Collection of Plasma From People Who Recovered From or Were Vaccinated to Emerging Infectious Diseases

Completed

• Conditions: Emerging Infectious Diseases; Infection; Communicable Diseases; Communicable Diseases, Emerging
• Interventions: Drug: Plasma

• Registration Number: NCT02338986
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

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:

- Ages 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 Description

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.

Study Timeline

• Study First Submitted: 2015-01-14
• Study First Submitted QC: 2015-01-14
• Study First Posted: 2015-01-15
• Study Start: 2015-03-04
• Status Verified: 2025-05
• Primary Completion: 2025-05-15
• Study Completion: 2025-05-15
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy Volunteers	Plasma	Collection of Plasma From Subjects That Recovered From or Were Vaccinated To Emerging Infectious Diseases

Primary Outcome Measures

Name	Time	Method
Number of units of plasma collected	5 years after enrollment	The number of units of human plasma collected from volunteers with high titer antibodies for a given emerging infectious disease, that is potentially suitable for infusion into humans as part of a separate treatment study.

Trial Locations

Locations (1)

National Institutes of Health Clinical Center; 🇺🇸 Bethesda, Maryland, United States