Vaccines and Related Biological Products Advisory Committee Meeting

May 16, 2001

Briefing Information

FDA's Briefing Document   pdf   html

Background References Included with VRBPAC Briefing Documents

Lewis Jr., Andrew M.; Philip Krause and Keith Peden for the Cell Substrate-Adventitious Agent Working/Interest Group: A Defined-Risks Approach to the Regulatory Assessment of the Use of Neoplastic Cells as Substrates for Viral Vaccine Manufacture, 31 pages

Tumorigenicity References

Routes, John M.; Sharon Ryan, Han Li, John Steinke, and James L. Cook: Dissimilar Immunogenicities of Human Papillomavirus E7 and Adenovirus E1A Proteins Influence Primary Tumor Development, Virology, 277, pages 48-57, (2000)

Routes, John M.; Sharon Ryan, Amanda Clase, Tanya Miura, Alicia Kuhl, Terry A. Potter, and James L. Cook: Adenovirus E1A Oncogene Expression in Tumor Cells Enhances Killing by TNF-Related Apoptosis-Inducing Ligand (TRAIL), The Journal of Immunology, pages 4522-4527, (2000)

Ozoren, Nesrin; Kunhong Kim, Timothy F. Burns, David T. Dicker, A. David Moscioni, and Wafik S. El-Deiry: The Caspase 9 Inhibitor Z-LEHD-FMK Protects Human Liver Cells while Permitting Death of Cancer Cells Exposed to Tumor Necrosis Factor-related Apoptosis-inducing Ligand, Cancer Research, 60, pages 6259-6265, (November 15, 2000)

Residual DNA References

Fung, Yuen-Kai T.; Lyman B. Crittenden, Aly M. Fadly, and Hsing-Jien Kung: Tumor Induction by Direct Injection of Cloned v-src DNA into Chickens, Proceedings of the national Academy of Science Use, 80, pages 353-357, (January 1983)

Brown, Kenneth; Miguel Quintanilla, Martin Ramsden, Ian B. Kerr, Sheena Young, and Allan Balmain: v-ras Genes from Harvey and BALB Murine Sarcoma Viruses Can Act as Initiators of Two-Stage Mouse Skin Carcinogenesis, Cell, 46, pages 447-456, (August 1, 1986)

Burns, Philip A; Andrew Jack, Fiona Neilson, Sheena Haddow, and Allan Balmain: Transformation of Mouse Skin Endothelial Cells In Vivo by Direct Application of Plasmid DNA Encloding the Human T24 H-ras Oncogene, Oncogene, 6, pages 1973-1978 (1991)

Lower, Johannes: Risk of Tumor Induction In Vivo by Residual Cellular DNA; Quantitative Considerations, Journal of Medical Virology, 31, pages 50-53 (1990)

Horaud, Florian: Viral Vaccines and Residual Cellular DNA, Biologicials, 23, pages 225-228, (1995)

Krause, Philip R., and Andrew M. Lewis, Jr.: Safety of Viral DNA in Biological Products, Biologicals, 26, pages 317-320, (1998)

Adventitious Agents References

Minor, P.: Introduction of Adventitious Agent Issues, 14 pages

Transmissible Spongiform Encephalopathy References

Vilette, D.; O. Andreoletti, F. Archer, M.F. Madelaine, J. L. Vilotte, S. Lehmann, and H. Laude: Ex vivo Propagation of Infectious Sheep Scrapie Agent in Heterologous Epithelial Cells Expressing Ovine Prion Protein, PNAS, 98, pages 4055-4059, (March 27, 2001)

Nishida, Noriyuki; David A. Harris, Didier Vilette, Hubert Laude, Yveline Frobert, Jacques Grassi, Danielle Casanova, Ollivier Milhavet, and Sylvain Lehmann: Successful Transmission of Three Mouse-Adapted Scrapie Strains to Murine Neuroblastoma Cell Lines Overexpressing Wild-Type Mouse Prion Protein, Journal of Virology, 74, pages 320-325, (January 2000)

Bosque, Patrick J.; and Stanley B. Prusiner: Cultured Cell Sublines Highly Susceptible to Prion Infection, Journal of Virology, 74, pages 4377-4386, (May 2000)

Foster, James; Christine Farquhar, Janet Fraser, Robert Somerville: Immunolocalization of the Prion Protein in Scrapie Affected Rodent Retinas, Neuroscience Letters, pages 1-4, (1999)

Schatzl, Hermann M.; Lajos Laszlo, David M. Holtzman, Jorg Tatzelt, Stephen J. DeArmond, Richard I. Weiner, William C. Mobley, and Stanley B. Pruisner: A Hypothalamic Neuronal Cell Line Persistently Infected with Scrapie Prions Exhibits Apoptosis, Journal of Virology, 71, pages 8821-8831, (November 1997)

Asher, D.M.; R. T. Yanagihara, N. G. Robers, C. J. Gibbs, Jr., and D. C. Gajdusek: Studies of the Viruses of Spongiform Encephalopathies in Cell Cultures, Slow Transmissible Diseases of the Nervous Systems, Volume 2, pages 235-242

Adenovirus Vectors and Designer Cell Substrate
(293 Cells and PER.C6 Cells) References

Pau, M. G.; C. Ophorst, M. H. Koldijk, G. Schouten, M. Mehtali, F. Uytdehaag: The Human Cell Line PER.C6 Provides a New Manufacturing System for the Production of Influenza Vaccines, Vaccine, 19, pages 2716-2721, (2001)

Benihoud, Karim; Patrice Yeh and Michel Perricaudet: Adenovirus vectors for Gene Delivery, Current Opinion in Biotechnology, 10, pages 440-447 (1999)

Fallaux, Frits J.; Abraham Bout, Ietje van der Velde, Diana J. M. van den Wollenberg, Kathleen M. Hehir, Jesse Keegan, Crys Auger, Steve J. Cramer, Hans van Ormondt, Alex J. van der Eb, Dinko Valerio, and Rob C. Hoeben: New Helper Cells and Matched Early Region 1-Deleted Adenovirus Vectors Prevent Generation of Replication-Competent Adenoviruses, Human Gene Therapy, 9, pages 1909-1917, (September 1, 1998)

Panel Audience Discussion on Designer Cell Substrates that occurred during the Workshop on Evolving Scientific and Regulatory Perspectives on Cell Substrates for Vaccine Development, (Panel Chair was John Coffin), September 7-10, 1999

Aiello, L.; R. Guilfoyle, K. Huebner, and R. Weinmann: Adenovirus 5 DNA Sequences present and RNA Sequences Transcribed in Transformed Human Embryo Kidney Cells (HEK-Ad-5 or 293), Virology, 94, pages 460-169, (1979)

Graham, F. L.; J. Smiley, W. C. Russell, and R. Nairn: Characteristics of a Human Cell Line Transformed by DNA from Human Adenovirus Type 5, Journal of General Virology, 36, pages 59-72, (1977)