Joint Service Chemical & Biological Defense Program Overview ...

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Medical Vaccines 44 Medical Biological Defense Vaccines Lead Service FY00-02 Developmental Countermeasures Vaccines Currently Funded for Development • Tularemia Vaccine • Smallpox Vaccine • Venezuelan Equine Encephalitis (VEE) Vaccine • Recombinant Botulinum Vaccine • Plague Vaccine • Combined VEE/Eastern Equine Encephalitis (EEE)/ Western Equine Encephalitis (WEE) • Ricin Vaccine • Next Generation Anthrax Vaccine • Staphylococcal Enterotoxin(s) (SE) Vaccine Contractors: DynPort Vaccine Company (DVC) FREDERICK, MD Joint Program Office for Biological Defense (JPO BD) Joint Vaccine Acquisition Program (JVAP) U.S. Army Medical Research and Materiel Command (USAMRMC)
FY00 Accomplishments: USAMRMC – Technology Base • Completed technical data package for recombinant SE vaccine candidates. • Developed vaccine candidate for VEE virus type 1E and tested for safety in animals. • Assessed the immunogenicity of vaccine components in multiagent vaccine delivery platforms. JPO BD – Advanced Development/Procurement • Executed phase 2a clinical trial for smallpox vaccine. • Continued process development required for manufacture of multivalent recombinant botulinum neurotoxin serotypes A, B, C, E, F vaccine. • Initiated process development required for manufacture of Tularemia live vaccine strain (LVS) vaccine. FY01 Objectives: USAMRMC – Technology Base • Test VEE type 1E vaccine candidates for safety and efficacy in nonhuman primates (NHP). • Determine immunogenic dose of live attenuated Brucella vaccine candidate in NHP. • Compare efficacy of recombinant protective antigen (rPA) and licensed anthrax vaccine in animals and prepare technical data package supporting transition to advanced development. • Complete Phase 0 Exit Criteria and prepare technical data package for recombinant plague vaccine. JPO BD – Advanced Development/Procurement • Transition plague vaccine to advanced development and NGAV vaccine component (rPA) to advanced development. FY02 Objectives: USAMRMC – Technology Base • Test VEE type III and EEE vaccine candidates for efficacy in rodents and WEE and EEE vaccine candidates for safety and efficacy in NHP. • Complete safety and efficacy testing of multiagent vaccine components in animal models. • Perform preclinical animal studies with small-scale pilot lot of Brucella vaccine candidate. • Evaluate intranasal, inhalation, and transdermal application of recombinant protein vaccine formulations. JPO BD – Advanced Development/Procurement • Manufacture consistency lots and conduct phase 2b clinical trial for smallpox vaccine (through FY04). • Manufacture plague vaccine candidate pilot lot. • Complete manufacturing process definition and manufacture pilot lot of Tularemia LVS vaccine; complete nonclinical studies; and initiate phase 1 clinical trials. FY02 Acquisition Phase: Partial List of Vaccines in Advanced Development and in the Technology Base FY00 FY01 FY02 FY03 FY04 FY05 FY06 FY07 Tularemia Smallpox VEE IAB/IE/IIIA Plague Next Generation Anthrax Staphylococcal Enterotoxin Multivalent Equine Encephalitis (EEE, WEE) Ricin Marburg Brucellosis Ebola Multivalent Recombinant Botulinum (A, B, C, E, F) 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 II III II I 0 I II I I 0 I 0 0 I 0 I 0 I II III II III Medical Vaccines 45
Page 2 and 3: Preface In 1993, Congress passed Pu
Page 4 and 5: Global Threat 2 A Dangerous World
Page 6 and 7: Support to Joint Vision 2020 4 Domi
Page 8 and 9: Integrated Approach to Counter the
Page 10 and 11: ACADA 8 Automatic Chemical Agent De
Page 12 and 13: Artemis 10 Artemis formerly Joint S
Page 14 and 15: BIDS 12 Biological Integrated Detec
Page 16 and 17: ICAM 14 Improved Chemical Agent Mon
Page 18 and 19: JBPDS 16 Joint Biological Point Det
Page 20 and 21: JCAD 18 Joint Chemical Agent Detect
Page 22 and 23: JSLNBCRS 20 Joint Service Lightweig
Page 24 and 25: JSLSCAD 22 Joint Service Lightweigh
Page 26 and 27: JWARN 24 Joint Warning and Reportin
Page 28 and 29: NBCRS Modifications 26 NBC Reconnai
Page 30 and 31: CBPS 28 Chemical Biological Protect
Page 32 and 33: CP DEPMEDS 30 Chemically Protected
Page 34 and 35: CPS Backfit/SCPE 32 Collective Prot
Page 36 and 37: JPACE/JSAM 34 Joint Protective Airc
Page 38 and 39: JSGPM 36 Joint Service General Purp
Page 40 and 41: JSLIST/JSLIST P3I 38 Joint Service
Page 42 and 43: JTCOPS 40 Joint Transportable Colle
Page 44 and 45: JBAIDS 42 Joint Biological Agent Id
Page 48 and 49: Medical CB Products 46 Medical CW/B
Page 50 and 51: Medical Pretreatments 48 Chemical W
Page 52 and 53: Medical CB Therapeutics and Diagnos
Page 54 and 55: JSFXD 52 Joint Service Fixed Site D
Page 56 and 57: JSSED 54 Joint Service Sensitive Eq
Page 58 and 59: MDS 56 Modular Decontamination Syst
Page 60 and 61: Sorbent 58 Sorbent Decontamination
Page 62 and 63: Modeling and Simulation 60 Modeling
Page 64 and 65: Science & Technology 62 Lead Servic
Page 66 and 67: ACTDs 64 What is an ACTD? Advanced
Page 68 and 69: Joint Service CB Defense Doctrine a
Page 70 and 71: Joint Management Structure 68 The N
Page 72 and 73: JSIG/JSMG Management 70 Joint Servi
Page 74 and 75: Army CBD Proponent Structure 72 Arm
Page 76 and 77: Navy CBD Proponent Structure 74 Nav
Page 78 and 79: Funding 76 FY01 CBDP Funding Distri
Page 80 and 81: Acronyms 78 AA Abbreviate Analysis
Page 82 and 83: Points of Contact 80 Office of the
Page 84 and 85: Points of Contact 82 Joint Service
Page 86 and 87: Points of Contact 84 Joint Science
Page 88: Requests for this document should b

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