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Scientific considerations for the regulation and clinical evaluation of HIV/AIDS preventive vaccines; report from a WHO-UNAIDS Consultation 13-15 March 2001, Geneva, Switzerland

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dc.contributor.other Van der Groen, G. en_US
dc.date.accessioned 2007-12-06T14:48:09Z
dc.date.available 2007-12-06T14:48:09Z
dc.date.issued 2002 en_US
dc.identifier.issn 0269-9370 en_US
dc.identifier.other ITG-M12A en_US
dc.identifier.other MICRO en_US
dc.identifier.other U-VIROL en_US
dc.identifier.other JIF en_US
dc.identifier.other ABSTRACT en_US
dc.identifier.uri http://hdl.handle.net/10390/1948
dc.description Not the final published version
dc.description.abstract The consultation was jointly organized by the WHO-UNAIDS HIV Vaccine Initiative and the Quality Assurance and Safety of Biologicals Team of the World Health Organization (WHO). Thirty-four experts from 16 developed and developing countries attended the meeting, bringing together expertise from academic institutions, clinical trial centres, national and international regulatory authorities. Representatives of major pharmaceutical companies were also invited. The primary objective of the meeting was to identify gaps that need to be addressed from regulatory perspective to ensure appropriate progress of HIV vaccine development from basic research to human trials, licensing and future application, with a special focus on needs of developing countries. As a result of discussions, the following priority needs were identified and recommendations were made in order to establish an appropriate regulatory framework for the development and evaluation of preventive HIV/AIDS vaccines, which were divided in two main areas: (a) standardization and control of candidate HIV/AIDS vaccines, and (b) approaches to the conduct of clinical trials of candidate HIV/AIDS vaccines. en_US
dc.language English en_US
dc.publisher Lippincott, Williams & Wilkins
dc.subject Viral diseases en_US
dc.subject HIV en_US
dc.subject AIDS en_US
dc.subject Vaccine development en_US
dc.subject Clinical trials en_US
dc.subject Regulation en_US
dc.subject Guidelines en_US
dc.title Scientific considerations for the regulation and clinical evaluation of HIV/AIDS preventive vaccines; report from a WHO-UNAIDS Consultation 13-15 March 2001, Geneva, Switzerland en_US
dc.type Article en_US
dc.citation.jtitle AIDS en_US
dc.citation.volume 16 en_US
dc.citation.pages W15-W25 en_US
dc.publisher.place Philadelphia
dc.identifier.pmid http://www.ncbi.nlm.nih.gov/pubmed/12131232
dc.citation.jabbreviation AIDS en_US


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