Severe Acute Respiratory Syndrome Coronavirus 2Phase 1NCT04702178

A Clinical Trial of COVAC-2 in Healthy Adults

A Phase 1 study testing COVAC-2 in people with Severe Acute Respiratory Syndrome Coronavirus 2, run by University of Saskatchewan at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

VIDO has developed a vaccine called COVAC-2. The 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: 61 participants
Where: 2 sitesCanada
Study dates: 10 Feb 2021to 2 Nov 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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

To be eligible for the study, each participant must satisfy all of the following criteria:
Male and female healthy adults ages 18 years of age or older;
Good general health as determined by screening evaluation no greater than 30 days before immunization;
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 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.

Who cannot join

Participant with any of the following criteria will be excluded:
Presence of any febrile illness or any known or suspected acute illness on the day of any immunization;
Any physical findings suggestive of acute or chronic illness;
Any immunodeficiency (congenital or acquired);
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;

Show all 17Show fewer

Cancer diagnosis in the last 5 years, excluding basal cell and squamous cell carcinoma of the skin, which are allowed;
Presence of autoimmune disease;
Receipt of any investigational drug within 6 months;
Receipt of any non-COVID-19 authorized vaccines within 2 weeks of study immunization;
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;
Known current or previous laboratory-confirmed SARS-CoV-1 OR SARS-CoV-2 infection, as documented by a positive polymerase chain reaction (PCR) test from a nasal swab OR known or laboratory-confirmed positive serology.

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

Canadian Center for Vaccinology, Dalhousie University
Halifax, Nova Scotia, B3K 6R8
Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8

Other trials in Canada

About this study

Official title: A Randomized, Observer-Blind, Dose-Escalation Phase 1 Clinical Trial of COVAC-2 in Healthy Adults

VIDO has developed a vaccine called COVAC-2.

The 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 belongs to a family of oil-based adjuvants that have been given to millions of people around the world as part of influenza vaccines. The COVAC-2 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 or reduce the severity of 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.

Phase 1 is a multi-centred trial of the COVAC-2 vaccine to be completed in Canada. It will be a randomized, observer-blinded, and placebo-controlled study to assess the safety and immunogenicity of three dosing levels (25, 50, and 100 µg protein) administered twice (4 weeks apart) in healthy adults 18 through 54 years of age (Phase 1a) and 55 years of age and older (Phase 1b).

Enrolment and vaccination of participants will be staggered over time based on participant age and vaccine dose. Approval will be sought from the Data Safety Monitoring Board (DSMB) to proceed with the second dose in each group, to enroll at each dose level, and to enroll in the older age group for each dose level.

Within the same age group, the 8 participants receiving the lowest dose are randomized with 4 participants receiving placebo; the 8 participants receiving the medium dose are randomized with 4 participants receiving placebo; and the 8 participants receiving the highest dose are randomized with 4 participants receiving placebo.

Within each dose level of 12 participants, it is proposed to immunize a first cohort of 3 participants (including at least 2 active vaccine participants) and pending no holding rule is met after 48 hours, to immunize the remaining 9 participants within that dose level.

Conditions: Severe Acute Respiratory Syndrome Coronavirus 2
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 groups in NCT04702178
Study group	Role	What they receive
Group A-2	Experimental	COVAC-2 25 µg: 8 healthy adults 18 to 54 years of age receive the vaccine on Day 0, followed by a second dose on Day 28. Receives: Biological: COVAC-2
Group B-2	Placebo comparator	Placebo Control: 4 healthy adults 18 to 54 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
Group C-2	Experimental	COVAC-2 50 µg: 8 healthy adults 18 to 54 years of age receive the vaccine on Day 0, followed by a second dose on Day 28. Receives: Biological: COVAC-2
Group D-2	Placebo comparator	Placebo Control: 4 healthy adults 18 to 54 years of age receive a dose of normal saline (placebo) on Day 0, followed by a dose of saline placebo on Day 28. Receives: Biological: Saline Placebo
Group E-2	Experimental	COVAC-2 100 µg: 8 healthy adults 18 to 54 years of age receive the vaccine on Day 0, followed by a second dose on Day 28. Receives: Biological: COVAC-2
Group F-2	Placebo comparator	Placebo Control: 4 healthy adults 18 to 54 years of age receive a dose of normal saline (placebo) on Day 0, followed by a dose of saline placebo on Day 28. Receives: Biological: Saline Placebo
Group G-2	Experimental	COVAC-2 25 µg: 8 or 9 healthy adults ≥ 55 years of age receive the vaccine on Day 0, followed by a second dose on Day 28. Receives: Biological: COVAC-2
Group H-2	Placebo comparator	Placebo Control: 4 or 5 healthy adults ≥ 55 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
Group I-2	Experimental	COVAC-2 50 µg: 8 healthy adults ≥ 55 years of age receive the vaccine on Day 0, followed by a second dose on Day 28. Receives: Biological: COVAC-2
Group J-2	Placebo comparator	Placebo Control: 4 healthy adults ≥ 55 years of age receive a dose of normal saline (placebo) on Day 0, followed by a dose of 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.

