Severe Acute Respiratory Syndrome Coronavirus 2Phase 2NCT05209009
A Clinical Trial of COVAC-2 in Adults
A Phase 2 study testing COVAC-2 in people with Severe Acute Respiratory Syndrome Coronavirus 2, run by University of Saskatchewan at 2 sites in Uganda.
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
- Severe Acute Respiratory Syndrome Coronavirus 2
- 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
- 150 participants
- Where
- 2 sitesUganda
- Study dates
- 24 Aug 2022to 1 Mar 2024
- Phase
- Phase 2
- 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 of age or older at the time of signing the informed consent form;
- Good general health as determined by screening evaluation not greater than 30 days before injection of first dose;
- 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 hospitalisation 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.
- If female 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 second injection;
- Male participants are eligible to participate in the study if they agree to the following requirements during the study period and for at least 28 days after the last injection of study dose, i.e.,
- o Be abstinent from any heterosexual intercourse with a female of childbearing potential as their preferred and usual lifestyle.
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- OR
- o Must agree to use a male condom when engaging in any activity that allows for passage of ejaculate to another person. In addition to male condom use, a highly effective method of contraception should be considered in women of child-bearing potential partners of male participants.
- AND
- o Must refrain from donating sperm; and
- Written informed consent, after review of the consent form and having adequate opportunity to discuss the study with an investigator or a qualified designee and pass the "Test of Understanding" (up to 3 attempts). For participants who cannot read or write, the consent must be witnessed by a literate third party not involved in study conduct.
Who cannot join
- Presence of any febrile illness or any known or suspected acute illness on the day of any immunization;
- Clinically significant bleeding disorder (e.g., clotting factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture.
- Any condition, which in the opinion of the Investigator, may make the participant inappropriate for the study;
- Receiving systemic immunosuppressive therapy or history of receiving chemotherapy in 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;
- 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 within 2 weeks of receiving study dose injection;
- Receipt of any authorized COVID-19 vaccine prior to study enrollment;
- 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;
- 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. Grade 1 abnormalities of laboratory values will not be exclusionary if considered not clinically significant by the investigator; and
- Pregnant and breastfeeding females.
Trial locations and contacts
2 sites in 1 country.
Uganda2 sites
Uganda Virus Research Institute
Entebbe
Epicentre, Mbarara Research Centre
Mbarara
About this study
Official title: A Randomized, Observer-Blind, Dose-Escalation Phase 2 Clinical Trial of COVAC-2 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 2, placebo-controlled, observer-blind, age-stratified randomized, multicentre study to test the safety and immunogenicity of a dose level of the COVAC-2 vaccine (25 µg protein) administered twice (4 weeks apart) in generally healthy adults 18+ years of age. Up to 300 participants will be enrolled. For an individual participant, the duration of study will be approximately 12 months from the first vaccination (Day 0).
- 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 |
|---|---|---|
| Group A | Experimental | COVAC-2 25 µg: 200 generally healthy adults > 18 years of age receive the vaccine on Day 0, followed by a second dose on Day 28. Receives: Biological: COVAC-2 |
| Group B | Placebo comparator | 100 generally healthy adults > 18 years of age receive a dose of normal saline (placebo) on Day 0, followed by a dose of normal saline (placebo) on Day 28. 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 COVID-19 vaccine (COVAC-2) following two consecutive injections (28 days apart) 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 up to 28 days post-injection; and any serious AEs (SAEs), medically attended events (MAE), or Adverse Event of Special Interest (AESI) up to Day 365.
Measured: Up to 365 days
Secondary outcomes (2)
To assess the induction of SARS-CoV-2 spike protein (S) antibodies following two consecutive injections (28 days apart) of COVAC-2 vaccine through use of Enzyme-Linked immunosorbent Assay (ELISA) up to Day 365
SARS-CoV-2 specific antibodies to Wuhan spike antigen or pseudovirus neutralizing antibodies pre- injection and post-injection as measured by spike protein-specific ELISA and serum neutralization assay.
Measured: Up to 365 days
To assess SARS-CoV-2 spike protein-specific, cell-mediated response up to Day 365 induced by two consecutive injections (28 days apart) of COVAC-2 vaccine
Measurement of SARS-CoV-2 spike protein-specific, 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 posted26 Jan 2022
- Study start24 Aug 2022
- Primary completion1 Mar 2024
- Study completion1 Mar 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 2Studies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 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
- NCT05209009
- Sponsor's protocol ID
- COVAC-003
- Status last verified
- Apr 2024
- First submitted
- 2 Dec 2021
- Last updated
- 2 May 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 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Observer-Blind, Dose-Escalation Phase 2 Clinical Trial of COVAC-2 in Generally Healthy Adults
- ClinicalTrials.gov ID
- NCT05209009
- Acronym / sponsor ID
- COVAC-003
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Collaborators
- Government of Canada, Government of Saskatchewan, Vaccine Formulation Institute (VFI), Seppic
- Study start
- 24 Aug 2022 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 26 Jan 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 2, placebo-controlled, observer-blind, age-stratified randomized, multicentre study to test the safety and immunogenicity of a dose level of the COVAC-2 vaccine (25 µg protein) administered twice (4 weeks apart) in generally healthy adults 18+ years of age. Up to 300 participants will be enrolled. For an individual participant, the duration of study will be approximately 12 months from the first vaccination (Day 0).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Biological: COVAC-2COVAC-2 25 µg: 200 generally healthy adults > 18 years of age receive the vaccine on Day 0, followed by a second dose on Day 28. |
| Group B | Placebo comparator | Biological: Saline Placebo100 generally healthy adults > 18 years of age receive a dose of normal saline (placebo) on Day 0, followed by a dose of normal saline (placebo) on Day 28. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Generally healthy male and female adults aged 18 years of age or older at the time of signing the informed consent form;
- Good general health as determined by screening evaluation not greater than 30 days before injection of first dose;
- 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 hospitalisation 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.
- If female 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 second injection;
- Male participants are eligible to participate in the study if they agree to the following requirements during the study period and for at least 28 days after the last injection of study dose, i.e.,
Key exclusion criteria (16 listed)
- Presence of any febrile illness or any known or suspected acute illness on the day of any immunization;
- Clinically significant bleeding disorder (e.g., clotting factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture.
- Any condition, which in the opinion of the Investigator, may make the participant inappropriate for the study;
- Receiving systemic immunosuppressive therapy or history of receiving chemotherapy in 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;
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 | Group A |
| Saline PlaceboIntramuscular injection of saline placebo | Biological | Group B |
Primary outcome
Assessment of the safety and tolerability of COVID-19 vaccine (COVAC-2) following two consecutive injections (28 days apart) 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 up to 28 days post-injection; and any serious AEs (SAEs), medically attended events (MAE), or Adverse Event of Special Interest (AESI) up to Day 365.
2 secondary outcomes
To assess the induction of SARS-CoV-2 spike protein (S) antibodies following two consecutive injections (28 days apart) of COVAC-2 vaccine through use of Enzyme-Linked immunosorbent Assay (ELISA) up to Day 365
Time frame: Up to 365 days
To assess SARS-CoV-2 spike protein-specific, cell-mediated response up to Day 365 induced by two consecutive injections (28 days apart) of COVAC-2 vaccine
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 2 May 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing COVAC-2 in people with Severe Acute Respiratory Syndrome Coronavirus 2, run by University of Saskatchewan at 2 sites in Uganda.
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 11 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 2 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 2 sites in Uganda. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 COVID-19 vaccine (COVAC-2) following two consecutive injections (28 days apart) 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 NCT05209009, 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 2 May 2024.