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

March 4, 2024 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Clinical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Men and women who have high titer antibodies for a given emerging infectious disease.@@@

Description

  • INCLUSION CRITERIA:

    1. Provide written informed consent before initiation of any study procedures
    2. Age >=8 years old, and <=70 years old
    3. 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)

      4) Weight >=110 pounds (50 kg)

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

      6) Willingness to have samples stored

EXCLUSION CRITERIA:

  1. 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
  2. Pregnancy
  3. Meets current blood establishment plasma donation exclusion criteria. A protocol amendment will not be needed to reflect updated/current blood donation exclusion criteria.
  4. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy Volunteers
Collection of Plasma From Subjects That Recovered From or Were Vaccinated To Emerging Infectious Diseases
Drug: Plasma
Plasma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of units of plasma collected
Time Frame: 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.
5 years after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Principal Investigator: Richard T Davey, M.D., National Institute of Allergy and Infectious Diseases (NIAID)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2015

Primary Completion (Estimated)

November 2, 2040

Study Completion (Estimated)

November 2, 2040

Study Registration Dates

First Submitted

January 14, 2015

First Submitted That Met QC Criteria

January 14, 2015

First Posted (Estimated)

January 15, 2015

Study Record Updates

Last Update Posted (Estimated)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 150056
  • 15-I-0056

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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