REQ FOR DETERMINATION INFORMED CONSENT DRUG AND VACCINES

File: 970101_sep96_decls31_0004.txt
Page: 0004
Total Pages: 16

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











                  JUSTIFICATION FOR WAIVER OF INFORMED CONSENT
                         FOR AN INVESTIGATIONAL NEW DRUG
                      BECAUSE OF MILITARY COMBAT EXIGENCIES


        1. IND

             Administration of Pentavalent (ABCDE) Botulinum Toxoid
        IND # 3723, Protocol Title: Administration of Pentavalent
        Botulism Toxoid to At-Risk Individuals During.

        2. INTENDED USE.

             Pentavalent (ABCDE) Botulinum Toxoid is intended as a
        prophylactic treatment in the prevention of botulinum toxin
        poisoning (Botulism) for service members involved in Operation
        Desert Shield who are at risk of exposure. A team of specially
        trained personnel will be sent with the vaccine to train medical
        personnel responsible for the vaccination procedures. This
        vaccine will be administered by qualified medical personnel
        specially trained in the administration of Pentavalent (ABCDE)
        botulinum toxoid. it is envisioned that the Pentavalent
        Botulinum toxoid will be administered either in medical
        facilities prior to deployment and/or within the area of
        operation. The method of administration is described in the
        Informational Brochure (Attachment 1).

        3. Safety of the drug.

             Since 1970, almost 10,000 injections of the toxoid have been
        administered to recipients who were subsequently observed for
        adverse reactions. The rate of moderate and severe local
        reactions was 5.8% for the initial series. The rate of systemic
        reaction was very low (3.0 %) consisting of mild symptoms such as
        fever, tiredness, headache, and muscle pain. These systemic
        reactions were usually concurrent with the local reaction. This
        vaccine has successfully protected laboratory workers for 25
        years with only minor reactogenicity and no fatalities.

        4. Effectiveness of the drug,

avalent
        (ABCDE) Botulinum Toxoid is immunogenic in humans in sufficient
        quantities after the third dose. Humans have neutralizing
        antibodies to the serotypes present in the vaccine and these
        levels are considered protective against the BW threat. Although
        no humans have been challenged with Botulism toxin an
        extrapolation of the animal data available suggests that humans
        are protected. In experiments with the toxoid, 30 persons were
        immunized on a 0-2-12 week interval. Antitoxin was detectable in
        80% of the volunteers two weeks after the third dose of the
        initial series. This vaccine has successfully protected
        laboratory workers handling the deadly botulinum toxins for the

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