Battling Malaria Strengthening the U.S. Military Malaria Vaccine Program (2006) / Chapter Skim
Currently Skimming:
4 The U.S. Military Malaria Vaccine Research and Development Program--Scientific Aspects
4 The U.S. Military Malaria Vaccine Research and Development Program--Scientific Aspects
Pages 41-55
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 41... ...
, problems with compliance both in terms of personal discipline and concerns over possible toxic side effects, and potential logistical failures. Consequently, a malaria vaccine that protects military personnel against infection and severe disease, although requiring a long and expensive research and development commitment to bring the product to Food and Drug Administration (FDA)
|
From page 42... ...
Although the current requirements were prepared under the auspices of the Army, the requirements are no different for the Navy and Marines. The requirements are used to guide the MIDRP Malaria Vaccine Program through the vaccine research and development process, including aiding in the decision process of when to move a product to advanced development.
|
From page 43... ...
For the first-generation vaccine, there is no objective criterion justifying the level of 60 percent -- it represents what the committee felt would likely be useful in addition to chemoprophylaxis. Vaccine development often follows a "generational" process whereby the first vaccine licensed and marketed is not fully effective, but is later replaced with a second-generation vaccine with greater efficacy, a different schedule, a different target age-group, and/or better safety.
|
From page 44... ...
CLINICAL TRIALS TO TEST EFFICACY OF A FIRST-GENERATION MALARIA VACCINE The MIDRP Malaria Vaccine Program has the goal of licensing a "U.S. military/travelers" vaccine that might not have relevance for preventing disease in indigenous pediatric populations in malarious areas.
|
From page 45... ...
Given the crucial importance of providing a clear path to licensure for a potential vaccine, the committee concluded that it was appropriate to discuss their view of the feasibility of undertaking such daunting key studies within the DoD system. In contrast, the various other clinical trials, including phase 1 and 2 safety and immunogenicity trials, Phase 2 experimental challenge model studies, and assessment of the large-scale safety and immunogenicity testing of three production lots of the vaccine are generic and well within the capability of the MIDRP Malaria Vaccine Program testing infrastructure.
|
From page 46... ...
The MIDRP Malaria Vaccine Program investigators working at AFRIMS in conjunction with Royal Thai Army rangers established the feasibility of carrying out an efficacy trial of a malaria vaccine in (semi-immune) volunteers who were not given chemoprophylaxis when sent to a field area of high malaria transmission (Brown et al., 1994)
|
From page 47... ...
CURRENT AND PLANNED SCIENTIFIC PROGRAM Table 4-2 shows the very large program of different constructs currently being tested by the MIDRP Malaria Vaccine Program, as well as the partners involved and projected time lines. The particular categories of antigens or constructs will be briefly discussed.
|
From page 50... ...
. However, the MIDRP Malaria Vaccine Program is more advanced in the phase 2 trial process for the 3D7 forms of MSP-1.
|
From page 51... ...
The above description summarizes the aspects of research, particularly those funded directly by MIDRP Malaria Vaccine Program, that were
|
From page 52... ...
Planned Clinical Trials To summarize the status of current vaccine candidates, ongoing and pending clinical trials are listed in Table 4-3. OVERALL ASSESSMENT OF SCIENTIFIC PROGRAM The committee noted the impressive scientific program and achievements and the unparalleled opportunities provided by the availability of the human sporozoite challenge model.
|
From page 53... ...
The MIDRP Malaria Vaccine Program has also been successful in leveraging additional funds and has had very successful collaborations. The research funded by the MIDRP Malaria Vaccine Program has been enormously beneficial to the overall global vaccine effort.
|
From page 54... ...
The MIDRP Malaria Vaccine Program
|
From page 55... ...
Recommendation 4.5: The MIDRP Malaria Vaccine Program should continue research on human immune processes and responses to malaria. The current incomplete understanding of the mechanisms of protective immunity to malaria in humans constitutes a barrier that impedes malaria vaccine development.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.