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Influenza A 2009 H1N1 Challenge Study in Healthy Adults

NCT01646138 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2016-05-09

Study results available
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Summary

Background:

\- A challenge study exposes a person to a disease and allows researchers to study the disease through the body's healing process. An influenza challenge study that looks at different amounts of the flu virus can provide more information on the smallest amount needed to cause an infection. Researchers want to give one dose of the Influenza A H1N1 virus to healthy volunteers to see how the body responds to the virus.

Objectives:

* To find the smallest dose of Influenza A H1N1 virus that may cause a mild to moderate flu infection in a healthy adult.
* To study how the body s immune system responds to the virus.

Eligibility:

* Healthy volunteers at least 18 years of age.
* Participants must be willing to remain in isolation for a minimum of 9 days.

Design:

* Participants will be admitted to a hospital inpatient isolation unit. They will be screened with a physical exam and medical history. They will also have heart and lung function tests. Blood, urine, and nasal swab/wash samples will be collected.
* Participants will receive a single nasal spray of the flu virus. They will stay on the inpatient unit for at least 9 days.
* Participants will be monitored for the length of their stay. They will have frequent blood tests and other procedures as needed.
* Participants will be allowed to go home once they have had two negative tests for the virus. The tests will be given on two consecutive days....

Conditions

Interventions

BIOLOGICAL

Ca/04/2009/H1N1 Vero Grown 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
NA
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
2012-02-29
Primary Completion
2013-12-31
Completion
2013-12-31

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 NCT01646138 on ClinicalTrials.gov