Battling Malaria: Strengthening the U.S. Military Malaria Vaccine Program Book

Contents

ABBREVIATIONS AND ACRONYMS....................xix
SUMMARY....................1
The Malaria Threat to the U.S. Military....................1
Malaria Vaccine Research and Development in the U.S. Military....................2
Malaria Vaccine Progress to Date....................2
Program Integration....................4
Need for Increased Resources....................5
Recommendations....................5
1 INTRODUCTION....................9
The Review Process and Inputs....................9
Scope and Organization of the Report....................11
2 THE MALARIA THREAT AND NEED FOR A VACCINE....................13
Global Malaria Problem....................13
Military Malaria Problem....................14
Cost and Time Needed to Produce a Vaccine....................19
3 MALARIA VACCINES....................21
Specific Military Needs with Respect to a Malaria Vaccine....................24
Malaria Vaccine Development....................26
Preerythrocytic Stages....................26
Erythrocytic Stages....................30
Multiantigen Multistage Approaches....................30
Scientific Barriers to Malaria Vaccine Development....................32
Insufficient Knowledge of Malaria Biology....................32
Lack of Understanding of Protective Immunity....................32
Inadequate Animal Models....................33
Poor Definition of Outcomes....................33
The Malaria Vaccine Technology Roadmap....................33
Department of Defense Scientific Contributions to the Global Malaria Vaccine Research Effort....................35
Status of Current VaccineCandidates....................36
4 THE U.S. MILITARY MALARIA VACCINE RESEARCH AND DEVELOPMENT PROGRAM-SCIENTIFIC ASPECTS....................41
Malaria Threat....................41
Department of Defense Mandate for a Malaria Vaccine....................42
Malaria Vaccine Requirements....................42
Clinical Trials to Test Efficacy of a First-Generation Malaria Vaccine....................44
Current and Planned Scientific Program....................47
RTS,S....................50
Recombinant Proteins....................50
Gene-Based Vaccines and Prime-Boost Approaches....................51
Antigen Discovery Using Genomics and Proteomics....................52
Attenuated Sporozoites....................52
Planned Clinical Trials....................52
Overall Assessment of Scientific Program....................52
5 ORGANIZATION AND MANAGEMENT OF THE PROGRAM....................56
Program Management....................56
Project Management Structure....................58
IRB Approval Process for Clinical Trials....................59
Business and Intellectual Property Issues....................59
Communication and Resource Sharing....................60
Program Reorganization....................61
Previous Reports Addressing DoD Vaccine Development and Acquisition....................63
Human Resource Commitments....................65
Financial Commitment....................67
REFERENCES....................71
APPENDIXES A Vaccine Trials....................81
B Current Requirements for a Malaria Vaccine....................95
C Suggested Design of Trials for Testing Malaria Vaccines in Nonimmune Adults Visiting Endemic Areas....................96
D Patents....................99
E Scientific Advisory Board for DoD Malaria Vaccine Research and Development Program (Draft Charter)....................102
F Recommendations of the IOM Report Protecting Our Forces....................105
G Executive Summary and Recommendations of the DoD Report Acquisition of Vaccine Production....................107
H Open Meeting Agenda....................110
I Committee and Staff Biographies....................115