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A Clinical Trial of a Prophylactic Plasmid DNA Vaccine for COVID-19 [Covigenix VAX-001] in 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04591184
Recruitment Status : Active, not recruiting
First Posted : October 19, 2020
Last Update Posted : September 14, 2021
Sponsor:
Collaborators:
Aegis Life, Inc.
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Entos Pharmaceuticals Inc.

Brief Summary:
This study is a Phase I/II clinical study in healthy adults designed to assess the safety, tolerability, and immunogenicity of receiving 2 IM injections of Covigenix VAX-001, 14 days apart. Covigenix VAX-001 is a plasmid DNA vaccine that expresses key antigenic determinants from SARS-CoV-2 and uses Entos Pharmaceuticals' Fusogenix PLV platform.

Condition or disease Intervention/treatment Phase
SARS-CoV-2 Biological: Covigenix VAX-001 placebo Biological: Covigenix VAX-001 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Unblinded study nurse with no other role in the trial administers VAX-001. Observer blinded.
Primary Purpose: Prevention
Official Title: Phase I/II Trial to Evaluate Safety, Tolerability, and Immunogenicity of a Prophylactic Plasmid DNA Vaccine Against SARS CoV-2 [Covigenix VAX-001] in Healthy Adults 18 Years and Older
Actual Study Start Date : April 7, 2021
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2022

Arm Intervention/treatment
Experimental: Active Covigenix VAX-001
Dose-ranging, 2 dose levels. 24 subjects receiving active i.m. vaccine
Biological: Covigenix VAX-001
Active Covigenix VAX-001

Placebo Comparator: Placebo
Placebo injection. 12 subjects receiving placebo
Biological: Covigenix VAX-001 placebo
Placebo vaccine




Primary Outcome Measures :
  1. Safety of a 2-dose regimen of VAX-001 when doses are given 14 days apart [ Time Frame: Day 0 - 42 ]
    Frequency and Grade (mild, moderate, severe, potentially life-threatening; Gr. 1-4, respectively) of solicited injection site and systemic adverse events and unsolicited systemic adverse events

  2. Mean change from baseline in safety laboratory measures [ Time Frame: Day 0 - 42 ]
    Adverse hematology /clinical chemistry parameter changes (mild, moderate, severe, or life-threatening; Gr. 1-4, respectively)

  3. Frequency of treatment-emergent Serious Adverse Events (SAE) throughout the study and up to 12 months post-second dose immunization (Day 379). [ Time Frame: Day 0 - 379 ]
    Frequency of serious AEs


Secondary Outcome Measures :
  1. Percent seroconversion defined as a 4-fold or greater increase in IgG titers after one or two doses as measured by IgG ELISA [ Time Frame: Up to Day 379 ]
    Percent seroconversion post second dose as measured by ELISA

  2. Geometric mean neutralizing antibody titers against pseudo-virion after one and two doses [ Time Frame: Up to Day 379 ]
    Geometric mean of antibody titers measured by pseudo-viral neutralization assay.

  3. Percent seroconversion defined as a 4-fold or greater increase in IgG titers after one or two doses as measured by pseudo-viral neutralization assay. [ Time Frame: up to Day 379 ]
    Seroconversion as measured by pseudo-viral neutralization

  4. Persistence of IgG antibody titers as measured by ELISA and neutralizing antibody titers measured by pseudo-virion neutralization assay, six months after the second vaccine dose [ Time Frame: Up to Day 379 ]
    Maintenance of antibody titers up to 12 months post second dose



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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

Inclusion criteria for Phase I:

Each participant must meet all of the following criteria to be enrolled in the Phase 1 part of the study:

  1. The participant is a healthy adult from 18 <55 years and with a BMI of ≤30 kg/m2 at the time of enrollment.
  2. If the participant is a WOCBP, she must have practiced adequate contraception for 30 days prior to IP Dose 1, have a negative pregnancy test on the day of IP Dose 1, and have agreed to continue adequate contraception until 90 days after IP Dose 2.
  3. If the participant is male, he must agree to continue adequate contraception until 90 days after IP Dose 2.
  4. The participant is able to provide consent to participate in the study and has signed an ICF.
  5. The participant is able and willing to complete all the scheduled study procedures during the whole study period (approximately 13 months).
  6. The participant is generally in good health, as determined by a review of medical history and a physical examination within 14 days prior to IP Dose 1.

Inclusion criteria for Phase II

Each participant must meet all of the following criteria to be enrolled in Phase II part of the study:

  1. The participant is 18 years and older.
  2. If the participant is a WOCBP, she must have a negative pregnancy test on the day of IP Dose 1, and have agreed to adequate contraception until 90 days after IP Dose 2 administration.
  3. If the participant is male, he must agree to continue adequate contraception until 90 days after IP Dose 2
  4. The participant can provide consent to participate in and having signed an ICF.
  5. The participant is able and willing to complete all the scheduled study procedures during the whole study follow-up period (approximately 13 months).

