Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2025-12-25 @ 8:16 PM
Study NCT ID:
NCT05736835
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-17
First Post:
2023-02-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase 2 Trial of the Immunogenicity and Safety of CVXGA Intranasal COVID Vaccine in Healthy Adults
Sponsor:
CyanVac LLC
Organization:
Study Overview
Official Title:
A Phase 2 Trial of the Immunogenicity and Safety of CVXGA Intranasal COVID Vaccine in Healthy Adults
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: