Immunochemotherapy of persistent post-kala-azar dermal leishmaniasis: a novel approach to treatment

Ahmed Mudawi Musa, Eltahir Awad Gasim Khalil, Fawzi Abd Elrahim Mahgoub, Sara Hamad Hassab Elgawi, Farroukh Modabber, Abd Elgadir Mohamed Yousif Elkadaru, Mona Hussein Aboud, Sassan Noazin, Hashim Warsama Ghalib, Ahmed Mohamed El-Hassan

Research output: Contribution to journalArticlepeer-review

Abstract

Post-kala-azar dermal leishmaniasis (PKDL) is a recognized dermatosis that follows successful treatment of visceral leishmaniasis in the Sudan. This randomized and double-blind study aimed to assess safety, immunogenicity and curative potentials of a novel immunochemotherapy regimen in patients with persistent PKDL. Following informed consent, 30 patients were randomized to receive alum-precipitated autoclaved Leishmania major (Alum/ALM) vaccine + Bacille Calmette-Guérin (BCG) and sodium stibogluconate (SSG) or vaccine diluent and SSG. The SSG+Alum/ALM+BCG proved safe with minimal local adverse events. In the SSG+vaccine group, 87% of the patients were cured by day 60 compared with 53% in the SSG alone group (SSG+vaccine efficacy = 71%, 95% CI for risk ratio 0.7-1.16). On day 90 of follow-up there were two relapses in the SSG alone arm and none in the SSG+vaccine arm. Pre-treatment cytokines showed high IFN-γ or high IFN-γ/IL-10 levels and leishmanin skin test (LST) non-reactivity, while healing/clinical improvement were associated with LST reactivity and low IFN-γ levels in both study groups (P = 0.004). In conclusion, SSG+Alum/ALM+BCG is safe and immunogenic with significant healing potentials in persistent PKDL lesions. Immunochemotherapy probably augmented IFN-γ production, which induced healing. Leishmanin skin reactivity is a good surrogate marker of cure in persistent PKDL lesions.

Original languageEnglish (US)
Pages (from-to)58-63
Number of pages6
JournalTransactions of the Royal Society of Tropical Medicine and Hygiene
Volume102
Issue number1
DOIs
StatePublished - Jan 1 2008
Externally publishedYes

Keywords

  • Immunotherapy
  • Post-kala-azar dermal leishmaniasis
  • Sodium stibogluconate
  • Sudan
  • Vaccines
  • Visceral leishmaniasis

ASJC Scopus subject areas

  • Parasitology
  • Public Health, Environmental and Occupational Health
  • Infectious Diseases

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