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)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN88133880

Enrollment

Registered

2005-06-07

Start date

2003-10-07

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dermal leishmaniasis Infections and Infestations Dermal leishmaniasis

Interventions

Intervention group: Alum-ALM and BCG combined with sodium stibo-gluconate (SSG) Control group: Sodium stibo-gluconate (SSG)

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
Not provided at time of registration	—

Secondary

Measure	Time frame
Not provided at time of registration	—

Countries

Sudan

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026