title: 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.
abstract: BACKGROUND
  Despite multidrug therapy, leprosy remains a public health issue. The intradermal Bacillus Calmette-Guérin (BCG) vaccine, Mitsuda test (lepromin skin test), and anti-phenolic glycolipid I (PGL-I) serology are widely used in leprosy studies and have shown great epidemiological value.
  
  
  METHODS
  This longitudinal study evaluated the relative risks and benefits of these three tools by comparing results observed in household contacts (HHCs) of leprosy patients who developed leprosy with those of HHCs who did not in a population of 2,992 individuals monitored during a 10-year period.
  
  
  RESULTS
  Seventy-five (2.5%) new leprosy cases were diagnosed, including 28 (0.9%) co-prevalent cases. Therefore, for the risk-benefit assessment, 47 (1.6%) HHCs were considered as truly diagnosed during follow-up. The comparison between healthy and affected contacts demonstrated that not only did BCG vaccination increase protection, but boosters also increased to 95% relative risk (RR) reduction when results for having two or more scars were compared with having no scars [RR, 0.0459; 95% confidence interval (CI), 0.006-0.338]. Similarly, Mitsuda reactions >7mm in induration presented 7-fold greater protection against disease development compared to reactions of 0-3mm (RR, 0.1446; 95% CI, 0.0566-0.3696). In contrast, anti-PGL-I ELISA seropositivity indicated a 5-fold RR increase for disease outcome (RR, 5.688; 95% CI, 3.2412-9.9824). The combined effect of no BCG scars, Mitsuda reaction of <7mm, and seropositivity to anti-PGL-I increased the risk for leprosy onset 8-fold (RR, 8.109; 95% CI, 5.1167-12.8511).
  
  
  CONCLUSIONS
  The adoption of these combined assays may impose measures for leprosy control strategies.
authors.affiliation: Centro de Referência Nacional em Dermatologia Sanitária e Hanseníase, Hospital de Clínicas, Universidade Federal de Uberlândia, Uberlândia, Minas Gerais, Brazil.
authors.forename: Sergio
authors.initials: S
authors.lastname: Araujo
authors.affiliation: Centro de Referência Nacional em Dermatologia Sanitária e Hanseníase, Hospital de Clínicas, Universidade Federal de Uberlândia, Uberlândia, Minas Gerais, Brazil.
authors.forename: Marina Monteiro Figueiredo
authors.initials: MM
authors.lastname: Rezende
authors.affiliation: Centro de Referência Nacional em Dermatologia Sanitária e Hanseníase, Hospital de Clínicas, Universidade Federal de Uberlândia, Uberlândia, Minas Gerais, Brazil.
authors.forename: Diogo Carrijo Rodrigues de
authors.initials: DC
authors.lastname: Sousa
authors.affiliation: Centro de Referência Nacional em Dermatologia Sanitária e Hanseníase, Hospital de Clínicas, Universidade Federal de Uberlândia, Uberlândia, Minas Gerais, Brazil.
authors.forename: Maraísa Resende
authors.initials: MR
authors.lastname: Rosa
authors.affiliation: Centro de Referência Nacional em Dermatologia Sanitária e Hanseníase, Hospital de Clínicas, Universidade Federal de Uberlândia, Uberlândia, Minas Gerais, Brazil.
authors.forename: Danielle Cristina Dos
authors.initials: DC
authors.lastname: Santos
authors.affiliation: Centro de Referência Nacional em Dermatologia Sanitária e Hanseníase, Hospital de Clínicas, Universidade Federal de Uberlândia, Uberlândia, Minas Gerais, Brazil.
authors.forename: Luiz Ricardo
authors.initials: LR
authors.lastname: Goulart
authors.affiliation: Centro de Referência Nacional em Dermatologia Sanitária e Hanseníase, Hospital de Clínicas, Universidade Federal de Uberlândia, Uberlândia, Minas Gerais, Brazil.
authors.forename: Isabela Maria Bernardes
authors.initials: IM
authors.lastname: Goulart
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000942:Antigens, Bacterial / Q000276:immunology*; D001500:BCG Vaccine / Q000276:immunology*; D002648:Child; D002675:Child, Preschool; D016358:Contact Tracing / Q000706:statistics & numerical data*; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D006017:Glycolipids / Q000276:immunology*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007916:Lepromin / Q000276:immunology; D007918:Leprosy / Q000276:immunology* / Q000517:prevention & control / Q000635:transmission; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D018570:Risk Assessment; D055815:Young Adult
chemical_list: D000942:Antigens, Bacterial; D001500:BCG Vaccine; D006017:Glycolipids; C045169:phenolic glycolipid I, Mycobacterium leprae; D007916:Lepromin