H10N7 Flu for Viral Infections

Overseen By Luca T Giurgea, M.D.

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Must not be taking: Antidepressants, NSAIDs, Antibiotics

Disqualifiers: Chronic pulmonary, Cardiovascular, Diabetes, Immunosuppression, Neurological, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to better understand how the H10N7 strain of bird flu infects humans. Researchers hope to use this information to develop new vaccines and treatments for various flu strains. Participants will be re-exposed to the H10N7 virus in a controlled setting. Ideal candidates are healthy individuals who have previously participated in an H10N7 study and are willing to stay in isolation for at least 9 days. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to contribute to groundbreaking flu research.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that the H10N7 bird flu virus usually causes only mild symptoms in people. Previous studies have determined a safe amount of this virus for healthy volunteers. These studies aim to understand how the virus affects people without causing serious illness, creating mild to moderate symptoms in a safe and controlled way.

Although the virus originates from birds, tests in humans have reported no serious side effects. Participants in past studies did not experience severe reactions, indicating that the virus is generally well-tolerated. However, as this is an early-stage trial, researchers are still learning about its full safety in humans. ^{1 2 3 4}

Why are researchers excited about this trial?

Most treatments for viral infections, like the flu, typically involve vaccines or antiviral medications that target the virus after infection. However, the H10N7 Flu treatment is unique because it involves infecting individuals with the H10N7 virus, which might sound strange at first. Researchers are excited about this approach because it could potentially train the immune system in a controlled setting to better fight off similar viruses in the future. This method is different from traditional vaccines as it uses a live virus to stimulate an immune response, which might lead to stronger or broader immunity. This could pave the way for novel strategies in preventing or mitigating viral infections.

What evidence suggests that this treatment might be an effective treatment for flu?

Research has shown that the H10N7 bird flu virus, specifically the A/Mallard/Ohio-99/MM4/1989 strain, usually causes mild symptoms in people. In this trial, participants will be infected with the H10N7 virus to study its effects. Studies have found that a safe amount of this virus can cause mild to moderate illness in at least 60% of healthy volunteers. This helps researchers understand how the virus behaves in humans and supports the development of new flu treatments and vaccines. Unlike some other bird flu strains, this virus does not typically cause severe illness, making it useful for studying flu infections without posing major health risks. ^{1 2 5 6 7}

Who Is on the Research Team?

Luca T Giurgea, M.D.

Principal Investigator

National Institute of Allergy and Infectious Diseases (NIAID)

Are You a Good Fit for This Trial?

Healthy individuals aged 18 to 55 who were previously infected with the H10N7 bird flu in a past study. They must be willing to stay in hospital isolation for at least 9 days and have no visitors, providing various health samples throughout.

Inclusion Criteria

Willing to remain in isolation for a minimum of 9 calendar days and to comply with all study requirements

Ability to speak English

I am between 18 and 55 years old.

Exclusion Criteria

Body mass index (BMI) below 18.5 or above 35

Smoking or vaping habits exceeding specified limits

History of facial reconstructive procedures or nasopharyngeal malformation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Inpatient Infection and Monitoring

Participants are infected with H10N7 virus and monitored for infection and symptoms

9 days

Inpatient stay

Follow-up

Participants are monitored for safety and effectiveness after treatment

9 weeks

2 visits (in-person) at 5 weeks and 9 weeks

Extended Monitoring

Participants' immune response is evaluated over an extended period

2 years

What Are the Treatments Tested in This Trial?

Interventions

• A/Mallard/Ohio-99/MM4/1989 H10N7

Trial Overview The trial involves re-infecting participants with the H10N7 bird flu virus by spraying it into their nostrils. The aim is to observe how this strain of bird flu infects humans, which could inform future vaccine and treatment development.

How Is the Trial Designed?

Group I: H10N7 Infection Experimental Treatment 1 Intervention

Subjects will be infected with H10N7 virus.

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05436444

Low Pathogenicity Avian H10N7 Influenza Virus in a ... Determine the safe dose of A/Mallard/Ohio/99/1989 H10N7 human challenge virus that induces MMID in at least 60% of healthy volunteers or identify the rate of ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05436444?term=DUCK&rank=5

Low Pathogenicity Avian H10N7 Influenza Virus in a ... Determine the safe dose of A/Mallard/Ohio/99/1989 H10N7 human challenge virus that induces MMID in at least 60% of healthy volunteers or identify the rate of ...

3. withpower.com withpower.com/trial/phase-1-rna-viruses-9-2025-f5b4f

H10N7 Flu for Viral Infections · Info for Participants A/Mallard/Ohio-99/MM4/1989 H10N7. Trial Overview The trial involves re-infecting participants with the H10N7 bird flu virus by spraying it into their nostrils.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4834448/

Comparative effectiveness of high-dose versus standard ... Comparative effectiveness of high-dose versus standard-dose influenza vaccines in US residents aged 65 years and older from 2012 to 2013 using Medicare data

5. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0008935

Influenza Virus in a Natural Host, the Mallard Our study suggests that LPAI infection has minor clinically measurable effects on mallards and that mallard ducks are able to mount immunological responses.

6. clinicaltrial.be clinicaltrial.be/fr/details/16348?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

Low Pathogenicity Avian H10N7 Influenza Virus in a Health... Primary Objective: Determine the safe dose of A/Mallard/Ohio/99/1989 H10N7 human challenge virus that induces MMID in at least 60 ...

7. kobia.kr kobia.kr/bbs/download.php?tbl=data05&no=4944

해외 바이오의약품 임상 현황 ('23년 10월 4주) Low Pathogenicity Avian H10N7. Influenza Virus in a Healthy Human. Challenge Model. Biological: A/Mallard/Ohio-99/MM4/1989. H10N7. National Institute of Allergy ...