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File: 970101_sep96_decls31_0007.txt
Subject: REQ FOR DETERMINATION INFORMED CONSENT DRUG AND VACCINES
Unit: OTSG
Parent Organization: HSC
Box ID: BX003201
Folder Title: REQUESTS FOR DETERMINATION INFORMED CONSENT DRUGS
Document Number: 1001
Folder Seq #: 16
INFORMATIONAL DROCHURE
PENTAVALENT (ABCDE) BOTULINUM TOXOID
(IND) in accordance with the from @imi experiments.
requirements of the U.S. food "
PENTAVALENT (ABCDE) BOTUL I KLON Drug Adnfnistratt w (FDA). It @ tIn experiments with the orfgf@t
be a&lnfstered under the (at of toxofd (2,3). 30 persons
is a coffbi net I @of almi@ supervision of qk)atifted wdicat were i@ized on a 0-2-12 week
Phosptiate-6dsorbed toxold 6ert@ pers@t. sch@te. Antitoxin titers were
f roes format,in-inattivated. det@tabte for all 5 types of toxin
Partially Purified @s A,B,C, 0, 2. The toxofd sh@td be in about 80% of the volunteers 2
ard E botuti@ toxins. Each viat administered Only to healthy mm weeks after the third dose of the
contains 0.02Z% formaldehyde and and women between the ages of 18 Initial series. Only a @tt
1:10,000 thimerosal asaard 65 years, since investigations percentage had measurable titers by
preservative. The currently have @ conducted exclusively In @ year, just before the boosters
distributed toxoid is manufactured that population. were given. fight weeks after the
boosters, 100% of the recipients
P@ ic Health. 3. @m The effects of had wasurable titers to all 5
Administration of the toxofd during @s.
pregnancy have not been
established. Data are net Since initiating the reqtjfr@t
SNAKE VELL before withdrawing each available wthe safety of for determining antitoxin levels in
dose. Administer 0.5 sit of vaccfm pentayatent botuti @ toxoid for recipients @ for boosters, the
via deep subcutaneous irliect@; do the developing fetus. There shwid i@enicity of the toxoid in
net Inject intracutanmnty or into be no risk to the fetus from the h@m has been reaffirmed. (only
s@rficiat structures. Vacci@s pr@t itself because the toxo(d types A, 0 andloc E ant(toxtr%s are
will remain in the area where the contains Only Inactivated I>rotein. rwti@ty assessed.) U%fle the
vaccine Is &&intstered for no tees Howver, a theoretical risk frw antitoxin titers attained after the
than 30 Minutes after r@tivtrq *ever* allergic reaction or 3rd shot of the initial series or*
each dose to v@ftor Immediate amphytaxis &es exist. the likely to decline in a mtter of a
adverse effects. A 48 hour past incidence of severe systemic few @ths, th@e "tabl lshed after
tr@ y tow (@ the first booster are relatively
desirable following each < 1%) in previous r@pi@ts (rate stable " g@ratty persist above
l@vtattm. Vacci@s should be and f@le) of this vaccine. In the detectable level for at least 2
informed that they are to report contrast. the risk to the years. A titer of 1:16 (0.15-0.30
any adverse t@at wwor systmfc ($evetopfng fetus of botutfm Is IU @tftoxin per at.) for either 8
reaction that occurs within one prot>ably c@ iderable. The toxofd or E antitoxin Is c@ fdered
week subsequent to the should be given only to those satisf@ t@ for deferring a
adn(mistratfoo of the voccf@. The persom -at risk- to booster for 2 more yes". After
first injection is represented by exposure of So@uti@ toxin. evel@tirg sera frm ISS recipients
week 0. there is a 2 week Interval Therefore, inahigh-risk taken in 1986, 1987 and 1988 Who
between the first secord situation, preg@rcy should net be were d* for booster. 81 (43%) Were
injection and a 12 week tnterv&L considered a c@traindicatfw for able to postpone thm.
between - the first"third vaccination kith botutfnum
injection. pentavat @t toxoid. The i@@icitfes In h@@ of
the two new tots of toxoid (Lots
d a A-2 and S-t) and of the origi@t
mt. deep sLA>cuta@ty at 0- second or subsequent booster tot (181) were assessed by the U.S.
Z-IZ weeks. f@i tati@ @tess laboratory test "Kedicat Research Institute for
have shown antitoxin type 6 and or Infectious Diseases (USAXRIID) and
first Booster: 0.5 ml. deep E to be bet" a satisfactory level. the results are available for
subcutaneous ty 12 K@ths after comparison (1). The type 13
the first fnj"tiw of the initial antitoxin levels attained after the
series. IKKUNDGENICITY 3rd injection of the new tots Were
Experience with 1>ent6vatent significantly higher for the
Receipt of each vaccine dose will botuti@ toxoid tas shown that-. origi@t tot.
be recorded in the indivickials (A) it is effective in protecting
@rw@nt vaccine file. animals against intraperit@at In 1988 USAKRIID eva t ua t ed
Additionally, a subset of approx. challenge with toxins of types immunized individuals for
100 vacimes receiving each vaccine A,B,C,D, ardEof Ctostridi mneutralizing antibodies to type A &
subtot Witt be prospectively t@tin@. (8) the serum antitoxin 8 botuti @ toxins. After the
as determined by Priiry series 91% had a type A
postcard-Wst-d qesti@ire. @se protection tests correlate titer 0.08 IU/m@, ard 78% type b
with protective activity , fird (c) titer 0.02 ]Ulmt. After the
PRECAUTIONS the toxoid intr@ed into man first booster all irdivi @ is
1. Botuti@ toxoid is m taprockxes levels of antitoxin tested had a d@,@trabte titer for
licensed pr@t and is distributed th@ht to be protective as judged type A & 8 (4).
as an investigate @t N "Drug by extrapolation of data @rived
ATTACHTIENT 1
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Document 16 f:/Week-36/BX003201/REQUESTS FOR DETERMINATION INFORMED CONSENT DRUGS/req for determination informed consent drug and :12249609312932
Control Fields 17
File Room = sep96_declassified
File Cabinet = Week-36
Box ID = BX003201
Unit = OTSG
Parent Organization = HSC
Folder Title = REQUESTS FOR DETERMINATION INFORMED CONSENT DRUGS
Folder Seq # = 16
Subject = REQ FOR DETERMINATION INFORMED CONSENT DRUG AND
Document Seq # = 1001
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 = 24-DEC-1996