Severe Acute Respiratory Syndrome Coronavirus 2Phase 1NCT05155982

A Clinical Trial of COVAC-1, a COVID-19 Vaccine, in Generally Healthy Adults

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

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

VIDO has developed a vaccine called COVAC-1. 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-1 contains an adjuvant called TriAdj. 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-1
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 0 participants
Where: No sites listed yet
Study dates: Jun 2022to Oct 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 of age or older at the time of signing the informed consent form (i.e., 18 to 54 for Arm 1a and ≥55 for Arm 1b);
Good general health as determined by screening evaluation no 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 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.
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

Presence of any febrile illness or any known or suspected acute illness on the day of any immunization;
Any immunodeficiency (congenital or acquired) disease, disorder, or finding that may significantly increase the risk of study participant or, in the Investigator's judgment, 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 IM injections or venipuncture;
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 prior to injection of first dose;
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;
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.

About this study

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

VIDO has developed a vaccine called COVAC-1.

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-1 contains an adjuvant called TriAdj. An adjuvant is a compound that is added to a vaccine to help the vaccine produce a better immune response. The TriAdj adjuvant is made up of three components (a toll-like receptor agonist polyI:C, an immunostimulatory host defense protein HDP IDR-1002 and a polyphosphazene carrier system, PCEP). The three components work together to improve the body's response to the S1 protein. The COVAC-1 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-1 vaccine was able to protect the vaccinated animals against a severe SARS-CoV-2 infection.

Phase 1 is a multi-centred, multi-national trial of the COVAC-1 vaccine to be completed in Canada and Brazil. It will be a randomized, observer-blinded, and placebo-controlled study to assess the safety and immunogenicity of two dosing levels (25 and 50 µg S1 protein) administered twice (4 weeks apart) in healthy adults 18 through 54 years of age (Arm 1a) and 55 years of age and older (Arm 1b).

Enrolment and vaccination of participants will be staggered over time based on vaccine dose. Study participants aged 18 to 54 and those >55 years of age will commence in parallel at the starting dose of 25 ug and after approval by Sponsor based upon recommendations from the Data Safety Monitoring Board (DSMB), new study participants will be allowed to receive the higher dose of 50 ug. Approval will also be sought from Sponsor, based on recommendations provided by the DSMB, to proceed with the second dose in each dosing and age group.

Within the same age group, the 8 participants receiving the lower 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, as determined by the 48-hour-post-dose 1 phone call, to immunize the remaining 9 participants within that dose level. Every attempt will be made to fully enroll all age groups.

Conditions: Severe Acute Respiratory Syndrome Coronavirus 2
Being tested: COVAC-1, Saline Placebo

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 groups in NCT05155982
Study group	Role	What they receive
Group A (18-54 yrs)	Experimental	COVAC-1 25 ug Receives: Biological: COVAC-1
Group B (18-54 yrs)	Placebo comparator	Placebo Control Receives: Biological: Saline Placebo
Group C (18-54 yrs)	Experimental	COVAC-1 50 ug Receives: Biological: COVAC-1
Group D (18-54 yrs)	Placebo comparator	Placebo Control Receives: Biological: Saline Placebo
Group E (55+ yrs)	Experimental	COVAC-1 25 ug Receives: Biological: COVAC-1
Group F (55+ yrs)	Placebo comparator	Placebo Control Receives: Biological: Saline Placebo
Group G (55+ yrs)	Experimental	COVAC-1 50 ug Receives: Biological: COVAC-1
Group H (55+ yrs)	Placebo comparator	Placebo Control 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 and;
- 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 42.
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 or measured by Neutralization Assay
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
Measured: Days 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
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.

Jun 2022Oct 2023

First posted14 Dec 2021
Study startJun 2022 (estimated)
Primary completionJun 2023 (estimated)
Study completionOct 2023 (estimated)

Why it stopped: Decided not to move forward with the study design.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05155982
Sponsor's protocol ID: COVAC-002
Status last verified: Aug 2022
First submitted: 30 Nov 2021
Last updated: 10 Aug 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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?

Official record

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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 10 Aug 2022. 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 of COVAC-1 in Generally Healthy Adults
ClinicalTrials.gov ID: NCT05155982
Acronym / sponsor ID: COVAC-002
Conditions: Severe Acute Respiratory Syndrome Coronavirus 2
Phase: Phase 1
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Decided not to move forward with the study design.
Enrolment: 0 participants (actual)
Lead sponsor: University of SaskatchewanUniversity, hospital or other
Collaborators: Government of Canada, Government of Saskatchewan
Study start: Jun 2022 (estimated)
Primary completion: Jun 2023 (estimated)
Study completion: Oct 2023 (estimated)
First posted: 14 Dec 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-1.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 8

Arm	Type	Receives
Group A (18-54 yrs)	Experimental	Biological: COVAC-1COVAC-1 25 ug
Group B (18-54 yrs)	Placebo comparator	Biological: Saline PlaceboPlacebo Control
Group C (18-54 yrs)	Experimental	Biological: COVAC-1COVAC-1 50 ug
Group D (18-54 yrs)	Placebo comparator	Biological: Saline PlaceboPlacebo Control
Group E (55+ yrs)	Experimental	Biological: COVAC-1COVAC-1 25 ug
Group F (55+ yrs)	Placebo comparator	Biological: Saline PlaceboPlacebo Control
Group G (55+ yrs)	Experimental	Biological: COVAC-1COVAC-1 50 ug
Group H (55+ yrs)	Placebo comparator	Biological: Saline PlaceboPlacebo Control

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Generally healthy male and female adults aged 18 years of age or older at the time of signing the informed consent form (i.e., 18 to 54 for Arm 1a and ≥55 for Arm 1b);
Good general health as determined by screening evaluation no 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 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.
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 (16 listed)

Presence of any febrile illness or any known or suspected acute illness on the day of any immunization;
Any immunodeficiency (congenital or acquired) disease, disorder, or finding that may significantly increase the risk of study participant or, in the Investigator's judgment, 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 IM injections or venipuncture;
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 prior to injection of first dose;

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	Group A (18-54 yrs), Group C (18-54 yrs), Group E (55+ yrs), Group G (55+ yrs)
Saline PlaceboIntramuscular injection of saline placebo	Biological	Group B (18-54 yrs), Group D (18-54 yrs), Group F (55+ yrs), Group H (55+ yrs)

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 and; * 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 42.

2 secondary outcomes

Specific antibody response induced by the vaccine against the SARS-CoV-2 S protein as measured by ELISA or measured by Neutralization Assay
Time frame: Days 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 was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
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.

Volker Gerdts, DVM study director

University of Saskatchewan

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, run by University of Saskatchewan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 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: withdrawn, as of the sponsor's last update on 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

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 was withdrawn before enrolling participants, so there are no results.

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 NCT05155982.

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 10 Aug 2022.