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

NCT02338986 | Completed FDA Drug

• 2 other identifiers: 15005615-I-0056
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Communicable Diseases; Communicable Diseases, Emerging; Emerging Infectious Diseases; Infection

Keywords

High Titer Antibodies; Convalescent Volunteers; Apheresis; Males; Quantitative IgG; Natural History

Outcome Measures

Primary Outcomes (1)

• Number of units of plasma collected

  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

Study Arms (1)

Healthy Volunteers

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

Drug: Plasma

Interventions

Plasma DRUG

Plasma

Healthy Volunteers

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Soo YO, Cheng Y, Wong R, Hui DS, Lee CK, Tsang KK, Ng MH, Chan P, Cheng G, Sung JJ. Retrospective comparison of convalescent plasma with continuing high-dose methylprednisolone treatment in SARS patients. Clin Microbiol Infect. 2004 Jul;10(7):676-8. doi: 10.1111/j.1469-0691.2004.00956.x.

  PMID: 15214887 BACKGROUND

• Mupapa K, Massamba M, Kibadi K, Kuvula K, Bwaka A, Kipasa M, Colebunders R, Muyembe-Tamfum JJ. Treatment of Ebola hemorrhagic fever with blood transfusions from convalescent patients. International Scientific and Technical Committee. J Infect Dis. 1999 Feb;179 Suppl 1:S18-23. doi: 10.1086/514298.

  PMID: 9988160 BACKGROUND

• Hung IF, To KK, Lee CK, Lee KL, Chan K, Yan WW, Liu R, Watt CL, Chan WM, Lai KY, Koo CK, Buckley T, Chow FL, Wong KK, Chan HS, Ching CK, Tang BS, Lau CC, Li IW, Liu SH, Chan KH, Lin CK, Yuen KY. Convalescent plasma treatment reduced mortality in patients with severe pandemic influenza A (H1N1) 2009 virus infection. Clin Infect Dis. 2011 Feb 15;52(4):447-56. doi: 10.1093/cid/ciq106. Epub 2011 Jan 19.

  PMID: 21248066 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Communicable Diseases; Communicable Diseases, Emerging; Infections

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Richard T Davey, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2015
• First Posted: January 15, 2015
• Study Start: March 4, 2015
• Primary Completion: May 15, 2025
• Study Completion: May 15, 2025
• Last Updated: May 16, 2025

Record last verified: 2025-05

Locations

US (1)