COVAX-19 – Phase 4 Australian Clinical Trial – FAQ

This is to be regarded as registering an expression of interest in participating. An application for approval for the clinical trial is being made to Ethics

Do I have to reside in SA? – The Ethics application seeks to make this an Australia wide clinical trial, but Clinical Trial sites in each State need to be identified.

Do I need to travel to SA to participate? – We hope that Trial will be conducted in each State, but this will depend on resources and identification of trial sites in each State.

When will the trial commence? – Once it has been approved by Ethics, we will start rolling the trial out in South Australia with other States following as soon as practical subject to resources.

Will every person registered for the clinical trial be accepted to participate? – Vaxine Pty Ltd have indicated that they will endeavour to accommodate as many people as possible – but not everyone will be able to be in the trial both because of the limited resources to pay for the trial but also because they may not be eligible. For example currently all participants need to be adults.

What happens if I have already had a Covid vaccine? – For this trial must be vaccine naive however we would like to conduct a trial on administering a booster, but that will be a separate trial.

What will be the primary goal of this clinical trial? – We are going to be looking at different intervals between the first and second dose. Every participant will get the vaccine on day 1 and then depending on which group you are randomised to the second dose will be given at week 3, 6, 9 or 12.

Will there be a placebo? – No, every participant will get an active vaccine.

Will there be any exclusions? – Yes, Inclusions and exclusions will be explained once approval has been obtained from Ethics.

Will the trial exclude pregnant or breastfeeding candidates? – Pregnant women will be excluded.

Will the trial exclude adolescents? – The trial will currently only accept people18 years and older.

Will the trial exclude participants 50 years of age and older? – No, anyone 18 years and over and meet the inclusion criteria will be included depending on resources.

Will the trial exclude participants who have contracted COVID-19? – Previous infection does not exclude you from the trial.

Will the fundraiser need to achieve a certain target for the clinical trial to proceed? – No, we are waiting on Ethics approval, however the Gofundme funds will help with towards the costs of the Ethics Application as well as towards the running of the trial. A trial of this size would normally cost millions of dollars, so unless we can raise these funds the trial sites might need to be severely limited. The more funds we raise the bigger the trial can be.

How do I find out about the vaccine mandate exemptions available to clinical trial participants applicable for my state? – We suggest you check with your State Health Department. If necessary ring or email them to clarify if Trial participants will be excluded from Mandates as South Australia and Western Australia Health Departments have already indicated.

Will I receive an email confirming my registration for the trial? – You will receive a letter acknowledging your interest however given the large number of Registrations this is taking longer than anticipated. This letter does not guarantee your participation.

How many doses? – Each person in the trial will receive two doses of vaccine 3-12 weeks apart.

If I am accepted into the trial, can I transfer my position to a family member who missed out? – No.

Is this clinical trial considered a full course of COVID-19 vaccine? – Yes, but like other vaccines boosters maybe needed in the future.

What will be the follow-up procedure? – You will be followed up for six months after the last dose of vaccine.

If I register, am I obligated to participate in the trial? – No, registration doesn’t guarantee your participation, you can pull out of the trial at any time.

Is there a closing date for registration? – Not at this stage.

How do I register? via the Vaxine Pty Ltd website or this link –> https://vaxine.net/registration-for-clinical-phase-4-trial-covax-19/