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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

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
Trial website
Trial related presentations / publications
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05542862