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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04619628
Recruitment Status : Completed
First Posted : November 6, 2020
Last Update Posted : June 28, 2022
Sponsor:
Information provided by (Responsible Party):
Codagenix, Inc

Tracking Information
First Submitted Date  ICMJE November 5, 2020
First Posted Date  ICMJE November 6, 2020
Last Update Posted Date June 28, 2022
Actual Study Start Date  ICMJE December 11, 2020
Actual Primary Completion Date June 26, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Immunogenicity of COVI-VAC, a Live Attenuated Vaccine Against COVID-19
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE COVID-19
Intervention  ICMJE
  • Biological: COVI-VAC
    intranasal, live attenuated vaccine against SARS-CoV-2
  • Other: Placebo
    normal saline
Study Arms  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 5, 2020)
48
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 30, 2022
Actual Primary Completion Date June 26, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 30 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04619628
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Current Responsible Party Codagenix, Inc
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Codagenix, Inc
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Daryl Bendel, MD Hvivo
PRS Account Codagenix, Inc
Verification Date June 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP