35 Participants Needed

Influenza Virus Challenge for Flu

RS
MJ
Overseen ByMatthew J Memoli, M.D.
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, it does exclude individuals with certain medical conditions and those who have received specific treatments recently, so it's best to discuss your medications with the trial team.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you have a significant medical condition or are taking certain medications like long-term aspirin therapy, you may be excluded from participating.

How is the drug A/Mallard/Ohio-99/MM4/1989 H10N7 different from other flu treatments?

The drug A/Mallard/Ohio-99/MM4/1989 H10N7 is unique because it involves a low pathogenicity avian influenza virus, which is not typically used in standard flu treatments. This approach may offer insights into how avian influenza viruses interact with hosts and could potentially inform the development of new strategies for managing flu infections.12345

How does the treatment A/Mallard/Ohio-99/MM4/1989 H10N7 differ from other flu treatments?

The treatment A/Mallard/Ohio-99/MM4/1989 H10N7 is unique because it involves using a low pathogenicity avian influenza virus, which is not a standard approach for treating flu in humans. This treatment is different from typical antiviral drugs like oseltamivir (Tamiflu) that target human-adapted flu strains.12345

What data supports the effectiveness of the treatment A/Mallard/Ohio-99/MM4/1989 H10N7 for flu?

The research indicates that low pathogenic avian influenza viruses, like H10N7, can trigger a strong but short-lived immune response in mallards, suggesting that the virus may be controlled effectively by the immune system. Additionally, similar H10N7 viruses have been involved in outbreaks, indicating their ability to cause infection, which may imply potential for vaccine development.15678

What data supports the effectiveness of the treatment A/Mallard/Ohio-99/MM4/1989 H10N7 for flu?

The research shows that low pathogenic avian influenza viruses, like H10N7, can trigger a strong but short-lived immune response in mallards, which are natural hosts. This suggests that the virus may be controlled effectively by the immune system, potentially indicating a similar response in humans.15678

Who Is on the Research Team?

MJ

Matthew J Memoli, M.D.

Principal Investigator

National Institute of Allergy and Infectious Diseases (NIAID)

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Agrees to not use tobacco products, marijuana, or vaping products during participation
I am a woman following specific fertility and contraception guidelines and do not have HIV.
Able to provide consent
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Exclusion Criteria

I have a serious long-term health condition like heart or lung disease.
I have a serious health condition like heart or lung disease, or I am immunocompromised.
I live with or am in close contact with high-risk individuals such as those over 65, under 5, or nursing home residents.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Inoculation and Monitoring

Participants are inoculated with one dose of the flu virus and monitored 24 hours a day in an isolation room for at least 10 days.

10 days
Continuous monitoring (in-patient)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with at least 4 follow-up visits over 8 weeks.

8 weeks
4 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • A/Mallard/Ohio-99/MM4/1989 H10N7
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: 1Experimental Treatment1 Intervention
All participants receive challenge virus

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials
3,361
Recruited
5,516,000+

Published Research Related to This Trial

Laughing gulls infected with low-pathogenicity avian influenza viruses (LPAIVs) primarily shed the virus through their respiratory system, indicating a potential for direct bird-to-bird transmission.
In contrast, mallards infected with different LPAIVs shed the virus through both respiratory and fecal routes, suggesting that water contamination plays a significant role in the spread of these viruses among birds.
Low-pathogenicity influenza viruses replicate differently in laughing gulls and mallards.Criado, MF., Moresco, KA., Stallknecht, DE., et al.[2021]
The low pathogenic avian influenza virus (LPAI) H1N1 triggers a strong but very short-lived innate immune response in mallards, with key immune genes RIG-I and Mx significantly upregulated just one day after infection but returning to normal levels by day two.
This rapid response suggests that the mallard's immune system has evolved to effectively control LPAI infections while minimizing potential damage from prolonged immune activation, highlighting the importance of the spleen in this process.
A rapid and transient innate immune response to avian influenza infection in mallards.Helin, AS., Wille, M., Atterby, C., et al.[2018]
The H10N7 avian influenza subtype caused outbreaks in Minnesota turkey farms in 1979 and 1980, with mortality rates reaching up to 31%, indicating a significant threat to poultry health.
The virus was found to be antigenically similar to strains isolated from healthy mallards nearby, suggesting that feral ducks may have introduced the virus to the turkey populations.
Influenza A outbreaks in Minnesota turkeys due to subtype H10N7 and possible transmission by waterfowl.Karunakaran, D., Hinshaw, V., Poss, P., et al.[2007]

Citations

Low-pathogenicity influenza viruses replicate differently in laughing gulls and mallards. [2021]
A rapid and transient innate immune response to avian influenza infection in mallards. [2018]
Influenza A outbreaks in Minnesota turkeys due to subtype H10N7 and possible transmission by waterfowl. [2007]
Development of Eurasian H7N7/PR8 high growth reassortant virus for clinical evaluation as an inactivated pandemic influenza vaccine. [2008]
A Comparative Study of the Innate Humoral Immune Response to Avian Influenza Virus in Wild and Domestic Mallards. [2020]
Pathobiology and virus shedding of low-pathogenic avian influenza virus (A/H1N1) infection in mallards exposed to oseltamivir. [2013]
Reoccurrence of Avian Influenza A(H5N2) Virus Clade 2.3.4.4 in Wild Birds, Alaska, USA, 2016. [2018]
Two avian H10 influenza A virus strains with different pathogenicity for mink (Mustela vison). [2019]
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