USE OF SPECIFIC HUMAN IMMUNE GLOBULIN MONOCLONAL ANTIBODY

File: 102496_sep96_decls8_0003.txt
Page: 0003
Total Pages: 3

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



        SGRD-UWF-J (7 Dec 90)
        SUBJECT: Use of specific human immune globulin monoclonal
        antibody or anti-septic vaccines in Operation Desert Shield.


             d. These vaccines have been extremely safe in humans since
        they are all chemical conjugates of non-toxic materials to safe
        carrier proteins. They all induce antibodies that protect
        against sepsis in animal models. Their clinical efficacy as
        active vaccines in humans has not yet been proven because they
        can only be tested in an operational type setting such as Desert
        Shield or hospital ICU'S. Human hyperimmune Ivig against
        organisms and endotoxin is completely safe and presents no IND
        safety issues since it is similar to the licensed IVIG that is
        used routinely throughout the world. Licensure revolves
        completely around lack of completed clinical trials.

        8. RECOMMENDATIONS:

             a. centoxin should be used in operation Desert Shield for
        treatment of sepsis in all injured personnel and prophylaxis in
        all severe abdominal, chest, burn or head wound trauma as
        outlined above.

             b. The three thousand available doses should be purchased
        at a reduced cost or under agreement that it could be substituted
        for material with a longer half life if not used.

             c. The five thousand doses that could be formulated in six
        weeks should be purchased and shipped to support Desert Shield.
        If not used or required it could be turned back to the company or
        put into the Depot for use in the military medical system when
        licensure occurs.

             d. Begin preparing hyperimmune IVIG against gram negative
        organisms and endotoxin as rapidly as possible to substitute for
        the more expensive Centoxin and provide broader coverage. Field
it becomes
        available.

             e. Development of vaccines must be accelerated to actively
        vaccinate combat personnel in operation Desert Shield with
        multivalent vaccines against gram negative organisms and
        Staphylococcus. Actively vaccinate combat personnel in operation
        Desert Shield against endotoxin when the active vaccine is
        available.





                                            POC: COL Jerald Sadoff
                                                  AV 291-3756

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