NCT05233826

Safety and Immunogenicity of COVI-VAC as a Booster Dose in Adults Previously Vaccinated Against COVID-19

Phase 1 Study Evaluating the Safety and Immunogenicity of COVI-VAC as a Booster Dose in Previously Vaccinated Adults Against COVID-19

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Codagenix, Inc · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to to evaluate the safety and immune response of COVI-VAC given as a single booster dose in healthy adults previously vaccinated against COVID-19 with an authorised mRNA or adenovirus-vectored vaccine. Approximately 30 participants who have been fully vaccinated ≥ 3 months ago will be enrolled and receive one dose of COVI-VAC. COVI-VAC is administered by drops into each nostril. To assess the safety of the vaccine, each participant will record symptoms and oral temperature in a diary daily for 7 days after receiving COVI-VAC or placebo. During the full study safety laboratory tests, physical exams, and vital signs (including oxygen saturation) will be conducted periodically for safety. Adverse events and medication use will be recorded. Blood samples and intranasal samples will be collected periodically to assess the immune response from the vaccine.

Conditions

• COVID-19
• SARS-CoV-2

Interventions

Type	Name	Description
BIOLOGICAL	COVI-VAC	Intranasal, live attenuated vaccine against SARS-CoV-2

Timeline

• Start date: 2022-04-14
• Primary completion: 2022-07-21
• Completion: 2022-12-22
• First posted: 2022-02-10
• Last updated: 2023-01-13

Locations

1 site across 1 country: United Kingdom