Plasmapheresis of Anthrax-Vaccinated Subjects for Production of Anthrax Immune Globulin
|First Received Date ICMJE||February 28, 2002|
|Last Updated Date||March 3, 2008|
|Start Date ICMJE||February 2002|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00031291 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Plasmapheresis of Anthrax-Vaccinated Subjects for Production of Anthrax Immune Globulin|
|Official Title ICMJE||Plasmapheresis of Anthrax-Vaccinated Subjects for Production of Anthrax Immune Globulin|
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:
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:
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.
Inhalational anthrax infection is associated with a 60-100% mortality rate, depending on the rapidity with which appropriate antimicrobial therapy is initiated. Experiments using an animal model of inhalational anthrax suggest that adjunctive therapy with equine-derived anti-anthrax antisera may be associated with higher survival rates, however no human-derived antisera are currently available. The purpose of this protocol is to provide a mechanism for obtaining high-titer anti-anthrax immunoglobulin by plasmapheresis of human volunteers who have recently received a course of anthrax vaccination. Volunteers are Department of Defense (DoD) employees and military personnel who are within 3 to 12 weeks of having received a fourth or greater dose of AVA if four to six total inoculations were given, or within 6 months of the last dose if seven or more AVA inoculations were given. All vaccinees were vaccinated as a requirement of their tour of duty and will otherwise meet all blood donor eligibility criteria, in accord with Food and Drug Administration (FDA) requirements and American Association of Blood Banks (AABB) standards. Plasmapheresis will be accomplished using licensed apheresis devices and standard collection techniques, and products will meet all blood safety testing requirements currently mandated by the FDA. Plasma components collected under this protocol will be stored in the frozen state as fresh frozen plasma (FFP) until a protocol for administration of these components to human patients critically ill with inhalational anthrax infection has been reviewed and approved by the IRB's of NIH, CDC, and USAMRIID. Following this approval, products will undergo standard Cohn-Oncley fractionation into a concentrated immunoglobulin preparation suitable for intravenous use, to be designated anthrax immune globulin intravenous (AIGIV). Intravenous administration of products derived from plasma collected under this protocol, whether as single-donor FFP or as AIGIV, will occur under a Phase I/II trial involving an Investigational New Drug (IND) exemption, with the IND held by the Centers for Disease Control and Prevention (CDC). The plasma products collected under this protocol will also be used in pharmacokinetic, dose finding, and efficacy studies in animals, and to establish a repository of reference serum standards at the CDC. This study represents a collaborative effort between the DTM/NIH, CDC, and DoD.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Drug: Anthrax Immune Globulin|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||March 2004|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Age range 18 to 65 years.
Weight greater than 110 pounds.
Fingerstick hemoglobin greater than or equal to 12.5 g/dL.
No known heart, lung, kidney disease, or bleeding disorders.
No history of hepatitis since age 11.
No history of intravenous injection drug use.
No tattoos or non-sterile skin piercing within the past 12 months.
No 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.
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.
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00031291|
|Other Study ID Numbers ICMJE||020137, 02-CC-0137|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institutes of Health Clinical Center (CC)|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||March 2004|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP