Covid-19 and Influenza Oral Vaccine Study
A Binded, Randomised, Controlled Cross-over Trial to Assess the Safety and Efficacy of Mucosal Covid-19 and Influenza Vaccines
Vaxine Pty Ltd
100 participants
May 1, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria3
- 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.
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Interventions
Recombinant SARS-CoV-2 spike protein with Advax-CpG55.2 adjuvant
Inactivated seasonal influenza vaccine with Advax-CpG55.2 adjuvant
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06355232