LEISH-F3 + GLA-SE and the LEISH-F3 + MPL-SE Vaccine
A Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of the Vaccine Candidates LEISH-F3 + GLA-SE, LEISH-F3 + MPL-SE, and LEISH-F3 + SE in Healthy Adult Subjects
2 other identifiers
interventional
48
1 country
1
Brief Summary
Investigational products: LEISH-F3 (recombinant protein antigen) + GLA-SE (adjuvant) leishmaniasis vaccine and LEISH-F3 (recombinant protein antigen) + MPL-SE (adjuvant) leishmaniasis vaccine. Stage of development: Phase 1 clinical development. Healthy adult subjects, 18 to 49 will be recruited through a U.S. site. Primary objective: To evaluate the safety and tolerability of the LEISH-F3 + GLA-SE vaccine and the LEISH-F3 + MPL-SE vaccine following intramuscular (IM) administration of 20 µg of LEISH-F3 together with 2 or 5 µg of GLA-SE or 10 µg of MPL-SE on Days 0, 28, and 168. Secondary objective: To assess the immunogenicity of LEISH-F3 formulated with GLA-SE, MPL-SE, or SE by evaluating IgG antibody responses to LEISH-F3 at Days 0, 28, 56, 168, 196, and 365, and T cell responses to LEISH-F3 at Days 0, 14, 42, 168, 182, and 365. Each subject's duration of participation will be about 18 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Mar 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 13, 2012
CompletedFirst Posted
Study publicly available on registry
December 17, 2012
CompletedStudy Start
First participant enrolled
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedJanuary 2, 2017
May 1, 2015
1.8 years
December 13, 2012
December 29, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
The number of serious adverse events considered related to the vaccination at any point during the study period.
approximately 533 days
The number of subjects experiencing solicited injection site reaction within 7 days following vaccination.
Through 7 days following vaccination
The number of subjects experiencing solicited systemic reactions within 7 days following vaccination.
Through 7 days following vaccination
The number of subjects spontaneously reporting adverse events considered related to the vaccination at any point during the study period.
Through Day 365
Secondary Outcomes (2)
The magnitude of Th1 and Th2 cytokine production in PBMCs in response to the LEISH-F3 antigen relative to baseline as assayed by Luminex.
Days 14, 42, 168, 182, and 365
The proportion of subjects with at least a 4-fold increase in IgG antibody responses to LEISH-F3 relative to baseline.
Days 28, 56, 168, 196, and 365
Study Arms (3)
Group #1
EXPERIMENTALN=16 subjects receive vaccine on day 0, 28, and 168 of 0.5 ml of 20 mcg of LEISH-F3 + 5 mcg Glucopyranosyl Lipid A- Stable oil-in-water emulsion (GLA-SE)
Group #2
EXPERIMENTALN=16 subjects receive vaccine on day 0, 28, and 168 of 0.5 ml of 20 mcg of LEISH-F3 + 10 mcg Monophosphoryl Lipid A-Stable oil-in-water emulsion (MPL-SE)
Group #3
EXPERIMENTALN=16 subjects receive vaccine on day 0, 28, and 168 of 0.5 ml of 20 mcg LEISH-F3 + Stable oil-in-water Emulsion (SE)
Interventions
Glucopyranosyl Lipid A- Stable oil-in-water emulsion (GLA-SE) is formulated in a stable oil-in-water emulsion (SE) to yield the adjuvant formulation GLA-SE. The combination of GLA-SE with a recombinant protein antigen (LEISH-F3) results in a Th1-type T cell response. GLA-SE appears as a milky- white liquid. 16 subjects receive vaccine on day 0, 28, and 168 of 0.5 ml of 20 mcg of LEISH-F3 + 5 mcg GLA-SE.
LEISH-F3 is a lyophilized formulation containing 50 mcg LEISH-F3 and excipients (mannitol, sucrose, and polysorbate 80). All subjects receive vaccine on day 0, 28, and 168 of 0.5 ml of 20 mcg of LEISH-F3.
Monophosphoryl Lipid A-Stable oil-in-water emulsion (MPL-SE) is an oil-in-water emulsion that contains Monophosphoryl Lipid A, an attenuated form of Lipid A from Salmonella Minnesota R595 in a emulsion (SE). The combination of MPL-SE with a recombinant protein antigen (LEISH-F3) results in a TH1-type T cell response. MPL-SE appears as a milky-white liquid. 16 subjects receive vaccine on day 0, 28, and 168 of 0.5 ml of 20 mcg of LEISH-F3+10 mcg MPL-SE.
Stable oil-in-water Emulsion (SE) is a squalene oil-in-water emulsion that has adjuvant properties of its own, but in a Th2-dependent manner. SE appears as milky-white liquid. 16 subjects receive vaccine on day 0, 28, and 168 of 0.5 ml of 20 mcg LEISH-F3 + SE.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Iowa - Vaccine Research and Education Unit
Iowa City, Iowa, 52242-2600, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 13, 2012
First Posted
December 17, 2012
Study Start
March 1, 2013
Primary Completion
January 1, 2015
Study Completion
January 1, 2015
Last Updated
January 2, 2017
Record last verified: 2015-05