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New COVID-19 vaccine shows promise in small trial

NCT ID NCT05279456

Vaccine 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tested a new COVID-19 vaccine called SpikoGen in 39 adults who had never received a COVID-19 vaccine. Participants received two doses one month apart, followed by a third booster dose either one or three months later. The goal was to see how well the vaccine triggered an immune response and whether it was safe.

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 with Advax-CpG55.2 adjuvant)
What this could lead to
If successful, this could provide a safe and effective COVID-19 vaccine option for people who have not yet been vaccinated.
What could go wrong
This is a small, early-phase trial with only 39 participants, so results may not apply to the general population. The vaccine may not produce strong enough immunity or could cause side effects.

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

39 people

The number who actually took part.

Started

Aug 2022

Finished

Dec 2023

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 * 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 Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

Coronavinae infectious disease 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.