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
CastleVax Inc.
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
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
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 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…
Interventions
- BiologicalNDV-HXP-S-KP.2
Nasal Administration of a COVID-19 vaccine to compare against a commercially available mRNA vaccine
- BiologicalCOVID-19 mRNA Vaccine
Used as a comparator to study vaccine
Locations (2)
- Skylight Health ResearchColorado Springs, Colorado
- Skylight Health ResearchBurlington, Massachusetts