Clinical Trial: Collection of Plasma From People Who Recovered From or Were Vaccinated to Emerging Infectious Diseases
Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Observational
Official Title: Collection of Plasma From Subjects That Recovered From or Were Vaccinated To Emerging Infectious Diseases
Brief Summary:
Background:
- There are more emerging infectious diseases recently. Some could affect many people. Some like Severe Acute Respiratory Syndrome (SARS) or Middle East Respiratory Syndrome (MERS) are caused by new germs. Sometimes known germs suddenly infect new and large areas, like Ebola. Many of these diseases don t have good treatments available. Researchers may be able to develop a treatment by using antibodies against these infections.
Objective:
- To collect antibodies from people with high levels of antibodies to the diseases being studied.
Eligibility:
- Healthy men 18-70 years old who weigh at least 110 pounds. They may have been infected with or vaccinated for one of the new infections researchers are studying.
Design:
- Participants will be screened with medical history and blood tests. Researchers will determine if the participant can have apheresis.
- Participants will have apheresis. First, they will be interviewed. Then, a needle will be placed in a vein. Blood will be drawn, and a machine will separate the blood cells from the antibodies and protein. The blood cells will then be returned to the participant through another vein. It takes about 60 minutes for the actual collection.
- Participants will be asked to have the procedure at least 3 times. They can participate in up to 20 sessions total as part of this study. There must be at least 7 days between sessions.
Detailed Summary: The administration of convalescent plasma is often used for treatment of emerging infectious diseases. This natural history protocol will collect plasma from subjects that were vaccinated to or recovered from an emerging infectious disease of interest, in a manner that the plasma can be given to other subjects as a therapeutic. Any administration of plasma to subjects will be under a separate protocol.
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Current Primary Outcome: Number of units of plasma collected [ Time Frame: 5 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: National Institutes of Health Clinical Center (CC)
Dates:
Date Received: January 14, 2015
Date Started: December 22, 2014
Date Completion: December 2, 2040
Last Updated: April 21, 2017
Last Verified: February 8, 2017
