A Pilot Study for Collection of Anti-Influenza A Immune Plasma

1. Provide written informed consent before initiation of any study procedures.

   2. Male adults between the ages of 18 and 60 years old

   3. History suggestive of having anti-influenza A antibodies (either of the following):

      1. An influenza like illness (e.g. fever, chills, malaise, cough, myalgias and nausea) consistent with influenza A infection. Subjects must not be symptomatic and be at least 7 days since the resolution of fever, and must enroll within 12 months of illness.
      2. Vaccination with a licensed influenza vaccine and at least 14 days following the last vaccination in the series, and enrolling within 12 months of vaccination.
      3. Some subjects may meet both requirements and enrollment should be within 12 months of the most recent event (illness or vaccination)

   4. Adequate clinical parameters (all of the following):

      1. Afebrile (temperature \< 38 Degrees C)
      2. Systolic blood pressure > 100 and \< 180 mmHg
      3. Diastolic blood pressure > 50 and \< 100 mmHg
      4. Heart rate between 50-100 beats/minute (Individual site blood establishment's SOPs may also permit healthy athletic subjects with heart rates \< 50 beats/minutes to donate plasma, and, if so, subjects with heart rates \< 50 beats/minutes may participate in this study)
   5. Weight greater than or equal to 110 pounds (50 kg)
   6. Adequate peripheral venous access for plasma donation (as judged by the examiner)
   7. Willingness to have samples stored

EXCLUSION CRITERIA:

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1. Any sign of active influenza, (as judged by the investigator) including but not limited to:

   1. Subjective or documented fever (> 38 Degrees C)
   2. Cough
   3. Shortness of breath
   4. Diarrhea

2. Has a medical history of

   1. Thrombocytopenia or other blood dyscrasias
   2. Congestive heart failure
   3. Pulmonary hypertension
   4. Bleeding diathesis or therapeutic anticoagulation
   5. Human immunodeficiency virus (HIV)/AIDS
   6. Hepatitis B
   7. Hepatitis C
   8. Known history of hepatitis after the 11th birthday
   9. Trypanosomiasis (Chagas' disease and sleeping sickness)
   10. Leishmaniasis (Kala-azar)
   11. Filariasis
   12. Q fever
   13. Yaws

3. History of cancer that meets any one of the following criteria:

   1. Leukemia or lymphoma: permanent deferral
   2. Melanoma: 10 year deferral (with exception of melanoma-in-situ: defer until biopsy site is healed)
   3. Squamous cell or basal cell cancer of skin: defer until excision site is healed
   4. All other cancers: defer for 2 years since end of treatment

4. Medication history that includes any of the following:

   1. Current use of oral or parenteral steroids, high-dose inhaled steroids (> 800 μg/day of beclomethasone dipropionate or equivalent) or other immunosuppressive or cytotoxic drugs
   2. Finasteride (Proscar, Propecia) within the last 1 month
   3. Isotretinoin (Accutane) within the last 1 month
   4. Acitretin (Soriatane) within the last 3 years
   5. Etretinate (Tegison) at any time
   6. Dutasteride (Avodart) within the last 6 months
   7. Growth hormone made from human pituitary glands at any time
   8. Beef insulin from the United Kingdom at any time
   9. Warfarin (Coumadin) within the last 1 week
   10. Antibiotics within the prior 48 hours

5. Has ever had any of the following:

   1. Sexual contact with someone known to have HIV
   2. Had a relative with Creutzfeldt-Jakob Disease, or been told that this disease is inherited within the family
   3. Received blood transfusion in the United Kingdom
   4. History of receiving money, drugs or other payment for sex
   5. History of receiving clotting factor concentrates
   6. History of a dura mater graft
   7. History of babesiosis
   8. For male donors, history of sexual contact with another male
   9. Used needles to take drugs, steroids, or other medications not prescribed by a physician
   10. 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
   11. History of living 3 or more months total (need not be consecutive) in the UK from 1980-1996
   12. History of living 5 or more years total (need not be consecutive) in Europe since 1980
   13. 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, Italy, or Greece)

6. Within the 8 weeks prior to enrollment:

   a. 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 4 months prior to enrollment has had:

   a. A blood donation of a double unit of red cells

8. Within the 12 months prior to enrollment has:

   1. Received any blood or blood component
   2. Donated blood at a paid donation center (donations at a hospital blood establishment do not apply)
   3. History of tattoo application
   4. History of unsafe (multiple-use equipment) acupuncture, or piercing practices
   5. Received an organ transplant
   6. Received a bone or skin graft
   7. Lived with someone who has any type of hepatitis
   8. Been incarcerated for more than 72 hours
   9. Oral or inhalation use of illegal drugs (i.e., those not prescribed by a physician)
   10. Had or has been treated (with or without confirmatory diagnosis) for syphilis or gonorrhea

9. Within the last 12 months has had sexual contact with (any of the following):

   1. An individual having viral hepatitis
   2. A prostitute or anyone else who takes money or drugs or other payment for sex
   3. Anyone who has ever used needles to take drugs, steroids, or anything else not prescribed by their doctor
   4. Anyone who has hemophilia or has used clotting factor concentrates
   5. For females, a male who has ever had sexual contact with another male

10. Participation in medical research that includes:

    1. 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
    2. Administration of any unlicensed drug within the last 3 months or during the duration of this study
    3. Administration of any unlicensed vaccine within the last 12 months or during the duration of this study.
11. Subjects that have participated in previous plasma collection or other cell component collection within the last 3 months may have restrictions to participation based on the site plasma collection SOP. In this scenario, discussion should occur with the blood establishment to ensure eligibility to donate plasma.

PLASMA DONATION CRITERIA (all of the following):

1. Anti-Influenza A HAI titer of 1:160 or greater and H3N2 HAI titer of at least 1:40

2. Adequate laboratory parameters from screening (must meet all of the criteria below)

   1. Hemoglobin level of greater than or equal to 12.5 g/dL
   2. HCT greater than or equal to 38%
   3. Platelets greater than or equal to 150 x 10\^3/cubic mm
   4. Total serum protein greater than or equal to 6.0 g/dl

   5. Quantitative immune globulin levels (all of the following)

      1. Ig A greater than or equal to 90 mg/dL
      2. Ig G greater than or equal 650 mg/dL
      3. Ig M greater than or equal 35 mg/dL
   6. Review of other screening labs should ensure no other underlying medical condition that would increase subject's risk of apheresis.

3. Negative serologic and molecular tests for blood borne pathogens, to include:

   1. Anti-HIV-1/2
   2. Anti-HTLV-I/II
   3. Anti-HCV
   4. HBsAg (hepatitis B surface antigen)
   5. Serologic test for syphilis (PK-TP)
   6. HIV NAT
   7. HCV NAT
   8. WNV NAT