Safety and Tolerability of a Newcastle Disease Virus-Based Mucosal COVID-19 Vaccine in Previously Vaccinated Adults

NCT07215520 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: CVX NDV-HXP-S-KP.2-2a
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

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

COVID-19

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability of the NDV-HXP-S-KP.2 Vaccine Compared With an Approved mRNA COVID-19 Vaccine

  Safety and tolerability of the NDV-HXP-S-KP.2 vaccine given intranasally and an approved mRNA COVID-19 vaccine given intramuscularly will be assessed in previously immunized adults. Outcomes include the percentage of participants with solicited local and systemic reactogenicity symptoms through 7 days, unsolicited adverse events through 30 days, and serious, medically attended, or special interest adverse events through 180 days. Clinically significant abnormal lab results (chemistry and hematology) will also be assessed through 7 days post-vaccination.

  Up to 180 days after vaccination

Secondary Outcomes (3)

• Percentage of Participants With Viral Vector-Related Illness or Shedding After Vaccination

  Through Day 31 post-vaccination

• Humoral Immune Response to the NDV-HXP-S-KP.2 Vaccine Compared With the Comparator Vaccine

  From Day 1 through Day 181 post-vaccination

• Mucosal Immune Response to the NDV-HXP-S-KP.2 Vaccine Compared With the Comparator Vaccine

  From Day 1 through Day 181 post-vaccination

Other Outcomes (1)

• Percentage of Participants Who Test Positive for SARS-CoV-2 After Vaccination

  From Day 15 through Day 181 post-vaccination

Study Arms (2)

IN administration of study drug plus placebo via IM

EXPERIMENTAL

Nasal Administration of NDV-HXP-S-KP.2 and administration of placebo via Intramuscular Injection

Biological: NDV-HXP-S-KP.2

IN administration of placebo plus COVID-19 vaccine via IM

ACTIVE COMPARATOR

Nasal Administration of Placebo plus administration of COVID-19 mRNA vaccine via Intramuscular Injection

Biological: COVID-19 mRNA Vaccine

Interventions

NDV-HXP-S-KP.2 BIOLOGICAL

Nasal Administration of a COVID-19 vaccine to compare against a commercially available mRNA vaccine

IN administration of study drug plus placebo via IM

COVID-19 mRNA Vaccine BIOLOGICAL

Used as a comparator to study vaccine

IN administration of placebo plus COVID-19 vaccine via IM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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).
• 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 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.
• 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.

You may not qualify 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 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.

Sponsors & Collaborators

• CastleVax Inc.: lead

Study Sites (2)

Skylight Health Research

Colorado Springs, Colorado, 80917, United States

RECRUITING

Skylight Health Research

Burlington, Massachusetts, 01803, United States

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

CVnCoV COVID-19 vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Michael Egan, PhD

  CastleVax Inc.

  STUDY CHAIR

Central Study Contacts

Skylight Health Research Colorado Springs

CONTACT

719-301-7162; info@skylighthealthresearch.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2025
• First Posted: October 10, 2025
• Study Start: November 3, 2025
• Primary Completion (Estimated): August 19, 2026
• Study Completion (Estimated): August 19, 2026
• Last Updated: November 6, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)