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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05279456




Registration number
NCT05279456
Ethics application status
Date submitted
7/03/2022
Date registered
15/03/2022
Date last updated
9/04/2024

Titles & IDs
Public title
A Phase 3b/4 Randomised Trial of 3 Doses of Protein-based Covid-19 Vaccine (SpikoGen)
Scientific title
A Phase 3b/4 Randomised Trial of 3 Doses of Protein-based Covid-19 Vaccine (SpikoGen)
Secondary ID [1] 0 0
AUST-C19-P3/4
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Advax-CpG55.2 adjuvanted recombinant spike protein

Experimental: Spikogen vaccine - accelerated arm - Spikogen vaccine 25 micrograms by intramuscular injection on study months 0, 1 and 2

Experimental: Spikogen vaccine - standard arm - Spikogen vaccine 25 micrograms by intramuscular injection on study months 0, 1 and 4


Other interventions: Advax-CpG55.2 adjuvanted recombinant spike protein
recombinant SARS-CoV-2 spike protein formulated with Advax-CpG55.2 adjuvant
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
First dose Seroconversion
Timepoint [1] 0 0
2-4 weeks post first immunisation
Primary outcome [2] 0 0
Second dose Seroconversion
Timepoint [2] 0 0
2-4 weeks post second immunisation
Primary outcome [3] 0 0
Third Dose Seroconversion
Timepoint [3] 0 0
2-4 weeks post third immunisation
Primary outcome [4] 0 0
Final Seroconversion
Timepoint [4] 0 0
through study completion, an average of 7 months
Primary outcome [5] 0 0
First Dose GMT
Timepoint [5] 0 0
2-4 weeks post first immunisation
Primary outcome [6] 0 0
Second Dose GMT
Timepoint [6] 0 0
2-4 weeks post second immunisation
Primary outcome [7] 0 0
Third Dose GMT
Timepoint [7] 0 0
2-4 weeks post third immunisation
Primary outcome [8] 0 0
Final GMT
Timepoint [8] 0 0
through study completion, an average of 7 months
Primary outcome [9] 0 0
First Dose Adverse events (AE)
Timepoint [9] 0 0
7 days post first immunisation
Primary outcome [10] 0 0
Second Dose Adverse events (AE)
Timepoint [10] 0 0
7 days post second immunisation
Primary outcome [11] 0 0
Third Dose Adverse events (AE)
Timepoint [11] 0 0
7 days post third immunisation
Primary outcome [12] 0 0
Serious adverse events (SAE)
Timepoint [12] 0 0
through study completion, an average of 7 months
Secondary outcome [1] 0 0
First dose Vaccine efficacy
Timepoint [1] 0 0
From 2 weeks post-first dose to 2 weeks after second dose
Secondary outcome [2] 0 0
Second dose Vaccine efficacy
Timepoint [2] 0 0
From 2 weeks post-second dose to 2 weeks after third dose
Secondary outcome [3] 0 0
Third dose Vaccine efficacy
Timepoint [3] 0 0
From 2 weeks post-third dose through study completion, an average of 7 months
Secondary outcome [4] 0 0
Total Covid-19 infections
Timepoint [4] 0 0
From first vaccine dose through study completion, an average of 7 months
Secondary outcome [5] 0 0
Seroconversion against variants of concern
Timepoint [5] 0 0
2-4 weeks post first, second and third immunisation and at study completion
Secondary outcome [6] 0 0
GMT against variants of concern
Timepoint [6] 0 0
2-4 weeks post first, second and third immunisation and at study completion

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/08/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2024
Actual
Sample size
Target
Accrual to date
Final
39
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
ARASMI - Adelaide
Recruitment postcode(s) [1] 0 0
5042 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Vaxine Pty Ltd
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Australian Respiratory and Sleep Medicine Institute
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
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 website
https://clinicaltrials.gov/ct2/show/NCT05279456
Trial related presentations / publications
Li L, Honda-Okubo Y, Huang Y, Jang H, Carlock MA, Baldwin J, Piplani S, Bebin-Blackwell AG, Forgacs D, Sakamoto K, Stella A, Turville S, Chataway T, Colella A, Triccas J, Ross TM, Petrovsky N. Immunisation of ferrets and mice with recombinant SARS-CoV-2 spike protein formulated with Advax-SM adjuvant protects against COVID-19 infection. Vaccine. 2021 Sep 24;39(40):5940-5953. doi: 10.1016/j.vaccine.2021.07.087. Epub 2021 Aug 3.
Public notes

Contacts
Principal investigator
Name 0 0
Dimitar Sajkov, MBBS
Address 0 0
ARASMI
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