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

NCT03302897 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2019-04-11

No results posted yet for this study

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.

Conditions

  • Leprosy

Interventions

BIOLOGICAL

LEP-F1 + GLA-SE

Investigational vaccine

Sponsors & Collaborators

  • American Leprosy Missions

    collaborator UNKNOWN

  • Access to Advanced Health Institute (AAHI)

    lead OTHER

Principal Investigators

  • Corey Casper, MD, MPH · Access to Advanced Health Institute (AAHI)

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-02
Primary Completion
2019-03-05
Completion
2019-03-05
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03302897 on ClinicalTrials.gov