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Blood and Plasma Collection For Use in Future H1N1 (Swine Flu) Clinical Trials

2014-08-27 03:13:14 | BioPortfolio

Summary

Treatment options are limited for the new strain of the H1N1 influenza virus, which differs from the seasonal H1N1 influenza virus. This study will collect blood from people who have been exposed to the H1N1 virus or who have received the H1N1 vaccine. The blood plasma will be used in a future clinical trial to treat people hospitalized with H1N1 influenza.

Description

Swine origin influenza virus (A/H1N1), commonly referred to as "swine flu," is a new influenza virus, which differs from the seasonal H1N1 influenza virus. Most people will not have immunity to this new H1N1 virus strain. There is a concern that this virus will become resistant to oseltamivir (commonly known as Tamiflu), as resistance to this medication has been observed in people with the seasonal H1N1 influenza virus. Because of the possibility of drug resistance, additional treatment options for the H1N1 virus are needed. The purpose of this study is to collect blood from people who have been exposed to the H1N1 virus or who have received the H1N1 vaccine. The blood will then be processed into Food and Drug Administration (FDA)-licensed fresh frozen plasma (FFP). In a future clinical trial, this plasma will be used as a treatment for people hospitalized with H1N1 influenza.

This study will enroll people who have recovered from H1N1 influenza, received the H1N1 vaccine, or have both recovered from H1N1 influenza and received the H1N1 vaccine. Participants will donate blood at FDA-licensed blood donor centers up to three times during the 240-day study period.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Conditions

Influenza A Virus, H1N1 Subtype

Location

Naval Medical Center San Diego
San Diego
California
United States
92134

Status

Recruiting

Source

National Institute of Allergy and Infectious Diseases (NIAID)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:14-0400

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