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Monovalent Recombinant COVID19 Vaccine (COVAX19)

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ClinicalTrials.gov Identifier: NCT04453852
Recruitment Status : Recruiting
First Posted : July 1, 2020
Last Update Posted : July 1, 2020
Sponsor:
Collaborator:
Central Adelaide Local Health Network Incorporated
Information provided by (Responsible Party):
Vaxine Pty Ltd

Study Description
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Brief Summary:
This is a study to test a new vaccine (Covax-19) against COVID-19. COVID-19 is a potentially deadly disease that is caused by a new strain of coronavirus called SARS-CoV-2. To date, SARS-CoV-2 has infected over 4 million people worldwide resulted in the deaths of over three hundred thousand people.

Condition or disease Intervention/treatment Phase
Coronavirus Infection COVID Biological: COVID19 vaccine Biological: Saline Phase 1

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised controlled study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Non-blind Staff administering vaccine do not participate in any other aspects of the study. Remaining trial staff and participant are blinded
Primary Purpose: Prevention
Official Title: A Randomised, Controlled, Phase 1 Study to Evaluate the Safety and Immunogenicity of a Candidate Adjuvanted Recombinant Protein SARS-COV-2 Vaccine in Healthy Adult Subjects
Actual Study Start Date : June 30, 2020
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : July 1, 2021

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Group A
Spike antigen (25ug) + 15 mg Advax-2 adjuvant
Biological: COVID19 vaccine
COVID19 recombinant spike protein with Advax-SM adjuvant
Other Name: COVAX-19 vaccine

Placebo Comparator: Group B
Saline
Biological: Saline
Saline control
Other Name: Saline control



Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Adverse Events [ Time Frame: 1 weeks post immunisation ]
    Incidence of Adverse Events 1 week post immunisation

  2. COVID19 neutralizing antibody titers [ Time Frame: 2 weeks post second immunisation ]
    COVID19 neutralizing antibody titers post immunisation

  3. COVID19 T cell immunogenicity [ Time Frame: 3 weeks post second immunisation ]
    Frequency of COVID19 spike specific T cells 3 weeks post second immunisation


Secondary Outcome Measures :
  1. Durability of antibody response [ Time Frame: 6 months post immunisation ]
    COVID19 spike specific antibody titers 6 months post second immunisation


Eligibility Criteria
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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 to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria

  • Are males or non-pregnant females, 18 years of age or older.
  • Provide written informed consent prior to initiation of any study procedures.
  • Are able to understand and comply with planned study procedures and be available for all study visits.
  • Are in good health as determined by medical history and physical examination to evaluate acute or currently ongoing chronic medical or psychiatric diagnoses or conditions, defined as those that have been present for at least 90 days, which would affect the assessment of the safety of subjects or the immunogenicity of study vaccinations in the opinion of the Investigator.
  • Screening laboratory bloods - White Blood Cells (WBC), Hemoglobin (Hgb), Platelets (PLTs), Alanine Aminotransferase (ALT), Total Bilirubin (T. Bili), Aspartate Aminotransferase (AST), Gamma-glutamyl Transferase (GGT), and Creatinine (Cr)) are within acceptable parameters as determined by the Investigator
  • Women of childbearing potential must use an acceptable contraception method and must have a negative urine or serum pregnancy test within 24 hours prior to the first study vaccination.

Exclusion criteria

  • Have an acute illness, as determined by the site Principal Investigator (PI) or appropriate sub-investigator, within 72 hours prior to study vaccination.
  • Have any medical disease or condition that, in the opinion of the site PI or appropriate sub-investigator, is a contraindication to study participation. *Including acute, subacute, intermittent or chronic medical disease or condition that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this trial.
  • Have immunosuppression as a result of an underlying illness or treatment, a recent history or current use of immunosuppressive or immunomodulating disease therapy.
  • Use of anticancer chemotherapy or radiation therapy (cytotoxic) within 3 years prior to study vaccination.
  • Have known active or recently active (12 months) neoplastic disease or a history of any hematologic malignancy. Non-melanoma, treated, skin cancers are permitted.
  • Have known human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection.
  • Have known hypersensitivity or allergy to insect stings or other components of the study vaccine.
  • Have a history of severe reactions following previous immunization with licensed or unlicensed vaccines.
  • Have a history of Guillain-Barré Syndrome.
  • Have a history of convulsions or encephalomyelitis within 90 days prior to study vaccination.
  • Have a history of Potentially Immune-Mediated Medical Conditions (PIMMCs).
  • Have a history of alcohol or drug abuse within 5 years prior to study vaccination.
  • Have any diagnosis, current or past, of schizophrenia, bipolar disease or other psychiatric diagnosis that may interfere with subject compliance or safety evaluations as determined by the site PI or appropriate sub-investigator.
  • Have been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others within 5 years prior to study vaccination.
  • Have taken oral or parenteral (including intra-articular) corticosteroids of any dose within 30 days prior to study vaccination.
  • Have taken high-dose inhaled corticosteroids within 30 days prior to study vaccination.
  • Have a known history of documented COVID-19 infection within the past 6 months.
  • Received an experimental agent within 30 days prior to the study vaccination or expect to receive another experimental agent during the trial-reporting period.
  • Female participants who are breastfeeding or plan to breastfeed from the time of the first study vaccination through 30 days after the last study vaccination.
  • Any participant whose enrolment, in the opinion of the investigator, would be detrimental to the participant or the study.
Contacts and Locations
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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): NCT04453852


Contacts
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Contact: Nikolai Petrovsky, MBBS, Ph.D +61413131635 nikolai.petrovsky@flinders.edu.au
Contact: David Gordon, MBBS, Ph.D d.gordon@flinders.edu.au

Locations
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Australia, South Australia
PARC, Recruiting
Adelaide, South Australia, Australia, 5000
Contact: Guy Ludbrook, MBBS       guy.ludbrook@sa.gov.au   
Contact: Kathy Heyman    +61 8 70744404    kathy.Heyman2@sa.gov.au   
Principal Investigator: David Gordon, MBBS, PhD         
Sub-Investigator: Pravin Hissaria, MBBS. PhD         
Sub-Investigator: Guy Ludbrook, MBBS         
Sponsors and Collaborators
Vaxine Pty Ltd
Central Adelaide Local Health Network Incorporated
Investigators
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Principal Investigator: David Gordon, MBBS, Ph.D CALHN
More Information
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Responsible Party: Vaxine Pty Ltd
ClinicalTrials.gov Identifier: NCT04453852    
Other Study ID Numbers: 13110
First Posted: July 1, 2020    Key Record Dates
Last Update Posted: July 1, 2020
Last Verified: June 2020
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
Keywords provided by Vaxine Pty Ltd:
COVID19
coronavirus
vaccine
adjuvant
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
 Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs