Correction: Geographic and socioeconomic factors associated with leprosy treatment default: An analysis from the 100 Million Brazilian Cohort.

[This corrects the article DOI: 10.1371/journal.pntd.0007714.].

Conditional Cash Transfer Program and Leprosy Incidence: Analysis of 12.9 Million Families From the 100 Million Brazilian Cohort.

Leprosy is a neglected tropical disease predominately affecting poor and marginalized populations. To test the hypothesis that poverty-alleviating policies might be associated with reduced leprosy incidence, we evaluated the association between the Brazilian Bolsa Familia (BFP) conditional cash transfer program and new leprosy case detection using linked records from 12,949,730 families in the 100 Million Brazilian Cohort (2007-2014). After propensity score matching BFP beneficiary to nonbeneficiary families, we used Mantel-Haenszel tests and Poisson regressions to estimate incidence rate ratios for new leprosy case detection and secondary endpoints related to operational classification and leprosy-associated disabilities at diagnosis. Overall, cumulative leprosy incidence was 17.4/100,000 person-years at risk (95% CI: 17.1, 17.7) and markedly higher in "priority" (high-burden) versus "nonpriority" (low-burden) municipalities (22.8/100,000 person-years at risk, 95% confidence interval (CI): 22.2, 23.3, compared with 14.3/100,000 person-years at risk, 95% CI: 14.0, 14.7). After matching, BFP participation was not associated with leprosy incidence overall (incidence rate ratio (IRR)Poisson = 0.97, 95% CI: 0.90, 1.04) but was associated with lower leprosy incidence when restricted to families living in high-burden municipalities (IRRPoisson = 0.86, 95% CI: 0.77, 0.96). In high-burden municipalities, the association was particularly pronounced for paucibacillary cases (IRRPoisson = 0.82, 95% CI: 0.68, 0.98) and cases with leprosy-associated disabilities (IRRPoisson = 0.79, 95% CI: 0.65, 0.97). These findings provide policy-relevant evidence that social policies might contribute to ongoing leprosy control efforts in high-burden communities.

Effect of a conditional cash transfer programme on leprosy treatment adherence and cure in patients from the nationwide 100 Million Brazilian Cohort: a quasi-experimental study.

BACKGROUND: Indirect financial costs and barriers to health-care access might contribute to leprosy treatment non-adherence. We estimated the association of the Brazilian conditional cash transfer programme, the Programa Bolsa Família (PBF), on leprosy treatment adherence and cure in patients in Brazil. METHODS: In this quasi-experimental study, we linked baseline demographic and socioeconomic information for individuals who entered the 100 Million Brazilian Cohort between Jan 1, 2007, and Dec 31, 2014, with the PBF payroll database and the Information System for Notifiable Diseases, which includes nationwide leprosy registries. Individuals were eligible for inclusion if they had a household member older than 15 years and had not received PBF aid or been diagnosed with leprosy before entering the 100 Million Brazilian Cohort; they were excluded if they were partial receivers of PBF benefits, had missing data, or had a monthly per-capita income greater than BRL200 (US$50). Individuals who were PBF beneficiaries before leprosy diagnosis were matched to those who were not beneficiaries through propensity-score matching (1:1) with replacement on the basis of baseline covariates, including sex, age, race or ethnicity, education, work, income, place of residence, and household characteristics. We used logistic regression to assess the average treatment effect on the treated of receipt of PBF benefits on leprosy treatment adherence (six or more multidrug therapy doses for paucibacillary cases or 12 or more doses for multibacillary cases) and cure in individuals of all ages. We stratified our analysis according to operational disease classification (paucibacillary or multibacillary). We also did a subgroup analysis of paediatric leprosy restricted to children aged up to 15 years. FINDINGS: We included 11 456 new leprosy cases, of whom 8750 (76·3%) had received PBF before diagnosis and 2706 (23·6%) had not. Overall, 9508 (83·0%) patients adhered to treatment and 10 077 (88·0%) were cured. After propensity score matching, receiving PBF before diagnosis was associated with adherence to treatment (OR 1·22, 95% CI 1·01-1·48) and cure (1·26, 1·01-1·58). PBF receipt did not significantly improve treatment adherence (1·37, 0·98-1·91) or cure (1·12, 0·75-1·67) in patients with paucibacillary leprosy. For patients with multibacillary disease, PBF beneficiaries had better treatment adherence (1·37, 1·08-1·74) and cure (1·43, 1·09-1·90) than non-beneficiaries. In the propensity score-matched analysis in 2654 children younger than 15 years with leprosy, PBF exposure was not associated with leprosy treatment adherence (1·55, 0·89-2·68) or cure (1·57, 0·83-2·97). INTERPRETATION: Our results suggest that being a beneficiary of the PBF, which facilitates cash transfers and improved access to health care, is associated with greater leprosy multidrug therapy adherence and cure in multibacillary cases. These results are especially relevant for patients with multibacillary disease, who are treated for a longer period and have lower cure rates than those with paucibacillary disease. FUNDING: CONFAP/ESRC/MRC/BBSRC/CNPq/FAPDF-Doenças Negligenciadas, the UK Medical Research Council, the Wellcome Trust, and Coordenação de Aperfeiçoamento de Pessoal de Nível Superior-Brazil (CAPES).