Occurrence of adverse events (AEs) from the first injection to Day 28, in all participants, in all groups
- The occurrence of each solicited local and general AE, during each 7-day follow-up period after injection (e.g. the day of injection and 6 subsequent days);
- The occurrence of any unsolicited AEs for the entire study period;
- The occurrence of any hematological (hemoglobin level, WBC, lymphocyte, neutrophil, eosinophil, and platelet count) and biochemical (ALT, AST, BUN, and Cr) clinically significant laboratory abnormality through to Day 28 and;
- The occurrence of any serious AEs (SAEs), medically attended events (MAE), or adverse event of special interest (AESI).
Measured: Day 0 - 28
Occurrence of AEs from the second injection to Day 56 (28 days post injection), in all participants, in all groups
- The occurrence of solicited local and general AE, during each 7-day follow-up period after the second injection (e.g. the day of 2nd injection and 6 subsequent days);
- The occurrence of any unsolicited AEs for the entire study period
Measured: Day 28 - 56

Secondary outcomes (2)

Specific antibody response induced by the vaccine against the SARS-CoV-2 S protein as measured by ELISA
The immune response to the study vaccine, as measured by antibody (e.g. IgG and other isotypes) directed to Wuhan spike antigen or neutralizing antibodies pre-injection (Day 0) and post-injection(s)
Measured: Days 0, 7, 14, 28, 35, 42, 56, 90, 120, and 365
Specific cell-mediated immunity (CMI) response induced by the vaccine against the SARS-CoV-2 virus
- The immune response to the study vaccine, as measured by cell immune response markers in PBMCs collected pre-injection (Day 0) and post-injection(s)
Measured: Days 0, 14, 28, 35, 42, 120, and 365

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Feb 20212 Nov 2022

First posted8 Jan 2021
Study start10 Feb 2021
Primary completion2 Nov 2022
Study completion2 Nov 2022

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 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 61 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04702178
Sponsor's protocol ID: COVAC-001
Status last verified: May 2023
First submitted: 6 Jan 2021
Last updated: 19 May 2023
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Severe Acute Respiratory Syndrome Coronavirus 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Observer-Blind, Dose-Escalation Phase 1 Clinical Trial of COVAC-2 in Healthy Adults
ClinicalTrials.gov ID: NCT04702178
Acronym / sponsor ID: COVAC-001
Conditions: Severe Acute Respiratory Syndrome Coronavirus 2
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 61 participants (actual)
Lead sponsor: University of SaskatchewanUniversity, hospital or other
Collaborators: Government of Canada, Government of Saskatchewan, Vaccine Formulation Institute (VFI), Seppic
Study start: 10 Feb 2021 (actual)
Primary completion: 2 Nov 2022 (actual)
Study completion: 2 Nov 2022 (actual)
First posted: 8 Jan 2021 (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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 10

