What side effects are associated with this type of intervention?

The most common treatments for influenza include oseltamivir, baloxavir, zanamivir, and peramivir. Oseltamivir is associated with gastrointestinal side effects such as nausea and vomiting, as well as dizziness. Baloxavir is generally well-tolerated but can cause diarrhea and vomiting, particularly in children, and has been linked to hypersensitivity reactions like anaphylaxis. Zanamivir can cause bronchospasm, especially in patients with asthma or chronic respiratory conditions, and gastrointestinal side effects. Peramivir, typically reserved for patients who cannot tolerate oral or inhaled agents, shares similar side effects with other neuraminidase inhibitors but is administered parenterally.

What prior FDA approvals exist?

The FDA has approved several antiviral drugs for the treatment of influenza. Oseltamivir (Tamiflu) is approved for use in children and adults and can shorten the duration of flu symptoms by about one day. Zanamivir (Relenza), administered via inhalation, is also approved and has shown efficacy in reducing symptom duration. Peramivir (Rapivab), given as a single intravenous dose, is approved for acute uncomplicated influenza and has demonstrated similar efficacy to oseltamivir. Baloxavir marboxil (Xofluza) is another approved antiviral that has shown to reduce the duration of flu symptoms and is effective against influenza B virus. These treatments are similar to those being studied for the Influenza H10N7 virus in terms of their antiviral properties and their role in managing flu symptoms.

What other types of research exist?

Promising, novel alternatives to Influenza H10N7 Virus for flu patients considering treatment in 2024 include: 1) H10N8 vaccine candidate based on A/Jiangxi-Donghu/346/13, which is being developed for both vaccine and monoclonal antibody research. 2) H7N9 virus-like particle (VLP) vaccines, which have shown complete protection in animal models and could be a critical alternative to traditional vaccines. 3) T cell-based vaccines, which are being explored for their potential to provide cross-protective immunity against various influenza strains.

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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

Must not have

Significant medical conditions including chronic pulmonary disease, chronic cardiovascular disease, chronic medical conditions requiring close medical follow-up or hospitalization, immunosuppression, ongoing malignancy, and neurological and neurodevelopmental conditions

Close or household high-risk contacts including persons over 65 years of age, children under 5 years of age, and residents of nursing homes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 28 days

Awards & highlights

No Placebo-Only Group

Summary

This trial involves giving healthy adults a small dose of the H10N7 flu virus. Researchers will observe how their bodies respond to help develop better flu vaccines.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a serious health condition like heart or lung disease, or I am immunocompromised.

Select...

I live with or am in close contact with high-risk individuals such as those over 65, under 5, or nursing home residents.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28 days

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The rate of MMID, defined as a positive FDA-approved clinical test for influenza plus one or more influenza symptoms, is induced.

Secondary study objectives

Daily and total score on FLUPRO questionnaire and number and duration of symptoms and signs elicited by daily oral history and clinical exam

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: 1Experimental Treatment1 Intervention

All participants receive challenge virus

0 / 3Eligibility criteria met

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.