Socioeconomic determinants of leprosy new case detection in the 100 Million Brazilian Cohort: a population-based linkage study.

BACKGROUND: Although leprosy is recognised as a disease of poverty, there is little evidence on the specific socioeconomic factors associated with disease risk. To inform targeted strategies for disease elimination, we investigated socioeconomic markers of leprosy risk in Brazil. METHODS: Socioeconomic data from the 100 Million Brazilian Cohort were linked to the Brazilian national disease registry (Sistema de Informação de Agravos de Notificação) for leprosy from Jan 1, 2007, to Dec 31, 2014. Using Poisson regression, we assessed the association of socioeconomic factors with risk of incident leprosy in the full cohort and in children (aged 0-15 years), by leprosy subtype and region of residence. FINDINGS: In an analysis of 23 899 942 individuals including 18 518 patients with leprosy, increased levels of deprivation were associated with an increased risk of leprosy in Brazil. Directions of effect were consistent in children younger than 15 years and across disease subtypes. Individuals residing in regions with the highest poverty in the country (central-west, north, and northeast regions) had a risk of leprosy incidence five-to-eight times greater than did other individuals. Decreased levels of income and education and factors reflecting unfavourable living conditions were associated with an up to two-times increase in leprosy incidence (incidence rate ratio 1·46, 95% CI 1·32-1·62, for lowest vs highest quartile of income per capita; 2·09, 95% CI 1·62-2·72, for lowest vs highest level of education). INTERPRETATION: Within the poorest half of the Brazilian population, the most deprived individuals have the greatest risk of leprosy. Strategies focusing on early detection and treatment in the poorest populations could contribute substantially to global disease control. FUNDING: Medical Research Council, Wellcome Trust, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (Brazil), the Conselho Nacional das Fundações Estaduais de Amparo à Pesquisa, Economic and Social Research Council, Biotechnology and Biological Sciences Research Council, Conselho Nacional de Desenvolvimento Científico e Tecnológico, and Fundação de Apoio à Pesquisa do Distrito Federal.

Socioeconomic risk markers of leprosy in high-burden countries: A systematic review and meta-analysis.

Over 200,000 new cases of leprosy are detected each year, of which approximately 7% are associated with grade-2 disabilities (G2Ds). For achieving leprosy elimination, one of the main challenges will be targeting higher risk groups within endemic communities. Nevertheless, the socioeconomic risk markers of leprosy remain poorly understood. To address this gap we systematically reviewed MEDLINE/PubMed, Embase, LILACS and Web of Science for original articles investigating the social determinants of leprosy in countries with > 1000 cases/year in at least five years between 2006 and 2016. Cohort, case-control, cross-sectional, and ecological studies were eligible for inclusion; qualitative studies, case reports, and reviews were excluded. Out of 1,534 non-duplicate records, 96 full-text articles were reviewed, and 39 met inclusion criteria. 17 were included in random-effects meta-analyses for sex, occupation, food shortage, household contact, crowding, and lack of clean (i.e., treated) water. The majority of studies were conducted in Brazil, India, or Bangladesh while none were undertaken in low-income countries. Descriptive synthesis indicated that increased age, poor sanitary and socioeconomic conditions, lower level of education, and food-insecurity are risk markers for leprosy. Additionally, in pooled estimates, leprosy was associated with being male (RR = 1.33, 95% CI = 1.06-1.67), performing manual labor (RR = 2.15, 95% CI = 0.97-4.74), suffering from food shortage in the past (RR = 1.39, 95% CI = 1.05-1.85), being a household contact of a leprosy patient (RR = 3.40, 95% CI = 2.24-5.18), and living in a crowded household (≥5 per household) (RR = 1.38, 95% CI = 1.14-1.67). Lack of clean water did not appear to be a risk marker of leprosy (RR = 0.94, 95% CI = 0.65-1.35). Additionally, ecological studies provided evidence that lower inequality, better human development, increased healthcare coverage, and cash transfer programs are linked with lower leprosy risks. These findings point to a consistent relationship between leprosy and unfavorable economic circumstances and, thereby, underscore the pressing need of leprosy control policies to target socially vulnerable groups in high-burden countries.

