← Back to Search

Virus Therapy

Influenza Virus Challenge for Flu

Phase 1
Recruiting
Led By Matthew J Memoli, M.D.
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age between 18 and 50
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights

Study Summary

This trial is testing the smallest dose of influenza H10N7 virus that may cause an uncomplicated mild to moderate flu infection in healthy people.

Who is the study for?
Healthy adults aged 18-50 who can consent and agree to stay in isolation for at least 10 days without using tobacco, marijuana, or vaping. Women must meet specific fertility and HIV criteria; men must meet certain fertility conditions. Excludes those with significant medical issues, high-risk contacts, abnormal test results, recent illness or vaccinations, drug/alcohol abuse, psychiatric problems, non-English speakers.Check my eligibility
What is being tested?
The trial is testing the smallest dose of H10N7 flu virus that causes mild to moderate infection in healthy people. This will help evaluate new flu vaccines' effectiveness. Participants will receive one dose via nasal spray and be monitored closely with frequent tests and symptom surveys.See study design
What are the potential side effects?
Potential side effects may include typical flu symptoms such as fever, coughing, sore throat, aches but are expected to be mild to moderate given the controlled setting of the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 50 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The rate of MMID, defined as a positive FDA-approved clinical test for influenza plus one or more influenza symptoms, is induced.
Secondary outcome measures
Daily and total score on FLUPRO questionnaire and number and duration of symptoms and signs elicited by daily oral history and clinical exam

Trial Design

1Treatment groups
Experimental Treatment
Group I: 1Experimental Treatment1 Intervention
All participants receive challenge virus

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for influenza include neuraminidase inhibitors like oseltamivir and zanamivir, and the cap-dependent endonuclease inhibitor baloxavir. Neuraminidase inhibitors work by blocking the neuraminidase enzyme on the surface of the influenza virus, preventing the release of new viral particles and thereby limiting the spread of infection within the body. Baloxavir inhibits the viral polymerase enzyme, which is essential for viral RNA replication. These treatments are crucial for flu patients as they can reduce the severity and duration of symptoms, lower the risk of complications, and decrease viral shedding, which helps in controlling the spread of the virus. This is particularly important in the context of studying immune responses to the H10N7 virus, as effective antiviral treatments can provide a controlled environment to better understand the body's defense mechanisms.
Diagnostic difficulties of AH1N1 influenza infection in children with acute lymphoblastic leukemia: Two case reports.Treating influenza with statins and other immunomodulatory agents.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,278 Previous Clinical Trials
5,487,507 Total Patients Enrolled
Matthew J Memoli, M.D.Principal InvestigatorNational Institute of Allergy and Infectious Diseases (NIAID)
14 Previous Clinical Trials
38,113 Total Patients Enrolled

Media Library

A/Mallard/Ohio-99/MM4/1989 H10N7 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05436444 — Phase 1
Flu Research Study Groups: 1
Flu Clinical Trial 2023: A/Mallard/Ohio-99/MM4/1989 H10N7 Highlights & Side Effects. Trial Name: NCT05436444 — Phase 1
A/Mallard/Ohio-99/MM4/1989 H10N7 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05436444 — Phase 1
~67 spots leftby Oct 2024