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 range18 Years – 55 Years
SexALL
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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.
Exclusion criteria
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
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
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.
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).