InfluenzaPhase 1/2NCT07291635

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

A Phase 1/2 study testing Recombinant Influenza vaccine candidate and Commercial Influenza vaccine in people with Influenza, run by Aramis Biotechnologies Inc. at 7 sites in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: Recombinant Influenza vaccine candidate and Commercial Influenza vaccine
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 728 participants
Where: 7 sitesCanada
Study dates: 25 Feb 2026to Dec 2026
Phase: Phase 1/2
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.
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.

Who cannot join

According to the Investigator's opinion, significant acute or chronic, uncontrolled medical or neuropsychiatric illness.
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.
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.
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.).
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.

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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.
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.
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.

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

Canada7 sites

Canadian Center for Vaccinology (CCfV) - IWK Health
Halifax, Nova Scotia, B3K 6R8
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
Vaccine Study Centre of McGill University Health Centre
Pierrefonds, Quebec, H9H 4Y6
CHU de Québec - Université Laval
Québec, Quebec, G1E 7G9
Diex Recherche - Sherbrooke
Sherbrooke, Quebec, J1L 0H8
Diex Recherche - Trois-Rivières
Trois-Rivières, Quebec, G9A 4P3
Diex Recherche - Victoriaville
Victoriaville, Quebec, G6P 3Z8

Other trials in Canada

About this study

Official title: 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

Conditions: Influenza
Being tested: Recombinant Influenza vaccine candidate, Commercial Influenza vaccine
Medical subject headings: Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Recombinant Influenza vaccine candidateBiological
Plant-Based Seasonal Recombinant Trivalent TVLP Influenza Vaccine
Commercial Influenza vaccineBiological
Influenza vaccine commercially available on the Canadian market

Study groups in NCT07291635
Study group	Role	What they receive
Group 1 (18-64): 15 μg	Experimental	Not described Receives: Biological: Recombinant Influenza vaccine candidate
Group 2 (18-64): 30 μg	Experimental	Not described Receives: Biological: Recombinant Influenza vaccine candidate
Group 3 (18-64): 60 μg	Experimental	Not described Receives: Biological: Recombinant Influenza vaccine candidate
Group 4 (18-64): STD TIV	Active comparator	Not described Receives: Biological: Commercial Influenza vaccine
Group 5 (65+): 30 μg	Experimental	Not described Receives: Biological: Recombinant Influenza vaccine candidate
Group 6 (65+): 60 μg	Experimental	Not described Receives: Biological: Recombinant Influenza vaccine candidate
Group 7 (65+): HD TIV	Active comparator	Not described Receives: Biological: Commercial Influenza vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

Immediate AEs
Percentage, intensity, and relationship to vaccination of immediate AEs (30 minutes post-vaccination)
Measured: 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)
Measured: 7 days
Unsolicited AEs
Percentage, intensity, and relationship of unsolicited AEs, including TEAEs, for 28 days following study vaccine administration
Measured: 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)
Measured: 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)
Measured: 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
Measured: Day 0 and Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Feb 2026Dec 2026

First posted18 Dec 2025
Study start25 Feb 2026
Primary completionOct 2026 (estimated)
Study completionDec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for InfluenzaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 728 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07291635
Sponsor's protocol ID: CP-sFLUVLP-001
Status last verified: Aug 2026
First submitted: 26 Nov 2025
Last updated: 4 Aug 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT07291635
Acronym / sponsor ID: CP-sFLUVLP-001
Conditions: Influenza
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 728 participants (estimated)
Lead sponsor: Aramis Biotechnologies Inc.Industry (pharma, biotech, devices)
Study start: 25 Feb 2026 (actual)
Primary completion: Oct 2026 (estimated)
Study completion: Dec 2026 (estimated)
First posted: 18 Dec 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 7

Arm	Type	Receives
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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.
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.

Key exclusion criteria (16 listed)

According to the Investigator's opinion, significant acute or chronic, uncontrolled medical or neuropsychiatric illness.
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.
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.
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.).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Recombinant Influenza vaccine candidatePlant-Based Seasonal Recombinant Trivalent TVLP Influenza Vaccine	Biological	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 vaccineInfluenza vaccine commercially available on the Canadian market	Biological	Group 4 (18-64): STD TIV, Group 7 (65+): HD TIV

Primary outcome

Immediate AEs
Time frame: 30 minutes
Percentage, intensity, and relationship to vaccination of immediate AEs (30 minutes post-vaccination)
Solicited local and systemic AEs
Time frame: 7 days
Percentage, intensity, and relationship to vaccination of solicited local and systemic AEs (for seven days following study vaccine administration)
Unsolicited AEs
Time frame: 28 days
Percentage, intensity, and relationship of unsolicited AEs, including TEAEs, for 28 days following study vaccine administration
Urine, haematological and blood biochemistry values
Time frame: Screening and Day 3
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)
Deaths, SAEs, AEs leading to withdrawal, TEAEs
Time frame: 182 days
Occurrences of deaths, SAEs, AEs leading to withdrawal, TEAEs, AESIs, NOCDs, and SUSARs up to the end of the study (D182)
HI antibody response (GMT)
Time frame: Day 0 and Day 28
HI antibody response (GMT) induced in TVLP Groups versus commercial comparator Groups against the homologous influenza strains on D0 and D28

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Brian Ward, MD study chair

McGill University

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Recombinant Influenza vaccine candidate and Commercial Influenza vaccine in people with Influenza, run by Aramis Biotechnologies Inc. at 7 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Immediate AEs (time frame: 30 minutes). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07291635.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.