Double Vaccinated for COVID-19 (For Phase 1 of the Study)Phase 1NCT05226702
Clinical Trial to Study the COVAC-2 Booster Dose (for COVID-19) in Generally Healthy Adults.
A Phase 1 study testing COVAC-2 in people with Double Vaccinated for COVID-19 (For Phase 1 of the Study) and Acute Respiratory Syndrome Coronavirus 2 (For Phase 2 Exploratory Group), run by University of Saskatchewan at 3 sites in Canada.
Trial summary
VIDO has developed a vaccine called COVAC-2. The COVAC-2 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-2 contains a SWE adjuvant. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Double Vaccinated for COVID-19 (For Phase 1 of the Study), Acute Respiratory Syndrome Coronavirus 2 (For Phase 2 Exploratory Group)
- What is being tested?
- COVAC-2
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 3 sitesCanada
- Study dates
- 22 Jul 2022to 13 Nov 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Generally healthy male and female adults aged 18 years or older at the time of signing the informed consent form.
- Good general health as determined by screening evaluation no greater than 30 days before injection of study vaccine.
- Note: Participants who are overtly healthy as determined by medical evaluation or are considered medically stable according to the judgment of the Investigator. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months prior to enrolment, and/or hospitalization within the entire study period is not anticipated. Also, the participant appears likely to be able to remain in follow-up through the end of protocol-specified period. Mild to moderate well-controlled comorbidities are allowed.
- Have received minimum of 2 doses of an authorized COVID-19 vaccine at least 4 months prior to Day 0.
- Male participant and females of child-bearing potential and heterosexually active, practice of adequate contraception for 30 days prior to injection, negative pregnancy test on the day of injection, and agreement to continue adequate contraception until 180 days after the injection.
- Written informed consent, after review of the consent form and having adequate opportunity to discuss the study with an Investigator or a qualified designee.
Who cannot join
- Presence of any febrile illness or any known or suspected acute illness on the day of immunization.
- Any condition, which in the opinion of the Investigator may make the participant inappropriate for the study.
- Clinically significant bleeding disorder (e.g., clotting factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following intramuscular injections or venipuncture.
- Receiving systemic immunomodulatory therapy or history of receiving chemotherapy in the last 5 years other than topical agents.
- Receipt of systemic glucocorticoids (a dose ≥20 mg/day prednisone or equivalent for 14 days) within 1 month, or any other cytotoxic or immunosuppressive drug within 6 months prior to injection of study vaccine.
- Cancer diagnosis in the last 5 years, excluding basal cell and squamous cell carcinoma of the skin, which are allowed.
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- Presence of autoimmune disease.
- Receipt of any investigational drug within 6 months.
- Receipt of any non-COVID-19 authorized vaccines, for example influenza, within 2 weeks of receiving study dose injection.
- Receipt of any other experimental SARS-CoV-2/COVID-19 or other experimental coronavirus vaccine(s) at any time prior to or during the study. Exception: Receipt of SARS CoV 2/COVID-19 vaccines at least 4 months prior to Day 0 that were experimental at the time of their administration but are currently authorized will not lead to exclusion.
- Receipt of blood products or immunoglobulin (IVIg or IMIg) within 3 months of study entry/baseline serologic evaluation.
- Current anti-tuberculosis therapy.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccine.
- Hematologic or biochemical laboratory abnormalities (blood or urine), as defined by lab normal ranges. To exclude transient abnormalities, the Investigator may repeat a test once, and if the repeat test is normal according to local reference ranges, participant may be enrolled. Abnormalities of laboratory values will not be exclusionary if considered not clinically significant by the Investigator.
- Previous (within 4 months prior to Day 0) SARS-CoV-2 infection, based on a documented positive polymerase chain reaction (PCR) test or rapid antigen test, or reported by participant or prior medical history.
- Member of the study personnel, or immediate family member or household member of the study personnel.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Manna Research (Burlington North)
Burlington, Ontario, L7M 4Y1
Canadian Center for Vaccinology
Saskatoon, Saskatchewan, B3K 6R8
Manna Research
Toronto, Ontario, M9W 4L6
About this study
Official title: A Phase 1 Clinical Trial to Study the Safety and Immunogenicity of a COVAC-2 Booster Dose in Generally Healthy Adults.
VIDO has developed a vaccine called COVAC-2.
