Severe Acute Respiratory Syndrome Coronavirus 2 InfectionPhase 1NCT05693272
A Clinical Trial to Study the COVAC-1 Booster Dose in Generally Healthy Adults
A Phase 1 study testing COVAC-1 in people with Severe Acute Respiratory Syndrome Coronavirus 2 Infection, run by University of Saskatchewan at 4 sites in Canada.
Trial summary
VIDO has developed a vaccine called COVAC-1. The COVAC-1 study vaccine contains a portion of the SARS-CoV-2 spike protein, called S1. The spike protein is the part of the virus that is responsible for attaching to the surface of host cells. COVAC-1 contains a TriAdj adjuvant. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Severe Acute Respiratory Syndrome Coronavirus 2 Infection
- What is being tested?
- COVAC-1
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 4 sitesCanada
- Study dates
- 31 Jan 2023to 4 Jun 2024
- 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
- Male and female participants 18-65 years of age at the time of signing the informed consent form for the study.
- Good general health as confirmed by assessments completed no more than 30 days before study D0. Participants with mild to moderate well controlled comorbidities or having a medically stable condition, will be eligible. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization due to worsening during the 3 months prior to enrollment, and according to the judgment of the Investigator, hospitalization during the entire study period is not anticipated.
- Have received a minimum of 2 doses of an authorized COVID-19 vaccine at least 4 months prior to the investigational booster dose injection. Proof of vaccination can be provided as a digital copy of the vaccination receipt on the participant's device, a screenshot of the receipt on the device, or a printed paper copy.
- Male participants, and heterosexually active females of child-bearing potential, must practice adequate contraception for 30 days prior to the injection and must agree to continue adequate contraception until 180 days after the injection. Negative pregnancy test will be obtained from female participants of child-bearing potential at screening and at Day 0.
- Provide a written informed consent for the study prior to performing any study-related procedure. The Investigator or a qualified designee must ensure the appropriate consent is in place.
Who cannot join
- Presence of any febrile illness or any known or suspected acute illness on the day of immunization.
- Clinically significant bleeding disorder (e.g., clotting factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following intramuscular injection or venipuncture.
- Presence of an autoimmune disease.
- Receiving systemic steroids in doses exceeding 20mg daily of prednisone or equivalent, for ≥ 14 days within 1 month, or has recently received any other cytotoxic or immunosuppressive drug within 6 months prior to the injection of the study vaccine.
- Has a known malignancy diagnosed within the past 5 years. Participants with basal cell carcinoma or squamous cell carcinoma of the skin are not excluded.
- Currently receiving systemic immunomodulatory therapy or received chemotherapy within the last 5 years excluding topical agents.
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- Has received blood products or immunoglobulins (IVIg or IMIg) within 3 months of study entry/baseline serologic evaluation.
- Currently on anti-tuberculosis therapy.
- Had SARS-CoV-2 infection within 4 months prior to study Day 0. A potential participant is considered to have COVID-19 infection base on one of the following:
- Positive polymerase chain reaction (PCR) or rapid antigen test.
- Documentation in a medical history report.
- Reported by candidate.
- Has received any non-COVID-19 authorized vaccines (e.g., influenza) within 2 weeks prior to receiving study dose injection.
- Has received any experimental SARS-CoV-2 / COVID-19 vaccines Receipt of SARSCoV-2/COVID-19 vaccines that were experimental at the time of administration but are currently authorized, more than 6 months prior to Day 0, will not lead to exclusion.
- Planning to receive booster doses of any authorized COVID-19 vaccine during the first two months days from study vaccination.
- Abnormal laboratory test results (hematology, biochemistry, and urinalysis) as compared to the local normal lab ranges. To exclude transient abnormalities, laboratory tests may be repeated once. Abnormal lab test results considered not clinically significant by the Investigator will not be exclusionary.
- Has a history of any reaction or known sensitivity likely to be exacerbated by any component of the study vaccine.
- Is currently participating in or has participated in a study of an investigational agent within 6 months prior to the injection of the booster vaccine under study.
- A female is not eligible to participate if she is pregnant or breast feeding
- Being a member of the study team, or an immediate family member or household member of a member on the study team.
- Any condition, which in the opinion of the investigator may deem the participant inappropriate for the study.
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Diex Recherche Joliette Inc.
Joliette, Quebec, J6E 2B4
Diex Recherche Quebec Inc.
Québec, Quebec, G1V 4T3
Diex Recherche Sherbrooke
Sherbrooke, Quebec, J1L 0H8
DIEX Recherche Victoriaville
Victoriaville, Quebec, G6P 6P6
About this study
Official title: A Randomized, Observer-Blind, Dose Escalation, Placebo-Controlled, Phase 1 Clinical Trial to Study the Safety and Immunogenicity of a COVAC-1 Booster Dose in Generally Healthy Adults
VIDO has developed a vaccine called COVAC-1.
