Clinical trial for Influenza (Healthy Volunteers)
Official title Establishing a Controlled Human Infection Model for Influenza H3N2 as a Foundation for Pandemic Preparedness
ClinicalTrials.gov ID: NCT07305207
What this study is testing
What is Intranasal inoculation of RG-A/Texas/71/2017 (H3N2) influenza in each naris on Day 1 of the study.?
Intranasal inoculation of RG-A/Texas/71/2017 (H3N2) influenza in each naris on Day 1 of the study. is an investigational medicine, being studied as a potential treatment for influenza (healthy volunteers).
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
- The overall objective is to establish an influenza Controlled Human Infection Model (CHIM) in Canada that can be used to assess the safety and efficacy of candidate vaccines, biologics, and therapeutics targeting influenza viruses.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45. Healthy volunteers may be eligible.
You may be able to join if
- Written informed consent obtained from the participant.
- 18-45 years of age.
- Good general health status, as determined by history and physical examination conducted no longer than 30 days prior to the challenge date.
- HAI antibody titer ≤1:40 against influenza A/Texas/71/2017 (H3N2).
- Eligibility laboratory values\ (complete blood cell count with differential (CBC-D), biochemistry (creatinine (Cr), total bilirubin, blood urea...
You likely can't join if
- Underlying chronic medical condition requiring ongoing follow-up and monitoring by a physician (e.g., diabetes, seizure disorder).
- Underlying renal disease or disorders requiring ongoing follow-up and monitoring by a physician. In the event a participant has a minimally elevated...
- Underlying coagulation disorder history. In the event a participant reports a personal history of undiagnosed prolonged bleeding and/or recurrent...
- Underlying cardiac conditions including:
- Hypertension, angina, or prior myocardial infarction
- Structural or functional cardiac disease (e.g., dilated cardiomyopathy, congestive heart failure)
See the full eligibility criteria
Who can join
- Written informed consent obtained from the participant.
- 18-45 years of age.
- Good general health status, as determined by history and physical examination conducted no longer than 30 days prior to the challenge date.
- HAI antibody titer ≤1:40 against influenza A/Texas/71/2017 (H3N2).
- Eligibility laboratory values\ (complete blood cell count with differential (CBC-D), biochemistry (creatinine (Cr), total bilirubin, blood urea nitrogen (BUN), aspartame aminotransferase (AST), alanine transaminase...
- Vital signs\ \ as follows:
- Pulse is 47 to 99 beats per minute
- Systolic blood pressure is 85 to 139 mmHg
- Diastolic blood pressure is 55 to 89 mmHg
- SpO2 ≥ 95%; RR ≤ 18
- Oral temperature is less than 38.1°C \ \ Clinical judgement when characterizing vital signs will be used in the context of certain populations according to the Toxicity Grading Scale for Healthy Adult and Adolescent...
- If a person is at risk of becoming pregnant, has practiced adequate contraception for 28 days prior to challenge, and has a negative pregnancy test on the screening day and the day before influenza A/H3N2 challenge...
- Documented hysterectomy
- Documented bilateral salpingectomy
- Documented bilateral oophorectomy
- Documented and current bilateral tubal ligation or occlusion
- Credible self-reported history of diagnosed infertility
- Hormone therapy (e.g. testosterone), provided it is administered consistently and medically assessed as sufficient to reduce pregnancy such that ovulation has ceased
- Any other condition, as determined by the Principal Investigator/study physician, that would render an individual incapable of becoming pregnant Adequate contraception is defined as a contraceptive method with a failure...
- Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, or transdermal
- Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, or implantable CI2403.03November2025\_V3.0 52
- Intra-uterine device (IUD) with or without hormonal release
- Vasectomized partner, if this is the participant's sole partner and the partner has received a medical assessment of the surgical success
- Credible (as deemed by the Investigator/study physician) self-reported history of abstinence for at least 28 days prior to challenge
- Participants who, in the opinion of the Investigator/study physician, can and will comply with the requirements of the protocol (e.g., inpatient stay, complete eDiary Cards, return for follow-up visits).
What rules you out
- Underlying chronic medical condition requiring ongoing follow-up and monitoring by a physician (e.g., diabetes, seizure disorder).
- Underlying renal disease or disorders requiring ongoing follow-up and monitoring by a physician. In the event a participant has a minimally elevated BUN and/or Cr at screening, the participant will either be excluded or...
- Underlying coagulation disorder history. In the event a participant reports a personal history of undiagnosed prolonged bleeding and/or recurrent nosebleeds or a personal or family history of coagulation disorders, a...