The COVAC-2 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-2 contains a SWE adjuvant. An adjuvant is a compound that is added to a vaccine to help the vaccine produce a better immune response. The SWE adjuvant is similar to another adjuvant, MF59, that is found in influenza vaccines and MF59 containing vaccines have been given to millions of people around the world. 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 severe COVID-19 illness. In animal studies, the immune response generated by the COVAC-2 vaccine was able to protect the vaccinated animals against a severe SARS-CoV-2 infection.
This is a Phase 1/2, placebo-controlled, observer-blind, age-stratified randomized, multicenter study to access the safety and immunogenicity of two dosing levels (10 and 25 µg S1 protein tested in parallel) administered once in healthy adults ≥18 of age who have received 2 doses of an authorized COVID-19 vaccine at least 6 months earlier. The study will also include an open-label exploratory study arm to evaluate safety and immunogenicity of a single COVAC-2 dose in previously SARS-CoV-2-infected individuals (Phase 2 only).
- Conditions
- Double Vaccinated for COVID-19 (For Phase 1 of the Study), Acute Respiratory Syndrome Coronavirus 2 (For Phase 2 Exploratory Group)
- Being tested
- COVAC-2, Saline Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVAC-2Biological
Intramuscular vaccine against SARS-CoV-2
Saline PlaceboBiological
Intramuscular injection of saline placebo
| Study group | Role | What they receive |
|---|---|---|
| COVAC-2 10 µg group | Experimental | 20 healthy adults ≥18 years of age receive the vaccine on Day 0. Receives: Biological: COVAC-2 |
| COVAC-2 25 µg group | Experimental | 20 healthy adults ≥18 years of age receive the vaccine on Day 0 Receives: Biological: COVAC-2 |
| Placebo Control | Placebo comparator | 20 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 and tolerability of COVAC-2 booster vaccine 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) or COVID-19 illness up to 365 days.
Measured: Up to 365 days
Secondary outcomes (2)
To assess the spike binding and neutralizing response induced by COVAC-2 booster vaccine
Antibody response induced by COVAC-2 booster pre-injection and post injection as measured by spike protein-specific Enzyme Linked Immunosorbent Assay (ELISA), virus microneutralization and/or pseudovirus neutralization assay.
Measured: Up to 365 days
To assess the immune response induced by COVAC-2 booster vaccine, as measured by cell immune response markers up to Day 365.
Measurement of COVAC-2 immune response by measuring cell-mediated response markers in Peripheral Blood Mononuclear Cells (PBMCs) pre- and post-injection.
Measured: Up to 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start22 Jul 2022
- Primary completion13 Nov 2023
- Study completion13 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Double Vaccinated for COVID-19 (For Phase 1 of the Study)Studies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Collaborators
- Government of Canada, Government of Saskatchewan, Vaccine Formulation Institute (VFI), Seppic
- Responsible party
- Principal investigator, Volker Gerdts, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05226702
- Sponsor's protocol ID
- COVAC-004
- Status last verified
- May 2024
- First submitted
- 3 Feb 2022
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hamonic G, Arora S, Garg R, Scruten E, Buchanan R, Saundh SL, Collin N, Sanche S, Vale N, Salter T, Halperin SA, Langley JM, Gerdts V, Racine T. Safety and immunogenicity of a booster dose of COVAC-2, a Sepivac SWE adjuvanted SARS-CoV-2 recombinant protein vaccine in previously vaccinated healthy adults; a randomized controlled multicentre trial. Hum Vaccin Immunother. 2026 Dec;22(1):2683765. doi: 10.1080/21645515.2026.2683765. Epub 2026 Jun 10.
PubMed 42268674Garg 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 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Trial to Study the Safety and Immunogenicity of a COVAC-2 Booster Dose in Generally Healthy Adults.
- ClinicalTrials.gov ID
- NCT05226702
- Acronym / sponsor ID
- COVAC-004
- Conditions
- Double Vaccinated for COVID-19 (For Phase 1 of the Study), Acute Respiratory Syndrome Coronavirus 2 (For Phase 2 Exploratory Group)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Collaborators
- Government of Canada, Government of Saskatchewan, Vaccine Formulation Institute (VFI), Seppic
- Study start
- 22 Jul 2022 (actual)
- Primary completion
- 13 Nov 2023 (actual)
- Study completion
- 13 Nov 2023 (actual)
- First posted
- 7 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.
VIDO has developed a vaccine called COVAC-2.
