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.
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 subjects of childbearing potential must 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 breastfeeding and must use at least one method of contraception from the time of study enrollment (Day 0) through 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 WBC 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.
History of infection with Mycobacterium leprae.
History of exposure to experimental products containing GLA-SE.
History of active tuberculosis or documented recurrence.
History of previous infection with other non-tuberculous mycobacteria.
Crossover
LepVax (2 μg LEP-F1 + 5 μg GLA-S): Low dose
Drug2 μg LEP-F1 + 5 μg GLA-SE will be administered by IM injection on Days 0,28, and 56 in healthy participants.
LepVax (10 μg LEP-F1 + 5 μg GLA-SE): High dose
Drug10 μg LEP-F1 + 5 μg GLA-SE will be administered by IM injection on Days 0,28, and 56 in healthy participants.
Placebo Comparator: Placebo
Other interventionSterile normal saline for injection will be administered by IM injection on Days 0, 28, and 56 in healthy participants and paucibacillary leprosy patients.
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.
Phase 1b_Number of participants experiencing unsolicited AEs
The number of participants spontaneously reporting adverse events from Day 0 to Day 84.
Phase 1b_The number of physician-attended adverse events
The number of physician-attended adverse events considered to be related to any of the study injections reported at any time during the study period.
Phase 1b_IgG antibody responses to LEP-F1 by ELISA on Days 0, 35, 63,and 168.
IgG antibody responses to LEP-F1 by ELISA on Days 0, 35, 63, and 168
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
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.
The T cell responses measured by multiparametric flow cytometry in PBMCs
The T cell responses measured by multiparametric flow cytometry in PBMCs on 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.
The assays of candidate biomarkers measured on Day 0 and 63 including gene expression signatures and serum protein multiplex assay.
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The Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)
Lead sponsor
Oswaldo Cruz Institute
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
