Clinical trial
Open-Label Safety Study of Three-Antigen Leishmania Polyprotein With Adjuvant…
NCT00486382 · Access to Advanced Health Institute (AAHI), Other · Completed
Key facts
| NCT number | NCT00486382 |
|---|---|
| Title | Open-Label Safety Study of Three-Antigen Leishmania Polyprotein With Adjuvant MPL-SE in Healthy Adults in India |
| Official title | A Phase 1, Open-Label, Dose Escalating Study to Evaluate the Safety, Tolerability, and Immunogenicity of the LEISH-111F + MPL-SE Vaccine (Recombinant Three-Antigen Leishmania Polyprotein With Adjuvant MPL-SE) in Healthy Adults In India |
| Lead sponsor | Access to Advanced Health Institute (AAHI), Other |
| Collaborators | Bill and Melinda Gates Foundation |
| Status | Completed |
| Phase | Phase 1 |
| Study type | Interventional |
| Conditions | Visceral Leishmaniasis, Post-kala-azar Dermal Leishmaniasis |
| Intervention type | Biological |
| Interventions | Leish-111f + MPL-SE Adjuvant |
| Enrollment | 36 |
| Start date | Apr 1, 2007 |
| Primary completion | Nov 1, 2008 |
| Completion | Nov 1, 2008 |
| First posted | Jun 14, 2007 |
| Last update posted | Apr 3, 2015 |
| Countries | India |
At a glance
- 1–9 Study sites
- No Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: