Ignite Creation Date:
2024-05-06 @ 1:08 PM
Last Modification Date:
2024-10-26 @ 1:09 PM
Study NCT ID:
NCT03947437
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-06-13
First Post:
2019-05-09
Brief Title:
Phase 1b2a Trial to Evaluate LEP-F1 GLA-SE in Healthy Adults and Leprosy Patients
Sponsor:
The Immunobiological Technology Institute Bio-Manguinhos Oswaldo Cruz Foundation Fiocruz
Organization:
The Immunobiological Technology Institute Bio-Manguinhos Oswaldo Cruz Foundation Fiocruz
Study Overview
Official Title:
A Phase 1b 2a Double-Blind Randomized Placebo-Controlled Antigen Dose-Escalation Clinical Trial to Evaluate the Safety Tolerability and Immunogenicity of LEP-F1 GLA-SE in Adult Participants in Areas Endemic for Leprosy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-06
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:
This is a phase 1b2a double-blind randomized placebo-controlled clinical trial to evaluate the safety tolerability and immunogenicity of the LEP-F1 GLA-SE investigational vaccine compared to placebo
Detailed Description:
The proposed clinical trial will establish an initial safety profile for the vaccine in a region endemic for leprosy The trial will enroll both healthy participants and paucibacillary leprosy patients receiving standard-of-care therapy Safety at the lower vaccine dose will be demonstrated in healthy participants prior to antigen dose-escalation Further safety in all healthy participants will be demonstrated prior to enrolling leprosy patients
Participants will be randomized within each Group to receive three doses of vaccine or placebo administered IM on Days 0 28 and 56 Participants will be monitored for one year following the last study injection
Participants will be randomized within each Group to receive three doses of vaccine or placebo administered IM on Days 0 28 and 56 Participants will be monitored for one year following the last study injection
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