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Phase 1 LEP-F1 + GLA-SE Vaccine Trial in Healthy Adult Volunteers

Leprosy Clinical Trial

Official title:
A Phase 1, Open Label, Antigen Dose-Escalation Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of LEP-F1 + GLA-SE in Healthy Adult Subjects

Clinical Trial Summary

The purpose of this study is to compare the safety, tolerability, and immunogenicity in healthy adult subjects of an investigational vaccine being developed for the prevention of leprosy. Two dose levels of the vaccine will be evaluated.

Clinical Trial Description

The purpose of this study is to compare the safety, tolerability, and immunogenicity of the LEP-F1 + GLA-SE vaccine. The vaccine consists of the recombinant four-antigen Mycobacterium leprae antigen LEP-F1 in combination with the adjuvant formulation GLA-SE (Glucopyranosyl Lipid A - Stable Emulsion) and is being developed for the prevention of leprosy disease. This is a first-in-human study and will be conducted in healthy adult subjects. Two dose levels of the vaccine (2 μg LEP-F1 + 5 μg GLA-SE and 10 μg LEP-F1 + 5 μg GLA-SE) will be given by intramuscular administration on study Days 0, 28, and 56. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03302897
Study type Interventional
Source IDRI
Contact
Status Completed
Phase Phase 1
Start date October 2, 2017
Completion date March 5, 2019
View Details
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