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

NCT07291635 | Recruiting Phase 1 DMC

• 1 other identifier: CP-sFLUVLP-001
• Study Type: interventional
• Target: 728
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Influenza

Outcome Measures

Primary Outcomes (6)

• Immediate AEs

  Percentage, intensity, and relationship to vaccination of immediate AEs (30 minutes post-vaccination)

  30 minutes

• Solicited local and systemic AEs

  Percentage, intensity, and relationship to vaccination of solicited local and systemic AEs (for seven days following study vaccine administration)

  7 days

• Unsolicited AEs

  Percentage, intensity, and relationship of unsolicited AEs, including TEAEs, for 28 days following study vaccine administration

  28 days

• Urine, haematological and blood biochemistry values

  Number and percentage of participants with normal and abnormal, clinically significant urine, haematological and blood biochemistry values, and urinalysis at Screening visit and D3 (Phase 1 participants only)

  Screening and Day 3

• Deaths, SAEs, AEs leading to withdrawal, TEAEs

  Occurrences of deaths, SAEs, AEs leading to withdrawal, TEAEs, AESIs, NOCDs, and SUSARs up to the end of the study (D182)

  182 days

• HI antibody response (GMT)

  HI antibody response (GMT) induced in TVLP Groups versus commercial comparator Groups against the homologous influenza strains on D0 and D28

  Day 0 and Day 28

Study Arms (7)

Group 1 (18-64): 15 μg

EXPERIMENTAL

Biological: Recombinant Influenza vaccine candidate

Group 2 (18-64): 30 μg

EXPERIMENTAL

Biological: Recombinant Influenza vaccine candidate

Group 3 (18-64): 60 μg

EXPERIMENTAL

Biological: Recombinant Influenza vaccine candidate

Group 4 (18-64): STD TIV

ACTIVE COMPARATOR

Biological: Commercial Influenza vaccine

Group 5 (65+): 30 μg

EXPERIMENTAL

Biological: Recombinant Influenza vaccine candidate

Group 6 (65+): 60 μg

EXPERIMENTAL

Biological: Recombinant Influenza vaccine candidate

Group 7 (65+): HD TIV

ACTIVE COMPARATOR

Biological: Commercial Influenza vaccine

Interventions

Recombinant Influenza vaccine candidate BIOLOGICAL

Plant-Based Seasonal Recombinant Trivalent TVLP Influenza Vaccine

Group 1 (18-64): 15 μg; Group 2 (18-64): 30 μg; Group 3 (18-64): 60 μg; Group 5 (65+): 30 μg; Group 6 (65+): 60 μg

Commercial Influenza vaccine BIOLOGICAL

Influenza vaccine commercially available on the Canadian market

Group 4 (18-64): STD TIV; Group 7 (65+): HD TIV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Participants must be 18 years of age and older at the Vaccination visit (Visit 2).
• Participant must have a body mass index (BMI) ≤ 39 kg/m2 at the Vaccination visit (Visit 2).
• 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.

You may not qualify if:

• According to the Investigator's opinion, significant acute or chronic, uncontrolled medical or neuropsychiatric illness.
• Participant is pregnant or lactating.
• 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.
• 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.
• Administration of influenza vaccine within four months prior to the Vaccination visit (Visit 2).
• 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.
• 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.
• Administration of any medication or treatment that may alter the vaccine immune responses.
• 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.
• History of anaphylactic allergic reactions to plants or plants components (including fruits and nuts).
• Participants with a history of Guillain-Barré Syndrome.
• 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.
• 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.

Sponsors & Collaborators

• Aramis Biotechnologies Inc.: lead

Study Sites (7)

Canadian Center for Vaccinology (CCfV) - IWK Health

Halifax, Nova Scotia, B3K 6R8, Canada

RECRUITING

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

RECRUITING

Vaccine Study Centre of McGill University Health Centre

Pierrefonds, Quebec, H9H 4Y6, Canada

RECRUITING

CHU de Québec - Université Laval

Québec, Quebec, G1E 7G9, Canada

RECRUITING

Diex Recherche - Sherbrooke

Sherbrooke, Quebec, J1L 0H8, Canada

RECRUITING

Diex Recherche - Trois-Rivières

Trois-Rivières, Quebec, G9A 4P3, Canada

RECRUITING

Diex Recherche - Victoriaville

Victoriaville, Quebec, G6P 3Z8, Canada

RECRUITING

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Brian Ward, MD

  McGill University

  STUDY CHAIR

Central Study 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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 18, 2025
• Study Start: February 25, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

CA (7)