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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04453852




Registration number
NCT04453852
Ethics application status
Date submitted
3/06/2020
Date registered
1/07/2020

Titles & IDs
Public title
Monovalent Recombinant COVID19 Vaccine
Scientific 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
Secondary ID [1] 0 0
13110
Universal Trial Number (UTN)
Trial acronym
COVAX19
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronavirus Infection 0 0
COVID 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - COVID19 vaccine
Treatment: Other - Saline

Experimental: Group A - Spike antigen (25ug) + 15 mg Advax-2 adjuvant

Placebo comparator: Group B - Saline


Treatment: Other: COVID19 vaccine
COVID19 recombinant spike protein with Advax-SM adjuvant

Treatment: Other: Saline
Saline control
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Adverse Events
Timepoint [1] 0 0
1 week post immunisation
Primary outcome [2] 0 0
COVID19 antibody titers
Timepoint [2] 0 0
3 weeks post second immunisation
Primary outcome [3] 0 0
COVID19 T cell immunogenicity
Timepoint [3] 0 0
3 weeks post second immunisation

Eligibility
Key inclusion criteria
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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/06/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/04/2021
Sample size
Target
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
PARC, - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Vaxine Pty Ltd
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
Central Adelaide Local Health Network Incorporated
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David Gordon, MBBS, Ph.D
Address 0 0
CALHN
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04453852