Protocol Number: 02-CC-0137

Title:

Plasmapheresis Of Anthrax-Vaccinated Subjects For Production Of Anthrax Immune Globulin

Number:

02-CC-0137

Summary:

This protocol is a joint project of the National Institutes of Health, the Centers for Disease Control and the United States Army Medical Research Institute for Infectious Diseases. It is designed to collect plasma from healthy employees of the Department of Defense who have been vaccinated against anthrax. The collected plasma will be pooled to make an anthrax-fighting antibody solution called anthrax immune globulin intravenous (AIGIV). This solution will be used for:

-Animal experiments to test its effectiveness in preventing the development of anthrax after inhalation exposure;

-Treating people severely ill with anthrax who are not improving with standard antibiotic therapy; and

-Treating people exposed to spores of the bacteria that cause anthrax to try to prevent development of the disease.

Healthy volunteers between 18 and 65 years of age who have received at least four doses of the anthrax vaccine and who meet the criteria for blood donors may be eligible to participate in this study. Volunteers will be recruited from Department of Defense civilian and military employees. Candidates will be screened with an interview and blood tests.

Participants will undergo the following procedures:

-Have a health history screen for donating plasma

-Measurement of heart rate, blood pressure and temperature

-Fingerstick to check hemoglobin level

-Blood tests for HIV, hepatitis B and C, syphilis and other infectious diseases

-Blood test for anthrax antibody levels

-Plasmapheresis to collect blood plasma (the liquid part of the blood)

In plasmapheresis, whole blood is drawn through a needle placed in an arm vein. The blood flows into a cell separator machine, where it is spun to separate the plasma from the blood cells. The plasma is collected in a plastic bag in the machine, while the rest of the blood is returned to the donor through the needle in the arm. During the procedure, the donor is given a blood thinner called citrate to prevent the blood from clotting while it is in the cell separator machine. The procedure lasts from 60 to 90 minutes. Only a small fraction of the body's total plasma is removed, and it is quickly replaced by the body with no long-term health effects. Participants may be requested to donate plasma as often as every 3 to 4 days or as infrequently as once a month for a maximum of six donations.

Sponsoring Institute:

Warren G. Magnuson Clinical Center (CC)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Male & Female

Referral Letter Required: Yes

Population Exclusion(s): Children

Eligibility Criteria:

Subjects must be in the age range 18 to 65 years.

Subjects must weigh greater than 110 pounds.

Subjects must have a fingerstick hemoglobin greater than or equal to 12.5 g/dL.

Subjects must have no known heart, lung, kidney disease, or bleeding disorders.

Subjects must have no history of hepatitis since age 11.

Subjects must have no history of intravenous injection drug use.

Subjects must not have had tattoos or non-sterile skin piercing within the past 12 months.

Subjects must not have a history of engaging in high-risk activities for exposure to AIDS or hepatitis viruses, as defined in the DTM Donor Alert.

Female subjects should not be pregnant.

Subjects must demonstrate completion of a primary AVA vaccination series (0, 2, 4 weeks and 6 months) and be within 3 to 12 weeks of receiving a dose at 6 months, 12 months, or 18 months; or within 6 months of an annual booster.

Special Instructions: Currently Not Provided

Keywords:

Anthrax

Immune Globulin

Plasmapheresis

Vaccine

Recruitment Keywords:

None

Conditions:

Healthy

Investigational Drug(s):

Anthrax Immune Globulin

Investigational Device(s):

None

Contacts:

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail: prpl@mail.cc.nih.gov

Citations:

Christopher GW, Cieslak TJ, Pavlin JA, Eitzen EM Jr Biological warfare A historical perspective JAMA 1997 Aug 6;278(5):412-7 PMID: 9244333

Pile JC, Malone JD, Eitzen EM, Friedlander AM Anthrax as a potential biological warfare agentArch Intern Med 1998 Mar 9;158(5):429-34 Review PMID: 9508220

Dixon TC, Meselson M, Guillemin J, Hanna PC Anthrax N Engl J Med 1999 Sep 9;341(11):815-26 Review No abstract availablePMID: 10477781

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