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

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

Overall Status

Enrolling by invitation

CT.gov ID

NCT02338986

Collaborator

(none)

1,000

Enrollment

Location

308

Anticipated Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Communicable Diseases Communicable Diseases, Emerging Emerging Infectious Diseases Infection

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 Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Collection of Plasma From Subjects That Recovered From or Were Vaccinated To Emerging Infectious Diseases

Actual Study Start Date :

Mar 4, 2015

Anticipated Primary Completion Date :

Nov 2, 2040

Anticipated Study Completion Date :

Nov 2, 2040

Arms and Interventions

Arm	Intervention/Treatment
Healthy Volunteers Collection of Plasma From Subjects That Recovered From or Were Vaccinated To Emerging Infectious Diseases

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.