A Binded, Randomised, Controlled Cross-over Trial to Assess the Safety and Efficacy of Mucosal Covid-19 and Influenza Vaccines
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:
• 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.
Locations
Other Locations
Australia
ARASMI
RECRUITING
Adelaide
Contact Information
Primary
Sharen Pringle, GradCert
office@arasmi.org
0437033400
Time Frame
Start Date:2024-05-01
Estimated Completion Date:2026-12-31
Participants
Target number of participants:100
Treatments
Experimental: Covid-19 vaccine group
Subjects in this group will receive two sublingual doses of COVID-19 vaccine two weeks apart. Three months after the second dose they will receive two sublingual doses of influenza vaccine two weeks apart.
Experimental: Influenza vaccine group
Subjects in this group will receive two sublingual doses of influenza vaccine two weeks apart. Three months after the second dose they will receive two sublingual doses of COVID-19 vaccine two weeks apart.
Experimental: Combined vaccine group
Subjects in this group will receive two sublingual doses of combined COVID-19 and influenza vaccine two weeks apart. Three months after the second dose they will receive two sublingual doses of placebo vaccine two weeks apart.