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NCT07095231 · ClinicalTrials.gov registry record · Phase 1
Safety, Reactogenicity, and Immunogenicity Trial of STX-S SARS-CoV-2 Vaccine in Adults
A Phase 1 study of COVID-19, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Active
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
- 3
- Study locations
NCT07095231 is a Phase 1 study of COVID-19 that is active but no longer recruiting, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 60 participants, below the 55,214-participant average among 203 other COVID-19 trials with a reported enrollment target (100% lower). The trial reports 3 study locations across 2 states.
The verdict
NCT07095231, a Phase 1 study of COVID-19, is active but no longer recruiting, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
- 3
- Study locations
Study 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.
Conditions Studied
Interventions
- BIOLOGICAL STX-S
Study Locations (3)
Washington
- Kaiser Permanente Washington Health Research Institute - Seattle
- The University of Washington - Virology Research Clinic - Seattle
New York
- University of Rochester Medical Center - Vaccine Research Unit - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2025-08-11 |
| Est. Completion | 2026-06-15 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07095231
The ClinicalTrials.gov registry entry for NCT07095231 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 55,214-participant average among 203 other COVID-19 trials with a reported enrollment target (100% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with COVID-19 appearing as the primary indexed condition, and to 1 intervention - of which STX-S is the first listed.
NCT07095231 reports 3 study locations spanning 2 distinct geographic areas - top geographies include Washington, New York.
Frequently Asked Questions
What is clinical trial NCT07095231 about?
NCT07095231 is a clinical study titled "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...
What is the current status of trial NCT07095231?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2025-08-11. Estimated completion is 2026-06-15.
What conditions does trial NCT07095231 study?
This clinical trial studies the following conditions: COVID-19.
What interventions are being tested in trial NCT07095231?
The interventions under investigation include: STX-S (BIOLOGICAL).
Who is sponsoring clinical trial NCT07095231?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07095231 being conducted?
This trial has 3 study locations across New York, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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