Influenza A 2009 H1N1 Challenge Study in Healthy Adults
Completed · Phase 1/Phase 2
Conditions studied: Influenza
In brief
Background: \- A challenge study exposes a person to a disease and allows researchers to study the disease through the body's healing process. An influenza challenge study that looks at different amounts of the flu virus can provide more information on the smallest amount needed to cause an infection. Researchers want to give one dose of the Influenza A H1N1 virus to healthy volunteers to see how the body responds to the virus. Objectives: * To find the smallest dose of Influenza A H1N1 virus that may cause a mild to moderate flu infection in a healthy adult. * To study how the body s immune system responds to the virus. Eligibility: * Healthy volunteers at least 18 years of age. * Participants must be willing to remain in isolation for a minimum of 9 days. Design: * Participants will be admitted to a hospital inpatient isolation unit. They will be screened with a physical exam and medical history. They will also have heart and lung function tests. Blood, urine, and nasal swab/wash samples will be collected. * Participants will receive a single nasal spray of the flu virus. They will stay on the inpatient unit for at least 9 days. * Participants will be monitored for the length of their stay. They will have frequent blood tests and other procedures as needed. * Participants will be allowed to go home once they have had two negative tests for the virus. The tests will be given on two consecutive days....
Key facts
- Study ID
- NCT01646138
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 49
- Starts
- 2012-02-01
- Expected to finish
- 2013-12-01
- Last updated by the study team
- 2016-05-09
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: 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., diabetes mellitus, renal dysfunction, hemoglobinopathies).
- Immunosuppression or ongoing malignancy.
- Neurological and neurodevelopmental conditions (e.g., cerebral palsy, epilepsy, stroke, seizures).
- Postinfectious or postvaccine neurological sequelae.
- Have close or household (i.e., share the same apartment or house) high-risk contacts including but not limited to:
- Persons greater than or equal to 65 years of age.
- Children < 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 metabolic disease (e.g., diabetes mellitus, renal dysfunction, hemoglobinopathies).
- Immunosuppression or cancer.
- Neurological and neurodevelopmental conditions (e.g., cerebral palsy, epilepsy, stroke, seizures).
- Children and teenagers who are receiving long-term aspirin therapy.
- Women who are pregnant or who are trying to become pregnant.
- Individual with body mass index (BMI) less than or equal to 18.5 and greater than or equal to 40.
- Smokes more than 4 cigarettes or other tobacco products on weekly basis.
- Complete blood count (CBC) with differential outside of the NIH Department of Laboratory Medicine (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 on electrocardiogram .
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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