The COVAC-1 study vaccine contains a portion of the SARS-CoV-2 spike protein, called S1. The spike protein is the part of the virus that is responsible for attaching to the surface of host cells. COVAC-1 contains a TriAdj adjuvant. An adjuvant is a compound that is added to a vaccine to help the vaccine produce a better immune response. The vaccine is expected to stimulate the body to make antibodies against the S1 protein. The antibodies will recognize the viral spike protein if the body is exposed to the virus and prevent COVID-19 illness. In animal studies, the immune response generated by the COVAC-1 vaccine was able to protect the vaccinated animals against a severe SARS-CoV-2 infection.
Read more
The COVAC-005 Study is a Phase I, multi-centre trial of a SARS-CoV-2 vaccine booster. This is a randomized, observer-blinded, and placebo-controlled study to assess the safety and immunogenicity of COVAC-1 booster dose administered once in generally healthy adults 18-65 years of age who have received a minimum of 2 doses of an authorized COVID-19 vaccine at least 4 months prior to Day 0.
The study will follow a dose-escalation design to test the safety and immunogenicity of three dosage levels (10, 25 and 50 µg). In each dose escalation group participants will be randomized in a 3:1 ratio, to receive either the investigational product or a placebo, respectively. Stratification will be according to the Investigational product dose received. Sub-analysis will be completed in two age groups, 18-54 and 55-65 years.
Study participants will be initially randomized to the lowest dose of 10 µg or placebo. After approval by the Sponsor and based on the recommendations from the DSMB following the Day 7 safety analysis, new study participants will be allowed to be randomized in the higher dose escalation group of 25 µg. Approval will also be sought from the Sponsor, based upon the DSMB recommendation, to proceed with the higher dose of 50 µg. Within each dose escalation group of 16 participants (12 active vaccine recipients, and 4 placebo recipients) it is proposed to randomize a first cohort of 4 participants, including at least 3 active vaccine recipients, and pending no holding rule is met after 48 hours, as determined by the post-injection phone call, the remaining 12 participants within that dose escalation group will be randomized.
- Being tested
- COVAC-1, Saline Placebo
- Keywords
- COVID-19 Booster Vaccine
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVAC-1Biological
Intramuscular vaccine against SARS-CoV-2
Saline PlaceboBiological
Intramuscular injection of saline placebo
| Study group | Role | What they receive |
|---|---|---|
| COVAC-01 10µg group | Experimental | 12 healthy adults ≥18 years of age receive the vaccine on Day 0. Receives: Biological: COVAC-1 |
| COVAC-01 25µg group | Experimental | 12 healthy adults ≥18 years of age receive the vaccine on Day 0. Receives: Biological: COVAC-1 |
| COVAC-01 50µg group | Experimental | 12 healthy adults ≥18 years of age receive the vaccine on Day 0. Receives: Biological: COVAC-1 |
| Placebo Control | Placebo comparator | 12 healthy adults ≥18 years of age receive a dose of normal saline (placebo) on Day 0. Receives: Biological: Saline Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the safety of COVAC-1 booster vaccine (10, 25 and 50 μg dosing of S1 antigen) in generally healthy volunteers
Incidence of solicited adverse events (AE) up to 7 days post-injection; unsolicited AEs up to 28 days post-injection; any clinically significant laboratory finding up to 28 days post-injection; and any serious AEs (SAEs), potential immune medicated disease (pIMDs), medically attended events or COVID-19 illness up to 365 days.
Measured: Up to 365 days
Secondary outcomes (5)
To assess the antibody response induced by COVAC-1 booster pre-injection and post injection as measured by spike protein-specific Enzyme Linked Immunosorbent Assay (ELISA)
Study samples will be tested to assess the level of anti-SARS-CoV-2 spike IgG binding antibodies present in the human serum samples by using a validated ELISA.
Measured: Up to Day 365.
To assess the immune response induced by COVAC-1 booster vaccine, as measured by cell immune response markers using flow cytometry.
Peripheral Blood Mononuclear Cells (PBMCs) samples collected pre- and post-injection will be assessed for spike protein-specific Helper T-lymphocytes (CD4+) and Cytotoxic T-lymphocytes (CD8+) population producing cytokine profile.
Measured: Up to Day 365.
To assess the immune response induced by COVAC-1 booster vaccine, as measured by cell immune response markers using an ELISpot assay.
Peripheral Blood Mononuclear Cells (PBMCs) samples collected pre- and post-injection will be assessed for spike peptide-specific T cell responses, IFN-gamma and IL-5, as a measurement of COVAC-1 immune response induction.
Measured: Up to Day 365.
To assess the antibody response induced by COVAC-1 booster pre-injection and post injection as measured by virus microneutralization assay.
