Actively Recruiting
Safety and Tolerability of a Newcastle Disease Virus-Based Mucosal COVID-19 Vaccine in Previously Vaccinated Adults
Led by CastleVax Inc. · Updated on 2025-11-06
200
Participants Needed
2
Research Sites
41 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Safety and Tolerability of a Newcastle Disease Virus-Based Mucosal COVID-19 Vaccine in Previously Vaccinated Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 through 64 years with at least 1 underlying condition putting them at high risk for severe COVID-19, or adults aged 65 years and older
- Completed any WHO/FDA-authorized or approved primary COVID-19 vaccination series
- Received last COVID-19 vaccine at least 6 months prior to study vaccination
- Sexually active females of childbearing potential must agree to use adequate birth control from screening through 90 days after vaccination
- Sexually active males must agree to abstinence or barrier method use from vaccination through 90 days after vaccination and not donate sperm during this period
- Medically stable as determined by the site investigator
- Agree not to participate in other SARS-CoV-2 prevention trials during this study
- Willing and able to provide informed consent
- Available for all study visits and willing to participate in all procedures
- Not planning to relocate during the study
You will not qualify if you...
- Acute illness within 72 hours prior to screening or vaccination
- Positive COVID-19 test within 90 days prior to screening or vaccination
- Current or planned participation in other interventional clinical trials
- Participation in research with investigational products within 45 days prior to screening or vaccination
- Receipt of any approved or authorized SARS-CoV-2 prevention products within 6 months prior to screening or vaccination
- Receipt of blood products or immunoglobulins within 60 days prior to screening or vaccination
- Received influenza vaccine within 14 days or any other vaccine within 30 days prior to screening or vaccination
- Significant autoimmune, immunodeficiency, or autoinflammatory diseases
- Active hepatitis B or C infection
- Peripheral arterial oxygen saturation below 92%, uncontrolled or severe asthma, or other severe lung diseases posing health risk
- Known active tuberculosis
- Unstable non-cardiac or cardiac illness requiring hospitalization or procedure recently
- History or risk of myocarditis, pericarditis, or related heart conditions
- Chronic kidney disease requiring dialysis or ultrafiltration
- Advanced or decompensated chronic liver disease
- Solid organ or blood stem cell transplant recipients
- Recent use of immunosuppressants or immune-modifying drugs as specified
- Known contraindications to intramuscular or intranasal vaccine administration
- Use of intranasal medications or nasal irrigation around vaccination period
- Allergies to vaccine components including egg products or polyethylene glycol
- Pregnant, breastfeeding, or planning pregnancy during the study
- Prior exposure to Newcastle Disease Virus or related risk factors
- Having high-risk close or household contacts within 14 days post-vaccination
- Any condition posing health risk or interfering with study as judged by investigator
- Study team members or first-degree relatives of study team members
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Skylight Health Research
Colorado Springs, Colorado, United States, 80917
Actively Recruiting
2
Skylight Health Research
Burlington, Massachusetts, United States, 01803
Actively Recruiting
Research Team
S
Skylight Health Research Colorado Springs
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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