Anti-PGL-1 Positivity as a Risk Marker for the Development of Leprosy among Contacts of Leprosy Cases: Systematic Review and Meta-analysis.

BACKGROUND: There is no point of care diagnostic test for infection with M. Leprae or for leprosy, although ELISA anti PGL-1 has been considered and sometimes used as a means to identify infection. METHODS: A systematic review of all cohort studies, which classified healthy leprosy contacts, at entry, according to anti-PGL1 positivity, and had at least one year follow up. The outcome was clinical diagnosis of leprosy by an experienced physician. The meta-analysis used a fixed model to estimated OR for the association of PGL-1 positivity and clinical leprosy. A fixed model also estimated the sensibility of PGL-1 positivity and positive predictive value. RESULTS: Contacts who were anti PGL-1 positive at baseline were 3 times as likely to develop leprosy; the proportion of cases of leprosy that were PGL-1 positive at baseline varied but was always under 50%. CONCLUSIONS: Although there is a clear and consistent association between positivity to anti PGL-1 and development of leprosy in healthy contacts, selection of contacts for prophylaxis based on anti PGL1 response would miss more than half future leprosy cases. Should chemoprophylaxis of controls be incorporated into leprosy control programmes, PGL1 appears not to be a useful test in the decision of which contacts should receive chemoprophylaxis.

Intrapatient comparison of Mycobacterium leprae by VNTR analysis in nasal secretions and skin biopsy in a Brazilian leprosy endemic region.

Background: This study compares the strains of genotypes of M. leprae from nasal secretions (NS) and skin biopsy (SB) in the same patient, supplementing conventional epidemiology to gain insight into the infection of leprosy in Fortaleza, Brazil. Methods: The sample consisted of 38 newly diagnosed leprosy patients attending the National Reference Center of Dermatology Dona Libania (CDERM), in Fortaleza, who tested positive for M. leprae by PCR in DNA extracts of nasal secretions. DNA was also extracted from skin biopsy (SB) scrapings of each patient and used for multiplex PCR amplification of M. leprae VNTR loci. The number of repeats at 15 loci were determined by the fragment length analysis method. Results: Locus VNTR genotypes were achieved in 38 NS, and in 38 SB specimens. M. leprae strains differed in their genotypes in paired specimens in all but two of 38 patients. The genotype similarity in the remainder ranged from 53% to 87%. Conclusion: M. leprae 15 VNTR loci genotypes of paired nasal and biopsy skin samples from five patients were identical, while as many as seven loci differed in the 33 other patients. When the NS and biopsy genotypes were pooled and compared, it was found that there was a great variability among different VNTR markers. It is important to investigate other molecular markers suitable for typing genetic variations of the bacilli.

Leprosy now: epidemiology, progress, challenges, and research gaps.

Leprosy continues to be a challenge to health worldwide, with about 250,000 new cases being detected every year. Despite widespread implementation of effective multidrug therapy, leprosy has not been eliminated. A third of newly diagnosed patients have nerve damage and might develop disabilities, although the proportion varies according to several factors, including level of self-care. Women who develop leprosy continue to be especially disadvantaged, with rates of late diagnosis and disability remaining high in this subgroup. Leprosy was not a specified disease in the Millennium Development Goals, but improvements in the other areas they cover, such as education and levels of poverty, will help leprosy patients and services. We review data and make recommendations for research on diagnosis, treatment, and prevention, such as further use of molecular analysis of the Mycobacterium leprae genome, implementation of BCG vaccination, and administration of chemoprophylaxis to household contacts. We also suggest development of tools for early diagnosis and detection of infection and nerve damage, and formulation of strategies to manage the chronic complications of leprosy, such as immune-mediated reactions and neuropathy.

