Booster Study of SpikoGen COVID-19 Vaccine

September 16, 2025 updated by: Vaxine Pty Ltd

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
81

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5042
        • ARASMI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SpikoGen vaccine
Single booster dose of SpikoGen Covid-19 vaccine
Biological: SpikoGen vaccine
Recombinant spike protein based Covid-19 vaccine
Other Names:
  • Covax-19

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Seroconversion
Time Frame: 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
Between baseline and 4 weeks post the booster dose
Seroprotection
Time Frame: 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
Between baseline and 4 weeks post the booster dose
Geometric mean titer fold change
Time Frame: Between baseline and 4 weeks post the booster dose
Increase in Geometric mean titer of spike neutralisation antibodies by primary vaccine group
Between baseline and 4 weeks post the booster dose
Safety assessment 1
Time Frame: Occurring within 7 days after booster dose.
Frequency of Adverse events by primary vaccine group
Occurring within 7 days after booster dose.
Safety assessment 2
Time Frame: 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
Between time of administration of booster dose and through study completion, an average of 3 months
SARS-CoV-2 infection
Time Frame: 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
Between time of administration of booster dose and through study completion, an average of 3 months
Antibody durability
Time Frame: 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.
Between time of administration of booster dose and through study completion, an average of 3 months
Seroconversion in participants with and without evidence of past infection
Time Frame: 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
Between baseline and 4 weeks post the booster dose and through study completion, an average of 3 months
Seroprotection in participants with and without evidence of past infection
Time Frame: 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
Between baseline and 4 weeks post the booster dose and through study completion, an average of 3 months
Spike antibody GMT in participants with and without evidence of past infection
Time Frame: 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.
Between baseline and 4 weeks post the booster dose and through study completion, an average of 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Antibody correlates of protection
Time Frame: 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
Baseline and 4 weeks post the booster dose, and through study completion, an average of 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vaxine Pty Ltd

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Cinnagen
Australian Respiratory and Sleep Medicine Institute Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dimitar Sajkov, MD/PhD, ARASMI
  • Study Director: Nikolai Petrovsky, MD/PhD, Vaxine Pty Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 7, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 16, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 8, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 16, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 17, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AUST-C19-booster

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings