Covid-19 and Influenza Oral Vaccine Study
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorVaxine Pty Ltd
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Covid-19 vaccine
- Influenza vaccine
Treatment groups
100 Participants
are divided into 3 treatment groupsSponsors and collaborators
Vaxine Pty Ltd
Lead sponsor
Australian Respiratory and Sleep Medicine Institute
Collaborator
Source ClinicalTrials.gov