Flu Challenge Study
Recruiting in Palo Alto (17 mi)
+2 other locations
Overseen byNadine Rouphael, MD
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: Emory University
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
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.
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.
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.
12345What 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.
14678Is 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.
126910Eligibility 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
+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.
+4 more
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
Emory University HospitalAtlanta, GA
Hope ClinicAtlanta, GA
Emory Children's Center Vaccine Research ClinicAtlanta, GA
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Who Is Running the Clinical Trial?
Emory UniversityLead Sponsor
References
Estimates of the number of human infections with influenza A(H3N2) variant virus, United States, August 2011-April 2012. [2021]Thirteen human infections with an influenza A(H3N2) variant (H3N2v) virus containing a combination of gene segments not previously associated with human illness were identified in the United States from August 2011 to April 2012. Because laboratory confirmation of influenza virus infection is only performed for a minority of ill persons and routine clinical tests may not identify H3N2v virus, the count of laboratory-confirmed H3N2v virus infections underestimates the true burden of illness.
[The 2002/2003 influenza season in the Netherlands and the vaccine composition for the 2003/2004 season]. [2014]As in the 2000/2001 and 2001/2002 seasons, the influenza epidemic in the 2002/2003 season started late (week 7 of 2003) and was only moderate in size. Influenza A (H3N2) and B viruses were detected in equal numbers among patients of general practitioners and these two viruses were therefore equally responsible for the epidemic. However, H3N2 viruses dominated isolates taken from hospitals. In haemagglutination-inhibition (HI) assays most of the H3N2 viruses proved highly reactive with antiserum to the vaccine-reference strain A/Moscow/10/99. This was also true for a number of isolates, including those obtained from nursing home residents, closely related to the reference strain A/Finland/170/03. However, an estimated 4% of the H3N2 isolates belonged to the variant A/Fujian/411/02 from China, which constituted the majority of the H3N2 viruses isolated in Europe in the later phase of the season. This variant reacted poorly with antiserum to A/Moscow/10/99. In H1 tests all influenza A(H1N1)-virus isolates and all B-virus isolates were closelyrelated to the corresponding vaccine-reference strains. Taking this data into consideration, the World Health Organization has advised the same vaccine composition for the 2003/2004 season as for the 2002/2003 season, namely: A/Moscow/10/99 (H3N2), A/New Caledonia/20/99 (H1N1) and B/Hong Kong/330/01. There is the possibility of a mismatch occurring between the H3N2-vaccine strain and the circulating H3N2 viruses in the coming influenza season. In March and April 2003 there was an outbreak of influenza-A (H7N7) fowl plague in the Netherlands. A special monitoring survey revealed that 91 people who had handled infected poultry became infected with the H7N7 virus. One of these later died as a result of this. None of the avian and human H7N7-virus isolates examined contained human or porcine influenza-A virus genes.
Distinguishing characteristics between pandemic 2009-2010 influenza A (H1N1) and other viruses in patients hospitalized with respiratory illness. [2021]Differences in clinical presentation and outcomes among patients infected with pandemic 2009 influenza A H1N1 (pH1N1) compared to other respiratory viruses have not been fully elucidated.
Validation of the wild-type influenza A human challenge model H1N1pdMIST: an A(H1N1)pdm09 dose-finding investigational new drug study. [2018]Healthy volunteer wild-type influenza challenge models offer a unique opportunity to evaluate multiple aspects of this important virus. Such studies have not been performed in the United States in more than a decade, limiting our capability to investigate this virus and develop countermeasures. We have completed the first ever wild-type influenza A challenge study under an Investigational New Drug application (IND). This dose-finding study will lead to further development of this model both for A(H1N1)pdm09 and other strains of influenza.
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]Outcome data from prospective follow-up studies comparing infections with different influenza virus types/subtypes are limited.
A Dose-finding Study of a Wild-type Influenza A(H3N2) Virus in a Healthy Volunteer Human Challenge Model. [2021]The development of vaccines and therapeutics has relied on healthy volunteer influenza challenge studies. A validated human infection model with wild-type A(H1N1)pdm09 was reported previously. Our objective was to characterize a wild-type influenza A/Bethesda/MM1/H3N2 challenge virus in healthy volunteers.
Human trials with wild-type H1N1 and recombinant H3N2-H1N1 influenza A viruses of 1977-1978. [2021]A series of trials was conducted in which wild-type A/USSR/90/77 (H1N1) influenza A virus and a few of its antigenic variants were inoculated into volunteers. Infections readily occurred in people of all ages who had initial low antibody titers, but clinical effects were generally mild in comparison with those of the previously tested subtypes, H0N1, H1N1, H2N2, H3N2. There was, however, an inverse relationship between severity of symptoms and age of volunteers, although the incidence of virus excretion and of increase in anti-hemagglutinin was apparently not age related. Naturally occurring recombinant viruses with H3 hemagglutinin and one or more genes of A/USSR/098/77-like strains were likewise studied in volunteers. These clones also produced mild symptoms, providing evidence of an attenuating effect on H3N2 viruses by the substitution of some of its genes with the genes of an H1N1 virus.
Characterisation of a wild-type influenza (A/H1N1) virus strain as an experimental challenge agent in humans. [2018]Human challenge models using respiratory viruses such as influenza are increasingly utilised in the development of novel vaccines and anti-viral modalities and can provide preliminary evidence of protection before evaluation in field trials. We describe the results of a clinical study characterising an A/H1N1 influenza challenge virus in humans.
[Characterization of epidemic influenza virus A(H3N2) strains circulating in Russia in the 2003-2004 epidemic season]. [2016]Studies indicated that the epidemic rise in the incidence of influenza was caused by its virus A (H3N2) circulation in Russia in the 2003-2004 season. The Center of Influenza Ecology and Epidemiology investigated 101 epidemic strains isolated the MDCK culture. Antigenic analysis showed that all viruses A(H3N2) were similar to the reference virus A/Fujian/411/02(H3N2) and only 5 strains slightly differed from the latter. Twelve (14%) strains resistant to rimantadine at a concentration of 0.5 mg/ml were identified. Investigation of paired sera from the patients demonstrated a rise of antibodies to the references of influenza virus A(H3N2) in 68.7% of cases and a less increase in those to influenza viruses A(H1N1) and B. The active circulation of A(H3N2) viruses was due not only to changes in their antigenic structure, but also to the low level of antibodies to these viruses, as shown by the analysis of donor sera.
Human infections with novel reassortant influenza A(H3N2)v viruses, United States, 2011. [2022]During July-December 2011, a variant virus, influenza A(H3N2)v, caused 12 human cases of influenza. The virus contained genes originating from swine, avian, and human viruses, including the M gene from influenza A(H1N1)pdm09 virus. Influenza A(H3N2)v viruses were antigenically distinct from seasonal influenza viruses and similar to proposed vaccine virus A/Minnesota/11/2010.