Clinical trial

A Phase 3b/4 Randomised Trial of 3 Doses of Protein-based Covid-19 Vaccine (SpikoGen)

Name

AUST-C19-P3/4

Description

This study will determine the immunogenicity of Spikogen in vaccine naïve individuals. Spikogen will be administered as two doses 1 month apart with a third booster dose either 1 or 3 months after the second dose. This study will provide key data on SARS-CoV-2 antibody responses.

Trial arms

Trial start

2022-08-15

Estimated PCD

2023-12-31

Trial end

2024-06-30

Status

Active (not recruiting)

Phase

Early phase I

Treatment

Advax-CpG55.2 adjuvanted recombinant spike protein

recombinant SARS-CoV-2 spike protein formulated with Advax-CpG55.2 adjuvant

Arms:

Spikogen vaccine - accelerated arm, Spikogen vaccine - standard arm

Other names:

Spikogen vaccine

Size

Primary endpoint

First dose Seroconversion

2-4 weeks post first immunisation

Second dose Seroconversion

2-4 weeks post second immunisation

Third Dose Seroconversion

2-4 weeks post third immunisation

Final Seroconversion

through study completion, an average of 7 months

First Dose GMT

2-4 weeks post first immunisation

Second Dose GMT

2-4 weeks post second immunisation

Third Dose GMT

2-4 weeks post third immunisation

Final GMT

through study completion, an average of 7 months

First Dose Adverse events (AE)

7 days post first immunisation

Second Dose Adverse events (AE)

7 days post second immunisation

Third Dose Adverse events (AE)

7 days post third immunisation

Serious adverse events (SAE)

through study completion, an average of 7 months

Eligibility criteria

Inclusion Criteria: * Able to provide written informed consent * Males or females\* 18 years of age or older * Understand and are likely to comply with planned study procedures and be available for all study visits. * Have not previously had a Covid-19 vaccine and do not intend to have a non-study Covid-19 vaccine within the next 6 months Exclusion Criteria: * History of Covid-19 vaccination. * History of serious vaccine allergy. * Pregnancy1 * Have received an experimental agent within 30 days prior to the study vaccination or expect to receive another experimental agent during the trial reporting period. * Any medical, social or mental condition which, in the opinion of the investigator, would be detrimental to the subjects or the study.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Subjects will be stratified for analysis by age, sex and seropositivity at time of study entry', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 39, 'type': 'ACTUAL'}}

Updated at

2024-04-09

1 organization

2 products

1 indication

Organization

Vaxine

Product

Advax-CpG55.2

Indication

COVID-19

Product

Advax-CpG55.2 adjuvanted recombinant spike protein