80 Participants Needed

Flu Challenge Study

Recruiting at 2 trial locations
Nadine Rouphael, MD, MSc profile photo
Overseen ByNadine Rouphael, MD, MSc
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

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

Yes, you must stop taking certain medications that could impact the influenza challenge. This includes prescription or over-the-counter medications like oseltamivir, zanamivir, and others, starting 14 days before and during the quarantine period, unless approved by the investigator.

Will I have to stop taking my current medications?

The trial requires participants to stop using certain medications that could affect the flu challenge or symptoms, such as flu antivirals, aspirin, and some over-the-counter drugs, at least 14 days before and during the quarantine period. It's best to discuss your specific medications with the study investigator to see if they are allowed.

What data supports the idea that Influenza Virus Challenge for Flu is an effective treatment?

The available research does not provide specific data supporting the effectiveness of the Influenza Virus Challenge for Flu as a treatment. The studies mainly discuss the characteristics and spread of different influenza strains, such as H3N2, and the challenges in matching vaccine strains to circulating viruses. There is no direct evidence or comparison to other treatments for the flu in the provided information.12345

What data supports the effectiveness of the treatment Influenza Virus Type A H3N2 Challenge, H3N2 Influenza Challenge Virus, Influenza A(H3N2) Challenge Virus?

The research indicates that the H3N2 virus was a significant part of the influenza epidemic in the 2002/2003 season, and the vaccine composition for the following season included a strain closely related to the H3N2 virus, suggesting its importance in flu prevention efforts.12345

What safety data exists for the Influenza A(H3N2) Challenge Virus?

The safety data for the Influenza A(H3N2) Challenge Virus is derived from human challenge studies. These studies have shown that infections with H3N2 viruses generally produce mild symptoms, especially when compared to other influenza subtypes. The studies also indicate that the severity of symptoms is inversely related to the age of the volunteers, with older participants experiencing milder symptoms. Additionally, recombinant H3N2 viruses with genes from H1N1 strains have been shown to produce mild symptoms, suggesting an attenuating effect. Overall, these studies provide evidence of the safety profile of the H3N2 challenge virus in healthy volunteers.14678

Is the Influenza A(H3N2) Challenge Virus safe for humans?

Studies involving the Influenza A(H3N2) Challenge Virus in healthy volunteers have shown that infections generally produce mild symptoms, suggesting it is generally safe for humans.14678

Is the Influenza Virus Type A H3N2 Challenge a promising treatment for flu?

The Influenza Virus Type A H3N2 Challenge is a promising treatment because it helps researchers understand how the virus behaves and how the body responds. This knowledge is crucial for developing effective vaccines and treatments for the flu.126910

How is the Influenza Virus Type A H3N2 Challenge treatment different from other flu treatments?

The Influenza Virus Type A H3N2 Challenge treatment is unique because it involves intentionally exposing healthy volunteers to a specific strain of the flu virus (H3N2) to study the virus and develop vaccines, rather than treating existing flu infections. This approach helps researchers understand how the virus behaves and how the immune system responds, which is different from typical flu treatments that focus on alleviating symptoms or preventing infection.126910

What is the purpose of this trial?

This study examines how the immune system responds to the flu virus (H3N2) during and after infection and how the flu virus is transmitted in the environment. The study will used a flu virus called the H3N2 influenza challenge virus which was produced specifically for use in clinical research in controlled conditions. The study will also assess the safety of the H3N2 influenza challenge in healthy subjects. Mild to moderate symptoms are expected based on previous studies with this strain of influenza.

Research Team

NR

Nadine Rouphael, MD

Principal Investigator

Emory University

Eligibility Criteria

Healthy adults aged 18-49 who can follow study procedures and are not pregnant, breastfeeding, or planning to become pregnant. They must use birth control if applicable, avoid certain medications before and during the trial, not smoke or use tobacco products, and have no chronic diseases like asthma or heart conditions.

