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New treatment option for Influenza
Official title Phase 1/2 Study of a Plant-Based Seasonal Recombinant Trivalent VLP Influenza Vaccine
ClinicalTrials.gov ID: NCT07291635
What this study is testing
What is Recombinant Influenza vaccine candidate?
Recombinant Influenza vaccine candidate is an investigational medicine, being studied as a potential treatment for influenza.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- Participants must have read, understood, and signed the informed consent form (ICF) prior to participating in the study; participants must also...
- 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...
- Participants cannot be living in an institutionalized setting (e.g. not living in rehabilitation centres or assisted living facilities; living in an...
You likely can't join if
- 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...
- 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...
- Current autoimmune disease requiring systemic treatment (such as rheumatoid arthritis, systemic lupus erythematosus or multiple sclerosis)...
- Administration of any non-influenza vaccine within 30 days prior to the Vaccination visit (Visit 2); planned administration of any vaccine up to Day...
See the full eligibility criteria
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Halifax, Nova Scotia, Canada
- Montreal, Quebec, Canada
- Pierrefonds, Quebec, Canada
- Québec, Quebec, Canada
- Sherbrooke, Quebec, Canada
- Trois-Rivières, Quebec, Canada
- Victoriaville, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Halifax, Nova Scotia, Canada; Montreal, Quebec, Canada; Pierrefonds, Quebec, Canada; Québec, Quebec, Canada; Sherbrooke, Quebec, Canada; Trois-Rivières, Quebec, Canada and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.