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.
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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
Phase 1b_Number of participants experiencing unsolicited AEs
Timeframe: Day 0 to Day 84 following each injection
Phase 1b_The number of physician-attended adverse events
Timeframe: Through study completion, an average of 1 year
Cassio P Ferreira, PhD, Principal investigator