Blood and Plasma Collection For Use in Future Clinical Trials
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|ClinicalTrials.gov Identifier: NCT01136057|
Recruitment Status : Active, not recruiting
First Posted : June 3, 2010
Last Update Posted : December 18, 2017
|Condition or disease||Intervention/treatment|
|Influenza A Virus Infection||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.
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||A Pilot Study for Collection of High-Titer Anti-Influenza A Plasma|
|Study Start Date :||April 2010|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||January 2019|
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|
- Collection of high antibody titer anti-influenza FFP [ Time Frame: Collected at each study visit ]
- Further define the hemagglutination inhibition (HAI) immune response in participants over time [ Time Frame: Collected at each study visit ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|