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Phase 1/2 Study of a Plant-Based Seasonal Recombinant Trivalent VLP Influenza Vaccine | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

Phase 1/2 Study of a Plant-Based Seasonal Recombinant Trivalent VLP Influenza Vaccine

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

NCT07291635•Aramis Biotechnologies Inc.

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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.
+6 more criteria

Locations (7)

Canadian Center for Vaccinology (CCfV) - IWK Health

Halifax, Nova Scotia, Canada

Montreal Heart Institute

Montreal, Quebec, Canada

Vaccine Study Centre of McGill University Health Centre

Pierrefonds, Quebec, Canada

CHU de Québec - Université Laval

Québec, Quebec, Canada

Diex Recherche - Sherbrooke

Sherbrooke, Quebec, Canada

Diex Recherche - Trois-Rivières

Trois-Rivières, Quebec, Canada

Diex Recherche - Victoriaville

Victoriaville, Quebec, Canada

Key Dates

Start Date

February 25, 2026

Primary Completion Date

June 1, 2026

Completion Date

December 1, 2026

Last Updated

March 13, 2026

Enrollment

728

ESTIMATED participants

Conditions

Influenza

Interventions

Recombinant Influenza vaccine candidate

BIOLOGICAL

Commercial Influenza vaccine

BIOLOGICAL

Contacts

Sonia Trepanier, Ph.D.

CONTACT

Canada: 1-418-655-7158 Strepanier@aramisbiotechnologies.com

Sebastien Soucy

CONTACT

Canada: 1-418-446-2032 ssoucy@aramisbiotechnologies.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Phase 1/2 Study of a Plant-Based Seasonal Recombinant Trivalent VLP Influenza Vaccine

Inclusion Criteria

Exclusion Criteria

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