pH1N1 Virus for Flu
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine the optimal dose of a specific flu virus strain (pH1N1) to enhance future flu treatments. Volunteers will receive either the virus or a harmless placebo to identify the dose that reliably causes flu symptoms and to monitor safety concerns. Participants should be in good health and have no history of chronic conditions affecting breathing, such as asthma, in the past five years. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, providing participants the opportunity to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
You may need to stop taking certain medications, like oseltamivir, zanamivir, and some others, 7 days before and during the confinement period of the study. However, exceptions can be made with approval from the study doctor.
What prior data suggests that this protocol is safe for developing a Controlled Human Infection Model for influenza?
Research has shown that the A/Arkansas/08/2020 (pH1N1) virus used in this trial has undergone animal testing to assess its safety. In these tests, some doses proved either not harmful or only slightly harmful, indicating that the virus generally did not cause serious problems in animals. However, long-term safety information for humans is not yet available. As this is an early-stage trial, the primary goal is to determine the virus's safety for people and to identify the appropriate dose that causes mild flu-like symptoms without serious side effects. Researchers closely monitor participants to ensure their safety.12345
Why are researchers excited about this trial?
Researchers are excited about the pH1N1 virus treatment because, unlike traditional flu vaccines that use inactivated or attenuated viruses, this treatment uses a live virus delivered intranasally. This method could potentially offer more robust immunity by mimicking natural infection without causing the disease itself. Additionally, the intranasal delivery system might enhance immune response directly in the respiratory tract, where the flu virus typically enters the body, offering a targeted approach that could improve effectiveness over current injection-based vaccines.
What evidence suggests that this trial's treatments could be effective for influenza?
This trial uses the A/Arkansas/08/2020 (pH1N1) flu virus to determine the optimal dose for inducing flu symptoms in a controlled setting. Participants will be randomly assigned to different cohorts, each receiving varying doses of the virus. This helps scientists understand how the virus affects people and how future treatments might work. Flu vaccines have varied in effectiveness, averaging about 40% in recent years. The trial aims to improve understanding of the virus and enhance future vaccine strategies. Identifying the right dose is essential for developing better flu prevention methods.678910
Are You a Good Fit for This Trial?
This trial is for healthy adults who have low immunity to the pH1N1 flu strain, as shown by specific blood tests. They'll be part of a study that could include 30 to 120 people but is expected to involve around 60 plus an additional few receiving a placebo.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are challenged with the pH1N1 influenza virus or receive a sham inoculation to determine the optimal infectious dose
Follow-up
Participants are monitored for safety and effectiveness after treatment, including clinical symptoms and viral detection
What Are the Treatments Tested in This Trial?
Interventions
- A/Arkansas/08/2020 (pH1N1)
- Sham/Diluent (1X SPG+Arg+Gel)
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor