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NCT01971255 · ClinicalTrials.gov registry record · Phase 1
Evaluation of Anti-Hemagglutinin (Anti-HA) Antibodies as Protection From the Flu in Healthy People
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 74
- Enrollment target
NCT01971255 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 74 participants.
The verdict
NCT01971255, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 74 participants
- Enrollment target
Study Summary
Background: \- Researchers want to know if a certain type of antibody in the blood affects whether people get influenza (the flu). They will study 2 different groups with different levels of anti-HA antibodies and expose them to the flu virus. They will study how the flu develops in a healthy person. This may lead to future studies to develop new vaccines and treatments for the flu. Objective: \- To study how people can be protected from flu infection. Eligibility: \- Healthy volunteers 18 to 50 years of age. Design: * Participants will be screened through the use of a medical history, physical exam, and laboratory tests. * Groups of 7 participants will stay in an isolation unit in a hospital for at least 9 days with no visitors. * Participants will be screened again upon admission. They will also have: * ECG: soft electrodes will be stuck to the skin. A machine will record the heart s electrical signals. * Echocardiogram: a small probe will be held to the chest to take pictures of the heart. * Lung tests: participants will blow into a machine. * They will also have nasal fluid collected. This will be done either with a swab or with a tube of water washing out the nose. This will be done once every day. * The flu virus will be sprayed into the participant s nose. This will be done only once. * Participants will complete a questionnaire on day 1 and twice a day after that for 14 days. * A medical team will watch participants 24 hours a day. They will go home after 2 days of negative flu tests. * Participants will have 4 follow-up visits over 8 weeks.
Interventions
- BIOLOGICAL Ca/04/2009/H1N1r Challenge Virus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2013-09 |
| Est. Completion | 2015-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01971255
The ClinicalTrials.gov registry entry for NCT01971255 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 74 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 Ca/04/2009/H1N1r Challenge Virus is the first listed.
NCT01971255 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01971255 about?
NCT01971255 is a clinical study titled "Evaluation of Anti-Hemagglutinin (Anti-HA) Antibodies as Protection From the Flu in Healthy People". Background: \- Researchers want to know if a certain type of antibody in the blood affects whether people get influenza (the flu). They will study 2 different groups with different levels of anti-HA antibodies and expose them to the flu virus. They will study how the flu develops in a healthy perso...
What is the current status of trial NCT01971255?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 74 participants. The study started on 2013-09. Estimated completion is 2015-09.
What interventions are being tested in trial NCT01971255?
The interventions under investigation include: Ca/04/2009/H1N1r Challenge Virus (BIOLOGICAL).
Who is sponsoring clinical trial NCT01971255?
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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