Study samples will be tested to assess the level of SARS-CoV-2 Wuhan neutralizing antibodies present in the human serum samples by SARS-CoV-2 live virus microneutralization assay.
Measured: Up to Day 365.
To assess the antibody response induced by COVAC-1 booster pre-injection and post injection as measured by pseudovirus neutralization assay.
Study samples will be tested to assess the level of SARS-CoV-2 Wuhan pseudovirus neutralizing antibodies present in the human serum samples by SARS-CoV-2 pseudotyped virus neutralization assay.
Measured: Up to Day 365.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start31 Jan 2023
- Primary completion4 Jun 2024
- Study completion4 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severe Acute Respiratory Syndrome Coronavirus 2 InfectionStudies 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
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Collaborators
- Government of Canada, Government of Saskatchewan
- Responsible party
- Principal investigator, Volker Gerdts, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05693272
- Sponsor's protocol ID
- COVAC-005
- Status last verified
- Dec 2024
- First submitted
- 22 Dec 2022
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Garg R, Liu Q, Van Kessel J, Asavajaru A, Uhlemann EM, Joessel M, Hamonic G, Khatooni Z, Kroeker A, Lew J, Scruten E, Pennington P, Deck W, Prysliak T, Nickol M, Apel F, Courant T, Kelvin AA, Van Kessel A, Collin N, Gerdts V, Koster W, Falzarano D, Racine T, Banerjee A. Efficacy of a stable broadly protective subunit vaccine platform against SARS-CoV-2 variants of concern. Vaccine. 2024 Aug 13;42(20):125980. doi: 10.1016/j.vaccine.2024.05.028. Epub 2024 May 19.
PubMed 38769033
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Observer-Blind, Dose Escalation, Placebo-Controlled, Phase 1 Clinical Trial to Study the Safety and Immunogenicity of a COVAC-1 Booster Dose in Generally Healthy Adults
- ClinicalTrials.gov ID
- NCT05693272
- Acronym / sponsor ID
- COVAC-005
- Keywords
- COVID-19 Booster Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Collaborators
- Government of Canada, Government of Saskatchewan
- Study start
- 31 Jan 2023 (actual)
- Primary completion
- 4 Jun 2024 (actual)
- Study completion
- 4 Jun 2024 (actual)
- First posted
- 20 Jan 2023 (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.
VIDO has developed a vaccine called COVAC-1.
The COVAC-1 study vaccine contains a portion of the SARS-CoV-2 spike protein, called S1. The spike protein is the part of the virus that is responsible for attaching to the surface of host cells. COVAC-1 contains a TriAdj adjuvant. An adjuvant is a compound that is added to a vaccine to help the vaccine produce a better immune response. The vaccine is expected to stimulate the body to make antibodies against the S1 protein. The antibodies will recognize the viral spike protein if the body is exposed to the virus and prevent COVID-19 illness. In animal studies, the immune response generated by the COVAC-1 vaccine was able to protect the vaccinated animals against a severe SARS-CoV-2 infection.
The COVAC-005 Study is a Phase I, multi-centre trial of a SARS-CoV-2 vaccine booster. This is a randomized, observer-blinded, and placebo-controlled study to assess the safety and immunogenicity of COVAC-1 booster dose administered once in generally healthy adults 18-65 years of age who have received a minimum of 2 doses of an authorized COVID-19 vaccine at least 4 months prior to Day 0.
The study will follow a dose-escalation design to test the safety and immunogenicity of three dosage levels (10, 25 and 50 µg). In each dose escalation group participants will be randomized in a 3:1 ratio, to receive either the investigational product or a placebo, respectively. Stratification will be according to the Investigational product dose received. Sub-analysis will be completed in two age groups, 18-54 and 55-65 years.
Study participants will be initially randomized to the lowest dose of 10 µg or placebo. After approval by the Sponsor and based on the recommendations from the DSMB following the Day 7 safety analysis, new study participants will be allowed to be randomized in the higher dose escalation group of 25 µg. Approval will also be sought from the Sponsor, based upon the DSMB recommendation, to proceed with the higher dose of 50 µg. Within each dose escalation group of 16 participants (12 active vaccine recipients, and 4 placebo recipients) it is proposed to randomize a first cohort of 4 participants, including at least 3 active vaccine recipients, and pending no holding rule is met after 48 hours, as determined by the post-injection phone call, the remaining 12 participants within that dose escalation group will be randomized.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| COVAC-01 10µg group | Experimental | Biological: COVAC-112 healthy adults ≥18 years of age receive the vaccine on Day 0. |
| COVAC-01 25µg group | Experimental | Biological: COVAC-112 healthy adults ≥18 years of age receive the vaccine on Day 0. |
| COVAC-01 50µg group | Experimental | Biological: COVAC-112 healthy adults ≥18 years of age receive the vaccine on Day 0. |
| Placebo Control | Placebo comparator | Biological: Saline Placebo12 healthy adults ≥18 years of age receive a dose of normal saline (placebo) on Day 0. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female participants 18-65 years of age at the time of signing the informed consent form for the study.