Seropositivity to anti-phenolic glycolipid-I in leprosy cases, contacts and no known contacts of leprosy in an endemic and a non-endemic area in northeast Brazil.

The seroprevalence rates of IgM anti-phenolic glycolipid-I (PGL-I) antibodies in four study groups with differing exposure to Mycobacterium leprae in Ceará, Brazil were investigated between March 2005 and August 2006. The first three groups in a high prevalence area included 144 cases of leprosy, their 380 contacts and 317 participants with no known leprosy contact. The fourth group in a low prevalence area consisted of 87 participants with no known leprosy contact living in an area in which no cases of leprosy had been reported in the previous 6 months. Seropositivity and levels of IgM antibodies to PGL-I were investigated using ELISA. The seropositivity levels of anti-PGL-I among the different clinical forms of leprosy cases were 61% for lepromatous, 25% for tuberculoid and 27% indeterminate. The levels of anti-PGL-I antibodies in the endemic area differentiated leprosy cases from non-cases. However, the seropositivity was similar among contact cases (15.8%) and no known leprosy contact cases from high (15.1%) and low (13.8%) prevalence areas. The seropositivity of both contacts and no known contacts was much higher than previously reported among no known contacts in other endemic areas. The study indicates that anti-PGL-I antibodies are not useful as immunological markers of household leprosy contacts and no known leprosy contacts in endemic areas.

BCG vaccination and leprosy protection: review of current evidence and status of BCG in leprosy control.

The bacillus Calmette-Guérin (BCG) vaccine, initially developed to provide protection against TB, also protects against leprosy; and the magnitude of this effect varies. Previous meta-analyses did not provide a summary estimate of the efficacy due to the heterogeneity of the results. We conducted a meta-analysis of published data including recently published studies (up to June 2009) to determine the efficacy of BCG protection on leprosy and to investigate whether age at vaccination, clinical form, number of doses, type of study, the latitude of study area and year of publication influence the degree of efficacy and explain the variation. In the light of the results, we argue for more emphasis on the role of BCG vaccination in leprosy control and research.

BCG revaccination does not protect against leprosy in the Brazilian Amazon: a cluster randomised trial.

BACKGROUND: Although BCG has been found to impart protection against leprosy in many populations, the utility of repeat or booster BCG vaccinations is still unclear. When a policy of giving a second BCG dose to school children in Brazil was introduced, a trial was conducted to assess its impact against tuberculosis, and a leprosy component was then undertaken in parallel. OBJECTIVE: to estimate the protection against leprosy imparted by a second dose of BCG given to schoolchildren. METHODS AND FINDINGS: This is a cluster randomised community trial, with 6 years and 8 months of follow-up. STUDY SITE: City of Manaus, Amazon region, a leprosy-endemic area in Brazil. PARTICIPANTS: 99,770 school children with neonatal BCG (aged 7-14 years at baseline), of whom 42,662 were in the intervention arm (revaccination). INTERVENTION: BCG given by intradermal injection. MAIN OUTCOME: Leprosy (all clinical forms). RESULTS: The incidence rate ratio of leprosy in the intervention over the control arm within the follow-up, in schoolchildren with neonatal BCG, controlled for potential confounders and adjusted for clustering, was 0.99 (95% confidence interval: 0.68 to 1.45). CONCLUSIONS/SIGNIFICANCE: There was no evidence of protection conferred by the second dose of BCG vaccination in school children against leprosy during the trial follow-up. These results point to a need to consider the effectiveness of the current policy of BCG vaccination of contacts of leprosy cases in Brazilian Amazon region.

Adverse effects from multi-drug therapy in leprosy: a Brazilian study.

INTRODUCTION: The WHO MDT for leprosy treatment was officially introduced in Brazil in 1991 and comprises three drugs: dapsone, rifampicin and clofazimine. There are few good studies on the frequency of side-effects attributable to MDT in Brazil. METHODS: A retrospective and descriptive study carried out in a LCP in Vitória, State of Espirito Santo, Brazil. A specific and detailed protocol about side-effects was prepared and filled in from the patient records. RESULTS: One hundred ninety four patients' records were analysed looking for side-effects attributable to MDT. Side-effects were attributed to at least one MDT component in 88 (45%) patients and 85 had side-effects due to dapsone, 24 due to rifampicin and 18 due to clofazimine. 185 episodes were identified. The suspected drug was stopped in 47 out of 88 episodes (24% patients); 46 had dapsone stopped, 5 had rifampicin stopped and no-one had clofazimine stopped. CONCLUSION: Side-effects attributed to MDT is more frequent than previously described, resulting in interruption of treatment in many patients.

