The purpose of the study is to assess the effectiveness of Spikogen vaccine when used asa 3rd or 4th dose booster in adults who have been previously vaccinated with any Covid-19vaccine types, including mRNA vaccine, adenoviral vector vaccines, recombinant proteinvaccines, or inactivated virus vaccines.
Currently in Australia, mRNA, adenoviral vector and recombinant protein vaccines have
provisional approval for use as 3rd or 4th booster doses. This study will provide
important data on the use of Spikogen as an alternative recombinant protein booster
vaccine. The study will provide data in ambulatory adults on the safety and effectiveness
of Spikogen vaccine when administered as a single intramuscular booster dose in those who
previously vaccinated with mRNA vaccine in comparison to those immunised with other
Covid-19 vaccine platforms.
Biological: SpikoGen vaccine
Recombinant spike protein based Covid-19 vaccine
Other Name: Covax-19
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.
ARASMI
Adelaide, South Australia, Australia