Flu Prevention Research Study

Seasonal influenza can lead to severe health complications, hospitalizations, or death, particularly in older adults, individuals with chronic medical conditions, and those with compromised immune systems. While yearly flu vaccines are recommended, real-world effectiveness can vary, and traditional vaccines rely on a healthy immune response to offer protection.

This flu prevention research study is evaluating the safety and effectiveness of an investigational single-dose injection aimed at preventing seasonal flu in adults and adolescents aged 12 and older who are at higher risk of flu complications due to age (65+), chronic health conditions, or weakened immunity (including those taking immunosuppressive therapies). By directly blocking the virus with a long-acting antiviral agent rather than relying solely on the body’s immune system, researchers hope this treatment can provide broad, season-long protection against influenza.

You may qualify for the flu prevention research study if you:

• Are 12 years of age or older
• Are at higher risk for complications from respiratory infections (like the flu) due to one of the following:
  • Being 65 years of age or older.
  • Having a stable chronic health condition, such as chronic lung disease, moderate-to-severe asthma, heart disease, insulin-dependent diabetes, or moderate kidney disease.
  • Having a weakened immune system due to a medical condition or treatment (such as recent cancer therapy, organ or stem cell transplant, advanced HIV, or taking medications that suppress the immune system).
• Are in stable overall health without recent hospitalizations or major changes in your ongoing medical treatments.
• Meet minimum body weight and body mass requirements.
• Are willing and able to follow study procedures, including completing health questionnaires on a smartphone, tablet, or electronic device.
• Agree to follow required birth control guidelines during the study, if applicable

You may not be eligible if you:

• Are currently pregnant, planning to become pregnant, or breastfeeding.
• Have an active fever, acute illness, or recent diagnosis or close contact with someone who has a viral respiratory infection (such as the flu or COVID-19).
• Have severe kidney disease or are currently undergoing dialysis treatment.
• Have a history of severe allergic reactions or anaphylaxis to similar treatments or study drug ingredients.
• Received a standard flu vaccine or specific preventive antiviral therapies within the required timeframe prior to starting the study.
• Had major surgery recently or have major surgery scheduled during the study period.
• Have a history of severe bleeding or blood-clotting disorders.
• Are currently enrolled in another clinical trial testing an experimental drug, or have previously taken part in a trial testing this specific medication.

Not sure if you qualify? That’s okay.

A member of our recruitment team will review your health history and medicines with you to see whether you may qualify.

You may also qualify for other studies.

By joining our flu prevention research study, you may receive or contribute to:

• Investigational Care at No Cost: Receive study-related medical evaluations, flu screening, laboratory tests, and the investigational study injection at no out-of-pocket cost.
• Specialist Medical Monitoring: Be closely monitored by experienced local doctors and research staff throughout your study participation.
• Advance Medical Research: Play a direct role in evaluating potential new flu prevention options for high-risk individuals in your community.
• Compensation: Reimbursement or compensation for study-related time, travel expenses, and completed study activities may be provided.
• Flexible Access: No health insurance or prior doctor’s referral is required to participate.

Here’s what to expect when you join this flu prevention research study:

• Study Treatment
  • Investigational Treatment: You will receive a single dose of the investigational study injection or a matching placebo.
  • Administration: Administered in the clinic by trained research staff as 3 subcutaneous (under-the-skin) injections during a single visit on Study Day 1.
• Study Duration
  • Total Participation: Participation typically lasts approximately 7 months (around 29 weeks), with an extended follow-up option if respiratory symptoms occur near the end of the study.
  • Screening Phase (Up to 21 days): Initial evaluations and health checks to confirm your eligibility before dosing.
  • Treatment & Follow-Up Phase (Approximately 28 weeks): A single dosing visit on Day 1 followed by periodic scheduled check-ins (in-clinic visits or phone calls) and regular eDiary updates on your smartphone or tablet.
• Health Assessments & Monitoring

During your scheduled visits and ongoing health surveillance, the research team will conduct routine health checks, which may include:

• • Electronic diary (eDiary) tracking for respiratory infection symptoms
  • Physical examinations, vital signs, and height/weight measurements
  • Nasal swabs and rapid antigen testing for respiratory viruses if symptoms develop
  • Routine safety blood tests, health questionnaires, and electrocardiograms (ECGs)

Compensation

Qualified participants who enroll and complete scheduled study visits and assessments may receive financial compensation or reimbursement for time and travel associated with trial participation.