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ACTIVE NOT RECRUITING Phase 1

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

NCT07095231 · View on ClinicalTrials.gov ↗

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

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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07095231 reports 3 study locations spanning 2 distinct geographic areas — top geographies include Washington, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07095231?

The interventions under investigation include: STX-S (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07095231?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial