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File: 120396_sep96_decls5_0004.txt
Subject: INFORMATION BROCHURE PENTAVALENT ABCDE BOTULINUM TOXOID
Unit: OTSG
Parent Organization: HSC
Box ID: BX003203
Folder Title: INFORMATIONAL BROCHURE PENTAVALENT BOTULINUM TOXOID
Document Number: 1
Folder SEQ #: 40
09/07/90 13:39 'M301 663 2982 HQ USkmc OTSG lao0s/008
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Experience with pentival*ztt betulinum toxoid has shown that: (A)
it is effective in protecting animals against intraperitoneal
challenge with toxins of types A,E,C,D, and I of cloatridium
botulinum, (B) the serum antitoxin levels in animals as determined
by mouse protection tests correlate with protective activity . and
(c) the tozoid introduced into man produces levels of antitoxin
thought to be protective as judged by extrapolation of data derived
from,animal experiments.
In experiments with the original lot of toxoid (2,3), $0 persons
were immunized on a 0-2-12 week schedule. Antitoxin titers were
detectable for :all 5 types of toxizi in about 804 of the volunteers
2 weeks after the initial series. These titers declined during the
next 12 weeks and only 'a small percentage had measurable titers by
one year, just before the boosters were given. Eight weeks after
the boosters, 100% of the recipients had measurable titers to all
5 types.
since -initiating the r@irement- for determining antitoxin levels
in recipients'dus for boosters, the J=ftunogenicity of'the tozoid in
humans has been reaffirmed. (only types 3 and/or B antitoxins are
routinely assessed.) While the antitoxin titers attained after the
3rd shot of the -initial series are likely to decline in a matter of
a few months, those established after the first booster are
latively stable and generally persist above the detectable level
f or at I east 2 -Years'. A titer of l.: 16 -(O.15-0.30 IV antitoxin per
ml.) for either 3 or 3 antitoxin is considered satisfactory for
deferring a booster for 2 more years. After evaluating sera from
185 recipients taken in igag,, 1987 and 2988 who were due for
boaster, $1 (43%) were able to postpone them..
The im=cgenicitios in humans of the two new lots of tozoid (Lots
A-2 and a-1) and of the original lot (IBI) were assessed by the
U68. Army Hadical Razearch institute for infectious Diseases
(19$MMIID) and the results are available for comparison (1). The
type Is antitoxin levels attained after the 3rd injection of the now
lots were significantly higher for the original lot.
TiL 1988 USAKRIID 'evaluated inmunizid individuals for neutralizing
antibodies to type a & 5 batulinuin toxins. After the primary
series 91% had a type a titer a. 0.08 lu/mi, and 7e% type 3 titer >
0.02 ID/ml. After the first booster all individuals tested had a
demnstrabl* titer for type A & B (4).
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Document 8 f:/Week-36/BX003203/INFORMATIONAL BROCHURE PENTAVALENT BOTULINUM TOXOID/information brochure pentavalent abcde botulinum:1108961508426
Control Fields 17
File Room = sep96_declassified
File Cabinet = Week-36
Box ID = BX003203
Unit = OTSG
Parent Organization = HSC
Folder Title = INFORMATIONAL BROCHURE PENTAVALENT BOTULINUM TOXOID
Folder Seq # = 40
Subject = INFORMATION BROCHURE PENTAVALENT ABCDE BOTULINUM
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 = 08-NOV-1996