The COVAC-2 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-2 contains a SWE adjuvant. An adjuvant is a compound that is added to a vaccine to help the vaccine produce a better immune response. The SWE adjuvant is similar to another adjuvant, MF59, that is found in influenza vaccines and MF59 containing vaccines have been given to millions of people around the world. 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 severe COVID-19 illness. In animal studies, the immune response generated by the COVAC-2 vaccine was able to protect the vaccinated animals against a severe SARS-CoV-2 infection.
This is a Phase 1/2, placebo-controlled, observer-blind, age-stratified randomized, multicenter study to access the safety and immunogenicity of two dosing levels (10 and 25 µg S1 protein tested in parallel) administered once in healthy adults ≥18 of age who have received 2 doses of an authorized COVID-19 vaccine at least 6 months earlier. The study will also include an open-label exploratory study arm to evaluate safety and immunogenicity of a single COVAC-2 dose in previously SARS-CoV-2-infected individuals (Phase 2 only).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| COVAC-2 10 µg group | Experimental | Biological: COVAC-220 healthy adults ≥18 years of age receive the vaccine on Day 0. |
| COVAC-2 25 µg group | Experimental | Biological: COVAC-220 healthy adults ≥18 years of age receive the vaccine on Day 0 |
| Placebo Control | Placebo comparator | Biological: Saline Placebo20 healthy adults ≥18 years of age receive a dose of normal saline (placebo) on Day 0. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Generally healthy male and female adults aged 18 years or older at the time of signing the informed consent form.
- Good general health as determined by screening evaluation no greater than 30 days before injection of study vaccine.
- Note: Participants who are overtly healthy as determined by medical evaluation or are considered medically stable according to the judgment of the Investigator. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months prior to enrolment, and/or hospitalization within the entire study period is not anticipated. Also, the participant appears likely to be able to remain in follow-up through the end of protocol-specified period. Mild to moderate well-controlled comorbidities are allowed.
- Have received minimum of 2 doses of an authorized COVID-19 vaccine at least 4 months prior to Day 0.
- Male participant and females of child-bearing potential and heterosexually active, practice of adequate contraception for 30 days prior to injection, negative pregnancy test on the day of injection, and agreement to continue adequate contraception until 180 days after the injection.
Key exclusion criteria (16 listed)
- Presence of any febrile illness or any known or suspected acute illness on the day of immunization.
- Any condition, which in the opinion of the Investigator may make the participant inappropriate for the study.
- Clinically significant bleeding disorder (e.g., clotting factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following intramuscular injections or venipuncture.
- Receiving systemic immunomodulatory therapy or history of receiving chemotherapy in the last 5 years other than topical agents.
- Receipt of systemic glucocorticoids (a dose ≥20 mg/day prednisone or equivalent for 14 days) within 1 month, or any other cytotoxic or immunosuppressive drug within 6 months prior to injection of study vaccine.
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-2Intramuscular vaccine against SARS-CoV-2 | Biological | COVAC-2 10 µg group, COVAC-2 25 µg group |
| Saline PlaceboIntramuscular injection of saline placebo | Biological | Placebo Control |
Primary outcome
Assessment of the safety and tolerability of COVAC-2 booster vaccine 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) or COVID-19 illness up to 365 days.
2 secondary outcomes
To assess the spike binding and neutralizing response induced by COVAC-2 booster vaccine
Time frame: Up to 365 days
To assess the immune response induced by COVAC-2 booster vaccine, as measured by cell immune response markers up to Day 365.
Time frame: Up to 365 days
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 3 May 2024.
- Derived from this study: PubMed 42268674Hamonic G, Arora S, Garg R, Scruten E, Buchanan R, Saundh SL, Collin N, Sanche S, Vale N, Salter T, Halperin SA, Langley JM, Gerdts V, Racine T. Safety and immunogenicity of a booster dose of COVAC-2, a Sepivac SWE adjuvanted SARS-CoV-2 recombinant protein vaccine in previously vaccinated healthy adults; a randomized controlled multicentre trial. Hum Vaccin Immunother. 2026 Dec;22(1):2683765. doi: 10.1080/21645515.2026.2683765. Epub 2026 Jun 10.
- 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
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.
3 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-2 in people with Double Vaccinated for COVID-19 (For Phase 1 of the Study) and Acute Respiratory Syndrome Coronavirus 2 (For Phase 2 Exploratory Group), run by University of Saskatchewan at 3 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 6 inclusion and 16 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 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 and tolerability of COVAC-2 booster vaccine 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 NCT05226702, which also lists 2 linked publications.
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 3 May 2024.