INCLUSION CRITERIA:
1. Age greater than or equal to 18 years old, and less than 60 years old.
2. Adequate clinical parameters (all of the following):
- Afebrile (temperature less than 38 degrees C)
- Systolic blood pressure greater than 100 and less than 180 mmHg
- Diastolic blood pressure greater than 50 and less than 100 mmHg
- Heart rate between 40-100 beats per minute
3. Weight greater than or equal to 110 pounds (50kg)
4. Adequate peripheral venous access for plasmapheresis (as judged by the examiner)
5. Females of child-bearing potential must (one of the following):
- Be surgically sterile.
- Be abstinent (or willing to be) 4 weeks prior to date of screening evaluation through the last apheresis session (estimate 6 months).
- Use oral contraceptives, or other form of hormonal birth control including hormonal vaginal rings or transdermal patches, and have been using these for three months prior to date of screening evaluation through the last apheresis session (estimate 6 months).
- Use an intra-uterine device (IUD) as birth control 4 weeks prior to date of screening evaluation through the last apheresis session (estimate 6 months).
- Use (by ensuring her male partner(s) uses ) barrier contraception (condom) with a spermicide as birth control 4 weeks prior to date of screening evaluation through the last apheresis session (estimate 6 months).
EXCLUSION CRITERIA:
1. Has a medical history of
- Thrombocytopenia or other blood dyscrasias
- congestive heart failure
- pulmonary hypertension
- bleeding diathesis or therapeutic anticoagulation
- HIV/AIDS
- Hepatitis B
- Hepatitis C
- Known history of hepatitis after the 11th birthday.
- Trypanosomiasis (Chagas' disease and sleeping sickness)
- Leshmaniasis (Kala-azar)
- Filariasis
- Q fever
- Yaws
- Allergy to eggs, thimerosal, or other components of the vaccine
- Severe reactions following immunization with contemporary influenza virus vaccines
- Autoimmune disease or a history of Guillain-Barre
2. History of cancer that meets any one of the following criteria:
- Non-melanoma skin cancers within the last 1 year
- Melanoma or any other cancer (excluding non-melanoma skin cancers) at any time
3. Medication history that includes any of the following:
- Current use of oral or parenteral steroids, high-dose inhaled steroids (greater than 800 mcg/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.
4. 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.
- 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.
- Was born, lived in, had blood donation in or ever had sexual contact with anyone who lived in Cameroon, Central African Republic, Chad, Congo, Equatorial Guinea, Gabon, Niger, or Nigeria after 1977.
- 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 U.S. 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, Turkey, Italy or Greece).
5. Within the last 3 weeks received the seasonal (conventional trivalent) flu vaccine
6. Within the last 8 weeks:
- Was vaccinated with the small pox vaccine, or was in close contact with someone who was vaccinated (i.e., close family member).
7. Within the last 3 months has:
- Current or previous participation in any other apheresis procedures/protocols (not related to this protocol).
8. Within the last 4 months has had:
- A blood donation of a double unit of red cells.
9. Within the last 12 months has:
- Received any blood or blood component.
- Donated blood at a paid donation center (donations at a hospital blood bank do not apply).
- History of unsafe (multiple-use equipment) tattoo, acupuncture, or piercing practices.
- Received an organ transplant.
- Received a bone or skin graft.
- Lived with someone who has any type of hepatitis.
- Traveled to areas with malaria.
- Been incarcerated for more than 72 hours.
- Oral or inhalation use of illegal drugs (i.e. those not prescribed by a physician)
- Had or been treated (with or without confirmatory diagnosis) for syphilis or gonorrhea
10. 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
- Anyone who has hemophilia or has used clotting factor concentrates.
- For females, a male who has ever had sexual contact with another male.
11. Participation in medical research that includes:
- Protocols that are currently ongoing or will start during the duration of this study that require more than 100cc of blood to be given in any 6-week period of time.
- Administration of any unlicensed drug within the last 3 months or during the duration of this study.
- Administration of any unlicensed vaccine within the last 12 months or during the duration of this study.
12. Currently pregnant (if known) or pregnant within the 6 weeks prior to enrollment.
13. Any condition that, in the opinion of the investigator, would render vaccination unsafe, would interfere with the antibody response or the evaluation of these responses, or would place the subject at increased risk of injury from apheresis.
APHERESIS CRITERIA (all of the following):
1. Adequate clinical parameters (must meet all of the criteria below):
a. Afebrile (temperature less than 38 degrees C)
b. Systolic blood pressure greater than 100 and less than 180 mmHg
c. Diastolic blood pressure greater than 50 and less than 100 mmHg
d. Heart rate between 40-100 beats per minute
e. Weight greater than or equal to 110 pounds (50kg)
2. Adequate laboratory parameters (must meet all of the criteria below):
a. Hemoglobin level of greater than or equal to 12.5 grams/dL
b. HCT greater than or equal too 38 percent
c. Platelets greater than or equal to 150,000 times 10(3) microliters
d. Total serum protein greater than or equal to 6.0 grams /100 milliliters of blood
e. Quantitative immune globulin levels (all of the following):
- Ig A greater than or equal to 90 mg/dL
- Ig G greater than or equal to 650 mg/dL
- Ig M greater than or equal to 35 mg/dL
3. Negative tests for blood borne pathogens (must meet all of the criteria below):
a. Human Immunodeficiency Virus 1/2 Antibody (Anti-HIV1/2) negative
b. Hepatitis B virus surface antigen (HBsAg) negative
c. Hepatitis C virus antibody (anti-HCV) negative
d. Human T cell lymphotropic I/II antibody (anti-HTLV I/II) negative
e. RPR non-reactive
4. If female, negative urine (or serum) pregnancy test
5. Adequate peripheral venous access for plasmapheresis (as judged by the examiner)
DAY OF DONATION SCREENING
DAY OF DONATION - INCLUSION CRITERIA:
1. Afebrile (temperature less than 38 degrees C)
2. Systolic blood pressure greater than 100 and less than 180 mmHg
3. Diastolic blood pressure greater than 50 and less then 100 mmHg
4. Heart rate between 40-100 beats per minute
5. Blood hemoglobin level of greater than or equal to 12.5 grams/dL
6. Total serum protein greater than or equal to 6.0 grams /100 milliliters of blood
7. Weight greater than or equal to 110 pounds (50kg)
8. RPR performed in the 4 months prior to the day of donation and non-reactive.
9. Quantitative immune globulin levels performed in the 4 months prior to the day of donation (and all of the following):
-Ig A greater than or equal to 90 mg/dL
-Ig G greater than or equal to 650 mg/dL
-Ig M greater than or equal to 35 mg/dL
DAY OF DONATION - EXCLUSION CRITERIA:
1. Signs/symptoms of an acute illness
2. Signs/symptoms of any skin disease at the site of phlebotomy or any such disease generalized to such an extent as to create a risk of contamination of the plasma
3. Skin punctures or scars indicative of addiction to self-injected narcotics
4. In the opinion of the interviewer, a donor that: (either of the following)
- appears to be under the influence of any drug or alcohol
- for any reason does not appear to be providing reliable answers to medical history questions
5. Within the last 8 weeks, has not had the red blood cells returned during a plasmapheresis procedure.
6. Within the last 8 weeks has been a donor of a unit of whole blood.
7. Known exposure (since screening or previous donation) to HIV, Hepatitis B or Hepatitis C.
8. Current or previous participation (within the last 3 months) in any other apheresis procedures/protocols (i.e. not related to this protocol).
9. Known or suspected pregnancy.
10. Platelets greater than 150,000 times 10(3) microliters
National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 09/20/2008