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Clinical trial

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

ID
Name
AUST-C19-booster
Description
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 arms
Trial start
2022-09-07
Estimated PCD
2023-12-31
Trial end
2024-06-30
Status
Active (not recruiting)
Phase
Early phase I
Treatment
SpikoGen vaccine
Recombinant spike protein based Covid-19 vaccine
Arms:
SpikoGen vaccine
Other names:
Covax-19
Size
150
Primary endpoint
Seroconversion
Between baseline and 4 weeks post the booster dose
Seroprotection
Between baseline and 4 weeks post the booster dose
Geometric mean titer fold change
Between baseline and 4 weeks post the booster dose
Safety assessment 1
Occurring within 7 days after booster dose.
Safety assessment 2
Between time of administration of booster dose and through study completion, an average of 3 months
SARS-CoV-2 infection
Between time of administration of booster dose and through study completion, an average of 3 months
Antibody durability
Between time of administration of booster dose and through study completion, an average of 3 months
Seroconversion in participants with and without evidence of past infection
Between baseline and 4 weeks post the booster dose and through study completion, an average of 3 months
Seroprotection in participants with and without evidence of past infection
Between baseline and 4 weeks post the booster dose and through study completion, an average of 3 months
Spike antibody GMT in participants with and without evidence of past infection
Between baseline and 4 weeks post the booster dose and through study completion, an average of 3 months
Eligibility criteria
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. 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All subjects will receive the same single intervention with analysis groups being based on the type of primary vaccine received', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 150, 'type': 'ESTIMATED'}}
Updated at
2024-04-09

1 organization

1 product

1 indication

Organization
Vaxine
Product
SpikoGen
Indication
COVID-19