Bethesda, Maryland 20892


Purpose:

This study will collect plasma from people who were vaccinated towards or recovered from an emerging infectious disease of interest, in a manner that the plasma can be given to other people as part of a separate treatment study.


Study summary:

The administration of convalescent plasma is often used for the treatment of emerging infectious diseases. The purpose of this study is to collect plasma from people with high titer antibodies for a given emerging infectious disease, which is potentially suitable for infusion into people as part of a separate treatment study. Prospective participants will attend a screening visit to confirm exposure/vaccination history and undergo a clinical and laboratory assessment to ensure that they are likely to meet plasma donation criteria. Once they have been found eligible, participants will be referred to the NIH Clinical Center Department of Transfusion Medicine. Participants will be asked to donate plasma at least 3 times and can donate a maximum of 20 times. Plasma collection will occur no more frequently than every 7 days. There are no additional study visits following plasma donation.


Criteria:

Inclusion Criteria: - Provide written informed consent before initiation of any study procedures - Age greater than or equal to 18 years old, and less than or equal to 60 years old - History of a known infection or vaccination towards emerging infectious diseases of interest: - For convalescent participants, the following criteria must be met: - At least 28 days since the participant was symptomatic from the infection - Afebrile (subjective history acceptable) for at least 28 days - Enrollment must occur within 24 months of illness. - For vaccinated participants, the following criteria must be met: - Participants must be at least 14 days after vaccination - If vaccinated on a blinded study, the study must be unblinded and the participant received active product - Enrollment must occur within 24 months of the last vaccination - Weight greater than or equal to 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 (greater than 38°C) - Cough - Shortness of breath - Diarrhea - Meets the blood establishment plasma donation exclusion criteria (except waiver of specific criteria for given disease as noted in Appendix A of the protocol). A protocol amendment will not be needed to reflect updated/current blood donation exclusion criteria. These criteria are generally: Has a medical history of: - Thrombocytopenia or other blood dyscrasias - Congestive heart failure - Pulmonary hypertension - Bleeding diathesis or therapeutic anticoagulation - Human immunodeficiency virus (HIV)/AIDS - Hepatitis B - Hepatitis C - Known history of hepatitis after the 11th birthday - Trypanosomiasis (Chagas' disease and sleeping sickness) - Leishmaniasis (Kala-azar) - Filariasis - Q fever - Yaws History of cancer that meets any one of the following criteria: - Leukemia or lymphoma: permanent deferral - Squamous cell or basal cell cancer of skin: defer until excision site is healed - All other cancers: defer for two years since end of treatment Medication history that includes any of the following: - Current use of oral or parenteral steroids, high-dose inhaled steroids (greater than 800 µg/day of beclomethasone dipropionate or equivalent) or other immunosuppressive or cytotoxic drugs - Finasteride (Proscar, Propecia) within the last 1 month - Isotretinoin (Accutane) within the last 1 month - Acitretin (Soriatane) within the last 3 years - Etretinate (Tegison) at any time - Dutasteride (Avodart) within the last 6 months - Growth hormone made from human pituitary glands at any time - Beef insulin from the United Kingdom at any time - Anticoagulants and Warfarin (Coumadin) within the last 1 week - Antibiotics within the prior 48 hours Has ever had any of the following: - Sexual contact with someone known to have HIV - Had a relative with Creutzfeldt-Jakob Disease, or been told that this disease is inherited within the family - Received blood transfusion in the United Kingdom (UK) or France - History of receiving money, drugs or other payment for sex - History of receiving clotting factor concentrates - History of a dura mater graft - History of babesiosis - For male donors, history of sexual contact with another male - Used needles to take drugs, steroids, or other medications not prescribed by a physician - History of living 3 or more months total (need not be consecutive) in the UK from 1980-1996 - History of living 5 or more years total (need not be consecutive) in Europe since 1980 - History of living 6 or more months total (need not be consecutive) on a US military base in Europe from 1980-1996 (specifically from 1980 through 1990 in Belgium, the Netherlands, or Germany, and from 1980 through 1996 in Spain, Portugal, Italy, or Greece) Within the 8 weeks prior to enrollment: - Was vaccinated with the smallpox vaccine, or was in close contact with someone who was vaccinated (i.e., close family member) - Donated a unit of blood Within the 4 months prior to enrollment has had: - A blood donation of a double unit of red cells Within the 12 months prior to enrollment has: - Received any blood or blood component - History of tattoo application - History of unsafe (multiple-use equipment) acupuncture, or piercing practices - Received an organ transplant - Received a bone or skin graft (other than autologous) - Lived with someone who has any type of hepatitis B or symptomatic hepatitis C - Been incarcerated for more than 72 hours - Oral or inhalation use of illegal drugs (i.e., those not prescribed by a physician) - Had or has been treated (with or without confirmatory diagnosis) for syphilis or gonorrhea Within the last 12 months has had sexual contact with (any of the following): - An individual having viral hepatitis - A prostitute or anyone else who takes money or drugs or other payment for sex - Anyone who has ever used needles to take drugs, steroids, or anything else not prescribed by their doctor - Anyone who has hemophilia or has used clotting factor concentrates Participation in medical research that includes: - Protocols that are currently ongoing or will start during the duration of this study that require more than 100 mL of blood to be given in any 8-week period of time - Administration of any unlicensed drug that is not related to the disease of interest within the last 3 months or during the duration of this study - Administration of any unlicensed vaccine that is not related to the disease of interest within the last 12 months or during the duration of this study. People who 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.


NCT ID:

NCT02406378


Primary Contact:

Principal Investigator
Richard T. Davey, Jr., MD
Clinical Research Section, LIR, NIAID, NIH


Backup Contact:

N/A


Location Contact:

Bethesda, Maryland 20892
United States

John Beigel, MD
Email: jbeigel@niaid.nih.gov

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 23, 2017

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