Influenza A H3N2 Human Challenge Study in Healthy Adult Volunteers

Completed · Phase 1

Conditions studied: Determine Minimally to Moderately Infective Dose (MMID) of Influenza A H3N2

In brief

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.

Key facts

Study ID

NCT02594189

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

49

Starts

2015-10-31

Expected to finish

2017-11-01

Last updated by the study team

2019-12-03

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Presence of self-reported or medically documented significant medical condition including but not limited to:
• Chronic pulmonary disease (e.g., asthma, emphysema).
• Chronic cardiovascular disease (e.g., cardiomyopathy, congestive heart failure, cardiac surgery, ischemic heart disease, known anatomic defects).
• Chronic medical conditions requiring close medical follow-up or hospitalization during the past 5 years (e.g., insulin-dependent diabetes mellitus, renal dysfunction, hemoglobinopathies).
• Immunosuppression or ongoing malignancy.
• Neurological and neurodevelopmental conditions (e.g., cerebral palsy, epilepsy, stroke, seizures).
• Post infectious or post vaccine neurological sequelae.
• Have close or household (i.e., share the same apartment or house) high-risk contacts including but not limited to:
• Persons more than or equal to 65 years of age.
• Children less than or equal to 5 years of age.
• Residents of nursing homes.
• Persons of any age with significant chronic medical conditions such as:
• Chronic pulmonary disease (e.g., asthma).
• Chronic cardiovascular disease (e.g., cardiomyopathy, congestive heart failure, cardiac surgery, ischemic heart disease, known anatomic defects).
• Contacts who required medical follow-up or hospitalization during the past 5 years because of chronic medical conditions (e.g., insulindependent diabetes mellitus, renal dysfunction, hemoglobinopathies).
• Immunosuppression or cancer.
• Neurological and neurodevelopmental conditions (e.g., cerebral palsy, epilepsy, stroke, seizures).
• Persons who are receiving long-term aspirin therapy.
• Women who are pregnant, trying to become pregnant, or breastfeeding.
• Individual with body mass index (BMI) less than or equal to 18.5 and more than 40.
• Smokes more than 4 cigarettes or other tobacco products on weekly basis.
• Complete blood count (CBC) with differential outside of the NIH DLM normal reference range and deemed clinically significant by the PI.
• Chemistries in the acute care, mineral, and/or hepatic panels, and/or any of the following: lactate dehydrogenase, uric acid, creatine kinase, and total protein outside of the NIH DLM normal reference range and deemed clinically significant by the PI.
• Urinalysis outside of the NIH DLM normal reference range and deemed clinically significant by the PI.
• Clinically significant abnormality as deemed by the PI on electrocardiogram (EKG)

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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