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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/NCT05148871




Registration number
NCT05148871
Ethics application status
Date submitted
27/11/2021
Date registered
8/12/2021
Date last updated
9/04/2024

Titles & IDs
Public title
Australian Phase 2b Study to Assess Effect of Dose Interval on Spikogen Covid-19 Vaccine
Scientific title
A Phase 2b Study to Assess the Effect of Dose Interval on the Effectiveness of a Protein-based Covid-19 Vaccine (Spikogen® Vaccine)
Secondary ID [1] 0 0
C19-P2/3B
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 - Spikogen/Covax-19

Active Comparator: 3 week arm - Subjects will receive two doses of vaccine 3 weeks apart

Active Comparator: 4 week arm - Subjects will receive two doses of vaccine 4 weeks apart

Active Comparator: 5 week arm - Subjects will receive two doses of vaccine 5 weeks apart

Active Comparator: 6 week arm - Subjects will receive two doses of vaccine 6 weeks apart


Other interventions: Spikogen/Covax-19
Spikogen/Covax-19 is a recombinant spike protein vaccine formulated with Advax-CpG55.2 adjuvant
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Spike antibody immunogenicity
Timepoint [1] 0 0
3 weeks post second vaccine dose
Primary outcome [2] 0 0
Spike antibody seroconversion
Timepoint [2] 0 0
3 weeks post second vaccine dose
Primary outcome [3] 0 0
SARS-CoV-2 protection
Timepoint [3] 0 0
Accrual of events starting 2 weeks post second vaccine dose
Secondary outcome [1] 0 0
Spike antibody durability
Timepoint [1] 0 0
6 months post-second vaccine dose
Secondary outcome [2] 0 0
Spike antibody seropositive persistence
Timepoint [2] 0 0
6 months post-second vaccine dose

Eligibility
Key inclusion criteria
- Provide written informed consent prior to initiation of any study procedures.

- No history of previous Covid-19 vaccinations

- Women of childbearing potential must use an acceptable contraception method from at
least 28 days before study vaccination until 14 days after last study vaccination.

- Understand and comply with planned study procedures and be available for all study
visits.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Have a history of severe systemic reactions (anaphylaxis, breathing difficulties,
severe rash) following previous immunization with licensed or unlicensed vaccines.

- Received an experimental agent within 30 days prior to the study vaccination or expect
to receive another experimental agent during the trial-reporting period.

- Intend to receive another Covid-19 vaccine during the time of 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 2/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
1/03/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2024
Actual
Sample size
Target
200
Accrual to date
Final
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
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
Cinnagen
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
A study to assess the effect of varying the time interval between doses on the immunogenicity
of an adjuvanted recombinant spike protein Covid-19 vaccine (Spikogen/Covax-19)
Trial website
https://clinicaltrials.gov/ct2/show/NCT05148871
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.
Tabarsi P, Anjidani N, Shahpari R, Mardani M, Sabzvari A, Yazdani B, Roshanzamir K, Bayatani B, Taheri A, Petrovsky N, Li L, Barati S. Safety and immunogenicity of SpikoGen(R), an Advax-CpG55.2-adjuvanted SARS-CoV-2 spike protein vaccine: a phase 2 randomized placebo-controlled trial in both seropositive and seronegative populations. Clin Microbiol Infect. 2022 Sep;28(9):1263-1271. doi: 10.1016/j.cmi.2022.04.004. Epub 2022 Apr 15.
Li L, Honda-Okubo Y, Baldwin J, Bowen R, Bielefeldt-Ohmann H, Petrovsky N. Covax-19/Spikogen(R) vaccine based on recombinant spike protein extracellular domain with Advax-CpG55.2 adjuvant provides single dose protection against SARS-CoV-2 infection in hamsters. Vaccine. 2022 May 20;40(23):3182-3192. doi: 10.1016/j.vaccine.2022.04.041. Epub 2022 Apr 18.
Public notes

Contacts
Principal investigator
Name 0 0
Dimitar Sajkov, MD, PhD
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