RecruitingCOVID-19
Safety and Tolerability of a Newcastle Disease Virus-Based Mucosal COVID-19 Vaccine in Previously Vaccinated Adults
Eligible age
18+ yrs
Accepts
All genders
Locations
2 states
Healthy volunteers
Yes
See if you qualify for this study
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About this study
A Double-blind, Randomized, Controlled, Phase 2a Study to Evaluate the Safety and Tolerability of a Newcastle Disease Virus-based Mucosal Vaccine (NDV-HXP-S-KP.2) Relative to an Approved Systemic mRNA Vaccine in Previously Vaccinated Adults
Sponsor: CastleVax Inc.
You may qualify if…
- ✓ 1. Is an adult 18 through 64 years of age at time of screening with at least 1 underlying condition that puts the participant at high risk for severe outcomes of COVID-19 per self-report OR is an adult ≥65 years of age at time of screening (with or without at least 1 underlying condition).
- ✓ 2. Has completed any WHO/FDA-authorized or approved primary COVID-19 vaccination series per self-report.
- ✓ 3. Has received last COVID-19 vaccine ≥6 months prior to study vaccination.
- ✓ 4. If a female of childbearing potential who is sexually active, agrees to use an adequate method of birth control from Screening through 90 days after study vaccination, and has used an adequate birth control method for at least 30 days prior to Screening. Sexually active male participants, unless the participant is sterile or otherwise unable to produce sperm, or has exclusively male sexual partners, must agree to abstinence or to use a barrier method (e.g., male condom) from vaccination through 90 days after study vaccination. Male participants must also agree to not donate sperm from vaccination through 90 days after study vaccination.
- ✓ 5. Is medically stable, as determined by the site investigator (based on review of health status, vital signs, medical history, and physical examination).
- ✓ 6. Agrees to not participate in any other SARS-CoV-2 infection prevention trial (vaccine, drug, biologic, pre-exposure prophylaxis \[PrEP\]) during participation in the study.
- ✓ 7. Willing and able to provide informed consent prior to initiation of study procedures.
- ✓ 8. Is available for all study visits, willing to participate in all study procedures, and not planning to relocate from the area for the duration of the study.
You may not qualify if…
- ✕ 1. Has an acute illness, as determined by the site investigator, within 72 hours prior to Screening or study vaccination.
- ✕ 2. Has had a positive COVID-19 test within the 90 days prior to Screening or study vaccination.
- ✕ 3. Current or planned participation in any other interventional clinical trial.
- ✕ 4. Participation in research involving any investigational product within 45 days prior to Screening or study vaccination.
- ✕ 5. Receipt of any approved or authorized products intended to prevent SARS-CoV-2 infection within 6 months prior to Screening or study vaccination.
- ✕ 6. Receipt of blood products or immunoglobulins within 60 days prior to Screening or study vaccination.
- ✕ 7. Received influenza vaccination within 14 days prior to Screening or study vaccination, or any other vaccine within 30 days prior to Screening or study vaccination.
- ✕ 8. Any significant autoimmune, immunodeficiency disease/condition, or auto inflammatory disorder (e.g., any known immunoglobulin A \[IgA\] deficiency, human immunodeficiency virus \[HIV\] infection, acquired immunodeficiency syndrome \[AIDS\])
Where it's recruiting
Colorado
Colorado Springs
Massachusetts
Burlington
Source: ClinicalTrials.gov · NCT07215520 · last updated 2025-11-06