Phase 1b/2a Trial to Evaluate LEP-F1 + GLA-SE in Healthy Adults and Leprosy Patients (NCT03947437) | Clinical Trial Compass
UnknownPhase 1/2
Phase 1b/2a Trial to Evaluate LEP-F1 + GLA-SE in Healthy Adults and Leprosy Patients
Brazil142 participantsStarted 2024-02
Plain-language 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.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. Female participants of childbearing age should have a negative serum pregnancy test at screening and a negative urine pregnancy test on study vaccination days (D0, D28 and D56). They must not be breast-feeding and are required to use at least one contraceptive method from the time of study inclusion (Day 0) until 30 days after the last injection if they have sex with men.
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Phase 1b_The number of participants who receive the injection and experience local and systemic reactions within 7 days of each study injection.
Timeframe: 7 days following each injection
2
Phase 1b_Number of participants experiencing unsolicited AEs
Timeframe: Days 0 to 84
3
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.
Timeframe: Days 0 to 421
4
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.
Timeframe: Days 0, 35 and 63.
5
Phase 2a_The number of participants who receive the injection and experience local and systemic reactions within 7 days of each study injection.
Timeframe: 7 days following each injection
6
Phase 2a_The number of participants spontaneously reporting adverse events from Day 0 to Day 84.
Timeframe: Day 0 to Day 84.
7
Trial details
NCT IDNCT03947437
SponsorThe Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
. 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.
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
Timeframe: Day 0 to Day 421
8
Phase 2a_The frequency and intensity of solicited adverse events within 7 days of each study injection.
Timeframe: 7 days following each injection
9
Phase 2a_The frequency and intensity of unsolicited adverse events during study participation (D0 to D421).
Timeframe: Day 0 to Day 421
10
Phase 2a_The frequency and causality of serious adverse events occurring during study participation (D0 to D421).