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SpikoGen booster shows promise in small COVID-19 study

NCT ID NCT05542862

Disease control Sponsor: Vaxine Pty Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested the SpikoGen vaccine as a booster shot in 81 adults who had already received a full course of any COVID-19 vaccine. The goal was to see if a third or fourth dose of SpikoGen could raise antibody levels and provide protection. Researchers measured immune responses and tracked safety, including any side effects or infections.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SpikoGen vaccine (recombinant spike protein based COVID-19 vaccine)
What this could lead to
If successful, this could show that SpikoGen is a safe and effective booster option for people who received different types of COVID-19 vaccines.
What could go wrong
This is a small, completed Phase 3 trial with only 81 participants, so results may not apply to larger populations. The study focuses on antibody levels, not long-term protection against infection.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

81 people

The number who actually took part.

Started

Sep 2022

Finished

Sep 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

COVID-19 prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

COVID-19

Contacts and locations

Locations

  • ARASMI

    Adelaide, South Australia, 5042, Australia

More trials for these conditions

Other studies related to the condition(s) this trial covers.