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

NCT05233826 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-01-13

No results posted yet for this study

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

Interventions

BIOLOGICAL

COVI-VAC

Intranasal, live attenuated vaccine against SARS-CoV-2

Sponsors & Collaborators

  • Codagenix, Inc

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-14
Primary Completion
2022-07-21
Completion
2022-12-22

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05233826 on ClinicalTrials.gov