Monovalent Recombinant COVID19 Vaccine

NCT04453852 | Completed Phase 1 DMC

• 1 other identifier: 13110
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronavirus Infection; COVID

Keywords

COVID19; coronavirus; vaccine; adjuvant

Outcome Measures

Primary Outcomes (3)

• Incidence of Adverse Events

  Incidence of Adverse Events 1 week post immunisation

  1 week post immunisation

• COVID19 antibody titers

  COVID19 antibody titers post immunisation

  3 weeks post second immunisation

• COVID19 T cell immunogenicity

  Frequency of COVID19 spike specific T cells 1-3 weeks post second immunisation

  3 weeks post second immunisation

Study Arms (2)

Group A

EXPERIMENTAL

Spike antigen (25ug) + 15 mg Advax-2 adjuvant

Biological: COVID19 vaccine

Group B

PLACEBO COMPARATOR

Saline

Biological: Saline

Interventions

COVID19 vaccine BIOLOGICAL

COVID19 recombinant spike protein with Advax-SM adjuvant

Also known as: COVAX-19 vaccine

Group A

Saline BIOLOGICAL

Saline control

Also known as: Saline control

Group B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Not 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.
• Includes 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vaxine Pty Ltd: lead
• Central Adelaide Local Health Network Incorporated: collaborator

Study Sites (1)

PARC,

Adelaide, South Australia, 5000, Australia

Location

MeSH Terms

Conditions

Coronavirus Infections; COVID-19

Interventions

COVID-19 Vaccines; SARS-CoV-2 recombinant spike protein with delta inulin and CpG-ODN adjuvant vaccine; Sodium Chloride

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• David Gordon, MBBS, Ph.D

  CALHN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Non-blind Staff administering vaccine do not participate in any other aspects of the study. Remaining trial staff and participant are blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomised controlled study

Study Record Dates

• First Submitted: June 3, 2020
• First Posted: July 1, 2020
• Study Start: June 30, 2020
• Primary Completion: February 1, 2021
• Study Completion: April 14, 2021
• Last Updated: March 2, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)