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

International Journal of Leprosy and Other Mycobacterial Diseases

Volumn 72, Issue 1, 2004, Pages 8-15

  Cunha, Sérgio S ^a,b   Dourado, Inês ^a   Barreto, Mauricio L ^a   Alexander, Neal ^b   Pereira, Susan M ^a   Ichihara, Yury ^a,c   Pereira, Emilia S ^d   Pedrosa, Valderiza ^d   Maroja, Fatima ^d   Ribas, Carla ^d   Rodrigues, Laura C ^b  

^a FEDERAL UNIVERSITY OF BAHIA   (Brazil)

^b LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE   (United Kingdom)

^c FUNDAÇÃO NACIONAL DE SAÚDE   (Brazil)

^d Fundacao Alfredo da Matta   (Brazil)

Author keywords

[No Author keywords available]

Indexed keywords

BCG VACCINE;

ADOLESCENT; ARTICLE; BCG VACCINATION; BRAZIL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG EFFICACY; ENDEMIC DISEASE; HOUSEHOLD; HUMAN; LEPROSY; MAJOR CLINICAL STUDY; RANDOMIZED CONTROLLED TRIAL; SCHOOL CHILD; SCHOOL HEALTH SERVICE; TUBERCULOSIS;

ADOLESCENT; BCG VACCINE; BRAZIL; CHILD; FOLLOW-UP STUDIES; HUMANS; INCIDENCE; INJECTIONS, INTRADERMAL; LEPROSY; MYCOBACTERIUM LEPRAE; VACCINATION;

EID: 2942615263     PISSN: 0148916X     EISSN: None     Source Type: Journal    
DOI: 10.1489/1544-581X(2004)072<0008:DOTLCO>2.0.CO;2     Document Type: Article

References (23)

1. BAGSHAWE, A., SCOTT, G. C., RUSSELL, D. A., WIGLEY, S. C., MERIANOS, A., and BERRY, G. BCG vaccination in leprosy: final results of the trial in Karimui, Papua New Guinea, 1963-1979. Bull. World Health Organ. 67(4) (1989) 389-399.
2. BARRETO, M. L., RODRIGUES, L. C., CUNHA, S. S., PEREIRA, S. M., HIJJAR, M. A., ICHIHARA, M. Y., DE BRITO, S. C., and DOURADO, I. Design of the Brazilian BCG-REVAC trial against tuberculosis: a large, simple randomised community trial to evaluate the impact on tuberculosis of BCG revaccination at school age. Control Clin. Trials 23 (2002) 540-553.
3. BERTOLLI, J., PANGI, C., FRERICHS, R., and HALLORAN, M. E. A case-control study of the effectiveness of BCG vaccine for preventing leprosy in Yangon, Myanmar. Int. J. Epidemiol. 26(4) (1997) 888-896.
4. CLEMENS, J., BRENNER, R., MENNG, M., TAFARI, N., and LOWE, C. Evaluating new vaccines for developing countries. Efficacy or effectiveness? JAMA 275 (1996) 390-397.
5. CONVIT, J., SMITH, P. G., ZUNIGA, M., SAMPSON, C., ULRICH, M., PLATA, J. A., SILVA, J., MOLINA, J., and SALGADO, A. BCG vaccination protects against leprosy in Venezuela: a case-control study. Int. J. Lepr. Other Mycobact. Dis. 61(2) (1993) 185-191.
6. DESMOND, M., COLLINS, M., and DE LISLE, G. W. BCG identification by DNA restriction fragment patterns. J. Gen. Microbiol. 133 (1987) 1431-1434.
7. FINE, P. E. Leprosy: the epidemiology of a slow bacterium. Epidemiol. Rev. 4 (1982) 161-188.
8. FINE, P. E. Primary prevention of leprosy. Int. J. Lepr. Other Mycobact. Dis. 64(suppl. 4) (1996) S44-S49.
9. FLEISS, J. Statistical Methods for Rates and Proportions. New York: John Wiley & Sons, 1973.
10. GUPTE, M. D., VALLISHAYEE, R. S., ANANTHARAMAN, D. S., NAGARAJU, B., SREEVATSA, BALASUBRAMANYAM, S., DE BRITTO, R. L., ELANGO, N., UTHAYAKUMARAN, N., MAHALINGAM, V. N., LOURDUSAMY, G., RAMALINGAM, A., KANNAN, S., and AROKIASAMY, J. Comparative leprosy vaccine trial in south India. Indian J. Lepr. 70(4) (1998) 369-388.
11. KARONGA PREVENTION TRIAL GROUP. Randomized controlled trial of single BCG, repeated BCG, or combined BCG and killed Mycobacterium leprae vaccine for prevention of leprosy and tuberculosis in Malawi. Lancet 348(9019) (1996) 17-24.
12. LOMBARDI, C., PEDRAZZANI, E. S., PEDRAZZANI, J. C., FILHO, P. F., and ZICKER, F. Protective efficacy of BCG against leprosy in São Paulo. Bull. Pan. Am. Health Organ. 30(1) (1996) 24-30.
13. LWIN, K., SUNDARESAN, T., GYI, M. M., BECHELLI, L. M., TAMONDONG, C., GARBAJOSA, P. G., SANSARRICQ, H., and NOORDEEN, S. K. BCG vaccination of children against leprosy: fourteen-year findings of the trial in Burma. Bull. World Health Organ. 63(6) (1985) 1069-1078.
14. MATOS, H., DUPPRE, N., ALVIN, M., VIEIRA, L., SARNO, E., and STRUCHINER, C. Epidemiologia da hanseníase em coorte de contatos intradomiciliares no Rio de Janeiro (1987-1991). Cad Saúde Pública 15 (1999) 533-542.
15. MINISTÉRIO DA SAÚDE. DATASUS. Available from: http://www.datasus.gov.br. Accessed on 20 September 2003.
16. MINISTÉRIO DA SAÚDE. Hanseníase. Vigilância Epidemiológica de Doenças e Agravos Específicos. Available from http://www.funasa.gov.br/pub/GVE/GVE0513A.htm. Accessed on 20 July 2003.
17. MINISTÉRIO DA SAÚDE. Segundo informe técnico sobre a vacinação e revacinação BCG. Brasilia, 1994.
18. RIDLEY, D. S., and JOPLING, W. H. Classification of leprosy according to immunity. A five-group system. Int. J. Lepr. 34 (1966) 255-273.
19. RODRIGUES, M. L., SILVA, S. A., NETO, J. C., DE ANDRADE, A. L., MARTELLI, C. M., and ZICKER, F. Protective effect of intradermal BCG against leprosy; a case-control study in central Brazil. Int. J. Lepr. Other Mycobact. Dis. 60(3) (1992) 335-339.
20. SMITH, W. C., and SMITH, C. M. Preventive treatment of leprosy: needs, opportunities, and feasibility. Int. J. Lepr. Other Mycobact. Dis. 67(suppl. 4) (1999) S38-S44.
21. STANLEY, S. J., HOWLAND, C., STONE, M. M., and SUTHERLAND, I. BCG vaccination of children against leprosy in Uganda: final results. J. Hyg. Lond. 87(2) (1981) 233-248.
22. TALBOT, E. A., PERKINS, M. D., SILVA, S. F., and FROTHINGHAM, R. Disseminated bacille Calmette-Guerin disease after vaccination: case report and review. Clin. Infect. Dis. 24 (1997) 1139-1146.
23. WORLD HEALTH ORGANIZATION. Leprosy - global situation. Weekly Epidemiol. Rec. 75 (2000) 226-231.