Ignite Creation Date:
2024-05-06 @ 10:37 AM
Last Modification Date:
2024-10-26 @ 12:32 PM
Study NCT ID:
NCT03302897
Status:
COMPLETED
Last Update Posted:
2019-04-11
First Post:
2017-10-02
Brief Title:
Phase 1 LEP-F1 GLA-SE Vaccine Trial in Healthy Adult Volunteers
Sponsor:
Access to Advanced Health Institute AAHI
Organization:
Access to Advanced Health Institute AAHI
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None