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File: 970107_sep96_decls33_0003.txt
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