Actively Recruiting

Phase 1
Age: 18Years +
All Genders
Healthy Volunteers
NCT06355232

Covid-19 and Influenza Oral Vaccine Study

Led by Vaxine Pty Ltd · Updated on 2025-09-17

100

Participants Needed

1

Research Sites

139 weeks

Total Duration

On this page

Sponsors

V

Vaxine Pty Ltd

Lead Sponsor

A

Australian Respiratory and Sleep Medicine Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

The purpose of the current study is to assess the effectiveness of protein-based COVID-19 or influenza vaccines when given individually or together via oral/ sublingual mucosal route instead of intramuscular delivery. The comparator will be a seasonal influenza vaccine which will also be administered with Advax-CpG adjuvant via the oral route. This study will use a cross-over design and everyone in the study will over a space of about 4 months receive both the COVID-19 and influenza vaccines.

CONDITIONS

Official Title

Covid-19 and Influenza Oral Vaccine Study

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
  • Do not plan to have a non-study COVID-19 or influenza vaccine within the next 6 months.
Not Eligible

You will not qualify if you...

  • Allergy to COVID-19 or seasonal influenza vaccine or one of its components e.g. polysorbate 80.
  • Have received a COVID-19 or influenza vaccine or an experimental agent within 30 days prior to the study vaccination or expect to receive another experimental agent or a COVID-19 or influenza vaccine 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.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

ARASMI

Adelaide, South Australia, Australia, 5042

Actively Recruiting

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Research Team

S

Sharen Pringle, GradCert

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

PREVENTION

Number of Arms

3

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