MedTrace Logo

Phase 1 LEISH-F3 Vaccine Trial in Healthy Adult Volunteers

NCT01484548 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2014-02-26

No results posted yet for this study

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.

Conditions

  • Leishmaniasis

Interventions

BIOLOGICAL

LEISH-F3 + GLA-SE

20 ug of LEISH-F3 and 2 ug of GLA-SE adjuvant. 3 injections at Days 0, 28, and 56.

BIOLOGICAL

LEISH-F3 + GLA-SE

20 ug of LEISH-F3 and 5 ug of GLA-SE adjuvant. 3 injections at Days 0, 28, and 56.

BIOLOGICAL

LEISH-F3 alone

20 ug of LEISH-F3 antigen alone. 3 injections at Days 0, 28, and 56.

Sponsors & Collaborators

  • Access to Advanced Health Institute (AAHI)

    lead OTHER

Principal Investigators

  • Franco Piazza, MD, MPH · Access to Advanced Health Institute (AAHI)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-08-31
Completion
2013-05-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT01484548 on ClinicalTrials.gov