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

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.

• INCLUSION CRITERIA:

• Provide written informed consent before initiation of any study procedures
• Age >=8 years old, and <=70 years old
• History of a known infection or vaccination towards emerging infectious diseases of interest:
• For convalescent subjects, the following criteria must be met:

• At least 28 days since the subject was symptomatic from the infection
• Afebrile (subjective history acceptable) for at least 28 days
• Enrollment must occur within 24 months of illness.
• For vaccinated subjects, the following criteria must be met:

• Subjects must be at least 14 days after vaccination
• If vaccinated on a blinded study, the study must be unblinded and the subject received active product.
• Enrollment must occur within 24 months of the last vaccination.
• (The above represent the minimum criteria - more restrictive criteria may be listed under disease specific criteria noted in Appendix A)

• Weight >=110 pounds (50 kg)

• Adequate peripheral venous access for plasma donation (as judged by the examiner)

• Willingness to have samples stored

Exclusion criteria

• Any sign of active infection (as judged by the investigator), including but not limited

to:

• Subjective or documented fever (>38 (Infinite)C)
• Cough
• Shortness of breath
• Diarrhea
• Pregnancy
• Meets current blood establishment plasma donation exclusion criteria. A protocol amendment will not be needed to reflect updated/current blood donation exclusion criteria.
• Subjects that have participated in previous plasma collection or other cell component collection procedures within the last 3 months may have restrictions to participation based on the site plasma collection standard operating procedure (SOP). In this scenario, discussion should occur with the blood establishment to ensure eligibility to donate plasma.