NCT05542862

Booster Study of SpikoGen COVID-19 Vaccine

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Vaxine Pty Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	SpikoGen vaccine	Recombinant spike protein based Covid-19 vaccine

Timeline

• Start date: 2022-09-07
• Primary completion: 2023-12-31
• Completion: 2025-09-16
• First posted: 2022-09-16
• Last updated: 2025-09-17

Locations

1 site across 1 country: Australia