Development of Immune Globulin Treatment for Avian Flu

This is an interventional other trial for Infectious Diseases focused on measuring Apheresis, Avian Flu, Healthy Volunteers, Infectious Diseases, IVIG, Healthy Volunteer, HV Read More

Inclusion Criteria

1. Age ≥ 18 years old, and < 60 years old.

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

   • Afebrile (temperature < 38° C)
   • Systolic blood pressure >100 & <180 mmHg
   • Diastolic blood pressure >50 & <100 mmHg
   • Heart rate between 40-100 beats/minute
3. Weight ≥ 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 3 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)
   • Leishmaniasis (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-Barré

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 (>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 has 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 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.

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).
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.