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Phase 1 LEISH-F3 Vaccine Trial in Healthy Adult Volunteers

Leishmaniasis Clinical Trial

Official title:
A Phase 1, Randomized Clinical Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of The LEISH-F3 + GLA-SE Vaccine Compared To The LEISH-F3 Protein Alone In Healthy Adult Subjects

Clinical Trial Summary

The purpose of this study is to determine the safety, tolerability, and immunogenicity in healthy adult subjects of an investigational vaccine being developed for the prophylaxis of visceral leishmaniasis. The vaccine, identified as LEISH-F3 + GLA-SE, consists of the recombinant two-antigen Leishmania recombinant protein LEISH-F3 together with the adjuvant GLA-SE.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01484548
Study type Interventional
Source IDRI
Contact
Status Completed
Phase Phase 1
Start date January 2012
Completion date May 2013
View Details
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