Safety, Reactogenicity, and Immunogenicity Trial of STX-S SARS-CoV-2 Vaccine in Adults (NCT07095231) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Safety, Reactogenicity, and Immunogenicity Trial of STX-S SARS-CoV-2 Vaccine in Adults
United States60 participantsStarted 2025-08-11
Plain-language 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 injection of three different dose levels (25 ng, 50 ng, and 125 ng) of STX-S in previously vaccinated healthy adults
Who can participate
Age range18 Years – 64 Years
SexALL
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Inclusion criteria
✓. Provides written informed consent before initiation of any study procedures.
✓. Able to understand and agree to comply with planned study procedures and be available for all study visits.
✓. Non-pregnant adults, 18 through 64 years of age at the time of study product administration.
✓. Participants of childbearing potential\* must agree to use or have practiced true abstinence\*\* or use at least one acceptable primary form of contraception\*\*\*
✓. Male participants must use acceptable contraception\* or be vasectomized and must refrain from donating sperm for 60 days following study product administration.
✓. Participants of childbearing potential must have a negative urine pregnancy test at screening and within 24 hours before study product administration.
✓. In general good health.\* \*As determined by medical history and physical examination, including vital signs, to evaluate acute or ongoing chronic medical diagnoses/conditions that have been present for at least 90 days, which would affect the assessment of the safety of participants. Chronic medical diagnoses/ conditions should be stable for the last 30 days (i.e., no hospitalizations, emergency room (ER), or urgent care for the condition). This includes no change in chronic prescription medication, dose, or frequency due to deterioration of the chronic medical diagnosis/condition 30 days before the study product administration. Any prescription change, due to a change of health care provider, insurance company, etc., or done for financial reasons and in the same class of medication will not be considered a deviation of this inclusion criterion. Participants may be on chronic or as-needed (prn) medications if, in the opinion of the participating site Principal Investigator or appropriate sub-investigator, they pose no additional risk to participant safety or assessment of reactogenicity and immunogenicity.
What they're measuring
1
Occurrence of abnormal clinical safety laboratory adverse events (AEs).
Timeframe: Through Day 8
2
Occurrence of adverse events of special interest (AESI)
Timeframe: Through 6 months post study product administration
3
Occurrence of medically attended adverse events (MAAEs)
Timeframe: Through 6 months post study product administration
4
Occurrence of new onset chronic medical conditions (NOCMCs)
Timeframe: Through 6 months post study product administration
5
Occurrence of serious adverse events (SAEs)
Timeframe: Through 6 months post study product administration
6
Occurrence of solicited local adverse events (AEs).
Timeframe: Through Day 7 post study product administration
7
Occurrence of solicited systemic adverse events (AEs).
Timeframe: Through Day 7 post study product administration
8
Occurrence of unsolicited adverse events (AEs).
Trial details
NCT IDNCT07095231
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
✓. Receipt of a complete primary authorized or approved COVID-19 vaccine series and at least one booster\* with the last vaccination at least 16 weeks before study product administration.
Exclusion criteria
✕0. Must agree to have samples stored for secondary research.
✕. Positive SARS-CoV-2 PCR at screening.
✕. Abnormal vital signs (Grade 1 or higher)\*:
✕. History of SARS-CoV-2 infection or receipt of any COVID-19 vaccine \< 16 weeks prior to study product administration.
✕. Participant who is pregnant or breastfeeding.
✕. Blood or plasma donation within 4 weeks before study product administration.
✕. Receipt of antibody or blood-derived products within 90 days before study product administration.
✕. Any self-reported or documented significant medical or psychiatric diseases\* or any other condition that, in the opinion of the site Principal Investigator (PI) or appropriate sub-investigator, precludes study participation.
Timeframe: Through Day 28 post study product administration