TOXICOLOGICAL RESEARCH VACCINE STORAGE AREA

File: 123096_sep96_decls53_0002.txt
Page: 0002
Total Pages: 19

Subject: TOXICOLOGICAL RESEARCH  VACCINE STORAGE AREA                    

Unit: OTSG        

Parent Organization: HSC         

Box  ID: BX003203

Folder Title: MEETING AT NATIONAL CENTER FOR TOXICOLOGICAL RESEARCH                                           

Document Number:          1

Folder Seq  #:         91









           14 August 1990

           MEMORANDUM FOR The Record

           SUBJECT: Meetings at National Center for Toxicological Research
           (NCTR), Jefferson, Arkansas: Contingency Vaccine Storage Area and
           Preclinical Vaccine Testing Facility.

           1. Dr. Larry Hale, WRAIR, MAJ Ron Banks, WRAIR, and Dr. Michael
           Roy, USAMMDA, attended meetings at NCTR from 0830 to 1600 hours
           on 1 August 1990. The morning sessions, attended by Mr. C. Dan
           Brand, Deputy Director for Research Services, Dr. Tom Bucci,
           Pathology Associates, Incorporated, Ms. Josephine Reed, Chief,
           Quality Assurance Branch, Mr. Jack Knowles, Chief, Microbiology
           Section, Mr. Wirt Franklin, Microbiologist, Mr. Bill McClure
           Microbiologist, Dr. Bill Witt, Chief, Laboratory Animal Branch,
           MAJ Ron Banks, Walter Reed Army Institute of Research (WRAIR),
           Dr. Larry Hale, WRAIR and Dr. Michael Roy, USAMMDA, focused upon
           the development of protocols and task orders/memoranda of need
           for the preclinical testing of candidate Shigella vaccines in
           nonhuman primates.

           2. As regards the preclinical testing of candidate Shigella
           vaccines, the first study (studies) will determine the Infectious
           Dose for 50% of the primates, using the challenge strain Shigella
           flexneri 2a, strain 2457T. Studies will typically be performed
           on groups of 24 Rhesus monkeys and under BSL-2 conditions. At
           least one group and possibly a second group of animals will be
           required to determine the ID50 for this or any other challenge
           strain. The next studies will test the safety and efficacy of
           the vaccines in Rhesus monkeys.

           3. Larry Hale, WRAIR, will be the Principal Investigator for
           each study and Tom Bucci will be the study director and co-

           of the tests (ID50 and safety/efficacy) and these will be
           reviewed by Tom Bucci, Jack Knowles, Ron Banks, Bill Witt and
           Mike Roy. Larry Hale will consider the reviewers comments and
           prepare the final protocols. These will be submitted to Bill Witt
           for review by the Laboratory Animal Committee at NCTR. Following
           approval by this committee, the protocols would be submitted to
           Headquarters, US Army Medical Research and Development Command
           for review and approval.

           4. Several Standard Operating Procedures must be prepared,
           reviewed and revised prior to initiation of the first studies.
           The microbiology SOP will be one already prepared by the Army, in
           support of human clinical studies of candidte Shigella vaccines
           at University of Maryland. Mike Roy will send one copy of this
           SOP and a copy of the IND amendment/clinical trial for the most
           recent Shigella vaccine to be tested in humans at U. Maryland.

Document 19 f:/Week-36/BX003203/MEETING AT NATIONAL CENTER FOR TOXICOLOGICAL RESEARCH/toxicological research vaccine storage area:12179609285454
Control Fields 17
File Room = sep96_declassified
File Cabinet = Week-36
Box ID = BX003203
Unit = OTSG
Parent Organization = HSC
Folder Title = MEETING AT NATIONAL CENTER FOR TOXICOLOGICAL RESEARCH
Folder Seq # = 91
Subject = TOXICOLOGICAL RESEARCH VACCINE STORAGE AREA
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 = 17-DEC-1996