NCT03302897

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Access to Advanced Health Institute (AAHI) · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Leprosy

Interventions

Type	Name	Description
BIOLOGICAL	LEP-F1 + GLA-SE	Investigational vaccine

Timeline

• Start date: 2017-10-02
• Primary completion: 2019-03-05
• Completion: 2019-03-05
• First posted: 2017-10-05
• Last updated: 2019-04-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study