- Underlying cardiac conditions including:
- Hypertension, angina, or prior myocardial infarction
- Structural or functional cardiac disease (e.g., dilated cardiomyopathy, congestive heart failure)
- With a history of arrhythmias/dysrhythmias (e.g., torsades de pointes, atrial fibrillation)
- Cardiac conduction abnormalities (e.g., congenital or acquired heart block)
- Uncorrected or ongoing serum electrolyte abnormalities (e.g., hypokalemia, hypomagnesemia, hypocalcemia)
- Underlying pulmonary disease including asthma, emphysema, chronic bronchitis, pulmonary tuberculosis or any other structural or functional pulmonary condition (e.g., history of severe airway hyper-responsiveness).
- FEV1/FEV6 \< 0.73 as an indication of potential airflow limitation.
- Known allergy to excipients in the challenge virus inoculum and placebo. The excipient (diluent and placebo) is SPG: sucrose, KH2PO4, K2HPO4, L-glutamic acid.
- Moderate or severe symptoms of health anxiety, anxiety, and mood symptoms. Self-reported current diagnosis of a major psychiatric illness, including, but not limited to, a schizophrenia spectrum disorder, bipolar...
- Habitual\ \ \ smoker of tobacco, e-cigarettes or marijuana. \ \ \ Habitual smokers are those who smoke more than four cigarettes, other tobacco products, e-cigarettes (to include vaping and Juuling products) or...
- Any current daily use of illicit drugs whereby the individual and/or study staff assess that the individual cannot abstain from during the isolation period.
- Any current daily alcohol consumption whereby the individual and/or study staff assess that the individual cannot abstain during the isolation period.
- History of allergic rhinitis and/or any condition that causes similar symptoms, including chronic cough.
- Pregnant (known before or established at the time of screening using a urine pregnancy test) or breastfeeding.
- Immunocompromised (with HIV/AIDS or receiving immunosuppressive therapy involving steroids) or any medical condition or medication that leads to a compromised immune system.
- Screening blood work positive for HBV, HCV, or HIV.
- Influenza virus detected in NPS sample prior to challenge using RT-qPCR and/or culture isolation, or detection of other respiratory infection.
- Received influenza vaccination within the last 4 months prior to screening based on history described by participant or planned receipt up to Study Day 57.
- Living with, working with, or in close contact with children less than 6 months of age, or a household member(s) highly recommended to receive an annual influenza vaccination by NACI\ \ \ \ and that have not been...
- All children 6-59 months of age
- Adults and children with the following chronic health conditions: i. Cardiac or pulmonary disorders (including bronchopulmonary dysplasia, cystic fibrosis and asthma) ii. Diabetes mellitus and other metabolic diseases...
- Any contraindication to receiving oseltamivir or zanamivir including known history of negative/anaphylactic reactions. Inability to take capsules containing gelatin or sorbitol (oseltamivir) or lactose-intolerant...
- Recent (within the 6 months before Screening Day) nasal or sinus surgery or diagnosis with nasal polyps.
- Recent use (4 weeks of Screening Day) of intranasal steroids, antihistamines, or any substance (including legally prohibited or prescription drug) that is administered nasally.
- Receipt of any investigational drug or vaccine within 6 months prior to challenge. An investigational drug or vaccine is one that is still being tested in clinical trials that has not yet been authorized for use in...
- Receipt of any authorized vaccines within 2 weeks prior to being challenged.
- Previous moderate or severe laboratory-confirmed SARS-CoV-2/COVID-19, influenza infection, or any other respiratory virus infection (e.g., RSV) that required hospitalization.
- Head trauma (e.g., fracture of the cribriform plate) within 1 year of screening.
- Symptoms indicative of acute respiratory illness (such as fever, cough, difficulty breathing) identified during the physical examination done on Study Day -1 (check-in) or Day 1 before a participant is challenged. In...
- History of Bell's Palsy, Guillain-Barre, and/or facial paralysis.
- Receipt of facial cosmetic filler, or any facial neuromodulator, in the past 3 months.
- Self-reported sleep apnea that requires a continuous positive airway pressure (cPap) machine
- Receipt of blood or blood products during the six months prior to the planned date of challenge.
- Plans to donate blood anytime throughout the study.
- Any other finding that the Investigator/study physician considers will make the participant unsuitable for the study or unable to comply with the study requirements.
The study team makes the final eligibility decision.
Where it's taking place
- Halifax, Nova Scotia, Canada
Compensation & support
This study's listing mentions compensation or reimbursement.
No amount is published here - ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 to 45 years. 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. 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.