Influenza A H3N2 Human Challenge Study in Healthy Adult Volunteers (NCT02594189) | Clinical Trial Compass
CompletedPhase 1
Influenza A H3N2 Human Challenge Study in Healthy Adult Volunteers
United States49 participantsStarted 2015-10-31
Plain-language summary
Background:
Influenza A H3N2 is a flu virus. Symptoms include fever, cough, and runny nose. It can also be more serious. Researchers want to know more about how influenza causes disease in people. They hope to develop new vaccines and treatments for flu infection.
Objective:
To find the smallest amount of Influenza A H3N2 virus that causes a mild to moderate flu infection in healthy people. Also, to study the body s immune response to this virus and how the infection develops.
Eligibility:
Healthy people ages 18 50 who are:
Non-smokers or non-habitual smokers
Willing to not smoke for at least 9 days
Design:
Participants will be screened under NIAID protocol #11-I-0183
Participants will stay at an isolation unit at the clinic for at least 9 days. They will remain in the isolation unit except for study-specific activities.
The influenza virus will be sprayed into the nose.
Participants will be monitored 24 hours a day. They will have tests, including:
Medical history
Physical exam
Daily questionnaires about symptoms
Blood and urine tests
Nasal wash and swab: A small tube of salt water is placed in the nose to wash it. It then collects the
fluid. Or the inside of the nose is rubbed with a swab.
ECG: Measures the heart s electrical signals
ECHO: Sound waves take pictures of the heart
PFTs/Spirometry: They will blow into a machine that measures the air they blow.
Participants will be discharged after they test negative for influenza A.
Participants will return to the clinic for 4 follow-up visits over 8 weeks. They may complete questionnaires at home.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion criteria
✓. Greater than or equal to 18 and less than or equal to 50 years of age.
✓. Agrees to not use tobacco products during participation in this study.
✓. Willingness to remain in isolation for the duration of viral shedding (at a minimum 9 days) and to comply with all study requirements.
✓. A female participant is eligible for this study if she is not pregnant or breastfeeding and meets 1 of the following criteria:
✓. Willing to have samples stored for future research.
✓. Pre-challenge serum hemaglutination-inhibition titer against the challenge strain of less than 1:40.
✓. HIV uninfected.
Exclusion criteria
✕. Presence of self-reported or medically documented significant medical condition including but not limited to:
Determine the minimally to moderately infective dose (MMID) of influenza A H3N2 human challenge virus, defined as the dose that induces uncomplicated mild to moderate influenza infection in at least 60% of healthy volunteers.
Timeframe: 2 yr
Trial details
NCT IDNCT02594189
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
✕. Chronic medical conditions requiring close medical follow-up or hospitalization during the past 5 years (e.g., insulin-dependent diabetes mellitus, renal dysfunction, hemoglobinopathies).