Actively Recruiting
Phase 1/2 Study of a Plant-Based Seasonal Recombinant Trivalent VLP Influenza Vaccine
Led by Aramis Biotechnologies Inc. · Updated on 2026-03-13
728
Participants Needed
7
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This Phase 1/2 study is intended to assess the safety, tolerability, and immunogenicity of recombinant TVLP in adults 18-64 and 65 years of age and above and to confirm the dose(s) to be developed further in these two age cohorts.
CONDITIONS
Official Title
Phase 1/2 Study of a Plant-Based Seasonal Recombinant Trivalent VLP Influenza Vaccine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and commitment to complete study procedures
- 18 years of age or older at vaccination visit
- Body mass index (BMI) of 39 kg/m2 or less at vaccination visit
- Considered reliable and likely to cooperate with study assessments and visits
- Not living in institutionalized settings like rehabilitation or assisted living centers
- In good general health with no acute or evolving medical problems or clinically relevant abnormalities as determined by medical evaluation
You will not qualify if you...
- Significant acute or chronic uncontrolled medical or neuropsychiatric illness
- Current immunosuppressive condition or immunodeficiency, including cancer, HIV, hepatitis B or C (except cured hepatitis B or C without immunodeficiency)
- Pregnant or lactating
- Planning to become pregnant during the study or unwilling to use effective birth control if of child-bearing potential
- Current autoimmune disease requiring systemic treatment, unless stable and approved by investigator
- Received any non-influenza vaccine within 30 days before vaccination visit or planned vaccine administration up to Day 28
- Received influenza vaccine within 4 months prior to vaccination visit
- Planned influenza vaccination for 6 months post-study or during seasonal campaigns
- Use of investigational or non-registered products within 30 days or five half-lives prior to vaccination or planned use during study
- Use of medications or treatments that may alter vaccine immune responses
- History of allergic reactions to vaccine components, egg, tobacco, plants, or anaphylaxis to plants
- History of Guillain-Barré Syndrome
- Use of prophylactic medications within 24 hours before vaccination visit to prevent vaccine symptoms
- Skin conditions or abnormalities at injection site that could affect reaction assessment
- Investigator, employee, or immediate family member involved in the study or employed by Aramis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Canadian Center for Vaccinology (CCfV) - IWK Health
Halifax, Nova Scotia, Canada, B3K 6R8
Actively Recruiting
2
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
Actively Recruiting
3
Vaccine Study Centre of McGill University Health Centre
Pierrefonds, Quebec, Canada, H9H 4Y6
Actively Recruiting
4
CHU de Québec - Université Laval
Québec, Quebec, Canada, G1E 7G9
Actively Recruiting
5
Diex Recherche - Sherbrooke
Sherbrooke, Quebec, Canada, J1L 0H8
Actively Recruiting
6
Diex Recherche - Trois-Rivières
Trois-Rivières, Quebec, Canada, G9A 4P3
Actively Recruiting
7
Diex Recherche - Victoriaville
Victoriaville, Quebec, Canada, G6P 3Z8
Actively Recruiting
Research Team
S
Sonia Trepanier, Ph.D.
CONTACT
S
Sebastien Soucy
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
7
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