NCT06355232 Covid-19 and Influenza Oral Vaccine Study
| NCT ID | NCT06355232 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Vaxine Pty Ltd |
| Condition | covid19 Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-05-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 100 participants in total. It began in 2024-05-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Dimitar Sajkov, MBBS/PhD
PRINCIPAL INVESTIGATOR
ARASMI
Frequently Asked Questions
Who can join the NCT06355232 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying covid19 Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06355232 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06355232 currently recruiting?
Yes, NCT06355232 is actively recruiting participants. Contact the research team at office@arasmi.org for enrollment information.
Where is the NCT06355232 trial being conducted?
This trial is being conducted at Adelaide, Australia.
Who is sponsoring the NCT06355232 clinical trial?
NCT06355232 is sponsored by Vaxine Pty Ltd. The principal investigator is Dimitar Sajkov, MBBS/PhD at ARASMI. The trial plans to enroll 100 participants.
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