TOXICOLOGICAL RESEARCH VACCINE STORAGE AREA

File: 123096_sep96_decls53_0003.txt
Page: 0003
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










           NCTR 14 August 1990 Page 2

           These will go to NCTR (to be reviewed by Tom BUCCI, Jack Knowles,
           Bill Witt), to Ron Banks and to Larry Hale.   Mike Roy will also
           send clinical and microbiological data collection sheets to Dr.
           Hale and these will be modified for use in collating data from
           the primates.   There is a method for grading of symptoms after
           oral inoculation of macaque monkeys and this was discussed;
           Larry Hale will base his criteria on this study.


           5. Three issues will be addressed by NCTR personnel. The
           possibility of placing a computer, with validated software for
           collecting data, into the animal facility. The possibility of
           hiring an animal technician capable of collecting clinical data
           and clinical specimens during these studies; such a person would
           be assigned to the DOD studies as needed but that person would
           work on other assignments under the NCTR Animal Care contract. A
           location for performing these studies prior to the completion of
           Area I is addressed in paragraph 9.

           6. Microbiology support is expected to be approximately 15 fecal
           samples (parasitology and routine bacteriology only during
           quarantine, and enteric bacteriology during the study) for each
           animal. Serum samples must be obtained from each animal at least
           three times. Perhaps the serum antibody titers should be
           performed at Univer of Maryland, Center for Vaccine Development
           (CVD) under Army contract. NCTR must draw the blood, remove the
           cells, split, freeze, store and ship the specimens. Will the
           serotyping of Shigella isolates be performed at NCTR? NCTR must
           also grow, split, store and ship Shigella isolates. These issues
           will be clarified in the first drafts of SoPs from Larry Hale and
           Ron Banks.

. A typical ID50 protocol will involve a 10 week quarantine, a
           7 day challenge, and a 10 day treatment period. A typical
           vaccine safety/efficacy study will include a 10 week quarantine,
           a 10 day oral vaccination period, a 20 to 25 day rest period, a 7
           day challenge period, and a 10 day antibiotic treatment period.
           During the vaccination, rest, challenge, and treatment periods,
           the animals must be observed and data recorded once each morning
           and again once each evening. All loose stools will be tested for
           occult blood from 7 days prior to challenge and until the animal
           has had 3 loose stools, post challenge. These issues will be
           clarified in the first drafts of SOPS.

           8. Prior to shipment to NCTR, an animal must have received one
           fecal examination (negative for enteric parasites and pathogenic
           organisms, including Shigelia sv.) and a TB test (negative).

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