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Evaluation of Anti-Hemagglutinin (Anti-HA) Antibodies as Protection From the Flu in Healthy People

NCT01971255 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2017-04-24

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

Ca/04/2009/H1N1r Challenge Virus

The human challenge virus will be administered intranasally to each participant using a nasal sprayer. A total volume of up to 1 mL of virus will be administered.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Matthew J Memoli, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01971255 on ClinicalTrials.gov