Booster Study of SpikoGen COVID-19 Vaccine

Phase 3

Active, not recruiting

• Conditions: COVID-19
• Interventions: Biological: SpikoGen vaccine

• Registration Number: NCT05542862
• Lead Sponsor: Vaxine Pty Ltd

Brief 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.

Study Timeline

• Study Start: 2022-09-07
• Study First Submitted: 2022-09-08
• Study First Submitted QC: 2022-09-13
• Study First Posted: 2022-09-16
• Primary Completion: 2023-12-31
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-06
• Last Update Posted: 2024-08-07
• Study Completion: 2024-10-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SpikoGen vaccine	SpikoGen vaccine	Single booster dose of SpikoGen Covid-19 vaccine

Primary Outcome Measures

Name	Time	Method
Seroconversion	Between baseline and 4 weeks post the booster dose	Proportion of study participants who seroconvert (4-fold or greater rise in serum spike antibody) by primary vaccine group
SARS-CoV-2 infection	Between time of administration of booster dose and through study completion, an average of 3 months	Frequency of SARS-CoV-2 infections in study participants by primary vaccine group, age, gender, co-morbidities, and past infection
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	Spike antibody seroconversion in baseline nuclear protein antibody positive versus negative participants by primary vaccine group
Safety assessment 1	Occurring within 7 days after booster dose.	Frequency of Adverse events by primary vaccine group
Seroprotection	Between baseline and 4 weeks post the booster dose	Proportion of study participants who achieve a spike protein neutralisation titer of 32 or greater by primary vaccine group
Geometric mean titer fold change	Between baseline and 4 weeks post the booster dose	Increase in Geometric mean titer of spike neutralisation antibodies by primary vaccine group
Safety assessment 2	Between time of administration of booster dose and through study completion, an average of 3 months	Frequency of Serious Adverse events by primary vaccine group
Antibody durability	Between time of administration of booster dose and through study completion, an average of 3 months	The proportion of subjects who remain seroprotected throughout the duration of the study including broken down by primary vaccine group.
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 seroprotection in baseline nuclear protein antibody positive versus negative participants by primary vaccine group
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	Spike antibody GMT in baseline nuclear protein antibody positive versus negative participants by primary vaccine group.

Secondary Outcome Measures

Name	Time	Method
Antibody correlates of protection	Baseline and 4 weeks post the booster dose, and through study completion, an average of 3 months	SARS-CoV-2 antibody levels in subjects with or without breakthrough SARS-CoV-2 infection

Trial Locations

Locations (1)

ARASMI; 🇦🇺 Adelaide, South Australia, Australia