INFORMATIONAL BROCHURE PENTAVALENT BOTULINUM TOXOID

File: 120396_sep96_decls46_0005.txt
Page: 0005
Total Pages: 8

Subject: INFORMATIONAL BROCHURE PENTAVALENT BOTULINUM TOXOID             

Unit: OTSG        

Parent Organization: HSC         

Box ID: BX003204

Folder Title: INFO PAPER PENTAVALENT ABCDE BOTULINUM TOXOID                                                   

Document Number:          1

Folder SEQ  #:         19




       09/07/90 15: 39 %Y3Ol 663 2982      HQ USAMRDC     4@4 OTSG          Q005/068


    $EN T BY:CDC COM, CENTER   8- 6-90  8:02   ATLANTA GEOR31A USA-      3016632BO4;#





                                        IMMUNOQENIC=


             Experience with pentavalout batulinum tozoid has shown that:      (A
             it is of fective in protecting animals against intraptritoneal
             challenge with toxins of types A,B,C,Ds and I of clostridium
             botulinum, (B) the serum antitoxin levels in animals as determined
             by mouse protection tests correlate with prot6etive activity , and
             (C) the toxoid introduced into man produces levels of antitoxin
             thought to be protective as judged by extrapolation of data derived
             from animal experiments.

             Zn experiments with the original lot of toxoid (2,3), $0 persons
             were immunized on a 0-2-12 weak schedule. Antitoxin titers were
             detectable for :all 5 types of toxin in about 80% of the volunteers
             2 weeks after the initial series. Theo* 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 typos.

             Since initiating the requirement. for determining antitoxin levels
             in recipients'due for boosters, the imunogenicity of the tozoid in
             humans has been reaffirmed. (only types 3 and/or E antitoxins are
             routinely assessed. ) While ths antitoxin titers attained after the
             3rd shot of the -initial aeries are likely to decline in a matter of
             a few months, those established after the first booster are
             relatively stabls and generally persist above the detectable level
             for at least 2,Yaars'. A titer of 1,*16 -(O.15-0.30 IV antitoxin par
   ml.) for either 3 or z antitoxin is considered satisfactory for
             deforring a booster for 2 more years. After evaluating sera from
             185 recipients taken in 1986, 1987 and 1988 who were due for
             booster, $1 (43%) were ablo to postpone them..
             The im=cgenicitiet in humans of the two now lots of tozoid (Lots
             A-2 and 2-1) and of the original lot (IBI) were assessed by the
             U#S. Army Xedical Research institute for infectious Diseases
             (USAXRIID) and the results are available for comparison (1). The
             type 9 antitoxin levels attained after the 3rd injection of the new
             lots were significantly higher for the original lot.

             ZiL 1988 USAMRIID *valuated immunized individuals for neutralizing
             antibodies to type a & 3 batulinum toxins,       After the primary
             series 91% had a type IL titer 2. 0,08 IU/ml, and 78% type B titer >
             0.02 tulml. After the first booster all individuals tested had a
             demnstrabl* titer for type A & 9 (4).

Document 8 f:/Week-36/BX003204/INFO PAPER PENTAVALENT ABCDE BOTULINUM TOXOID/informational brochure pentavalent botulinum tox:1122961634164
Control Fields 17
File Room = sep96_declassified
File Cabinet = Week-36
Box ID = BX003204
Unit = OTSG
Parent Organization = HSC
Folder Title = INFO PAPER PENTAVALENT ABCDE BOTULINUM TOXOID
Folder Seq # = 19
Subject = INFORMATIONAL BROCHURE PENTAVALENT BOTULINUM TOX
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 = 22-NOV-1996