COVER SHEET FOR DOCUMENT TRANSMISSION

File: 970107_sep96_decls61_0003.txt
Page: 0003
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







                     1. Status of development

                           This vaccine is far along in development. We have a
                     No- Dollar agreement with the company. The vaccine is
                     being developed under an Investigational New Drug
                     Exemption, and we have performed three studies with HAV
                     vaccines. In the largest of these, 152 soldiers at Ft.
                     Campbell received the vaccine. 99% developed antibody.
                     Counting studies done elsewhere, over 6,000 volunteers have
                     received this vaccine. we are presently carrying out a
                     field efficacy study in 40,000 children in Thailand with
                     this vaccine.

                     2.  Data pertinent to use in U.S. Forces

                         a. 101st Airborne Division

                            (1) Methods

                             Volunteers in the loist Airborne Division at Ft.
                         Campbell were given three injections of hepatitis A
                         vaccine in the deltoid. This vaccine contained 360
                         ELISA units of antigen. (Current preparations have 720
                         ELISA units.) Vaccine was given by needle or jet gun at
                         times 0, 1, and 6 months. serum specimens were
                         collected just before each dose and at 8 months.
                         Questionaires were given with each dose and volunteers
                         were asked to return them after three days had passed.
                         Volunteers not sending forms were questioned in person
                         at the tine of the next dose. Serum was tested by
                         standard HAVAB tests using Abbott kits. 30 sera were
                         also tested for neutralizing antibody by the RIFIT      test.

                            (2) Results

185    Rank    05  4    E9  2
                    20-25   101               Female 21             04  4    E8  2
                    26-30   43                                      03  13   E7  6
                    31-35   20                                      02  2    E6  15
                    36-40   11                                      01  2    E5  26
                    41-45     6                                              E4  63
                    46-50     2                                              E3  19
                                                                             E2  30
                                                                             El  18
                                           Antibody to Hepatitis A virus
                    Vaccine             Percent with positive liAVAB test
               Group Received Number    Month 0 Month I Month 6 Month 8
                 1 RAV Needle 54         0%        15%       32%        93%
                 2 HAV Jetgun 56         0%        41%*      66%*       93%

                 Jet gun was significantly more    immunogenic at months 1 and 6.


                                                   2

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