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Battling Malaria: Strengthening the U.S. Military Malaria Vaccine Program (2006)

Chapter: Appendix H Open Meeting Agenda

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Suggested Citation:"Appendix H Open Meeting Agenda." Institute of Medicine. 2006. Battling Malaria: Strengthening the U.S. Military Malaria Vaccine Program. Washington, DC: The National Academies Press. doi: 10.17226/11656.
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Appendix H
Open Meeting Agenda

COMMITTEE ON DOD’S MALARIA VACCINE RESEARCH—A PROGRAM REVIEW

January 23–25, 2006

Courtyard by Marriott

8506 Fenton St.

Silver Spring, MD 20910

Tel 301-589-4899

Meeting Room

AGENDA

Meeting Objectives

  • Obtain perspectives from DoD on the malaria threat to the force

  • Review DoD’s P. falciparum malaria vaccine research program

  • Review nonmilitary malaria vaccine efforts

  • Develop initial findings and recommendations regarding DoD’s Program

Suggested Citation:"Appendix H Open Meeting Agenda." Institute of Medicine. 2006. Battling Malaria: Strengthening the U.S. Military Malaria Vaccine Program. Washington, DC: The National Academies Press. doi: 10.17226/11656.
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Monday, January 23, 2006

Closed Session

8:00

Bias and Conflict Discussion

Susanne Stoiber

Executive Director, Institute of Medicine

Open Session

9:00

MIDRP Welcome

COL David Vaughn, MC

Director, Military Infectious Disease Research Program

Fort Detrick, Maryland

9:15

Chairman’s Remarks and Introductions

9:30

MIDRP and Malaria Program Overview and Review of Committee Charge

COL David Vaughn

10:30

Break

11:00

Overview Malaria Vaccine Development

Dr. Filip Dubovsky

Scientific Director, Malaria Vaccine Initiative

12:00

Lunch

1:00–5:15

Program Review—Protein-based vaccine strategy

1:00

Objectives and Strategy

COL Gray Heppner

1:30

Progress towards an RTS,S-Based Vaccine by Year 2010: New Adjuvants, Antigens, and Vectors

  • Status of RTS,S/AS02A

COL Gray Heppner

  • Adjuvant AS01B: RTS,S/AS02A vs. RTS,S/AS01B

COL Kent Kester

  • GMP Pf Antigens MSP-1, AMA-1, and LSA-1

Dr. Evelina Angov

  • Adenovirus 35 with circumsporozoite protein

Dr. Ann Stewart

Suggested Citation:"Appendix H Open Meeting Agenda." Institute of Medicine. 2006. Battling Malaria: Strengthening the U.S. Military Malaria Vaccine Program. Washington, DC: The National Academies Press. doi: 10.17226/11656.
×

2:50

Break

3:00

Clinical Trials of an RTS,S-Based Vaccine

COL Gray Heppner

3:30

Future Vaccines

  • Antigen Discovery

COL Chris Ockenhouse

  • Vivax

COL Chris Ockenhouse

  • Attenuated Knock-out

COL Gray Heppner

4:00

Building the RTS,S-Based Vaccine

  • One Allele or Two?

COL Chris Ockenhouse

  • The role of molecular analyses

  • Making Development Earlier

COL Chris Ockenhouse

  • The potential microarrays

  • Assays of Immune Response

Dr. Ann Stewart

  • From robust to validated

4: 30

Barriers from Proof of Concept to Licensure

COL Gray Heppner

  • Funding

  • Industrial Partners

  • Licensure Trials

5:00

Discussion

6:30–8:30

Committee Dinner at Redrock Canyon Restaurant, Silver Spring, Maryland

Suggested Citation:"Appendix H Open Meeting Agenda." Institute of Medicine. 2006. Battling Malaria: Strengthening the U.S. Military Malaria Vaccine Program. Washington, DC: The National Academies Press. doi: 10.17226/11656.
×

Tuesday, January 24, 2006

Open Session

8:00–12:30

Program Review—DNA-based vaccine strategy

8:00

Objective, Background & Rationale

CAPT Tom Richie

8:30

Program History

CAPT Tom Richie

8:50

Functional Elements & Activities

  • Overview

CAPT Tom Richie

  • Discovery Research

Dr. Denise Doolan

  • Target Antigens

  • Immune Mechanism

9:50

Break (30 minutes)

