCG vaccination in leprosy : final results of the trial in Karimui, Papua New Guinea, 1963-79" 67 : 389-399, 1989

46 Merle CS, "BCG vaccination and leprosy protection : review of current evidence and status of BCG in leprosy control" 9 : 209-222, 2010

47 Brown JA, "B. C. G. vaccination of children against leprosy in Uganda : results at end of second follow-up" 1 : 24-27, 1968

48 Chaudhury S, "An eight-year field trial on antileprosy vaccines among high-risk household contacts in the Calcutta metropolis" 62 : 389-394, 1994

49 Bertolli J, "A case-control study of the effectiveness of BCG vaccine for preventing leprosy in Yangon, Myanmar" 26 : 888-896, 1997