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
1 other identifier
interventional
48
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 covid19
Started Dec 2020
Longer than P75 for phase_1 covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 5, 2020
CompletedFirst Posted
Study publicly available on registry
November 6, 2020
CompletedStudy Start
First participant enrolled
December 11, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 26, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2022
CompletedJune 28, 2022
June 1, 2022
7 months
November 5, 2020
June 24, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (2)
IgG titre
Days 1, 15, 29, 43, 57, 120, 210, and 400
Neutralizing antibody titre
Days 1, 15, 29, 43, 57, 120, 210, and 400
Study Arms (7)
Saline
PLACEBO COMPARATORNormal saline
Low dose cohort 1
EXPERIMENTALCOVI-VAC, single dose
Medium dose cohort 1
EXPERIMENTALCOVI-VAC, single dose
High dose cohort 1
EXPERIMENTALCOVI-VAC, single dose
Low dose cohort 2
EXPERIMENTALCOVI-VAC, two doses 28 days apart
Medium dose cohort 2
EXPERIMENTALCOVI-VAC, two doses 28 days apart
High dose cohort 2
EXPERIMENTALCOVI-VAC, two doses 28 days apart
Interventions
Eligibility Criteria
You may qualify if:
- Subjects who meet all of the following criteria may be included in the study:
- Men and women aged between 18 to 30 years of age, inclusive, on the day of signing the informed consent form (ICF)
- 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
- 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)
- Negative drugs of abuse, cotinine, and alcohol screen (unless explained by prescribed medication)
- Negative pregnancy test for women who have not been surgically sterilised
- Negative COVID Clear test
You may not qualify if:
- Subjects who meet any of the following criteria will be excluded from the study:
- Haemoglobin A1c ≥6.0% or 42 mmol/mol
- Forced expiratory volume in 1 second (FEV1) less than 80% predicted value
- Signs or symptoms suggestive of upper or lower respiratory tract infection (including fever or persistent cough) within 28 days of Day 1
- Pregnant, possibly pregnant, or lactating women
- Women who have been pregnant through the third trimester or given birth within the past 6 months
- Planning a pregnancy (subject or partner) within 90 days after the last IMP dose
- Inadequate venous access for repeated phlebotomy
- History of confirmed or suspected SARS-CoV-2 infection
- Contact with any individual subsequently confirmed to have SARS-CoV-2 within 14 days after contact
- History of wheeze treated with inhaler(s)
- Respiratory symptoms, including wheeze, that have ever resulted in hospitalisation
- Known bronchial hyperreactivity to viruses
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Codagenix, Inclead
Study Sites (1)
hVIVO
London, E1 2AX, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daryl Bendel, MD
Hvivo
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 5, 2020
First Posted
November 6, 2020
Study Start
December 11, 2020
Primary Completion
June 26, 2021
Study Completion
May 30, 2022
Last Updated
June 28, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share