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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
Full description
This is a double-blind (supported by a double-dummy design), randomized, active comparator-controlled Phase 2a safety and tolerability study. The study will enroll approximately 200 previously COVID-19-vaccinated, male and nonpregnant female adult participants aged ≥18 years. Participants 18 through 64 years of age must have at least 1 underlying condition that puts them at high risk for severe outcomes from COVID-19
Enrollment
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Inclusion criteria
Exclusion criteria
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 interventional 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 syndrome [AIDS])
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 uncontrolled or severe chronic lung disease or known bronchial hyper-reactivity to viruses that, in the opinion of the site investigator, would pose a health risk to the individual if enrolled.
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 hospitalization or medical procedure (e.g., stenting, cardiac surgery, etc.) during the 1 year prior to Screening or study vaccination.
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 the investigator, increases risk of myocarditis, pericarditis, or myopericarditis.
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:
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 of chronic rhinitis, nasal septal defect causing significant breathing problems, unrepaired cleft palate, nasal polyps, or other nasal abnormality that might affect vaccine administration).
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 medicine products (e.g., Ayurvedic oil or other naturopathic substances).
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 NDV).
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 results.
Study team member or first-degree relative of any study team member (inclusive of CastleVax and site personnel involved in the study).
Primary purpose
Allocation
Interventional model
Masking
200 participants in 2 patient groups
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Central trial contact
Skylight Health Research Colorado Springs
Data sourced from clinicaltrials.gov
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