IN NUNAN CHALLENGE EXPERINENTS(U) JON A BURNS SCHOOL USI FE OF MEDICINE HONOLULU HI N J NARCHETTE 91 APR SI. 1:tis 6/13 N. DIM1-93-C3047F/0 mmmohohhhu
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1 IN NUNAN CHALLENGE EXPERINENTS(U) JON A BURNS SCHOOL USI FE OF MEDICINE HONOLULU HI N J NARCHETTE 91 APR SI 6/13 N 1:tis DIM1-93-C347F/ mmmohohhhu
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3 :.i. Ln AD MC.tILE (UiO Safety Testinq of Dengue-2 and Denque-4 Viruses for Use in Human Chal, nqe Experiments Final Peport Nyven J. Marchette April 1, 1988 Supported by U.S. ARMY MEDICAL RESEARCH AND DEVELOPMENT COMMAND Fort Detrick, Frederick, Maryland V Contract No. DAMDl7-83-C-347 DTIC ECTE University of Hawaii -MAY School of Medicine Honolulu, Hawaii H DOD DISTPIBUTION STATEMENT Approved for public release; distribution unlimited The findings in this report are not to be construed as an official Department of the Army position unless so designated by other authorized documents. "4 %? " ","",,'"'",P """ ";, " " " ",.".", ' -,,.,"-",,",'".,,. ". ".",",, ".",",',"
4 SECURITY CLASSIFICATION OF THIS PAGE Form Approved REPORT DOCUMENTATION PAGE OMB No la. REPORT SECURITY CLASSIFICATION lb RESTRICTIVE MARKINGS Unclassified 2a. SECURITY CLASSIFICATION AUTHORITY 3 DISTRIBUTION /AVAILABILITY OF REPORT 2b. DECLASSIFICATON/DOWNGRADING SCHEDULE Approved for public release; distribution unlimited 4. PERFORMING ORGANIZATION REPORT NUMBER(S) 5. MONITORING ORGANIZATION REPORT NUMBER(S) 6a. NAME OF PERFORMING ORGANIZATION W OFFICE SYMBOL 7a. NAME OF MONITORING ORGANIZATION University of Hawaii (If applicable) School of Medicine I 6c. ADDRESS (City, State, and ZIP Code) 7b. ADDRESS (City, State, and ZIP Code) Honolulu, Hawaii Ba. NAME OF FUNDING/SPONSORING 8b. OFFICE SYMBOL 9. PROCUREMENT INSTRUMENT IDENTIFICATION NUMBER ORGANIZATION U.S. Army Medical (If applicable) Research & Development Command Contract No. DAMDl7-83-C-347 8c. ADDRESS (City, State, and ZIP Code) 1. SOURCE OF FUNDING NUMBERS PROGRAM PROJECT TASK WORK UNIT Fort Detrick, Frederick, Maryland ELEMENT NO. NO. 3M16 NO. ACCESSION NO. 11. TITLE (Include Security Classification) 6277A 277A871 AA 11 Safety Testing of Dengue-2 and Dengue-4 Viruses for Use in Human Challenge Experiments 12. PERSONAL AUTHOR(S) Nyven J. Marchette 13a. TYPE OF REPORT 13b. TIME COVERED 14. DATE OF REPORT (Year, Month, Day) 15. PAGE COUNT Final Report FROM /1i/83 TO4u_ 1988 April SUPPLEMENTARY NOTATION 17. COSATI CODES 18. SUBJECT TERMS (Continue on reverse if necessary and identify by block number) FIELD GROUP SUB-GROUP Dengue Fever, Viruses, Mice, Rabbits, Guinea Pig, 6 13 Tropical Medicine, Virology, Safety Testing ABSTRACT (Continue on reverse if necessary and identify by block number).n' 2. DISTRIBUTION/AVAILABILITY OF ABSTRACT 21 ABSTRACT SECURITY CLASSIFICATION [ UNCLASSIFIED/UNLIMITED IM SAME AS RPT. [ D,, r L'"R3 Unclassified 22a. NAME OF RESPONSIBLE INDIVIDUAL 22b TELEPHONE (Include Area Code) 22c OFFICE SYMBOL Mrs. Virainia Miller 31/ SCRD-RMI-S A DO Form 1473, JUN 86 Previous editions are obsolete. SECURITY CLASSIFICATION OF THIS PAGE -.: %'. - C*.~IC* -,.
5 FOREWORD In conducting research usina animals, the investigator(s) adhered to the "Guide for the Care and Use of Laboratory Animals," prepared by the Committee on Care and Use of Laboratory Animals of the Institute of Laboratory Animal Resources, National Research Council (NIH Publication No , Revised 1985). Citations of commercial organizations and trade names in this report do not constitute an official Department of the Army endorsement or approval of the products or services of these organizations. Acoession For NTIS -GRA&T DTIC TA3 -] Uu:nnnowut, d Just If f iot I -'u- ] By -.. Distribitlon/.. AvaeiblbIlity Ccdeo Aveil and/or Dial Special I~Vd I
6 L~ ~~ I.T- - 1 SSafety viruses: testing of attenuated dengue virus vaccines and challenge Dengue 2 (PR-159) Parent, non-attenuated; January Lot No. I (Human challenge virus). 'Dengue 4 (H-241) Parent, non-attenuated' December Lot No. I (Human challenge virus). Dengue 3 (H53489) Production seed and control fluids i) For each of the viruses, the following substances were tested separately for sterility and presence of adventitious agents: Freeze dried virus> Virus fluids, unclarified. Control fluids, day 7, unclarified' Control fluids, day 14, unclarified Pre-inoculation fluids, In addition, the identify of each virus was determined by breakthrough neutralization tests. All tests were concluded satisfactorily. No adventitious agents were detected and the identity of the viruses was confirmed The detailed final report for each virus tested is appended., Initially, there were problems with the Dengue 4 challenge virus in that carbon dioxide from the dry ice in the shipping container leaked into the vials and inactivated the virus. This was eventually corrected and the third lot of this virus arrived in good shape and the safety testing completed. No equipment was purchased on this contract and there is no government property remaining. U,] U,2 e ri'' - V%'~ 2 ~ ~ ~J %'~~ M~%URJ qwh,
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