NCT05736835

A Phase 2 Trial of the Immunogenicity and Safety of CVXGA Intranasal COVID Vaccine in Healthy Adults

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 227 (actual)
• Sponsor: CyanVac LLC · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The purpose of this trial is to evaluate immunogenicity and safety of CVXGA administered as a single intranasal dose against SARS-CoV-2 S-protein in participants. The trial will enroll up to 400 healthy participants, age 18-80 years.

Detailed description

This is a randomized, placebo controlled, blinded study to evaluate the immunogenicity and safety of CVXGA. Trial Population: Up to 400 healthy adults (18-80 years) that may have had prior COVID vaccination or COVID infection at least 5 months prior to planned study vaccine receipt. Vaccine: CVXGA is a recombinant parainfluenza virus type 5 (PIV5) that carries the SARS-CoV-2 S protein. The vaccine will be administered as a single intranasal dose as a spray. Study visits: Participants will be asked to complete 3 clinic visits and 1 follow-up phone call. Participants \>= 65 yrs of age will have an additional 2 clinic visits to test for vaccine shedding. Follow-up will be for 6 months after single vaccination.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	CVXGA	CVXGA is a live viral vector, consisting of a recombinant parainfluenza virus type 5 that carries the SARS-CoV-2 S-protein from WA.1 (not enrolling) or XBB1.5 strain.

Timeline

• Start date: 2023-06-30
• Primary completion: 2027-06-30
• Completion: 2028-06-30
• First posted: 2023-02-21
• Last updated: 2025-10-20

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study