Study to Test Safety and Effectiveness of Oral Mucosal COVID-19 and Influenza Vaccines Using a Cross-over Design

What this Trial Is About

Researchers are evaluating the effectiveness of protein-based COVID-19 and influenza vaccines administered via the oral or sublingual mucosal route compared to traditional intramuscular delivery. This study aims to improve mucosal immunity, which may better prevent infection and transmission at the bodys respiratory surfaces. It uses a cross-over design where participants receive both vaccines over about four months. Participants will be randomly assigned to one of three groups one receiving two sublingual doses of COVID-19 vaccine followed by two influenza doses three months later another receiving influenza vaccine doses followed by COVID-19 doses and a third group receiving combined COVID-19 and influenza vaccines followed by placebo doses. All vaccines use Advax-CpG adjuvant and are given two weeks apart in two doses. During the study, participants will attend multiple visits for vaccine administration and monitoring. Researchers will assess immune responses by measuring antibody levels and seroconversion two weeks after vaccination. Safety will be monitored throughout an average 10-month period, along with tracking COVID-19 and influenza infections. Antibody durability and correlates of protection will also be evaluated during follow-up.

Covid-19 and Influenza Oral Vaccine Study