COVID-19Phase 1NCT05233826
Safety and Immunogenicity of COVI-VAC as a Booster Dose in Adults Previously Vaccinated Against COVID-19
A Phase 1 study testing COVI-VAC in people with COVID-19 and SARS-CoV-2, run by Codagenix, Inc at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19, SARS-CoV-2
- What is being tested?
- COVI-VAC
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Apr 2022to 22 Dec 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women aged 18 to 65 years of age, inclusive, on the day of signing the ICF
- Body mass index (BMI) ≤ 35 kg/m2
- 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
- Previous receipt of an authorised mRNA or adenovirus-vectored COVID-19 vaccine with completion of vaccine regimen ≥ 3 months before Day 1
Who cannot join
- Residents of residential care facilities
- Pregnant or lactating women
- Inadequate venous access for repeated phlebotomy
- History of confirmed or suspected SARS-CoV-2 infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- COVID-19, SARS-CoV-2
- Being tested
- COVI-VAC
- Keywords
- Covid-19 vaccines, Covid-19 vaccine booster shot, Heterologous prime boost, COVID-19 vaccination, Vaccines, attenuated
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVI-VACBiological
Intranasal, live attenuated vaccine against SARS-CoV-2
| Study group | Role | What they receive |
|---|---|---|
| COVI-VAC | Experimental | COVI-VAC Nose Drops Receives: Biological: COVI-VAC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Humoral Immunogenicity
IgG Titer measured by ELISA on day 1
Measured: Day 1
Humoral Immunogenicity
IgG Titer measured by ELISA on day 29
Measured: Day 1
Humoral Immunogenicity
IgG Titer measured by ELISA on day 181
Measured: Day 181
Humoral Immunogenicity measured by neutralizing antibodies
neutralising antibody titer measured by microneutralisation assay in serum on days 1
Measured: Day 1
Humoral Immunogenicity measured by neutralizing antibodies
neutralising antibody titer measured by microneutralisation assay in serum on day 29
Measured: Day 29
Humoral Immunogenicity measured by neutralizing antibodies
neutralising antibody titer measured by microneutralisation assay in serum on day 181
Measured: Day 181
Secondary outcomes (2)
Vaccine and Virus Shedding
SARS-CoV-2 genome copy number/mL as assessed by quantitative polymerase chain reaction (qPCR) assay in nasopharyngeal swab samples collected on Day 4
Measured: Day 4
Vaccine and Virus Shedding
SARS-CoV-2 genome copy number/mL as assessed by quantitative polymerase chain reaction (qPCR) assay in nasopharyngeal swab samples collected on Day 8
Measured: Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start14 Apr 2022
- Primary completion21 Jul 2022
- Study completion22 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Codagenix, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05233826
- Sponsor's protocol ID
- CDX-CoV-002
- Status last verified
- Jan 2023
- First submitted
- 3 Feb 2022
- Last updated
- 13 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study Evaluating the Safety and Immunogenicity of COVI-VAC as a Booster Dose in Previously Vaccinated Adults Against COVID-19
- ClinicalTrials.gov ID
- NCT05233826
- Acronym / sponsor ID
- CDX-CoV-002
- Conditions
- COVID-19, SARS-CoV-2
- Keywords
- Covid-19 vaccines, Covid-19 vaccine booster shot, Heterologous prime boost, COVID-19 vaccination, Vaccines, attenuated
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Codagenix, IncIndustry (pharma, biotech, devices)
- Study start
- 14 Apr 2022 (actual)
- Primary completion
- 21 Jul 2022 (actual)
- Study completion
- 22 Dec 2022 (actual)
- First posted
- 10 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVI-VAC | Experimental | Biological: COVI-VACCOVI-VAC Nose Drops |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women aged 18 to 65 years of age, inclusive, on the day of signing the ICF
- Body mass index (BMI) ≤ 35 kg/m2
- 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
- Previous receipt of an authorised mRNA or adenovirus-vectored COVID-19 vaccine with completion of vaccine regimen ≥ 3 months before Day 1
Key exclusion criteria (4 listed)
- Residents of residential care facilities
- Pregnant or lactating women
- Inadequate venous access for repeated phlebotomy
- History of confirmed or suspected SARS-CoV-2 infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVI-VACIntranasal, live attenuated vaccine against SARS-CoV-2 | Biological | COVI-VAC |
Primary outcome
Humoral Immunogenicity
Time frame: Day 1
IgG Titer measured by ELISA on day 1
Humoral Immunogenicity
Time frame: Day 1
IgG Titer measured by ELISA on day 29
Humoral Immunogenicity
Time frame: Day 181
IgG Titer measured by ELISA on day 181
Humoral Immunogenicity measured by neutralizing antibodies
Time frame: Day 1
neutralising antibody titer measured by microneutralisation assay in serum on days 1
Humoral Immunogenicity measured by neutralizing antibodies
Time frame: Day 29
neutralising antibody titer measured by microneutralisation assay in serum on day 29
Humoral Immunogenicity measured by neutralizing antibodies
Time frame: Day 181
neutralising antibody titer measured by microneutralisation assay in serum on day 181
2 secondary outcomes
Vaccine and Virus Shedding
Time frame: Day 4
Vaccine and Virus Shedding
Time frame: Day 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing COVI-VAC in people with COVID-19 and SARS-CoV-2, run by Codagenix, Inc at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Humoral Immunogenicity (time frame: Day 1). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2023.