Influenza Challenge Study to Determine the Optimal Infection Dose and Safety of a Recombinant H3N2 (A/Texas/71/2017 (H3N2, Clade 3C3a) Influenza Strain
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial uses a specially made flu virus to find the safest dose that still makes people sick. Healthy adults are chosen because they are less likely to have other health issues. Researchers give different doses of the virus and watch how the body responds to find the best amount for future studies.
Will I have to stop taking my current medications?
The trial requires participants to stop using certain medications, such as specific antiviral drugs and over-the-counter medications like aspirin and NSAIDs, at least 7 days before and during the confinement period, unless approved by the investigator. If you are on other medications, it is best to discuss with the study team to see if they are allowed.
Is the treatment generally safe for humans?
The treatment, evaluated under different names, has been studied in various contexts, including influenza vaccines. Some studies report that vaccines are generally well tolerated, but allergic reactions like anaphylaxis (a severe allergic reaction) can occur in some individuals. These reactions may not be directly caused by the vaccine's unique components.12345
How does the Influenza RG-A/Texas/71/2017 (H3N2) Challenge treatment differ from other influenza treatments?
The Influenza RG-A/Texas/71/2017 (H3N2) Challenge treatment is unique because it involves a specific H3N2 strain that has evolved to escape antibodies elicited by existing vaccines, making it a valuable tool for studying immune responses and vaccine effectiveness against this variant. This strain has specific changes in its hemagglutinin protein that affect how it binds to cells and evades immune detection, which is not typically addressed by standard influenza vaccines.678910
What data supports the effectiveness of the drug Influenza RG-A/Texas/71/2017 (H3N2) Challenge?
The research indicates that influenza vaccines, including those targeting H3N2 strains, often face challenges due to the virus's ability to mutate, leading to reduced effectiveness. However, the World Health Organization updates vaccine formulations to improve their match with circulating strains, which suggests ongoing efforts to enhance vaccine effectiveness.1112131415
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Challenge
Participants are challenged with a recombinant H3N2 influenza virus to determine the optimal infection dose and safety
Post-challenge Monitoring
Participants are monitored for viral shedding, clinical symptoms, and immune responses
Follow-up
Participants are monitored for safety and effectiveness after the challenge
What Are the Treatments Tested in This Trial?
Interventions
- Influenza RG-A/Texas/71/2017 (H3N2) Challenge
- Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor