Phase 1b/2a Trial to Evaluate LEP-F1 + GLA-SE in Healthy Adults and Leprosy Patients
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
1 other identifier
interventional
142
1 country
1
Brief Summary
This is a phase 1b/2a, 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Feb 2024
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
May 9, 2019
CompletedFirst Posted
Study publicly available on registry
May 13, 2019
CompletedStudy Start
First participant enrolled
February 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2025
CompletedJune 13, 2023
June 1, 2023
29 days
May 9, 2019
June 12, 2023
Conditions
Outcome Measures
Primary Outcomes (10)
Phase 1b_The number of participants who receive the injection and experience local and systemic reactions within 7 days of each study injection.
The number of participants who receive the injection and experience local and systemic reactions within 7 days of each study injection.
7 days following each injection
Phase 1b_Number of participants experiencing unsolicited AEs
The number of participants spontaneously reporting adverse events from Day 0 to Day 84.
Days 0 to 84
Phase 1b_The number of adverse events attended by physicians considered related to any of the study injections reported at any time during the study period.
The number of adverse events attended by physicians considered related to any of the study injections reported at any time during the study period.
Days 0 to 421
Phase 1b_The LEP-F1 specific T cell IFN--γ production responses in assay with PBMCs evaluated by ELISA on Days 0, 35 and 63.
The LEP-F1 specific T cell IFN-γ production responses in assay with PBMCs evaluated by ELISA on Days 0, 35 and 63.
Days 0, 35 and 63.
Phase 2a_The number of participants who receive the injection and experience local and systemic reactions within 7 days of each study injection.
The number of participants who receive the injection and experience local and systemic reactions within 7 days of each study injection.
7 days following each injection
Phase 2a_The number of participants spontaneously reporting adverse events from Day 0 to Day 84.
The number of participants spontaneously reporting adverse events from Day 0 to Day 84.
Day 0 to Day 84.
Phase 2a_The number of physician-assisted adverse events considered related to any of the study injections reported at any time during the study period
The number of physician-assisted adverse events considered related to any of the study injections reported at any time during the study period
Day 0 to Day 421
Phase 2a_The frequency and intensity of solicited adverse events within 7 days of each study injection.
The frequency and intensity of solicited adverse events within 7 days of each study injection.
7 days following each injection
Phase 2a_The frequency and intensity of unsolicited adverse events during study participation (D0 to D421).
The frequency and intensity of unsolicited adverse events during study participation (D0 to D421).
Day 0 to Day 421
Phase 2a_The frequency and causality of serious adverse events occurring during study participation (D0 to D421).
The frequency and causality of serious adverse events occurring during study participation (D0 to D421).
Day 0 to Day 421
Secondary Outcomes (7)
Phase 1b_IgG antibody responses to LEP-F1 by ELISA on Days 0, 35, 63, and 168.
Days 0, 35, and 63
Phase 1b_ The T cell responses measured by LEP-F1-specific cytokine production in PBMC assay by ELISA or multiplex assay on Days 0, 35, 63, and 168.whole blood assay
Days 0, 35, 63 and 168
Phase 2a_IgG antibody responses to LEP-F1 by ELISA on Days 0, 35, 63, and 168.
Days 0, 35, 63, and 168.
Phase 2a_T cell responses measured by LEP-F1-specific cytokine production in PBMC assay by ELISA or multiplex assay on Days 0, 35, 63, and 168.
on Days 0, 35, 63, and 168.
Phase 2a_The neurological nerve function as measured by clinical and neurophysiological tests
Day 0 to Day 421
- +2 more secondary outcomes
Other Outcomes (4)
Phase 1b_The T cell responses measured by intracellular cytokine (ICS) staining in PBMCs on Days 0, 35, 63, and 168.
Days 0, 35, 63, and 168.
Phase 1b_The assays of candidate biomarkers measured on Day 0 and 63 including gene expression signatures and serum protein multiplex assay.
Day 0 and 163
Phase 2a_The T cell responses measured by intracellular cytokine staining of PBMCs on Days 0, 35, 63 and 168
Days 0, 35, 63 and 168
- +1 more other outcomes
Study Arms (4)
Low dose
EXPERIMENTAL2 μg LEP-F1 + 5 μg GLA-SE will be administered by IM injection on Days 0, 28, and 56 in healthy participants.
High dose
EXPERIMENTAL10 μg LEP-F1 + 5 μg GLA-SE will be administered by IM injection on Days 0, 28, and 56 in healthy participants.
TBD dose in patients
EXPERIMENTALTBD μg LEP-F1 + 5 μg GLA-SE will be administered by IM injection on Days 0, 28, and 56 in paucibacillary leprosy patients. Dose will be determined by safety and immunogenicity data from healthy participants.
Placebo
PLACEBO COMPARATORSterile normal saline for injection will be administered by IM injection on Days 0, 28, and 56 in healthy participants and paucibacillary leprosy patients.
Interventions
Leprosy antigen formulated with an adjuvant.
Eligibility Criteria
You may qualify if:
- Men and women between 18 and 55 years old.
- They should be in good general health, confirmed by a medical history and physical examination, with negative clinical evaluation for leprosy.
- Screening laboratory tests with normal, within laboratory reference limits for:: sodium, potassium, AST, ALT, total bilirubin, alkaline phosphatase, creatinine, glucose, total leukocyte count, hemoglobin and platelet count. Abnormal results may be repeated at the discretion of the Principal Investigator and/or sub-investigators, who may share doubts with the sponsor's Scientific Leader and if necessary with the DSMB.
- Negative serological tests for: HIV 1/2 antibody, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibody.
- Normal or not clinically significant urinalysis as determined by the study doctor or designee. Abnormal results may be repeated at the discretion of the Principal Investigator.
- Must be able to complete the study adverse events diary.
- Must consent to participate in the study, be able and willing to make all evaluation visits, be accessible by telephone or home visits, and live in the region until study follow-up completion.
You may not qualify if:
- Individuals who meet ANY of the following criteria will be considered ineligible:
- History of infection with Mycobacterium leprae.
- History of exposure to experimental products containing GLA-SE.
- History of active or documented latent tuberculosis.
- History of previous infection with other non-tuberculous mycobacteria.
- Participation in another trial protocol and/or receipt of any trial products in the last 3 months prior to screening.
- Treatment with immunosuppressive drugs (eg oral or injected steroids, such as prednisone; high doses of inhaled steroids) or cytotoxic therapies (eg chemotherapy or radiation) within 6 months prior to screening.
- Have received blood transfusion within the last 3 months prior to screening.
- Donated blood products (platelets, whole blood, plasma, etc.) within the last month prior to screening.
- Received any vaccine 1 month prior to screening or planned immunizations during the follow-up from D0 to D63 and D154 to D168.
- History of autoimmune disease or other immunosuppressive causes.
- History of any other acute or chronic decompensated disease (including cardiovascular, pulmonary, neurological, hepatic, rheumatic, haematological, metabolic or renal disease, uncontrolled hypertension) or use of medication that, in the opinion of the Principal Investigator, may interfere with safety or immunogenicity of the vaccine.
- Rash, tattoos or any other dermatological condition that may adversely affect the injection site of the vaccine or interfere with its evaluation.
- Body mass index (BMI) ≥ 32.
- Systemic arterial hypertension (systolic \> 150 or diastolic \> 95).
- +34 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Veronica Schmitz Pereira
Rio de Janeiro, FIOCRUZ - 33.781.055/0001, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Veronica Schmitz Pereira, PHD
Instituto Oswaldo Cruz
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- This is a double-blind study. Participants, investigators, study personnel performing any study-related assessments following study injection, and laboratory personnel performing immunology assays will be blinded to treatment assignment.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2019
First Posted
May 13, 2019
Study Start
February 1, 2024
Primary Completion
March 1, 2024
Study Completion
April 1, 2025
Last Updated
June 13, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share