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
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Vaxine Pty Ltd Industry-sponsored |
| Locations | 1 site (Adelaide, South Australia) |
| Status | Recruiting |
| Started | May 1, 2024 |
| Main results expected | December 31, 2025 |
| Study ends | December 31, 2026 |
| Registry record updated | September 17, 2025 |
| Trial ID | NCT06355232 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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.