NCT01136057

Blood and Plasma Collection For Use in Future Clinical Trials

A Pilot Study for Collection of High-Titer Anti-Influenza A Plasma

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 21 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: Male
• Age: 18 Years – 59 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Influenza A Virus Infection

Interventions

Type	Name	Description
BIOLOGICAL	Collection of Anti-Influenza A Immune Plasma

Timeline

• Start date: 2010-04-01
• Primary completion: 2019-01-04
• Completion: 2019-01-04
• First posted: 2010-06-03
• Last updated: 2019-03-13

Locations

2 sites across 1 country: United States