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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05542862




Registration number
NCT05542862
Ethics application status
Date submitted
8/09/2022
Date registered
16/09/2022
Date last updated
7/08/2024

Titles & IDs
Public title
Booster Study of SpikoGen COVID-19 Vaccine
Scientific title
Immunogenicity and Safety Study in Ambulatory Adults of a Single Intramuscular Dose of SpikoGen Vaccine as a Heterologous or Homologous Booster Dose Following Completion of a Primary Course of Covid-19 Vaccine
Secondary ID [1] 0 0
AUST-C19-booster
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
Treatment: Other - SpikoGen vaccine

Experimental: SpikoGen vaccine - Single booster dose of SpikoGen Covid-19 vaccine


Treatment: Other: SpikoGen vaccine
Recombinant spike protein based Covid-19 vaccine
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Seroconversion
Timepoint [1] 0 0
Between baseline and 4 weeks post the booster dose
Primary outcome [2] 0 0
Seroprotection
Timepoint [2] 0 0
Between baseline and 4 weeks post the booster dose
Primary outcome [3] 0 0
Geometric mean titer fold change
Timepoint [3] 0 0
Between baseline and 4 weeks post the booster dose
Primary outcome [4] 0 0
Safety assessment 1
Timepoint [4] 0 0
Occurring within 7 days after booster dose.
Primary outcome [5] 0 0
Safety assessment 2
Timepoint [5] 0 0
Between time of administration of booster dose and through study completion, an average of 3 months
Primary outcome [6] 0 0
SARS-CoV-2 infection
Timepoint [6] 0 0
Between time of administration of booster dose and through study completion, an average of 3 months
Primary outcome [7] 0 0
Antibody durability
Timepoint [7] 0 0
Between time of administration of booster dose and through study completion, an average of 3 months
Primary outcome [8] 0 0
Seroconversion in participants with and without evidence of past infection
Timepoint [8] 0 0
Between baseline and 4 weeks post the booster dose and through study completion, an average of 3 months
Primary outcome [9] 0 0
Seroprotection in participants with and without evidence of past infection
Timepoint [9] 0 0
Between baseline and 4 weeks post the booster dose and through study completion, an average of 3 months
Primary outcome [10] 0 0
Spike antibody GMT in participants with and without evidence of past infection
Timepoint [10] 0 0
Between baseline and 4 weeks post the booster dose and through study completion, an average of 3 months
Secondary outcome [1] 0 0
Antibody correlates of protection
Timepoint [1] 0 0
Baseline and 4 weeks post the booster dose, and through study completion, an average of 3 months

Eligibility
Key inclusion criteria
* Able to provide written informed consent
* Males or females 18 years of age or older
* Have previously had a primary course of Covid-19 vaccine with the most recent dose no less than 3 months previously.
* Understand and are likely to 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
Exclusion Criteria

* Allergy to Spikogen vaccine or one of its components, e.g. polysorbate 80.
* 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 serious 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
Not applicable
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
Single group
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
7/09/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/10/2024
Actual
Sample size
Target
150
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 Ltd
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
The purpose of the study is to assess the effectiveness of Spikogen vaccine when used as a 3rd or 4th dose booster in adults who have been previously vaccinated with any Covid-19 vaccine types, including mRNA vaccine, adenoviral vector vaccines, recombinant protein vaccines, or inactivated virus vaccines.
Trial website
https://clinicaltrials.gov/study/NCT05542862
Trial related presentations / publications
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.
Tabarsi P, Anjidani N, Shahpari R, Roshanzamir K, Fallah N, Andre G, Petrovsky N, Barati S. Immunogenicity and safety of SpikoGen(R), an adjuvanted recombinant SARS-CoV-2 spike protein vaccine as a homologous and heterologous booster vaccination: A randomized placebo-controlled trial. Immunology. 2022 Nov;167(3):340-353. doi: 10.1111/imm.13540. Epub 2022 Jul 13.
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.
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, Kafi H, Fallah N, Ebrahimi A, Taheri A, Petrovsky N, Barati S. Evaluating the efficacy and safety of SpikoGen(R), an Advax-CpG55.2-adjuvanted severe acute respiratory syndrome coronavirus 2 spike protein vaccine: a phase 3 randomized placebo-controlled trial. Clin Microbiol Infect. 2023 Feb;29(2):215-220. doi: 10.1016/j.cmi.2022.09.001. Epub 2022 Sep 10.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05542862