Status:
COMPLETED
A Phase 3b/4 Randomised Trial of 3 Doses of Protein-based Covid-19 Vaccine (SpikoGen)
Lead Sponsor:
Vaxine Pty Ltd
Collaborating Sponsors:
Australian Respiratory and Sleep Medicine Institute
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study will determine the immunogenicity of Spikogen in vaccine naïve individuals. Spikogen will be administered as two doses 1 month apart with a third booster dose either 1 or 3 months after the...
Detailed Description
The SARS-CoV-2 outbreak has caused millions of deaths globally. It has a particularly high mortality rate in elderly people and those with chronic disease where mortality rates can be as high as 20-30...
Eligibility Criteria
Inclusion
- Able to provide written informed consent
- Males or females\* 18 years of age or older
- Understand and are likely to comply with planned study procedures and be available for all study visits.
- Have not previously had a Covid-19 vaccine and do not intend to have a non-study Covid-19 vaccine within the next 6 months
Exclusion
- History of Covid-19 vaccination.
- History of serious vaccine allergy.
- Pregnancy1
- 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 medical, social or mental condition which, in the opinion of the investigator, would be detrimental to the subjects or the study.
Key Trial Info
Start Date :
August 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT05279456
Start Date
August 15 2022
End Date
December 31 2023
Last Update
September 17 2025
Active Locations (1)
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1
ARASMI
Adelaide, South Australia, Australia, 5042