  • Preclinical Research

Dr. Denise Doolan

  • Preclinical Development

Dr. Denise Doolan

  • Regulatory Affairs

Ms. Gail Levine

  • Clinical Trials

LCDR David Regis

11:05

Clinical Development Plan

CAPT Tom Richie

11:30

Barriers to Progress

CAPT Tom Richie

12:00

Attenuated Sporozoite Vaccine

CAPT Tom Richie

12:30

Lunch

Closed Executive Session

1:30

Discussion of the DoD program including review of questions posed by the sponsor about the Vaccine Program

5:30–5:45

Chairman’s time

6:30–8:30

Dinner at hotel, local restaurant of choice OR evening working session

Suggested Citation:"Appendix H Open Meeting Agenda." Institute of Medicine. 2006. Battling Malaria: Strengthening the U.S. Military Malaria Vaccine Program. Washington, DC: The National Academies Press. doi: 10.17226/11656.
×

Wednesday, January 25, 2006

Closed Executive Session*

8:00–12:00

Structured discussion of the DoD malaria vaccine research program

  • Clarify gaps or missing information

  • Finish discussions regarding key program questions

  • Develop initial findings and recommendations

  • Establish second meeting date to review report draft.

* An open portion of this meeting was posted from 9:00–9:45 and will be honored if needed.

Suggested Citation:"Appendix H Open Meeting Agenda." Institute of Medicine. 2006. Battling Malaria: Strengthening the U.S. Military Malaria Vaccine Program. Washington, DC: The National Academies Press. doi: 10.17226/11656.
×
Page 110
Suggested Citation:"Appendix H Open Meeting Agenda." Institute of Medicine. 2006. Battling Malaria: Strengthening the U.S. Military Malaria Vaccine Program. Washington, DC: The National Academies Press. doi: 10.17226/11656.
×
Page 111
Suggested Citation:"Appendix H Open Meeting Agenda." Institute of Medicine. 2006. Battling Malaria: Strengthening the U.S. Military Malaria Vaccine Program. Washington, DC: The National Academies Press. doi: 10.17226/11656.
×
Page 112
Suggested Citation:"Appendix H Open Meeting Agenda." Institute of Medicine. 2006. Battling Malaria: Strengthening the U.S. Military Malaria Vaccine Program. Washington, DC: The National Academies Press. doi: 10.17226/11656.
×
Page 113
Suggested Citation:"Appendix H Open Meeting Agenda." Institute of Medicine. 2006. Battling Malaria: Strengthening the U.S. Military Malaria Vaccine Program. Washington, DC: The National Academies Press. doi: 10.17226/11656.
×
Page 114
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Malaria is an infectious disease common to several parts of the world, including Africa, northern South America, and Asia. During their service in the military, U.S. active members may be sent to any part of the world, including parts of the world where Malaria is an issue. In Liberia in 2003, for example, there was a 28 percent attack rate in Marines who spent a short time ashore, and half of the 80 Marines affected needed to be evacuated to Germany. This was not only costly to the U.S. military but dangerous as well. To fight against this disease, there exists a Malaria Vaccine program in the U.S. military. However, there exists a variety of potential vaccine targets for the most severe and important form of malaria; malaria from the species Plasmodium falciparum. Issues also arise with the fact that there are three possible stages to create vaccines against—preerythrocytic, blood, or transmission.

The Department of Defense (DoD), through the commanding general of the U.S. Army Medical Research and Materiel Command (USAMRMC), requested that the Institute of Medicine (IOM) conduct a programmatic review of the military Plasmodium falciparum malaria vaccine research and development program. There was to be a focus on vaccine against the preerythrocytic and blood stages. The IOM formed a committee of 11 experts with collective expertise in malaria vaccine research, parasite immunology, malarial biology, clinical trials and regulatory affairs, industrial and public-sector vaccine development, biologic products research and development (vaccinology), military research and development programs, tropical medicine, and public health.

The committee focused different tasks including determining whether the DoD malaria vaccine research and development program is scientifically sound and able to achieve the vaccine program objectives within specified timelines, recommending how to overcome significant, identified barriers, and identifying major strategic goals and timelines based on the material received and presentations made by the DoD's program representatives. Battling Malaria: Strengthening the U.S. Military Malaria Vaccine Program presents the committee's findings, current malaria vaccines, and recommendations for the development of the U.S. Military vaccine research.

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