Blood and Plasma Collection For Use in Future H1N1 (Swine Flu) Clinical Trials
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 or seasonal influenza vaccine. The blood plasma will be used in a future clinical trial to treat people hospitalized with H1N1 influenza.
Influenza A Subtype H5N1 Infection
Biological: Collection of Anti-Influenza A/H1N1 Immune Plasma
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Pilot Study for Collection of High-Titer Anti-Influenza A H1N1 (Swine Flu) Plasma|
- Collection of high antibody titer anti-influenza H1N1 FFP [ Time Frame: Collected at each study visit ] [ Designated as safety issue: No ]
- Further define the hemagglutination inhibition (HAI) immune response to swine H1N1 (infection and/or vaccine) in participants over time [ Time Frame: Collected at each study visit ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Whole blood will be collected from participants.
|Study Start Date:||April 2010|
|Estimated Study Completion Date:||April 2014|
|Estimated Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
Participants will include people who have recovered from H1N1 influenza, received the H1N1 vaccine or seasonal influenza vaccine after July 2010, or have both recovered from H1N1 influenza and received the H1N1 vaccine.
|Biological: Collection of Anti-Influenza A/H1N1 Immune Plasma|
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 or a seasonal influenza 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 seasonal influenza vaccine after July 2010, 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.
|United States, California|
|Naval Medical Center San Diego||Recruiting|
|San Diego, California, United States, 92134|
|Contact: CAPT Mary Bavaro, MC, USN 619-532-7475|
|United States, Maryland|
|Naval Medical Research Center||Recruiting|
|Bethesda, Maryland, United States, 20889|
|Contact: Thomas C. Luke, MD 301-295-0275 Thomas.Luke@med.navy.mil|
|Principal Investigator:||LCDR Janine Danko, MC, USN, MD, MPH, FACP||Virology and Rickettsial Diseases Department, Naval Medical Research Center|