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File: 102496_sep96_decls8_0001.txt
Subject: USE OF SPECIFIC HUMAN IMMUNE GLOBULIN MONOCLONAL ANTIBODY
Unit: OTSG
Parent Organization: HSC
Box ID: BX003202
Folder Title: DESERT SHIELD MEDICAL ISSUES REVIEW AND AD HOC WORKING GROUP
Document Number: 5
Folder SEQ #: 31
UNCLASSIFIED
DEPARTMENT OF THE ARMY
WALTER REED ARMY INSTrrUTE OF RESEARCH
WALTER REED ARMY MEDICAL CENTER
WASHINGTON. O.C 20307-5100
Appendix D
IN REPLY RE@ TO
SGRD-UWF-J 7 December 1990
MEMORANDUM FOR Head, Tri-Service Vaccine Task Force
SUBJECT: Use of specific human immune globulin monoclonal
antibody or anti-septic vaccines in Operation Desert Shield.
1. BACKGROUND: Centoxin is a human monoclonal antibody which
prevents death from septic shock due to gram negative bacteria by
neutralizing the endotoxin which causes sepsis. This antibody
has been found to be completely safe in the over 400 patients
that have received it in clinical trials. In septic patients
with gram negative bacteremia, Centoxin reduced mortality by 40%.
In patients with gram negative bacteremia in shock it reduced
mortality by 58%. It is therefore clearly indicated for the
treatment of gram negative sepsis. Centoxin is currently being
studied for prevention of sepsis following thoracic, abdominal
surgery or trauma. Previous studies with a less potent human
serum against endotoxin showed that such prophylaxis prevented
septic shock, organ failure and death in these patients.
Although animal studies indicate that refractory blood loss shock
may be due to endotoxin release, clinical studies have not yet
been performed on the usefulness of Centoxin in refractory shock
due to blood loss.
2. MILITARY RELEVANCE: Wounded and burned soldiers,
especially those with chest and abdominal wounds, would most
benefit from Centoxin prophylaxis and treatment. If this drug
had been available during the Viet Nam conflict numerous lives
could have been saved. Mortality due to skin exposure to
blistering agents such as Mustard gas may in large part be due to
secondary infection and sepsis. Centoxin would likely also play
a major role in the treatment of such casualties.
3. PRODUCTION AND AVAILABILITY: Three thousand doses are
currently available. The shelf live of the currently available
bottled product varies depending on its bottling date but
averages between 6-9 months. Enough finished bulk material is
available for production of another 5000 doses. This would
require six weeks. This material would have a shelf life of 18
months. Any additional material would require four months to
produce finished acceptable product.
4. ALTERNATIVE PRODUCT AVAILABILITY: A mouse monoclonal
against endotoxin, Zoma E5, has also been tested in clinical
trials. Data reported thus far reveals no efficacy for patients
Declassified per SECARMY by CMH: 10-10-1996
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Document 3 f:/Week-36/BX003202/DESERT SHIELD MEDICAL ISSUES REVIEW AND AD HOC WORKING GROUP/use of specific human immune globulin monoclonal:1011961539129
Control Fields 17
File Room = sep96_declassified
File Cabinet = Week-36
Box ID = BX003202
Unit = OTSG
Parent Organization = HSC
Folder Title = DESERT SHIELD MEDICAL ISSUES REVIEW AND AD HOC WORKING GROUP
Folder Seq # = 31
Subject = USE OF SPECIFIC HUMAN IMMUNE GLOBULIN MONOCLONAL
Document Seq # = 5
Document Date =
Scan Date =
Queued for Declassification = 01-JAN-1980
Short Term Referral = 01-JAN-1980
Long Term Referral = 01-JAN-1980
Permanent Referral = 01-JAN-1980
Non-Health Related Document = 01-JAN-1980
Declassified = 11-OCT-1996