RECRUITINGPhase 1INTERVENTIONAL

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

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Able to provide written willing to sign a consent form - 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. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

BIOLOGICAL

Covid-19 vaccine

Recombinant SARS-CoV-2 spike protein with Advax-CpG55.2 adjuvant

BIOLOGICAL

Influenza vaccine

Inactivated seasonal influenza vaccine with Advax-CpG55.2 adjuvant

Locations (1)

ARASMI

Adelaide, South Australia, Australia