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Clinical Trial to Study the COVAC-2 Booster Dose (for COVID-19) in Generally Healthy Adults.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05226702
Recruitment Status : Not yet recruiting
First Posted : February 7, 2022
Last Update Posted : May 17, 2022
Sponsor:
Collaborators:
Government of Canada
Government of Saskatchewan
Vaccine Formulation Institute (VFI)
SEPPIC
Information provided by (Responsible Party):
Volker Gerdts, University of Saskatchewan

Brief 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. 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).


Condition or disease Intervention/treatment Phase
Double Vaccinated for COVID-19 (For Phase 1 of the Study) Acute Respiratory Syndrome Coronavirus 2 (For Phase 2 Exploratory Group) Biological: COVAC-2 Biological: Saline Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 380 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 1/2 Clinical Trial to Study the Safety, Tolerability and Immunogenicity of a COVAC-2 Booster Dose in Generally Healthy Adults.
Estimated Study Start Date : June 2022
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023


Arm Intervention/treatment
Experimental: COVAC-2 10 µg group
20 healthy adults ≥18 years of age receive the vaccine on Day 0.
Biological: COVAC-2
Intramuscular vaccine against SARS-CoV-2

Experimental: COVAC-2 25 µg group
20 healthy adults ≥18 years of age receive the vaccine on Day 0
Biological: COVAC-2
Intramuscular vaccine against SARS-CoV-2

Placebo Comparator: Placebo Control
20 healthy adults ≥18 years of age receive a dose of normal saline (placebo) on Day 0.
Biological: Saline Placebo
Intramuscular injection of saline placebo




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. To assess the spike binding and neutralizing response induced by COVAC-2 booster vaccine [ Time Frame: Up to 365 days ]
    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.

  2. 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 ]
    Measurement of COVAC-2 immune response by measuring cell-mediated response markers in Peripheral Blood Mononuclear Cells (PBMCs) pre- and post-injection.


Other Outcome Measures:
  1. To assess the induction of SARS-CoV-2 Receptor Binding Domain (RBD) antibodies following the booster dose of COVAC-2 vaccine [ Time Frame: Up to 365 days ]
    SARS-CoV-2 RBD antibodies collected pre- and post-injection as measured by RBD protein-specific Enzyme Linked Immunosorbent Assay (ELISA).

  2. Assessment of the safety and immunogenicity of single dose of COVAC-2 vaccine in subjects previously infected with SARS-CoV-2. [ Time Frame: Up to 365 Days ]
    Antibody response induced by COVAC-2 booster pre-injection and post injection as measured by RBD protein & spike protein-specific ELISA, virus neutralization assay against variant of concern, by measuring cell-mediated response markers in Peripheral Blood Mononuclear Cells (PBMCs).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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 2 doses of an authorized COVID-19 vaccine at least 6 months prior to recruitment(not applicable for subjects in exploratory Phase 2 study arm).
  • 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 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.
  • Exploratory Phase 2 study arm: Unvaccinated participants with a documented history of infection with SARS-COV-2 (positive PCR or serology for SARS-CoV-2) or positive rapid SARS-CoV-2 antibody test at screening.

Exclusion Criteria:

  • 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 immunosuppressive 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.
  • 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.
  • 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.
  • 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 (not applicable for subjects in exploratory Phase 2 study arm).
  • Exploratory Phase 2 study arm: Known current or previous laboratory-confirmed SARS-CoV-1 infection, and known current laboratory-confirmed SARS-CoV-2 infection, as documented by a positive polymerase chain reaction (PCR) test from a nasal swab.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05226702


Contacts
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Contact: Trina Racine 13069663328 trina.racine@usask.ca

Sponsors and Collaborators
University of Saskatchewan
Government of Canada
Government of Saskatchewan
Vaccine Formulation Institute (VFI)
SEPPIC
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Responsible Party: Volker Gerdts, Director & CEO, University of Saskatchewan
ClinicalTrials.gov Identifier: NCT05226702    
Other Study ID Numbers: COVAC-004
First Posted: February 7, 2022    Key Record Dates
Last Update Posted: May 17, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases