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

• ClinicalTrials.gov Identifier: NCT04619628
• Recruitment Status: Completed
• First Posted: November 6, 2020
• Last Update Posted: June 28, 2022
• Sponsor: Codagenix, Inc
• Information provided by (Responsible Party): Codagenix, Inc

Tracking Information

• First Submitted Date: November 5, 2020
• First Posted Date: November 6, 2020
• Last Update Posted Date: June 28, 2022
• Actual Study Start Date: December 11, 2020
• Actual Primary Completion Date: June 26, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 5, 2020)

• Reactogenicity [ Time Frame: 14 days after each dose ]
  Percentage of subjects with reactogenicity events
• Adverse events [ Time Frame: Days 1 through 57 ]
  Percentage of subjects with adverse events
• Serious adverse events [ Time Frame: Days 1-400 ]
  Percentage of subjects with serious adverse events

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 5, 2020)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Safety and Immunogenicity of COVI-VAC, a Live Attenuated Vaccine Against COVID-19
• Official Title: 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

Brief Summary

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention
• Condition: COVID-19

Intervention

• Biological: COVI-VAC
  intranasal, live attenuated vaccine against SARS-CoV-2
• Other: Placebo
  normal saline

Study Arms

• Placebo Comparator: Saline
  Normal saline
  Intervention: Other: Placebo
• Experimental: Low dose cohort 1
  COVI-VAC, single dose
  Intervention: Biological: COVI-VAC
• Experimental: Medium dose cohort 1
  COVI-VAC, single dose
  Intervention: Biological: COVI-VAC
• Experimental: High dose cohort 1
  COVI-VAC, single dose
  Intervention: Biological: COVI-VAC
• Experimental: Low dose cohort 2
  COVI-VAC, two doses 28 days apart
  Intervention: Biological: COVI-VAC
• Experimental: Medium dose cohort 2
  COVI-VAC, two doses 28 days apart
  Intervention: Biological: COVI-VAC
• Experimental: High dose cohort 2
  COVI-VAC, two doses 28 days apart
  Intervention: Biological: COVI-VAC

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 5, 2020): 48
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: May 30, 2022
• Actual Primary Completion Date: June 26, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 30 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT04619628
• Other Study ID Numbers: CDX-CoV-001
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Codagenix, Inc
• Original Responsible Party: Same as current
• Current Study Sponsor: Codagenix, Inc
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Daryl Bendel, MD; Hvivo

• PRS Account: Codagenix, Inc
• Verification Date: June 2022