ISRCTN88133880
Completed
N/A
Phase I clinical trial to evaluate the safety and immunogenicity of aluminium hydroxide precipitated autoclaved Leishmania major (Alum-ALM) + Bacillus Calmette-Guerin (BCG) combined with sodium stibo-gluconate (SSG) compared with SSG alone in the treatment of post kala azar dermal leishmaniasis (Sudan)
ICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)0 sites30 target enrollmentJune 7, 2005
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Dermal leishmaniasis
- Sponsor
- ICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)
- Enrollment
- 30
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Males and females 7 \- 60 years
- •2\. Skin rash of greater than six months duration following a history of successful treatment for Visceral Leishmaniasis (VL)
- •3\. Absence of other skin conditions
- •4\. Positive Direct Agglutination Rest (DAT) or rk39
- •5\. Willing for hospitalisation at Khartoum for 90 days
- •6\. Informed consent
Exclusion Criteria
- •1\. Pregnant or lactating women
- •2\. Concurrent/chronic illness
- •3\. Known allergy to vaccine components
- •4\. Other allergies requiring steroids and Levamisole
- •5\. Known immunological deficiency\-including human immunodeficiency virus (HIV)
- •6\. Concurrent participation in any other drug or vaccine trial
- •7\. Known or planned vaccination within one month prior to study
Outcomes
Primary Outcomes
Not specified
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