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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02338986
Recruitment Status : Enrolling by invitation
First Posted : January 15, 2015
Last Update Posted : July 7, 2022
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( 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.

Condition or disease
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.

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Study Type : Observational
Estimated 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 : March 4, 2015
Estimated Primary Completion Date : November 2, 2040
Estimated Study Completion Date : November 2, 2040

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



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.@@@
Criteria
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02338986


Locations
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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: Richard T Davey, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
Additional Information:
Publications:
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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT02338986    
Obsolete Identifiers: NCT02406378
Other Study ID Numbers: 150056
15-I-0056
First Posted: January 15, 2015    Key Record Dates
Last Update Posted: July 7, 2022
Last Verified: April 14, 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):
High Titer Antibodies
Convalescent Volunteers
Apheresis
Males
Quantitative IgG
Natural History
Additional relevant MeSH terms:
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Communicable Diseases
Infections
Communicable Diseases, Emerging
Disease Attributes
Pathologic Processes