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File: 970107_sep96_decls33_0003.txt
Page: 0003
Total Pages: 7

Subject: PREVENTION OF HEPATITIS A IN SOLDIERS                           

Unit: OTSG        

Parent Organization: HSC         

Box  ID: BX003205

Folder Title: HEPATITIS A - VACCINES                                                                          

Document Number:          1

Folder Seq  #:         62








                     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 F.AV
                     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 101st 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 time of the next dose. Serum was tested by
                        standard IIAVAB tests using Abbott kits. 30 sera were
                        also tested for neutralizing antibody by the RIFIT       test.

                            (2) Results

   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  IS
                                           Antibody to Hepatitis A virus
                    Vaccine             Percent with positive FAVAB test
              Group Received Number     Month 0 Month I Month 6 Month 8
                 1 HAV Needle 54         0%        15%      32%         93%
                 2 liAV Jetgun 56        0%        41%*     66%*        93%

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


                                                   2

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Document 7 f:/Week-36/BX003205/HEPATITIS A - VACCINES/prevention of hepatitis a in soldiers:01029715472734
Control Fields 17
File Room = sep96_declassified
File Cabinet = Week-36
Box ID = BX003205
Unit = OTSG
Parent Organization = HSC
Folder Title = HEPATITIS A - VACCINES
Folder Seq # = 62
Subject = PREVENTION OF HEPATITIS A IN SOLDIERS
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