TY - JOUR
T1 - Immunochemotherapy of persistent post-kala-azar dermal leishmaniasis
T2 - a novel approach to treatment
AU - Musa, Ahmed Mudawi
AU - Khalil, Eltahir Awad Gasim
AU - Mahgoub, Fawzi Abd Elrahim
AU - Elgawi, Sara Hamad Hassab
AU - Modabber, Farroukh
AU - Elkadaru, Abd Elgadir Mohamed Yousif
AU - Aboud, Mona Hussein
AU - Noazin, Sassan
AU - Ghalib, Hashim Warsama
AU - El-Hassan, Ahmed Mohamed
PY - 2008/1
Y1 - 2008/1
N2 - 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.
AB - 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.
KW - Immunotherapy
KW - Post-kala-azar dermal leishmaniasis
KW - Sodium stibogluconate
KW - Sudan
KW - Vaccines
KW - Visceral leishmaniasis
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U2 - 10.1016/j.trstmh.2007.08.006
DO - 10.1016/j.trstmh.2007.08.006
M3 - Article
C2 - 17963805
AN - SCOPUS:36549028707
SN - 0035-9203
VL - 102
SP - 58
EP - 63
JO - Transactions of the Royal Society of Tropical Medicine and Hygiene
JF - Transactions of the Royal Society of Tropical Medicine and Hygiene
IS - 1
ER -