Clinical trial Recruiting at 1 site Phase 1 Interventional Ages 18 and up

Oral vaccine for COVID-19 and influenza

Official title: A Binded, Randomised, Controlled Cross-over Trial to Assess the Safety and Efficacy of Mucosal Covid-19 and Influenza Vaccines

Run by Vaxine Pty Ltd · NCT06355232 · Data updated 2026-11-12

This study is testing whether an oral vaccine for COVID-19 and influenza can boost immunity better than traditional shots, making it easier for people to get vaccinated.

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment100 (estimated)
SponsorVaxine Pty Ltd
Industry-sponsored
Locations1 site (Adelaide, South Australia)
StatusRecruiting
StartedMay 1, 2024
Main results expectedDecember 31, 2025
Study endsDecember 31, 2026
Registry record updatedSeptember 17, 2025
Trial IDNCT06355232 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 and older who can provide informed consent and comply with study procedures.

Probably not a fit

Patients with allergies to COVID-19 or influenza vaccines or those who have recently received any vaccine may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of protein-based vaccines for COVID-19 and influenza administered orally or sublingually, as opposed to the traditional intramuscular route. Participants will receive both vaccines over a four-month period in a cross-over design, allowing for direct comparison of their immune responses. The study aims to address the waning immunity observed with current vaccines, particularly against newer variants of COVID-19. The oral delivery method could potentially enhance accessibility and compliance for vaccination.

Why it matters

Potential benefit: If successful, this approach could provide a more effective and convenient vaccination method for preventing COVID-19 and influenza.

How similar studies have gone: While there have been studies on oral vaccines, this specific approach using protein-based vaccines for COVID-19 and influenza is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.
* Do not plan to have a non-study COVID-19 or influenza vaccine within the next 6 months.

Exclusion Criteria:

* 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.

Where it's running

  • Arasmi
    Adelaide, South Australia, Australia
    Recruiting

Study contacts

  • Principal investigator: Dimitar Sajkov, MBBS/PhD — Arasmi
  • Study coordinator: Sharen Pringle, GradCert
  • Email: office@arasmi.org
  • Phone: 0437033400

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.