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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: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
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, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
This was determined by presence of the combination of symptoms of influenza and presence of a positive clinical test for influenza. If both were present then the participant had positive MMID.
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 |
What the finished NCT01971255 record still lists
NCT01971255 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% higher).
The record links to 0 conditions, and to 1 intervention - of which Ca/04/2009/H1N1r Challenge Virus is the first listed.
NCT01971255 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01971255's enrollment target sits among peer trials
74 725th of 2000 higher than 1,269 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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