Influenza Human Challenge Model
Emory University
Summary
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.
Description
Influenza continues to cause a significant burden of disease globally and in the United States. In the United States alone, it's estimated that in the 2017-2018 season there were 959,000 hospitalizations related to influenza illness, and 79,400 deaths. Worldwide, the World Health Organization (WHO) estimates that annual influenza epidemics cause 3-5 million cases of severe disease, with 290,000-650,000 of these severe cases resulting in death. Although annual influenza immunizations are recommended and antivirals are available, both have several limitations. The efficacy of the seasonal influe…
Eligibility
- Age range
- 18–49 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Provide written informed consent prior to initiation of any study procedures. * Are able to understand and comply with all planned study procedures. * Healthy males and non-pregnant, non-breast-feeding females aged ≥18 and ≤49 years of age inclusive at enrollment. * Women of childbearing potential must be practicing abstinence or using an acceptable method of birth control for at least 30 days prior to enrollment through the duration of the trial. Male subjects must agree not to father a child for the duration of the trial. * Women of childbearing potential must have a n…
Interventions
- BiologicalInfluenza Virus Type A H3N2 Challenge
The intervention product is a live challenge virus that is manufactured in the USA under Good Manufacturing Practice (GMP). The challenge will be administered intranasally using a sprayer device, by natural exposure to infected participants, by inhalation from an aerosol generator or nebulizer, or by inhalation within a tent. Participants will be admitted to the hospital and quarantined for 8 to 12 days for monitoring, and will receive care and supportive treatment as necessary. Participants will be followed for a total of 12 weeks.
Locations (2)
- Hope ClinicAtlanta, Georgia
- Emory University HospitalAtlanta, Georgia