Exclusion Criteria

Exclusion criteria for Phase I

Participants meeting any of the following criteria will be excluded from Phase I of the study:

  1. The participant has history of anaphylaxis to any allergen.
  2. The participant has history of seizure disorder, encephalopathy or psychosis.
  3. The female participant is pregnant (positive urine pregnancy test), lactating, or plans to become pregnant during the 3 months of enrollment.
  4. The participant has a positive test result for HIV or hepatitis B and C.
  5. The participant has a positive test results of IgG antibodies against SARS CoV 2 from RCT.
  6. The participant has a positive test result of real-time quantitative PCR screening of nasopharyngeal swab/sputum for SARS-CoV-2.
  7. The participant has a laboratory (hematological and biochemistry) examination that is out of normal range, or greater than a Grade 1 abnormality and clinically significant as assessed by the investigator including test results for: CBC, PT, PTT, ALT, AST, ALP, T Bil, Cr, lipase, and blood glucose;

    - Transient mild laboratory abnormalities may be rescreened once, and the participant will be excluded if the laboratory repeat test is abnormal as per local laboratory normal values and the investigator's assessment.

  8. The participant presents with any acute febrile disease (oral temperature ≥38.0°C) or active infectious disease.
  9. The participant has a medical history of SARS-CoV-1.
  10. The participant has unstable concomitant underlying conditions.

    - Note: Stable condition defined as: The participant is appropriately managed on consistent disease management, for example participants with well controlled hypertension, adult-onset diabetes, Benign Prostate Hypertrophy (BPH) or hypothyroid disease will be eligible for enrollment. The treatment regimen should be stable for at least 3 months prior to entering the study. Once IP treatment has started, must be willing to maintain all aspects of the treatment regimen and forgo any elective changes in medication or management. Emergency changes in medication or management would be captured as an adverse event.

  11. The participant has a history of Guillain-Barre Syndrome or degenerative neurological disorders; a history of autoimmune, inflammatory disease or potential immune-mediated medical conditions (PIMMCs), or any condition that may put the participant at increased risk of safety events
  12. The participant has serious cardiovascular diseases, such as arrhythmia, conduction block, history of myocardial infarction, severe hypertension not controlled with medication.
  13. The participant has a serious chronic disease such as asthma, diabetes, or thyroid disease.
  14. The participant has immunodeficiency, asplenia, or functional asplenia.
  15. The participant has a platelet disorder or other bleeding disorder that may cause contraindication for IM injection.
  16. The participant has chronic obstructive pulmonary disease, current smoker or vaper.
  17. The participant has a history or diagnosis of coagulopathies.
  18. The participant has received immunosuppressive medication, cytotoxic therapy, or corticosteroids (excluding corticosteroid spray for allergic rhinitis, surface corticosteroid therapy for acute non-complicated dermatitis) in the last 6 months.
  19. The participant received the blood products in last 4 months.
  20. The participant has received other investigational drugs within 1 month before Day 0, or planned use during the study period.
  21. The participant had prior administration of any live attenuated vaccine within 1 month before Day 0.
  22. The participant had prior administration of a subunit or inactivated non SARS CoV 2 vaccine within 2 weeks before Day 0.
  23. The participant had prior administration of any other vaccine considered (or being considered) to be protective against SARS-CoV-2 any time before Day 0.
  24. The participant had prior participation in other studies involving study intervention containing lipid nanoparticles.
  25. The participant has any condition that, in the opinion of the investigator, may interfere with the participant's compliance, evaluation of study objectives, or informed consent process (i.e. medical, psychological, social or other conditions).
  26. The participant is at high risk of acquiring SARS-CoV-2 infection due to their surroundings, contacts or circumstances. Explicitly exclude healthcare and essential workers/at risk population.

Exclusion criteria for Phase II

Participants meeting any of the following criteria will be excluded from Phase II part of the study:

  1. The participant has history of anaphylaxis to any allergen.
  2. The female participant is pregnant (positive urine pregnancy test), lactating, or plans to become pregnant during the next 3 months.
  3. The participant has any acute febrile disease (oral temperature ≥38.0°C [100.4ºF]) or active infectious disease on the day of IP administration (participants may be re scheduled).
  4. The participant has a medical history of SARS-CoV-1.
  5. The participant has a history of immunodeficiency, asplenia, or functional asplenia.
  6. The participant has received immunosuppressive medication, cytotoxic therapy, inhaled corticosteroids (excluding corticosteroid spray for allergic rhinitis, surface corticosteroid therapy for acute non-complicated dermatitis) in the last 6 months.
  7. The participant has received other investigational drugs within 1 month before first dose administration or planned use during the study period.
  8. The participant has received any live attenuated vaccine within 1 month before first dose administration or any inactivated vaccine within 2 weeks before first dose administration.
  9. The participant has received prior administration of any other vaccine considered (or being considered) to protect against SARS-CoV-2 any time before study onset.
  10. The participant has a history of any medical conditions that place them at higher risk for severe illness due to SARS-CoV-2 including but not limited to asthma, chronic kidney disease being treated with dialysis, chronic lung disease, diabetes, hemoglobin disorders, immunocompromised, liver disease, serious heart conditions, or severe obesity.
  11. The participant has any condition that in the opinion of the investigators may interfere with the participants' compliance, evaluation of study objectives, or informed consent process (i.e., medical, psychological, social or other conditions).

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): NCT04591184


Locations
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Canada, Nova Scotia
Canadian Centre for Vaccinology, Dalhousie University
Halifax, Nova Scotia, Canada, B3K 6R8
Sponsors and Collaborators
Entos Pharmaceuticals Inc.
Aegis Life, Inc.
Canadian Institutes of Health Research (CIHR)
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Responsible Party: Entos Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT04591184    
Other Study ID Numbers: ENTVAX01-101
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: September 14, 2021
Last Verified: September 2021

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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
Keywords provided by Entos Pharmaceuticals Inc.:
COVID-19
SARS-CoV-2
anti-infective
prophylaxis
healthy volunteer
prevention
Covigenix VAX-001
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