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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: Active Phase 1 study of COVID-19, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

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 38,465-participant average among 298 other COVID-19 trials with a reported enrollment target (100% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 60 participants
Start Date 2025-08-11
Est. Completion 2026-06-15
Phase Phase 1

What the registry record for NCT07095231 still lists

NCT07095231 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 38,465-participant average among 298 other COVID-19 trials with a reported enrollment target (100% lower).

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 a single indexed study location in 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.

Similar trials for COVID-19

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT07095231's enrollment target sits among peer trials

60 233rd of 298 higher than 60 of 298 other COVID-19 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other COVID-19 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT07095231, the US trial registry maintained by the National Library of Medicine. NCT07095231 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.