Evaluation of Anti-Hemagglutinin (Anti-HA) Antibodies as Protection From the Flu in Healthy People
Public ClinicalTrials.gov record NCT01971255. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Evaluation of Anti-Hemagglutinin Antibodies as a Correlate of Protection in an H1N1 Influenza Healthy Human Challenge Model
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01971255
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 74 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 50 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 31, 2013
- Primary completion
- Aug 31, 2015
- Completion
- Aug 31, 2015
- Last update posted
- Apr 23, 2017
2013 – 2015
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | 20892 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01971255, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 23, 2017 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01971255 live on ClinicalTrials.gov.