Collection of Plasma From People Who Recovered From or Were Vaccinated to Emerging Infectious Diseases
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 1/17/2019 |
| Start Date: | January 14, 2015 |
| End Date: | December 2, 2040 |
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:
- Healthy men 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.
- 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:
- Healthy men 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.
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.
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.
- INCLUSION CRITERIA:
1. Provide written informed consent before initiation of any study procedures
2. Male, age greater than or equal to18 years old, and greater than or equal to 70
years old
3. History of a know 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.
- 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:
1. Any sign of active infection (as judged by the investigator), including but not
limited to:
- Subjective or documented fever (>38 degrees C)
- Cough
- Shortness of breath
- Diarrhea
2. Meets the blood establishment plasma donation exclusion criteria. 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 MEET 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 (>800
microgram/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 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 small pox vaccine, or was in close contact with someone
who was vaccinated (i.e., close family member)
- Donated a unit of blood
WITHIN THE 4 MONTH PRIOR TO ENROLLMENT HAD:
- A blood donation of a double unit of red cells
WITHIN THE 12 MONTH 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
PATICIPATION IN THE 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.
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.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
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