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)
Completed
- Conditions
- Dermal leishmaniasisInfections and Infestations
- Registration Number
- ISRCTN88133880
- Lead Sponsor
- ICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ot provided at time of registration
- Secondary Outcome Measures
Name Time Method ot provided at time of registration