Characteristics of known leprosy contact in a high endemic area in Brazil.

BACKGROUND AND PURPOSE: The annual number of new cases of leprosy has not declined in Brazil over the last 15 years, indicating that transmission continues at the same level. To study transmission, we interviewed leprosy patients about their known leprosy contact (KLC). METHODS: Clinical and demographic data were collected from 506 leprosy patients in four health units in the Metropolitan Region of Vitria, State of Espírito Santo, Brazil. SPSS 9.0 was used as a database and analysis. RESULTS: Two hundred and twenty-six (44.7%) of 506 leprosy patients reported KLC, 136 (60.2%) of 226 were parents. Among 226, the mean of KLC was 1.89 (SD +/- 1.65), and 61.3% had one KLC. KLC as a household contact was reported by 92 (40.7%) out of 226, and 121 (53.5%) had no household contact. KLC were most frequently sisters and brothers in the PB cases, and sons/daughters in MB cases. Mothers occurred more frequently as a KLC than fathers. From the leprosy patients that had reported household contacts, 73% said that at the onset of their skin lesions, the KLCs were either undergoing were not yet released from treatment (RFT), and 23.45% had not begun the treatment yet. Altogether, 62.3% of 226 cases had daily contact with the KLC. CONCLUSION: In Brazil, household contacts, including the family members (mothers, sisters and brothers), as well as the social contact need to be investigated by the control programs.

Delay in the diagnosis of leprosy in the Metropolitan Region of Vitória, Brazil.

This paper reports on the time between the onset of the first lesion and diagnosis, defined as delay, and is based on results obtained by interviewers from a survey carried out amongst 450 leprosy patients in a leprosy endemic area in the Metropolitan Region of Vitória (MRV), state of Espirito Santo, Brazil. The mean age at diagnosis in all cases was 41.47 years and the median was 42.5 years. The mean age at diagnosis in MB (42.9 years) was greater than in PB (38.5 years). The mean of the delay in all cases was 25.25 months, median 12 months and range 0-360 months. The mean of the delay in MB (27.2 months) was greater than in PB (21.3 months). The results of this study suggest that although the delay in leprosy diagnosis in this region of Brazil was not too long when it was compared with other studies in endemic countries, it is still a problem: 65.4% of patients were diagnosed after a delay of 6 months. The Leprosy Control Programme in this state needs more effective health education in order to reduce the current period of delay before diagnosis.

Socioeconomic, environmental, and behavioural risk factors for leprosy in North-east Brazil: results of a case-control study.

BACKGROUND: Brazil reports almost 80% of all leprosy cases in the Americas. This study aimed to identify socioeconomic, environmental, and behavioural factors associated with risk of leprosy occurrence in the endemic North-eastern region. METHODS: A case-control study in four municipalities. CASES: cases of leprosy diagnosed in the previous 2 years, with no other known, current, or past case of leprosy in the household or in the neighbourhood. CONTROLS: individuals presenting for reasons other than skin problems to the health unit where the case was diagnosed and who lived in the same municipality as the case with whom it was matched. For each case four controls were selected. A semi-structured questionnaire was used to collect demographic, socioeconomic, environmental, and behavioural data. A multivariate hierarchical analysis was performed according to a previously defined framework. RESULTS: 226 cases and 857 controls were examined. Low education level, ever having experienced food shortage, bathing weekly in open water bodies (creek, river and/or lake) 10 years previously, and a low frequency of changing bed linen or hammock (>or=biweekly) currently were all significantly associated with leprosy. Having a BCG vaccination scar was found to be a highly significant protective factor. CONCLUSIONS: Except for BCG vaccination, variables that remained significant in the hierarchical analysis are cultural or linked to poverty. They may act on different levels of the transmission of Mycobacterium leprae and/or the progress from infection to disease. These findings give credit to the hypothesis that person-to-person is not the only form of M. leprae transmission, and that indirect transmission might occur, and other reservoirs should exist outside the human body.

