Clinical Trial of a Plant-Based Seasonal Influenza Vaccine in Adults

The purpose of this study is to assess the safety, tolerability (side effects) and immune response to an influenza (flu) vaccine being developed by Aramis Biotechnologies Inc. This plant-based experimental vaccine is made by producing three types of influenza virus proteins based on the three strains of seasonal flu viruses that are predicted to circulate during the 2025-2026 flu season. When these proteins are produced by the plant cells, they spontaneously form into virus-like particles (VLPs) that look very similar to flu viruses.

Seasonal influenza (flu) is a potentially serious infection associated with a wide range of health concerns. While most people will recover from a flu infection within 7 to 10 days, some can develop complications that require hospitalization. Infants, the elderly, and immunocompromised people are at greater risk of becoming more sick. Influenza vaccines help protect against serious infections.

This study is looking for volunteers who are:

• Aged 18 years or older
• Don’t have any uncontrolled medical conditions
• Have not had any influenza (flu) vaccinations for 4 months prior to their participation in the study
• Have a Body Mass Index (BMI) of less than 39

A member of the study team will go over additional eligibility requirements with you during the screening process.

This study involves:

• 4-5 clinic visits and 3 phone calls over 6 months;
• One injection;
• Blood tests and 2 urine samples;
• Reporting any symptoms or side effects with an app on a smartphone (or via paper if you do not have access to a smartphone).

The study vaccine will be compared to the current seasonal influenza vaccine (not a saltwater placebo injection). This means that participants will receive either:

• One dose of the trivalent virus-like particles (TVLP) study vaccine OR
• The currently recommended dose of influenza vaccine approved by Health Canada for the 2025-2026 flu season

This is a randomized study. Randomized means that your vaccine group (which vaccine you receive in the study) will be chosen at random by a computer. You won’t know which vaccine you receive.