Phase 1/2 Study of a Plant-Based Seasonal Recombinant Trivalent VLP Influenza Vaccine
NCT ID: NCT07291635
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1/PHASE2
728 participants
INTERVENTIONAL
2026-02-28
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Group 1 (18-64): 15 μg
Recombinant Influenza vaccine candidate
Plant-Based Seasonal Recombinant Trivalent TVLP Influenza Vaccine
Group 2 (18-64): 30 μg
Recombinant Influenza vaccine candidate
Plant-Based Seasonal Recombinant Trivalent TVLP Influenza Vaccine
Group 3 (18-64): 60 μg
Recombinant Influenza vaccine candidate
Plant-Based Seasonal Recombinant Trivalent TVLP Influenza Vaccine
Group 4 (18-64): STD TIV
Commercial Influenza vaccine
Influenza vaccine commercially available on the Canadian market
Group 5 (65+): 30 μg
Recombinant Influenza vaccine candidate
Plant-Based Seasonal Recombinant Trivalent TVLP Influenza Vaccine
Group 6 (65+): 60 μg
Recombinant Influenza vaccine candidate
Plant-Based Seasonal Recombinant Trivalent TVLP Influenza Vaccine
Group 7 (65+): HD TIV
Commercial Influenza vaccine
Influenza vaccine commercially available on the Canadian market
Interventions
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Recombinant Influenza vaccine candidate
Plant-Based Seasonal Recombinant Trivalent TVLP Influenza Vaccine
Commercial Influenza vaccine
Influenza vaccine commercially available on the Canadian market
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
Yes
Sponsors
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Aramis Biotechnologies Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Brian Ward, MD
Role: STUDY_CHAIR
McGill University
Central Contacts
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Other Identifiers
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CP-sFLUVLP-001
Identifier Type: -
Identifier Source: org_study_id