[Memorandum to Presidential Advisory Council on HIV and AIDS Research Committee Members from Bruce G. Weniger]

FROM ' OPRAqGEN PHONE NO.: 01483 560074 JTan. 06 199"? 11:21PM PO4 2. The Vaccines There are potentially four approaches to a vaccine protective against the disease of AIDS based on our current knowledge of what constitutes a successful virus vaccine. These are: the whole or part of a killed pathogenic virus; a live attenuated virus; virus-like particles and, if the DNA based influenza vaccine works, plasmid DNA. Each such vaccine type may be manifested in a multitude of actual forms. 3. The Components of a Vaccine Discovery and Development System. The development, production and evaluation of a virus vaccine requires a suite of facilities into which the various vaccine options can be plugged. Such a suite may consist of the following elements: * an epidemiology unit * a virus identification unit * a virus assay unit (by several methods to give viability as well as quantity) * a virus production unit at the laboratory scale (requires an associated utility which can produce the cell culture systems in which the virus can be grown) * a virus production facility at the pilot plant scale (c. 1001itrc reactors) for the production of test lots of vaccine at putative commercial scales of operation) * a virus purification unil * a vaccine formulation unit * n vaccine assay unit using; physicochemical assays for mass, antigenicity, heterogeneity cell culture assays for in vitro neutralisation on more than one cell line immune cell assays in vitro (antibody and/or CTL response) small animal assays which for HIV can be sensitised mice (SCID) small primate assays large primate assays target animal assays (humans who are infected; humans who are not infected) * a biochemical unit to provide characterization data based on now and innovative assay systems; this unit may also generate putative vaccine materials, provide understanding on the way inactivation mechanisms work, examine the stability of the virus and the way it is modified immunogenically when formulated as a vaccine and examine at the biochemical level aspects of virus pathogenesis * a pathogenesis unit to examine at the organismal and cellular level the life history of the virus and the way it causes disease * a genetics unit to provide information on genetic changes to the virus and their implications for the production of an effective vaccine 3

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Title
[Memorandum to Presidential Advisory Council on HIV and AIDS Research Committee Members from Bruce G. Weniger]
Author
Weniger, Bruce
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Page 3
Publication
1997-01-10
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"[Memorandum to Presidential Advisory Council on HIV and AIDS Research Committee Members from Bruce G. Weniger]." In the digital collection Jon Cohen AIDS Research Collection. https://name.umdl.umich.edu/5571095.0495.212. University of Michigan Library Digital Collections. Accessed June 11, 2025.
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