- Good general health as confirmed by assessments completed no more than 30 days before study D0. Participants with mild to moderate well controlled comorbidities or having a medically stable condition, will be eligible. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization due to worsening during the 3 months prior to enrollment, and according to the judgment of the Investigator, hospitalization during the entire study period is not anticipated.
- Have received a minimum of 2 doses of an authorized COVID-19 vaccine at least 4 months prior to the investigational booster dose injection. Proof of vaccination can be provided as a digital copy of the vaccination receipt on the participant's device, a screenshot of the receipt on the device, or a printed paper copy.
- Male participants, and heterosexually active females of child-bearing potential, must practice adequate contraception for 30 days prior to the injection and must agree to continue adequate contraception until 180 days after the injection. Negative pregnancy test will be obtained from female participants of child-bearing potential at screening and at Day 0.
- Provide a written informed consent for the study prior to performing any study-related procedure. The Investigator or a qualified designee must ensure the appropriate consent is in place.
Key exclusion criteria (21 listed)
- Presence of any febrile illness or any known or suspected acute illness on the day of immunization.
- Clinically significant bleeding disorder (e.g., clotting factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following intramuscular injection or venipuncture.
- Presence of an autoimmune disease.
- Receiving systemic steroids in doses exceeding 20mg daily of prednisone or equivalent, for ≥ 14 days within 1 month, or has recently received any other cytotoxic or immunosuppressive drug within 6 months prior to the injection of the study vaccine.
- Has a known malignancy diagnosed within the past 5 years. Participants with basal cell carcinoma or squamous cell carcinoma of the skin are not excluded.
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 |
|---|---|---|
| COVAC-1Intramuscular vaccine against SARS-CoV-2 | Biological | COVAC-01 10µg group, COVAC-01 25µg group, COVAC-01 50µg group |
| Saline PlaceboIntramuscular injection of saline placebo | Biological | Placebo Control |
Primary outcome
Assessment of the safety of COVAC-1 booster vaccine (10, 25 and 50 μg dosing of S1 antigen) in generally healthy volunteers
Time frame: Up to 365 days
Incidence of solicited adverse events (AE) up to 7 days post-injection; unsolicited AEs up to 28 days post-injection; any clinically significant laboratory finding up to 28 days post-injection; and any serious AEs (SAEs), potential immune medicated disease (pIMDs), medically attended events or COVID-19 illness up to 365 days.
5 secondary outcomes
To assess the antibody response induced by COVAC-1 booster pre-injection and post injection as measured by spike protein-specific Enzyme Linked Immunosorbent Assay (ELISA)
Time frame: Up to Day 365.
To assess the immune response induced by COVAC-1 booster vaccine, as measured by cell immune response markers using flow cytometry.
Time frame: Up to Day 365.
To assess the immune response induced by COVAC-1 booster vaccine, as measured by cell immune response markers using an ELISpot assay.
Time frame: Up to Day 365.
To assess the antibody response induced by COVAC-1 booster pre-injection and post injection as measured by virus microneutralization assay.
Time frame: Up to Day 365.
To assess the antibody response induced by COVAC-1 booster pre-injection and post injection as measured by pseudovirus neutralization assay.
Time frame: Up to Day 365.
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 5 Dec 2024.
- Derived from this study: PubMed 38769033Garg R, Liu Q, Van Kessel J, Asavajaru A, Uhlemann EM, Joessel M, Hamonic G, Khatooni Z, Kroeker A, Lew J, Scruten E, Pennington P, Deck W, Prysliak T, Nickol M, Apel F, Courant T, Kelvin AA, Van Kessel A, Collin N, Gerdts V, Koster W, Falzarano D, Racine T, Banerjee A. Efficacy of a stable broadly protective subunit vaccine platform against SARS-CoV-2 variants of concern. Vaccine. 2024 Aug 13;42(20):125980. doi: 10.1016/j.vaccine.2024.05.028. Epub 2024 May 19.
- Individual participant dataSharing planned: No
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing COVAC-1 in people with Severe Acute Respiratory Syndrome Coronavirus 2 Infection, run by University of Saskatchewan at 4 sites in Canada.
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 5 inclusion and 21 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 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. 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. Some participants in this study may receive a placebo. 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?
Assessment of the safety of COVAC-1 booster vaccine (10, 25 and 50 μg dosing of S1 antigen) in generally healthy volunteers (time frame: Up to 365 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05693272, which also lists 1 linked publication.
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 5 Dec 2024.