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NCT02594189 · ClinicalTrials.gov registry record · Phase 1
Influenza A H3N2 Human Challenge Study in Healthy Adult Volunteers
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 49
- Enrollment target
NCT02594189 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 49 participants.
The verdict
NCT02594189, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 49 participants
- Enrollment target
Study 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.
Interventions
- OTHER Live recombinantly derived A/Bethesda/MM1/H3N2 virus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2015-10-31 |
| Est. Completion | 2017-11-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02594189
The ClinicalTrials.gov registry entry for NCT02594189 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 49 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Live recombinantly derived A/Bethesda/MM1/H3N2 virus is the first listed.
NCT02594189 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02594189 about?
NCT02594189 is a clinical study titled "Influenza A H3N2 Human Challenge Study in Healthy Adult Volunteers". 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 ...
What is the current status of trial NCT02594189?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 49 participants. The study started on 2015-10-31. Estimated completion is 2017-11-01.
What interventions are being tested in trial NCT02594189?
The interventions under investigation include: Live recombinantly derived A/Bethesda/MM1/H3N2 virus (OTHER).
Who is sponsoring clinical trial NCT02594189?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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