Booster Study of SpikoGen COVID-19 Vaccine

Vaxine

Status and phase

Completed

Phase 3

Conditions

COVID-19

Treatments

Biological: SpikoGen vaccine

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT05542862

AUST-C19-booster

Details and patient eligibility

About

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.

Full description

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.

Enrollment

81 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.