Trials / Completed
CompletedNCT04954287
Phase 1 Study of Intranasal PIV5 COVID-19 Vaccine Expressing SARS-CoV-2 Spike Protein in Healthy Adults and Adolescents
A Phase 1 Open-Label, Dose-Ranging Trial to Evaluate the Safety and Immunogenicity of Intranasal Parainfluenza Virus Type 5- SARS CoV-2 S Vaccine (CVXGA1) in Healthy Adults Aged 18 to 55 Years and Adolescents Aged 12 to 17 Years
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 72 (actual)
- Sponsor
- CyanVac LLC · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
This Phase 1 trial is an open-label trial to evaluate the safety, reactogenicity and immunogenicity of two dosages (10\^6 PFU and 10\^7 PFU) of intranasal CVXGA1 administered as a single dose in healthy adults age 18-55 years and in adolescents age 12-17.
Detailed description
This is an open-label, dose-ranging phase 1 trial of the PIV5 virus-vectored SARS CoV-2 S glycoprotein vaccine (CVXGA1) in healthy adults (males and nonpregnant females) 18 to 55 years of age that have not had a prior COVID vaccination (Groups 1 and 2), and in healthy adults 18 to 55 years of age (Groups 3) and adolescents 12-17 years of age (Group 4) who have received at least two doses of mRNA-based COVID vaccines (Pfizer Comirnaty® or Moderna Spikevax™) with the last dose at least 5 months prior to planned receipt of CVXGA1 study vaccine. The trial is designed to assess the safety, reactogenicity, and immunogenicity of a single dose of intranasal CVXGA1. Two dose levels will be assessed, CVXGA1-low lose (LD) at 106 plaque-forming units (PFU) (Group 1) and CVXGA1-high dose (HD) at 107 PFU (Groups 2, 3 and 4).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CVXGA1 low dose | see arm/group description |
| BIOLOGICAL | CVXGA1 high dose | see arm/group description |
Timeline
- Start date
- 2021-08-06
- Primary completion
- 2023-06-10
- Completion
- 2023-06-10
- First posted
- 2021-07-08
- Last updated
- 2024-02-07
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04954287. Inclusion in this directory is not an endorsement.