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.
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.
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.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
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.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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