Current strategy for leprosy control in Brazil: time to pursue alternative preventive strategies?

La estrategia actual para el control de la lepra en Brasil se basa en dos actividades principales: la detección precoz de casos y el tratamiento de casos con farmacoterapia combinada. Además de dichas medidas, se realizan esfuerzos complementarios para identificar los contactos domésticos para el diagnóstico precoz y la vacunación con el bacilo de Calmette-Guérin (BCG). Sin embargo, la eficacia de estas acciones a la hora de reducir la incidencia de la lepra es aún discutible. Esto genera dudas acerca de la factibilidad de eliminar la lepra en Brasil e indica que deberían adoptarse otras medidas de prevención. A pesar del hecho de que la vacunación de los contactos se practica desde hace varios años, falta información sobre el impacto de esta medida sobre la incidencia de la lepra en la comunidad. Además, con frecuencia no se tiene en cuenta el impacto de la vacunación neonatal con la vacuna BCG. Sostenemos que hay lugar para la investigación de métodos alternativos en el control y recomendamos que el programa brasileño de control haga un seguimiento esmerado de las tasas de cobertura para la vacunación neonatal en aquellas zonas donde la lepra es endémica, con el fin de lograr que la cobertura siga siendo elevada. Además, recomendamos la realización de estudios, orientados hacia el desarrollo de políticas, sobre la eficacia, factibilidad e impacto de estrategias alternativas más previsoras. Algunos posibles temas para estos estudios serían: 1) el impacto de la vacunación de contactos sobre la incidencia de la enfermedad en la población en general, 2) la factibilidad y el impacto de la quimioprofilaxis, y 3) el impacto de la identificación de grupos de alto riesgo (o mediante la adopción de una definición amplia de los contactos expuestos a la lepra, o mediante la creación de nuevas herramientas diagnósticas), y del diseño de programas para la detección precoz y la administración de farmacoterapia combinada específicamente para estos grupos.

Design of the leprosy component of the Brazilian BCG revaccination trial for assessing BCG effectiveness against leprosy in school children.

BACKGROUND: BCG vaccination confers protection against leprosy, and vaccination among household contacts has been recommended in Brazil. Nevertheless, vaccination of the entire community against leprosy is not advocated as leprosy has low incidence in most populations. Despite that, in Brazil, BCG vaccination is recommended among school children to prevent tuberculosis and this large scale vaccination may also affect the occurrence of leprosy, which led to investigations of its impact on leprosy in endemic areas of Brazil. OBJECTIVES: To estimate the effectiveness against leprosy of a dose of BCG vaccine given to school children in a population with a high coverage of neonatal BCG. Long term objectives are to compare the impact of vaccination among schoolchildren with the existing recommendation to vaccinate household contacts of leprosy. STUDY DESIGN: Cluster randomized controlled field trial with no placebo. STUDY POPULATION: Children aged 7 to 14 years attending state schools with high coverage of neonatal BCG. METHODS: 286 state schools in the city of Manaus, Brazil, were randomized to receive BCG or not. Identifying information was collected for 152,438 school children, of whom 72,980 are in intervention schools. BCG vaccination was given intradermically to children in schools allocated to vaccination. Follow-up relies on ascertainement of cases diagnosed at the health services and notified to the reference center for leprosy.

Neonatal BCG protection against leprosy: a study in Manaus, Brazilian Amazon.

There is clear evidence that BCG protects against leprosy, but cross-immunity with environmental mycobacteria can interfere with vaccination protection. Some have cast doubts whether BCG vaccination can offer a significant impact against leprosy in the Brazilian Amazon, which is an endemic area for leprosy and with a high prevalence of environmental mycobacteria. This study was designed to estimate the vaccine effectiveness of neonatal BCG against leprosy in Amazon region, in Brazil. This is a cohort study nested in a randomized community trial. The study had two main results. First, neonatal BCG vaccination in Brazilian Amazon elicited protection of 74% (95% CI 57-86) against all forms of leprosy cases. Second, the highest protection was observed for multibacillary cases, 93% (95% CI 71-98). It is concluded that the study provides evidence that neonatal BCG may have an important and overlooked impact on the occurrence and transmission of leprosy, maybe even more in the future when the cohort which received a high coverage of BCG reaches the age of high incidence of leprosy.