Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2025-12-24 @ 10:45 PM
NCT ID:
NCT05736835
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.
Study:
NCT05736835
Study Brief:
Protocol Section:
NCT05736835