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)
| ISRCTN | ISRCTN88133880 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88133880 |
| Protocol serial number | A30468 |
| Sponsor | UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR) |
| Funder | United Nations Children's Fund (UNICEF)/United Nations Development Programme (UNDP)/World Bank/World Health Organization (WHO) - Special Programme for Research and Training in Tropical Diseases (TDR) |
- Submission date
- 05/04/2005
- Registration date
- 07/06/2005
- Last edited
- 26/03/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr S Naozin
Scientific
Scientific
20, Avenue Appia
Geneva -27
CH 1211
Switzerland
| naozins@who.int |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Dermal leishmaniasis |
| Intervention | Intervention group: Alum-ALM and BCG combined with sodium stibo-gluconate (SSG) Control group: Sodium stibo-gluconate (SSG) |
| Intervention type | Drug |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | Aluminium hydroxide precipitated autoclaved Leishmania major (Alum-ALM) + Bacillus Calmette-Guerin (BCG) + sodium stibo-gluconate (SSG) |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/01/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 30 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 07/10/2003 |
| Date of final enrolment | 01/01/2004 |
Locations
Countries of recruitment
- Sudan
- Switzerland
Study participating centre
20, Avenue Appia
Geneva -27
CH 1211
Switzerland
CH 1211
Switzerland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
