2nd meeting on novel adjuvants currently in/close to human clinical testing: World Health Organization—Organization Mondiale de la Santé Fondation Mérieux, Annecy, France, 5–7 June 2000
In response to the broad interest in the use and development of adjuvant technologies expressed in an earlier meeting [1], the WHO sponsored a second workshop at the Fondation Merieux in Annecy, France in June 2000 to update and discuss the current status of the use of adjuvants in human vaccines. T...
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Published in: | Vaccine Vol. 20; no. 17; pp. 2155 - 2163 |
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Abstract | In response to the broad interest in the use and development of adjuvant technologies expressed in an earlier meeting [1], the WHO sponsored a second workshop at the Fondation Merieux in Annecy, France in June 2000 to update and discuss the current status of the use of adjuvants in human vaccines. The meeting included scientists representing academia, government and industry who reported on development efforts for several adjuvant formulations that are in or near clinical trials, with an emphasis on parasitic diseases. Each of the participants discussed their current efforts to develop vaccines in the context of one or more adjuvants in a preclinical model or human vaccine study. While aluminum salts remain the most widely used immunomodulators for human vaccines, a wide variety of agents are being tested to improve the adjuvant properties in various settings and to minimize the potential for side effects. Particular progress has been made in manufacturing processes, the use of large mammals and primates to study mechanisms of action, clinical trials that include validated assays and sufficient power and robust sample size to answer the study objectives, and the management of toxicity by alteration of formulations. Several immunological issues must still be addressed for many adjuvants, such as tolerance, autoimmunity, and immunopotentiation. This is particularly true as products begin to be studied in children. This report will summarize the various presentations and is organized by adjuvant type as summarized in Table 1. |
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AbstractList | In response to the broad interest in the use and development of adjuvant technologies expressed in an earlier meeting [1], the WHO sponsored a second workshop at the Fondation Merieux in Annecy, France in June 2000 to update and discuss the current status of the use of adjuvants in human vaccines. The meeting included scientists representing academia, government and industry who reported on development efforts for several adjuvant formulations that are in or near clinical trials, with an emphasis on parasitic diseases. Each of the participants discussed their current efforts to develop vaccines in the context of one or more adjuvants in a preclinical model or human vaccine study. While aluminum salts remain the most widely used immunomodulators for human vaccines, a wide variety of agents are being tested to improve the adjuvant properties in various settings and to minimize the potential for side effects. Particular progress has been made in manufacturing processes, the use of large mammals and primates to study mechanisms of action, clinical trials that include validated assays and sufficient power and robust sample size to answer the study objectives, and the management of toxicity by alteration of formulations. Several immunological issues must still be addressed for many adjuvants, such as tolerance, autoimmunity, and immunopotentiation. This is particularly true as products begin to be studied in children. This report will summarize the various presentations and is organized by adjuvant type as summarized in Table 1. |
Author | Regina Rabinovich, N. Engers, Howard D. Price, Virginia L. Pichyangkul, Sathit Kenney, Richard T. |
Author_xml | – sequence: 1 givenname: Richard T. surname: Kenney fullname: Kenney, Richard T. organization: US Food and Drug Administration/CBER, Bethesda, MD, USA – sequence: 2 givenname: N. surname: Regina Rabinovich fullname: Regina Rabinovich, N. organization: Malaria Vaccine Initiative/PATH, Rockville, MD, USA – sequence: 3 givenname: Sathit surname: Pichyangkul fullname: Pichyangkul, Sathit organization: Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand – sequence: 4 givenname: Virginia L. surname: Price fullname: Price, Virginia L. organization: UNDP/World Bank, WHO Special Programme of Research and Training in Tropical Diseases, Avenue Appia 20, CH-1211, Geneva 27, Switzerland – sequence: 5 givenname: Howard D. surname: Engers fullname: Engers, Howard D. email: engersh@who.ch organization: UNDP/World Bank, WHO Special Programme of Research and Training in Tropical Diseases, Avenue Appia 20, CH-1211, Geneva 27, Switzerland |
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SubjectTerms | Adjuvants, Immunologic Animals Clinical Trials as Topic Emulsions France Global Health Human clinical trials Humans Minerals Novel adjuvants Preclinical testing Review Surface-Active Agents Vaccine Vaccines World Health Organization |
Title | 2nd meeting on novel adjuvants currently in/close to human clinical testing: World Health Organization—Organization Mondiale de la Santé Fondation Mérieux, Annecy, France, 5–7 June 2000 |
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