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Tests treatment safety and results for COVID-19
Official title Safety and Tolerability of a Newcastle Disease Virus-Based Mucosal COVID-19 Vaccine in Previously Vaccinated Adults
ClinicalTrials.gov ID: NCT07215520
What this study is testing
What is NDV-HXP-S-KP.2?
NDV-HXP-S-KP.2 is an investigational medicine, being studied as a potential treatment for covid-19.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Has completed any WHO/FDA-authorized or approved primary COVID-19 vaccination series per self-report.
- Has received last COVID-19 vaccine ≥6 months prior to study vaccination.
- 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...
- Is medically stable, as determined by the site investigator (based on review of health status, vital signs, medical history, and physical...
You likely can't join if
- Has an acute illness, as determined by the site investigator, within 72 hours prior to Screening or study vaccination.
- Has had a positive COVID-19 test within the 90 days prior to Screening or study vaccination.
- Current or planned participation in any other treatment clinical trial.
- Participation in research involving any investigational product within 45 days prior to Screening or study vaccination.
- Receipt of any approved or authorized products intended to prevent SARS-CoV-2 infection within 6 months prior to Screening or study vaccination.
- Receipt of blood products or immunoglobulins within 60 days prior to Screening or study vaccination.
See the full eligibility criteria
Who can join
- 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...
- Has completed any WHO/FDA-authorized or approved primary COVID-19 vaccination series per self-report.
- Has received last COVID-19 vaccine ≥6 months prior to study vaccination.
- 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...
- Is medically stable, as determined by the site investigator (based on review of health status, vital signs, medical history, and physical examination).
- 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.
- Willing and able to provide informed consent prior to initiation of study procedures.
- 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.
What rules you out
- Has an acute illness, as determined by the site investigator, within 72 hours prior to Screening or study vaccination.
- Has had a positive COVID-19 test within the 90 days prior to Screening or study vaccination.
- Current or planned participation in any other treatment clinical trial.
- Participation in research involving any investigational product within 45 days prior to Screening or study vaccination.
- Receipt of any approved or authorized products intended to prevent SARS-CoV-2 infection within 6 months prior to Screening or study vaccination.
- Receipt of blood products or immunoglobulins within 60 days prior to Screening or study vaccination.
- 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.
- 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...
- Has current active hepatitis B or hepatitis C infection (based on self-reported medical history).
- Has a peripheral arterial oxygen saturation (SpO2) level \<92% at Screening, uncontrolled or severe asthma (e.g., more than 1 hospitalization for asthma exacerbation within the 12 months prior to Screening), or other...
- Has known active tuberculosis.
- Unstable non-cardiac illness (acute or chronic illness) requiring hospitalization or medical procedure during the 90 days prior to Screening or study vaccination, or cardiac condition (acute or chronic) requiring...
- History of myocarditis, pericarditis, myopericarditis, or idiopathic cardiomyopathy, or presence of any medical condition (e.g., viral illness within 30 days of Screening or study vaccination) that, in the opinion of...
- Chronic kidney disease requiring dialysis or any type of ultrafiltration. Individuals with chronic kidney disease that does not require dialysis or ultrafiltration may be included.
- Individuals with advanced or decompensated chronic liver disease as determined by the site investigator.
- Presence of any transplanted solid organs (heart, kidney, lung, liver, pancreas, and/or intestine) or prior receipt of a blood stem cell transplant.
- Administration of immunosuppressants, systemic glucocorticoids, or other immune-modifying drugs within the following timeframes:
- B-cell therapies within the 6 months prior to Screening or study vaccination.
- Prednisone, ≥20 mg or equivalent for more than 2 weeks, within the 30 days prior to Screening or study vaccination.
- Monoclonal antibodies that may suppress aspects of immune response (e.g., Dupixent) within the 6 months prior to Screening or study vaccination.
- Other medications in this category, including but not limited to high-dose inhaled corticosteroids (\>800 mcg/day of beclomethasone dipropionate or equivalent); antimetabolites; transplant immunosuppressive agents...
- Any medication for any period of time that, in the opinion of the site investigator, could impede immune response to vaccination.
- Known contraindication to IM injection (e.g., bleeding diathesis, acquired coagulopathy) or to IN administration (e.g., significant nasal abnormality or severe nasal obstruction, significant chronic rhinitis or history...
- Receipt or anticipated receipt, within 7 days prior through 7 days after study vaccination, of any Intranasal medication, including FDA-approved prescription or over-the-counter products or non-FDA-approved alternative...
- Anticipated use of nasal irrigation (e.g., Neti PotTM) from Screening through 30 days after study vaccination.
- Any known allergies to components contained in NDV-HXP-S (including egg products) or the comparator vaccine (including polyethylene glycol [PEG] allergies).
- Women who are pregnant, breastfeeding, or who plan to become pregnant during the study.
- Current or prior potential for NDV exposure (e.g., prior NDV-based vaccination, NDV-based oncologic immunotherapy, prior or current experience as a bird-handler, poultry farmer, or scientist conducting research with...
- Individuals who will have close or household high-risk contacts, within 14 days following study vaccination, including but not limited to:
- Any other condition that, in the opinion of the site investigator, would pose a health risk to the participant if enrolled or could interfere with evaluation of the investigational product or interpretation of study...
- Study team member or first-degree relative of any study team member (inclusive of CastleVax and site personnel involved in the study).
The study team makes the final eligibility decision.
Where it's taking place
- Colorado Springs, Colorado, United States
- Burlington, Massachusetts, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Colorado Springs, Colorado, United States; Burlington, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.