INCLUSION CRITERIA:
1. Provide written informed consent before initiation of any study procedures.
2. Age greater than or equal to 18 years old, and < 60 years old
3. History suggestive of having anti-influenza H1N1 antibodies (either of the following):
- An influenza like illness (e.g. fever, chills, malaise, cough, myalgias and nausea) consistent with novel H1N1 influenza or otherwise having met the Centers of Disease Control definitions for a suspected, probable or confirmed case of H1N1. Subjects must not be symptomatic and be at least seven days since the resolution of fever, and enroll within 6 months of illness.
- Vaccinated with a licensed or investigational H1N1 vaccine at least 14 days since the last vaccination in the series.
4. Adequate clinical parameters (all of the following):
- Afebrile (temperature < 38 Degrees C)
- Systolic blood pressure > 100 and < 180 mmHg
- Diastolic blood pressure > 50 and < 100 mmHg
- Heart rate between 40-100 beats/minute
5. Weight greater than or equal to 110 pounds (50 kg)
6. Adequate peripheral venous access for plasmapheresis (as judged by the examiner)
7. Willingness to have samples stored
8. 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 (up to 120 days following enrollment in the protocol))
- Use oral contraceptives, or other form of hormonal birth control including hormonal vaginal rings or transdermal patches, and have been using these for 3 months prior to date of screening evaluation through the last apheresis session (up to 120 days)
- Use an intra-uterine device (IUD) as birth control 4 weeks prior to date of screening evaluation through the last apheresis session (up to 120 days)
- Use (by ensuring her male partner(s) uses) barrier contraception (condom) as birth control 4 weeks prior to date of screening evaluation through the last apheresis session (up to 120 days)
EXCLUSION CRITERIA:
1. Any sign of active influenza, including but not limited to:
- Subjective or documented fever (> 38 Degrees C)
- Cough
- Shortness of breath
- Diarrhea
2. 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
3. History of cancer that meets any one of the following criteria:
- Leukemia or lymphoma: permanent deferral
- Melanoma: 10 year deferral (with exception of melanoma-in-situ: defer until biopsy site is healed)
- Squamous cell or basal cell cancer of skin, or cervical carcinoma-in-situ: defer until excision site is healed
- All other cancers: defer for two years since end of treatment
4. Medication history that includes any of the following:
- Current use of oral or parenteral steroids, high-dose inhaled steroids (> 800 microg/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
- Warfarin (Coumadin) within the last 1 week
- Antibiotics within the prior 48 hours
5. 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, Italy, or Greece)
6. 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)
7. Within the 3 months prior to enrollment has:
- Current or previous participation in any other apheresis procedures/protocols (not related to this protocol)
8. Within the last 4 weeks donated WBC or Platelets at any donor center
9. Within the 4 months prior to enrollment has had:
- A blood donation of a double unit of red cells
10. Within the 12 months prior to enrollment 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 tattoo application
- History of unsafe (multiple-use equipment) acupuncture, or piercing practices
- Received an organ transplant
- Received a bone or skin graft
- Lived with someone who has any type of hepatitis
- 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
11. 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
- For females, a male who has ever had sexual contact with another male
12. 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 8-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, with the exception of unlicensed H1N1 vaccine
13. Currently pregnant
APHERESIS CRITERIA (all of the following):
1. Novel H1N1 HAI titer of 1:80 or greater
2. Adequate laboratory parameters (must meet all of the criteria below)
- Hemoglobin level of greater than or equal to 12.5 grams/dL
- HCT greater than or equal to 38%
- Platelets greater than or equal to 150 times 10 (3)/micorL
- Total serum protein greater than or equal to 6.0 grams /100 milliliters of blood
- Quantitative immune globulin levels (all of the following)
-- Ig A greater than or equal to 90 mg/dL
-- Ig G greater than or equal 650 mg/dL
-- Ig M greater than or equal 35 mg/dL
3. Negative serologic and molecular tests for blood borne pathogens, to include:
- Anti-HIV-1/2
- Anti-HTLV-I/II
- Anti-HCV
- Anti-T. cruzi (EIA for Chagas disease)
- HBsAg (hepatitis B surface antigen)
- Serologic test for syphilis (PK-TP)
- HIV NAT
- HCV NAT
- WNV NAT
4. Testing for Anti-HBc (hepatitis B core antibody) is a special case. A negative test is required for all components that will be issued as FFP or thawed plasma. A positive test result is acceptable for plasma that will undergo further manufacture into IVIG. Therefore, all subjects will be screened for anti-HBc, and those subjects found reactive (if other tests are negative) may have their components quarantined and labeled to indicate that they are only for use in further manufacture into IVIG.
National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 11/25/2009