Blood and Plasma Collection For Use in Future Clinical Trials
Treatment options are limited for the treatment of influenza. This study will collect blood from people who have been exposed to the influenza virus or who have received a seasonal influenza vaccine. The blood plasma will be used in a future clinical trial to treat people hospitalized with influenza.
Influenza A Virus Infection
Biological: Collection of Anti-Influenza A Immune Plasma
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Pilot Study for Collection of High-Titer Anti-Influenza A Plasma|
- Collection of high antibody titer anti-influenza FFP [ Time Frame: Collected at each study visit ] [ Designated as safety issue: No ]
- Further define the hemagglutination inhibition (HAI) immune response 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 2015|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
Influenza A Exposure
Participants will include people who have recovered from influenza, received a seasonal influenza vaccine, or have both recovered from influenza and received a seasonal influenza vaccine.
|Biological: Collection of Anti-Influenza A Immune Plasma|
There is a concern that the influenza virus will become resistant to the standard of care, oseltamivir (commonly known as Tamiflu), as resistance to this medication has been observed in people infected with the seasonal influenza virus. Because of the possibility of drug resistance, additional treatment options for influenza are needed. The purpose of this study is to collect blood from people who have recovered from influenza or who have received 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 influenza.
This study will enroll people who have recovered from influenza or received a seasonal influenza vaccine. Participants will donate blood at FDA-licensed blood donor centers up to three times during the 240-day study period.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01136057
|United States, California|
|Naval Medical Center San Diego|
|San Diego, California, United States, 92134|
|United States, Maryland|
|Naval Medical Research Center|
|Bethesda, Maryland, United States, 20889|
|Principal Investigator:||LCDR Nicholas Martin, USN, MSC||Virology and Rickettsial Diseases Department, Naval Medical Research Center|