Inclusion Criteria

Are able to understand and comply with all planned study procedures
I will not take certain medications that could affect flu study results for 14 days before and during the study.
Demonstrate knowledge and comprehension of the study by scoring ≥70% on a quiz of the study protocol and policies
See 7 more

Exclusion Criteria

I am in close contact with vulnerable individuals, including young children, pregnant women, elderly, or those with chronic conditions.
I have been on high-dose steroids for more than 2 weeks in the last 3 months.
I have an active HIV, hepatitis B, or hepatitis C infection.
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Challenge and Observation

Participants are exposed to the influenza virus and observed for symptoms

8-12 days
Inpatient stay at Emory University Hospital

Follow-up

Participants are monitored for safety and effectiveness after the challenge

Up to 12 weeks
Outpatient visits at the Hope Clinic of the Emory Vaccine Center

Treatment Details

Interventions

  • Influenza Virus Type A H3N2 Challenge
Trial Overview The trial is testing how people's immune systems respond to a controlled flu virus infection (H3N2 strain) and how this virus spreads in an environment. It aims to understand the body's defense mechanisms against flu and assesses the safety of exposing healthy individuals to this specific flu strain.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Influenza Challenge Model with Influenza A H3N2 StrainExperimental Treatment1 Intervention
Participants exposed to a previously validated influenza challenge model with influenza A H3N2 strain (A/Perth/16/2009 H3N2).

Influenza Virus Type A H3N2 Challenge is already approved in United States, United Kingdom for the following indications:

🇺🇸
Approved in United States as H3N2 Influenza Challenge Virus for:
  • Research Use Only - Not for Therapeutic Use
🇬🇧
Approved in United Kingdom as H3N2 Influenza Challenge Virus for:
  • Research Use Only - Not for Therapeutic Use

Find a Clinic Near You

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials
1,735
Recruited
2,605,000+

Findings from Research

The study estimated that there were approximately 2055 illnesses caused by the H3N2v virus in the U.S. from August 2011 to April 2012, indicating that the virus was more widespread than laboratory-confirmed cases suggested.
Using a multiplier model, the researchers found that the true burden of illness was significantly underestimated, with multipliers of 200 for children and 255 for adults, highlighting the need for improved surveillance and detection of H3N2v infections.
Estimates of the number of human infections with influenza A(H3N2) variant virus, United States, August 2011-April 2012.Biggerstaff, M., Reed, C., Epperson, S., et al.[2021]
The 2002/2003 influenza season saw a moderate epidemic primarily caused by Influenza A (H3N2) and B viruses, with H3N2 dominating hospital isolates, indicating a need for effective monitoring and vaccination strategies.
A variant of H3N2, A/Fujian/411/02, was identified as a potential concern due to its poor reaction with the vaccine strain, suggesting a risk of vaccine mismatch for the upcoming season.
[The 2002/2003 influenza season in the Netherlands and the vaccine composition for the 2003/2004 season].de Jong, JC., Rimmelzwaan, GF., Bartelds, AI., et al.[2014]
During the peak of the 2009 H1N1 pandemic, 52% of hospitalized patients had a single respiratory virus, with pH1N1 being associated with more severe symptoms like fever, cough, and gastrointestinal issues compared to other viruses.
The mortality rate for patients with pH1N1 was higher (2.1%) than for those with other respiratory viruses (0.3%), indicating a greater risk associated with pH1N1 infection.
Distinguishing characteristics between pandemic 2009-2010 influenza A (H1N1) and other viruses in patients hospitalized with respiratory illness.Chan, PA., Mermel, LA., Andrea, SB., et al.[2021]

References

Estimates of the number of human infections with influenza A(H3N2) variant virus, United States, August 2011-April 2012. [2021]
[The 2002/2003 influenza season in the Netherlands and the vaccine composition for the 2003/2004 season]. [2014]
Distinguishing characteristics between pandemic 2009-2010 influenza A (H1N1) and other viruses in patients hospitalized with respiratory illness. [2021]
Validation of the wild-type influenza A human challenge model H1N1pdMIST: an A(H1N1)pdm09 dose-finding investigational new drug study. [2018]
Comparison of the Outcomes of Individuals With Medically Attended Influenza A and B Virus Infections Enrolled in 2 International Cohort Studies Over a 6-Year Period: 2009-2015. [2022]
A Dose-finding Study of a Wild-type Influenza A(H3N2) Virus in a Healthy Volunteer Human Challenge Model. [2021]
Human trials with wild-type H1N1 and recombinant H3N2-H1N1 influenza A viruses of 1977-1978. [2021]
Characterisation of a wild-type influenza (A/H1N1) virus strain as an experimental challenge agent in humans. [2018]
9.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Characterization of epidemic influenza virus A(H3N2) strains circulating in Russia in the 2003-2004 epidemic season]. [2016]
10.United Statespubmed.ncbi.nlm.nih.gov
Human infections with novel reassortant influenza A(H3N2)v viruses, United States, 2011. [2022]
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