Plant-based seasonal three-strain recombinant influenza vaccine for adults

A Randomized, Observer-Blind, Adaptive, Active Comparator-Controlled, Dose-Ranging, Multicenter, Safety, Tolerability, and Immunogenicity Phase 1/2 Study of a Plant-Based Seasonal Recombinant Trivalent VLP Influenza Vaccine in Adults 18 Years of Age and Older

This trial will test a plant-based seasonal trivalent recombinant flu vaccine in adults 18–64 and people 65+ to see if it is safe, well tolerated, and triggers a good immune response.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 728 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Aramis Biotechnologies Inc. (Industry-sponsored)
• Locations: 7 sites (Halifax, Nova Scotia and 6 other locations)
• Trial ID: NCT07291635 on ClinicalTrials.gov

What this trial studies

This is a Phase 1/2, dose-confirmation study enrolling two adult cohorts (18–64 and 65+) to characterize safety, tolerability, and immunogenicity of a plant-derived recombinant trivalent virus-like particle (VLP) influenza vaccine. Participants will receive the investigational recombinant VLP vaccine at one of several dose levels and may be compared with a licensed commercial influenza vaccine as a reference. The trial will collect safety data, monitor adverse events, and measure immune responses to determine which dose(s) should move forward. The study is being conducted at multiple Canadian vaccine centers and will inform next steps for development in these age groups.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who can give informed consent, have a BMI ≤ 39 kg/m2, are in generally good health (not institutionalized), and can attend study visits at the trial sites.

Not a fit: People under 18, those with significant uncontrolled medical conditions or contraindications to vaccination, individuals with BMI > 39 kg/m2, or those unable to attend visits at the listed Canadian sites are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, this vaccine could offer a plant-based seasonal influenza option with acceptable safety and improved or comparable immune protection, including for older adults.

How similar studies have performed: Other plant-based VLP influenza vaccine programs have shown promising immunogenicity and acceptable safety in prior trials, though this specific recombinant trivalent candidate is still under clinical evaluation.

Eligibility criteria

Inclusion Criteria:

1. Participants must have read, understood, and signed the informed consent form (ICF) prior to participating in the study; participants must also commit to complete study-related procedures and communicate with the study staff at visits and by phone during the study.
2. Participants must be 18 years of age and older at the Vaccination visit (Visit 2).
3. Participant must have a body mass index (BMI) ≤ 39 kg/m2 at the Vaccination visit (Visit 2).
4. Participants are considered by the Investigator to be reliable and likely to cooperate with the assessment procedures and be available for the duration of the study.
5. Participants cannot be living in an institutionalized setting (e.g. not living in rehabilitation centres or assisted living facilities; living in an elderly community like independent senior housing is acceptable), must be in good general health, and have no acute or evolving medical problems prior to study participation and no clinically relevant abnormalities that could jeopardize participant safety or interfere with study assessments, as assessed by the Principal Investigator or sub-Investigator (thereafter referred as Investigator) and determined by medical history, physical examination, serology, clinical chemistry and haematology tests, urinalysis, and vital signs. Investigator discretion will be permitted with this inclusion criterion.

Exclusion Criteria:

1. According to the Investigator's opinion, significant acute or chronic, uncontrolled medical or neuropsychiatric illness.
2. Any confirmed or suspected current immunosuppressive condition or immunodeficiency, including cancer, human immunodeficiency virus infection, hepatitis B or C (participants with a history of cured hepatitis B or C infection without any signs of immunodeficiency at present time are allowed). Investigator discretion is permitted with this exclusion criterion.
3. Participant is pregnant or lactating.
4. Participants who plan to become pregnant during the study period. Participants of child-bearing age who are currently or who become sexually active during the study should be willing to use effective birth control for the duration of the study. Participants of childbearing potential will undergo pregnancy testing at the screening visit and on Day 0 prior to vaccination.
5. Current autoimmune disease requiring systemic treatment (such as rheumatoid arthritis, systemic lupus erythematosus or multiple sclerosis). Investigator discretion is permitted with this exclusion criterion, and participants may be eligible to participate with appropriate written justification in the source document (i.e. participants with a history of autoimmune disease who are disease-free without treatment for three years or more, or on stable thyroid replacement therapy, mild psoriasis \[i.e. a small number of minor plaques requiring no systemic treatment\], etc.).
6. Administration of any non-influenza vaccine within 30 days prior to the Vaccination visit (Visit 2); planned administration of any vaccine up to Day 28 of the study. Immunization on an emergency basis during the study will be evaluated on case-by-case basis by the Investigator.
7. Administration of influenza vaccine within four months prior to the Vaccination visit (Visit 2).
8. Planned administration of influenza vaccine (other than the study vaccine) for six months post-administration or roll-out of the follow-year's seasonal influenza vaccination campaign: whichever comes first.
9. Use of any investigational or non-registered product within 30 days or five half-lives, whichever is longer, prior to the Vaccination visit (Visit 2) or planned use during the study period. Participants who are in a prolonged post-administration observation period of another investigational or marketed drug clinical study, for which there is no ongoing exposure to the investigational or marketed product and all scheduled on-site visits are completed, will be allowed to take part in this study, if all other eligibility criteria are met.
10. Administration of any medication or treatment that may alter the vaccine immune responses.
11. History of possible allergic reaction to any of the constituents of TVLP, any components of licensed vaccines, egg, or tobacco, based on the PI's assessment.
12. History of anaphylactic allergic reactions to plants or plants components (including fruits and nuts).
13. Participants with a history of Guillain-Barré Syndrome.
14. Use of prophylactic medications (e.g. antihistamines \[H1 receptor antagonists\], nonsteroidal anti-inflammatory drugs \[NSAIDs\], systemic and topical glucocorticoids, non-opioid and opioid analgesics) within 24 hours prior to the Vaccination visit (Visit 2) to prevent or pre-empt symptoms due to vaccination.
15. Have a rash, dermatological condition, tattoos, muscle mass, or any other abnormalities at the injection site that may interfere with injection site reaction rating. Investigator discretion will be permitted with this exclusion criterion.
16. Participants identified as an Investigator or employee of the Investigator or clinical site with direct involvement in the proposed study, or identified as an immediate family member (i.e. parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study, or any employees of Aramis.

Where this trial is running

Halifax, Nova Scotia and 6 other locations

• Canadian Center for Vaccinology (CCfV) - IWK Health — Halifax, Nova Scotia, Canada (Recruiting)
• Montreal Heart Institute — Montreal, Quebec, Canada (Recruiting)
• Vaccine Study Centre of McGill University Health Centre — Pierrefonds, Quebec, Canada (Recruiting)
• CHU de Québec - Université Laval — Québec, Quebec, Canada (Recruiting)
• Diex Recherche - Sherbrooke — Sherbrooke, Quebec, Canada (Recruiting)
• Diex Recherche - Trois-Rivières — Trois-Rivières, Quebec, Canada (Recruiting)
• Diex Recherche - Victoriaville — Victoriaville, Quebec, Canada (Recruiting)

Study contacts

• Study coordinator: Sonia Trepanier, Ph.D.

Conditions Influenza