We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
ClinicalTrials.gov Menu

Monovalent Recombinant COVID19 Vaccine (COVAX19)

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: NCT04453852
Recruitment Status : Completed
First Posted : July 1, 2020
Last Update Posted : March 2, 2022
Central Adelaide Local Health Network Incorporated
Information provided by (Responsible Party):
Vaxine Pty Ltd

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

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual 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
Actual Primary Completion Date : February 1, 2021
Actual Study Completion Date : April 14, 2021

Resource links provided by the National Library of Medicine

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
Biological: Saline
Saline control
Other Name: Saline control

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

  2. COVID19 antibody titers [ Time Frame: 3 weeks post second immunisation ]
    COVID19 antibody titers post immunisation

  3. COVID19 T cell immunogenicity [ Time Frame: 3 weeks post second immunisation ]
    Frequency of COVID19 spike specific T cells 1-3 weeks post second immunisation

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.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion criteria

  • Subjects eligible to participate in this trial had to meet all of the following inclusion criteria:
  • Provide written informed consent prior to initiation of any study procedures.
  • Healthy males or non-pregnant females, aged 18 years to 65 years inclusive.
  • Women of childbearing potential2 must use an acceptable contraception method3 from at least 30 days before study vaccination until 90 days after study vaccination.

    2Not sterilized via, bilateral oophorectomy, salpingectomy, hysterectomy, (permanent, non-surgical, non-hormonal sterilization) with documented radiological confirmation test at least 90 days after the procedure, and still menstruating or <1 year has passed since the last menses if menopausal.

    3Includes full abstinence from sexual intercourse with a male partner, monogamous relationship with vasectomized partner who has been vasectomized for 180 days or more barrier methods such as condoms, effective intrauterine devices, tubal ligation, and approved hormonal methods such as implants, injectables or oral contraceptives ("the pill").

  • Women of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to study vaccination
  • Are able to understand and comply with planned study procedures and be available for all study visits.

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 a history of documented COVID-19 infection or a known positive COVID-19 antibody test.
  • Liver function tests (ALT, AST or GGT) > 2 times upper limit of normal
  • eGFR <55 mL/min/1.73 m2
  • 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.
  • Have known human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection.
  • Have a history of severe systemic reactions following previous immunization with licensed or unlicensed vaccines.
  • Have a history of Guillain-Barré Syndrome.
  • Have known hypersensitivity or allergy to insect stings or other components of the study vaccine.
  • Have a history of epilepsy or febrile convulsions
  • 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.
  • 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.
  • Positive urine or serum pregnancy test within 24 hours prior to any study vaccination
  • Received an experimental agent within 30 days prior to the study vaccination or expect to receive another experimental agent during the trial-reporting period.
  • Have any medical disease or condition that, in the opinion of the Investigator, is a contraindication to study participation.
  • 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.
  • Any participant whose enrolment, in the opinion of the investigator, would be detrimental to the participant or the study.

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

Layout table for location information
Australia, South Australia
Adelaide, South Australia, Australia, 5000
Sponsors and Collaborators
Vaxine Pty Ltd
Central Adelaide Local Health Network Incorporated
Layout table for investigator information
Principal Investigator: David Gordon, MBBS, Ph.D CALHN
Layout table for additonal information
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: March 2, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vaxine Pty Ltd:
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Immunologic Factors
Physiological Effects of Drugs