This phase 1 clinical trial will evaluate the safety, reactogenicity, and immunogenicity of STX-S in adults who have previously received a primary series and at least one booster with an authorized or licensed SARS-CoV-2 parenteral vaccine. The study is designed as a non-randomized, open-label, dose-escalation clinical trial evaluating three dose levels of STX-S. A sample size of 60 participants (20 participants per dose cohort) is anticipated. The primary objective is to evaluate the safety and reactogenicity of a single intramuscular injection of three different dose levels (25 ng, 50 ng, and 125 ng) of STX-S in previously vaccinated healthy adults
Age range
18 Years – 64 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.
Occurrence of abnormal clinical safety laboratory adverse events (AEs).
Timeframe: Through Day 8
Occurrence of adverse events of special interest (AESI)
Timeframe: Through 6 months post study product administration
Occurrence of medically attended adverse events (MAAEs)
Timeframe: Through 6 months post study product administration
Occurrence of new onset chronic medical conditions (NOCMCs)
Timeframe: Through 6 months post study product administration
Occurrence of serious adverse events (SAEs)
Timeframe: Through 6 months post study product administration
Occurrence of solicited local adverse events (AEs).
Timeframe: Through Day 7 post study product administration
Occurrence of solicited systemic adverse events (AEs).
Timeframe: Through Day 7 post study product administration
Occurrence of unsolicited adverse events (AEs).
Timeframe: Through Day 28 post study product administration