Safety and Immunogenicity of COVI-VAC, a Live Attenuated Vaccine Against COVID-19

First-in-human, Randomised, Double-blind, Placebo-controlled, Dose-escalation Study in Healthy Young Adults Evaluating the Safety and Immunogenicity of COVI-VAC, a Live Attenuated Vaccine Candidate for Prevention of COVID-19

This is the first study of COVI-VAC in humans. The purpose of the study is to evaluate the safety and immune response of COVI-VAC (a live attenuated vaccine to prevent COVID-19) in healthy adults aged 18 to 30 years. Approximately 48 participants will be enrolled into 1 of 3 dose groups (low, medium, high). Within each of these dose groups, participants will be assigned randomly to receive either 2 doses of COVI-VAC 28 days apart, 2 doses of placebo (saline), or 1 dose of COVI-VAC and 1 dose of placebo. COVI-VAC or placebo is administered by drops into each nostril. Neither the participants nor the researchers will know whether COVI-VAC or placebo has been received.

To assess the safety of the vaccine, each participant will record symptoms and oral temperature in a diary daily for 14 days after each dose. Safety laboratory tests, physical exams, ECGs, and a chest X-ray will also be performed, and peak expiratory flow and vital signs will be measured. Adverse events and medication use will be recorded.

Blood samples and intranasal samples will be collected to assess the immune response from the vaccine.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Other: Placebo; Biological: COVI-VAC

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, E1 2AX
    • hVIVO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 26 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects who meet all of the following criteria may be included in the study:

  1. Men and women aged between 18 to 30 years of age, inclusive, on the day of signing the informed consent form (ICF)
  2. In good health with no history, or current evidence, of clinically significant medical conditions with particular reference to, but not restricted to, hypertension, diabetes, thromboembolic disorders, coronary heart disease, chronic obstructive lung disease, and no clinically significant test abnormalities that will interfere with subject safety, as defined by medical history, physical examination, vital signs (including oxygen saturation), ECG, spirometry, and safety laboratory tests as determined by the Investigator
  3. Total body weight of greater or equal to 50 kg and body mass index (BMI) greater or equal to 18.0 kg/m2 and less than or equal to 28.0 kg/m2 (the upper limit of the BMI may be increased to less than or equal to 30 kg/m2 at the Investigator's discretion in case of a muscular healthy subject for whom BMI may be biased upwards)
  4. Negative drugs of abuse, cotinine, and alcohol screen (unless explained by prescribed medication)
  5. Negative pregnancy test for women who have not been surgically sterilised
  6. Negative COVID Clear test

Exclusion Criteria:

Subjects who meet any of the following criteria will be excluded from the study:

1. Haemoglobin A1c ≥6.0% or 42 mmol/mol
2. Forced expiratory volume in 1 second (FEV1) less than 80% predicted value
3. Signs or symptoms suggestive of upper or lower respiratory tract infection (including fever or persistent cough) within 28 days of Day 1
4. Pregnant, possibly pregnant, or lactating women
5. Women who have been pregnant through the third trimester or given birth within the past 6 months
6. Planning a pregnancy (subject or partner) within 90 days after the last IMP dose
7. Inadequate venous access for repeated phlebotomy
8. History of confirmed or suspected SARS-CoV-2 infection
9. Contact with any individual subsequently confirmed to have SARS-CoV-2 within 14 days after contact
10. History of wheeze treated with inhaler(s)
11. Respiratory symptoms, including wheeze, that have ever resulted in hospitalisation
12. Known bronchial hyperreactivity to viruses
13. Any significant abnormality altering the anatomy of the nose in a substantial way or nasopharynx that may interfere with the aims of the study and in particular any of the nasal assessments or viral challenge (historical nasal polyps can be included, but large nasal polyps causing current and significant symptoms and/or requiring regular treatments in the last month are excluded)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Saline; Normal saline	Other: Placebo; normal saline
Experimental: Low dose cohort 1; COVI-VAC, single dose	Biological: COVI-VAC; intranasal, live attenuated vaccine against SARS-CoV-2
Experimental: Medium dose cohort 1; COVI-VAC, single dose	Biological: COVI-VAC; intranasal, live attenuated vaccine against SARS-CoV-2
Experimental: High dose cohort 1; COVI-VAC, single dose	Biological: COVI-VAC; intranasal, live attenuated vaccine against SARS-CoV-2
Experimental: Low dose cohort 2; COVI-VAC, two doses 28 days apart	Biological: COVI-VAC; intranasal, live attenuated vaccine against SARS-CoV-2
Experimental: Medium dose cohort 2; COVI-VAC, two doses 28 days apart	Biological: COVI-VAC; intranasal, live attenuated vaccine against SARS-CoV-2
Experimental: High dose cohort 2; COVI-VAC, two doses 28 days apart	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
Reactogenicity	Percentage of subjects with reactogenicity events	14 days after each dose
Adverse events	Percentage of subjects with adverse events	Days 1 through 57
Serious adverse events	Percentage of subjects with serious adverse events	Days 1-400

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IgG titre	IgG titre measured by ELISA in serum collected on Days 1, 15, 29, 43, 57, 120, 210, and 400	Days 1, 15, 29, 43, 57, 120, 210, and 400
Neutralizing antibody titre	Neutralising antibody level measured by microneutralisation assay in serum	Days 1, 15, 29, 43, 57, 120, 210, and 400

Collaborators and Investigators

• Sponsor: Codagenix, Inc
• Investigators: Principal Investigator: Daryl Bendel, MD, hVIVO

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2020
• Primary Completion (Actual): June 26, 2021
• Study Completion (Actual): May 30, 2022

Study Registration Dates

• First Submitted: November 5, 2020
• First Submitted That Met QC Criteria: November 5, 2020
• First Posted (Actual): November 6, 2020

Study Record Updates

• Last Update Posted (Actual): June 28, 2022
• Last Update Submitted That Met QC Criteria: June 24, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: SARS-CoV-2; COVID-19; live attenuated; live attenuated vaccine
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: CDX-CoV-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

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