COVER SHEET FOR DOCUMENT TRANSMISSION

File: 970107_sep96_decls61_0006.txt
Page: 0006
Total Pages: 7

Subject: COVER SHEET FOR DOCUMENT TRANSMISSION                           

Unit: OTSG        

Parent Organization: HSC         

Box  ID: BX003205

Folder Title: 4TH USAMRDC LEISHMANIASIS VARIOUS LEVELS                                                        

Document Number:          1

Folder Seq  #:         12



                         potential need for repeated doses in theater.

                         (2) Comparison of protection afforded by IIAV vaccine
                         as compared to ISG

                            (a) Field efficacy trials with the IIAV vaccines
                            have not been completed. However, it is known
                            that most or all volunteers develop neutralizing
                            antibody of a titer higher than that provided by
                            ISG. Since ISG is providing only antibody
                            mediated protection, it is probable that the
                            antibody stimulated by vaccine represents a degree
                            of protection which is superior to that afforded
                            by ISG.

                         (3) Potential target populations

                         All soldiers in Saudi Arabia would be at equal risk
                         of this enterically transmitted disease.

                         (4) Implication of fielding this IND product.

                         Data on over 6000 successful administrations of this
                         vaccine have been obtained. However, licensure is
                         not anticipated in the immediate future. Therefore,
                         all use of this product would cone under the rules
                         governing use of IND products. Informed consent
                         possibly in an abbreviated form, may be required. A
                         protocol for large scale use will be required. Some
                         data will have to be collected from the volunteers.
                         A brochure will be required for use of the vaccine by
                         unit physicians.

                   6. Recommendation for use of this vaccine

                      a. Arrangements should be made purchase all available
                      doses of this vaccine.

    b. vaccine should be given to the following groups of
                      soldiers:

                         (1) Soldiers who have not had ISG yet.
                         (2) Soldiers who require updating of ISG.

                B. MSD

                   1. Status of development

                        This vaccine is in also in IND status. Versions of it
                   have been given to fewer than 100 persons, but it appears
                   to be highly immunogenic and safe. Data provided by the
                   company indicate that a preparation containing either 200
                   or 400 ng of viral protein will stimulate antibody,
                   detectable by a nodified HAVAB test in all recipients.
                   However, only 10 recipients have been evaluated for each
                   vaccine schedule. The vaccine also appears to be quite
                   safe.

                   2. Availability



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Document 7 f:/Week-36/BX003205/4TH USAMRDC LEISHMANIASIS VARIOUS LEVELS/cover sheet for document transmission:01029715474762
Control Fields 17
File Room = sep96_declassified
File Cabinet = Week-36
Box ID = BX003205
Unit = OTSG
Parent Organization = HSC
Folder Title = 4TH USAMRDC LEISHMANIASIS VARIOUS LEVELS
Folder Seq # = 12
Subject = COVER SHEET FOR DOCUMENT TRANSMISSION
Document Seq # = 1
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 = 02-JAN-1997