Development of Immune Globulin Treatment for Avian Flu
Stopped early · Phase 2
Conditions studied: Infectious Diseases, Influenza, Avian Flu
In brief
This study will determine how best to use a vaccine for generating high levels of antibodies called immune globulins (IVIG) in people, which, in turn, can be collected and used to develop a possible treatment for avian influenza (bird flu). Immune globulins are proteins made by the body that attack the influenza virus. This study will use an experimental bird flu vaccine to stimulate immune globulin production in healthy people. The vaccine is similar to the regular influenza vaccine and has been studied in more than 450 people. This study will use high doses of the vaccine to generate high antibody levels that can be collected for producing the new treatment. Healthy adults between 18 and 60 years of age who weigh at least 110 pounds may be eligible for this study. Candidates are screened with a medical history and physical examination. Participants are given one of three doses of the vaccine, depending on when they enter the study. The first 25 people enrolled receive a dose of 90 micrograms (mcg). If this dose is well tolerated, the next 25 people receive 120 mcg, and if this dose is also well tolerated, the last 25 people receive 180 mcg. Vaccination consists of either two shots (one in the muscle of each arm) or one shot in the buttock on four occasions. Subjects are vaccinated on four occasions, each 4 weeks apart. On the day of each vaccination, subjects provide a blood sample to evaluate blood counts, chemistries, and antibody levels, and to test for HIV, hepatitis B and C, syphilis, and antibody against avian flu. For 7 days after each vaccination, subjects keep a diary card to record any symptoms, such as pain, fever, muscle aches, or others. At the end of the 7 days, they are contacted by study staff to report the symptoms. In addition to the vaccinations, subjects undergo apheresis to collect IVIG once their blood test shows moderately high antibody levels. For this procedure, blood is collected through a needle in an arm vein and flows through a catheter (plastic tube) into a machine that separates the blood cells from the antibodies and protein. The antibodies and protein are collected and the rest of the blood is returned to the body. Subjects are asked to undergo at least three apheresis procedures. ...
Key facts
- Study ID
- NCT00383071
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 126
- Starts
- 2006-08-01
- Expected to finish
- 2014-12-01
- Last updated by the study team
- 2018-07-31
Who can join
Age: 18 and older, up to 59. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Age ≥ 18 years old, and < 60 years old.
- 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
- Weight ≥ 110 pounds (50kg)
- Adequate peripheral venous access for plasmapheresis (as judged by the examiner)
- 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).
You may not qualify if…
- 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
- 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
- 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.
Where it is running
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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