Viewing Study NCT06627257



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Last Modification Date: 2024-10-26 @ 3:42 PM
Study NCT ID: NCT06627257
Status: NOT_YET_RECRUITING
Last Update Posted: None
First Post: 2023-08-21

Brief Title: Trial LEP-F1 GLA-SE in Healthy Adult in Areas Endemic for Leprosy
Sponsor: None
Organization: None

Study Overview

Official Title: A Phase 1b Double-Blind Randomized Placebo-Controlled Antigen Dose-Escalation Clinical Trial to Evaluate the Safety Tolerability and Immunogenicity of LEP-F1 GLA-SE in Healthy Adult Participants in Areas Endemic for Leprosy
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This is a phase 1b double-blind randomized placebo-controlled clinical trial to evaluate the safety tolerability and immunogenicity of LEP-F1 GLA-SE compared to placebo administered as three intramuscular IM injections in adult participants aged 18 to 55
Detailed Description: The LepVax Clinical Development Plan includes two indications for use The first would be the prophylactic indication where individuals at greater risk such as contacts of patients affected by leprosy and who may be subclinically infected with M leprae would be vaccinated This concept is not unique and many countries such as Brazil re-immunize leprosy patients and their close contacts with BCG 5 12 13 The proposed clinical trial however is to establish an initial safety profile in a leprosy endemic region where healthy adults will be included The second use indication is for therapeutic indication of the vaccine that would be an adjuvant to the current treatment for leprosy After vaccine safety is established phase 2 protocols in leprosy patients will be proposed to assess vaccine dose and safety in this population and then move on to phase 3 where vaccine efficacy will be evaluated

This phase 1b double-blind randomized placebo-controlled clinical trial will evaluate the safety tolerability and immunogenicity of LEP-F1 GLA-SE in healthy adults Two dose levels of LEP-F1 will be tested 2 and 10 µg of LEP-F1 and a fixed dose of 5 µg of GLA-SE in adults These doses were selected because they demonstrated an acceptable safety and immunogenicity profile in the LEPVPX-118 study the first clinical trial in humans This study will establish a safety and immunogenicity profile in an endemic population that will allow the vaccine to advance in clinical development

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 including safety laboratory analyses 7 days following each study injection Blood samples will be obtained for immunological assays at Days 0 35 63 and 168

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None