USE OF SPECIFIC HUMAN IMMUNE GLOBULIN MONOCLONAL ANTIBODY

File: 102496_sep96_decls8_0002.txt
Page: 0002
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 specif ic human immune globulin monoclonal
         antibody or anti-septic vaccines in Operation Desert Shield.


         in septic shock due to gram negative organisms.

         5 .  TARGET I>OPULATION, Treatment of all military personnel with
         sepsis, especially those with septic shock. Prophylaxis of all
         personnel with severe wounds or trauma to the abdomen or chest.
         Prophylaxis of all patients when it is anticipated that they will
         recfuire prolonged intubation such as those with head trauma or
         flail chest, etc. Prophylaxis of all patients with severe burns
         once fluid requirements have been stabilized. Treatment of all
         patients with severe mustard gas wounds.

         6. COST: The current cost is $2500/dose. With a large purchase
         the cost might be decreased. Because the drug has been so safe
         and is a globulin product, risk for using it under IND are
         negligible. This drug will be licensed for use and will become
         the standard of care. The DOD should be providing such a
         standard of care to its troops in battle.

         7. other vaccines against sepsis:

              a. A vaccine which activelv induces antibodv like Centoxin
         has been developed by WRAIR scientists. This vaccine has been
         produced and bottled and is scheduled to undergo Phase I clinical
         tests in January 1991. This vaccine could be used to actively
         vaccinate against sepsis. This vaccine could be available for
         use in Desert Shield in 5 months. It would be considerably
         cheaper.

              b. Multivalent vaccines against P. aeruginosa, Klebsiella,
         E. Coli and Staphylococcus have been prepared and tested in
         ifumans by WRAIR scientists and their collaborators. These
         organisms represent up to 70% of those causing post-wound
terial sepsis.
         Currently the prophylactic efficacy of hyperimmune globulin
         prepared from volunteers immunized with P. aeruginosa and
         Klebsiella is being tested in a joint DOD-VA clinical trial.
         These vaccines have all been tested in humans, are safe and
         induce antibodies that protect in animal models.

              c. The first 50,000 doses of the WRAIR anti-endotoxin
         vaccine and the multivalent vaccines against gram negative
         organisms and staphylococcus can be obtained at no charge. Costs
         for immunization of the entire Desert Shield forces would have to
         be negotiated but should not exceed $1-5/vaccine dose which
         represents actual manufacturing costs. These vaccines are
         manufactured by the WRAIR and under CRDAs with the Swiss Serum
         and Vaccine Institute in Bern Switzerland and with Univax
         corporation, Rockville Md. IVIG products can be manufactured at
         costs of $100-400/dose.

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