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

January 11, 2023 updated by: Codagenix, Inc

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Men and women aged 18 to 65 years of age, inclusive, on the day of signing the ICF
  2. Body mass index (BMI) ≤ 35 kg/m2
  3. In good health with no history, or current evidence, of clinically significant medical conditions with particular reference to, but not restricted to, thromboembolic disorders, coronary heart disease, chronic obstructive lung disease, and no clinically significant test abnormalities that will interfere with participant safety, as defined by medical history, physical examination, vital signs (including oxygen saturation), and safety laboratory tests as determined by the Investigator
  4. Previous receipt of an authorised mRNA or adenovirus-vectored COVID-19 vaccine with completion of vaccine regimen ≥ 3 months before Day 1

Exclusion Criteria:

  1. Residents of residential care facilities
  2. Pregnant or lactating women
  3. Inadequate venous access for repeated phlebotomy
  4. History of confirmed or suspected SARS-CoV-2 infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: COVI-VAC
COVI-VAC Nose Drops
Biological: COVI-VAC
Intranasal, live attenuated vaccine against SARS-CoV-2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Humoral Immunogenicity
Time Frame: Day 1
IgG Titer measured by ELISA on day 1
Day 1
Humoral Immunogenicity
Time Frame: Day 1
IgG Titer measured by ELISA on day 29
Day 1
Humoral Immunogenicity
Time Frame: Day 181
IgG Titer measured by ELISA on day 181
Day 181
Humoral Immunogenicity measured by neutralizing antibodies
Time Frame: Day 1
neutralising antibody titer measured by microneutralisation assay in serum on days 1
Day 1
Humoral Immunogenicity measured by neutralizing antibodies
Time Frame: Day 29
neutralising antibody titer measured by microneutralisation assay in serum on day 29
Day 29
Humoral Immunogenicity measured by neutralizing antibodies
Time Frame: Day 181
neutralising antibody titer measured by microneutralisation assay in serum on day 181
Day 181

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vaccine and Virus Shedding
Time Frame: Day 4
SARS-CoV-2 genome copy number/mL as assessed by quantitative polymerase chain reaction (qPCR) assay in nasopharyngeal swab samples collected on Day 4
Day 4
Vaccine and Virus Shedding
Time Frame: Day 8
SARS-CoV-2 genome copy number/mL as assessed by quantitative polymerase chain reaction (qPCR) assay in nasopharyngeal swab samples collected on Day 8
Day 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Codagenix, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2022

Primary Completion (Actual)

July 21, 2022

Study Completion (Actual)

December 22, 2022

Study Registration Dates

First Submitted

February 3, 2022

First Submitted That Met QC Criteria

February 8, 2022

First Posted (Actual)

February 10, 2022

Study Record Updates

Last Update Posted (Estimate)

January 13, 2023

Last Update Submitted That Met QC Criteria

January 11, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDX-CoV-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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