Oral vaccine for COVID-19 and influenza
A Binded, Randomised, Controlled Cross-over Trial to Assess the Safety and Efficacy of Mucosal Covid-19 and Influenza Vaccines
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 |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vaxine Pty Ltd Industry-sponsored |
| Locations | 1 site (Adelaide, South Australia) |
| Trial ID | NCT06355232 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who can provide informed consent and comply with study procedures.
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.
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 performed: While there have been studies on oral vaccines, this specific approach using protein-based vaccines for COVID-19 and influenza is relatively novel.
Eligibility criteria
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 this trial is running
Adelaide, South Australia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.