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A Randomised, Double-Blind, Controlled Trial of a Killed L. Major Vaccine Plus Bcg Against Zoonotic Cutaneous Leishmaniasis in Iran Publisher Pubmed



Momeni AZ1 ; Jalayer T1 ; Emamjomeh M1 ; Khamesipour A2 ; Zicker F3 ; Ghassemi RL1 ; Dowlati Y2 ; Sharifi I4 ; Aminjavaheri M1 ; Shafiei A1 ; Alimohammadian MH5 ; Hashemifesharki R6 ; Nasseri K7 ; Godal T3 Show All Authors
Authors
  1. Momeni AZ1
  2. Jalayer T1
  3. Emamjomeh M1
  4. Khamesipour A2
  5. Zicker F3
  6. Ghassemi RL1
  7. Dowlati Y2
  8. Sharifi I4
  9. Aminjavaheri M1
  10. Shafiei A1
  11. Alimohammadian MH5
  12. Hashemifesharki R6
  13. Nasseri K7
  14. Godal T3
  15. Smith PG8
  16. Modabber F3
Show Affiliations
Authors Affiliations
  1. 1. Isfahan Univ. of Medical Sciences, P.O. Box 119, 81465 Isfahan, Iran
  2. 2. Ctr. Res. Train. Skin Dis. Leprosy, P.O. Box 14155, 6383 Tehran, Iran
  3. 3. UNDP/World Bank/WHO Spec. Prog. R., CH 1211 Geneva, Switzerland
  4. 4. Kerman Univ. of Medical Sciences, P.O. Box 444, Kerman, Iran
  5. 5. Pasteur Institute, P.O. Box 13164, Tehran, Iran
  6. 6. Razi Institute, P.O. Box 11365-1558, Hessarak, Iran
  7. 7. Public Health Institute, Berkeley, CA, United States
  8. 8. London Sch. of Hyg. and Trop. Med., London, UK Keppel Street, London WC1E 7HT, United Kingdom

Source: Vaccine Published:1999


Abstract

Safety and efficacy of killed (autoclaved) L. major promastigotes, ALM, mixed with BCG against zoonotic cutaneous leishmaniasis was tested in healthy volunteers (n = 2453) in a randomized double blind trial vs. BCG as control. Side-effects were similar in both groups but tended to be slightly more frequent and prolonged in the ALM + BCG group. Leishmanin skin test conversion (induration ≥5 mm) was significantly greater in the ALM + BCG than in the BCG group (36.2% vs. 7.9% on day-80 and 33% vs. 19%, after 1 year, respectively). Cumulative incidence rates for 2 years, were similar in both groups (18.0% vs. 18.5%). However, LST responders on day 80 (≥5 mm) had a significantly lower incidence (35%) of CL during the first year than non- responders. A single dose of ALM + BCG is not sufficiently immunogenic to provide a measurable response when compared to BCG alone. A single dose of this vaccine has been shown to be safe with no evidence of an exacerbating response following natural infection; hence, multiple doses or other adjuvants should be considered to increase its immunogenicity.
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