Arm	Type	Receives
Group A-2	Experimental	Biological: COVAC-2COVAC-2 25 µg: 8 healthy adults 18 to 54 years of age receive the vaccine on Day 0, followed by a second dose on Day 28.
Group B-2	Placebo comparator	Biological: Saline PlaceboPlacebo Control: 4 healthy adults 18 to 54 years of age receive a dose of normal saline (placebo) on Day 0, followed by a dose of normal saline (placebo) on Day 28.
Group C-2	Experimental	Biological: COVAC-2COVAC-2 50 µg: 8 healthy adults 18 to 54 years of age receive the vaccine on Day 0, followed by a second dose on Day 28.
Group D-2	Placebo comparator	Biological: Saline PlaceboPlacebo Control: 4 healthy adults 18 to 54 years of age receive a dose of normal saline (placebo) on Day 0, followed by a dose of saline placebo on Day 28.
Group E-2	Experimental	Biological: COVAC-2COVAC-2 100 µg: 8 healthy adults 18 to 54 years of age receive the vaccine on Day 0, followed by a second dose on Day 28.
Group F-2	Placebo comparator	Biological: Saline PlaceboPlacebo Control: 4 healthy adults 18 to 54 years of age receive a dose of normal saline (placebo) on Day 0, followed by a dose of saline placebo on Day 28.
Group G-2	Experimental	Biological: COVAC-2COVAC-2 25 µg: 8 or 9 healthy adults ≥ 55 years of age receive the vaccine on Day 0, followed by a second dose on Day 28.
Group H-2	Placebo comparator	Biological: Saline PlaceboPlacebo Control: 4 or 5 healthy adults ≥ 55 years of age receive a dose of normal saline (placebo) on Day 0, followed by a dose of normal saline (placebo) on Day 28.
Group I-2	Experimental	Biological: COVAC-2COVAC-2 50 µg: 8 healthy adults ≥ 55 years of age receive the vaccine on Day 0, followed by a second dose on Day 28.
Group J-2	Placebo comparator	Biological: Saline PlaceboPlacebo Control: 4 healthy adults ≥ 55 years of age receive a dose of normal saline (placebo) on Day 0, followed by a dose of 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 (5 listed)

To be eligible for the study, each participant must satisfy all of the following criteria:
Male and female healthy adults ages 18 years of age or older;
Good general health as determined by screening evaluation no greater than 30 days before immunization;
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 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.

Key exclusion criteria (17 listed)

Presence of any febrile illness or any known or suspected acute illness on the day of any immunization;
Any physical findings suggestive of acute or chronic illness;
Any immunodeficiency (congenital or acquired);
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-2, Group C-2, Group E-2, Group G-2, Group I-2
Saline PlaceboIntramuscular injection of saline placebo	Biological	Group B-2, Group D-2, Group F-2, Group H-2, Group J-2

Primary outcome

Occurrence of adverse events (AEs) from the first injection to Day 28, in all participants, in all groups
Time frame: Day 0 - 28
* The occurrence of each solicited local and general AE, during each 7-day follow-up period after injection (e.g. the day of injection and 6 subsequent days); * The occurrence of any unsolicited AEs for the entire study period; * The occurrence of any hematological (hemoglobin level, WBC, lymphocyte, neutrophil, eosinophil, and platelet count) and biochemical (ALT, AST, BUN, and Cr) clinically significant laboratory abnormality through to Day 28 and; * The occurrence of any serious AEs (SAEs), medically attended events (MAE), or adverse event of special interest (AESI).
Occurrence of AEs from the second injection to Day 56 (28 days post injection), in all participants, in all groups
Time frame: Day 28 - 56
* The occurrence of solicited local and general AE, during each 7-day follow-up period after the second injection (e.g. the day of 2nd injection and 6 subsequent days); * The occurrence of any unsolicited AEs for the entire study period

2 secondary outcomes

Specific antibody response induced by the vaccine against the SARS-CoV-2 S protein as measured by ELISA
Time frame: Days 0, 7, 14, 28, 35, 42, 56, 90, 120, and 365
Specific cell-mediated immunity (CMI) response induced by the vaccine against the SARS-CoV-2 virus
Time frame: Days 0, 14, 28, 35, 42, 120, and 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 19 May 2023.
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.

Joanne M Langley, MD principal investigator

Canadian Center for Vaccinology

2 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 Severe Acute Respiratory Syndrome Coronavirus 2, run by University of Saskatchewan at 2 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 17 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 19 May 2023. 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 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?

Occurrence of adverse events (AEs) from the first injection to Day 28, in all participants, in all groups (time frame: Day 0 - 28). The study lists 2 primary outcomes in all. 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 NCT04702178, 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 19 May 2023.