Safety, Reactogenicity, and Immunogenicity Trial of STX-S SARS-CoV-2 Vaccine in Adults

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

NCT Number	NCT07095231
Lead Sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Conditions	COVID-19
Enrollment	60 participants
Start Date	2025-08-11
Primary Completion	2026-06-16 (estimated)
Study Completion	2026-06-16 (estimated)
Updated on ClinicalTrials.gov	2026-06-26