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ACTIVE NOT RECRUITING
NCT07095231
PHASE1

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

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

View on ClinicalTrials.gov

Summary

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 (IM) injection of three different dose levels (25 ng, 50 ng, and 125 ng) of STX-S in previously vaccinated healthy adults.

Official title: A Phase 1 Dose Escalation Study to Assess the Safety, Reactogenicity, and Immunogenicity of STX-S for Prevention of SARS-CoV-2 Infection as a Booster Dose

Key Details

Gender

All

Age Range

18 Years - 64 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-08-11

Completion Date

2026-06-15

Last Updated

2026-02-06

Healthy Volunteers

Yes

Conditions

Interventions

BIOLOGICAL

STX-S

A proprietary vaccine developed internally by Capricor utilizing exosomes that were engineered to express spike proteins on the surface

Locations (3)

University of Rochester Medical Center - Vaccine Research Unit

Rochester, New York, United States

Kaiser Permanente Washington Health Research Institute

Seattle, Washington, United States

The University of Washington - Virology Research Clinic

Seattle, Washington, United States