A replication-competent adenovirus assay for E1-deleted Ad35 vectors produced in PER.C6 cells

Vaccine

Volumn 25, Issue 12, 2007, Pages 2228-2237

  Marzio, G ^a   Kerkvliet, E ^a   Bogaards, J A ^a   Koelewijn, S ^a   De Groot, A ^a   Gijsbers, L ^a   Weverling, G J ^a   Vogels, R ^a   Havenga, M ^a   Custers, J ^a   Pau, M G ^a   Guichoux, J Y ^a   Lewis, J ^a,b   Goudsmit, J ^a  

^a CRUCELL HOLLAND BV   (Netherlands)

^b AecselaBiologics   (United States)

Author keywords

Adenovirus; Assay; HDEP; PER.C6; RCA

Indexed keywords

ADENOVIRUS VECTOR; BETA LACTAMASE; GLYCOPROTEIN E1; PHOSPHOGLYCERATE KINASE;

ADENOVIRUS; ARTICLE; BIOSAFETY; CELL STRAIN; CELL STRAIN A549; CELL STRAIN HEK293; CELL STRAIN PER C6; CYTOPATHOGENIC EFFECT; DILUTION; DOSE RESPONSE; GENE DELETION; HELPER DEPENDENT E1 POSITIVE PARTICLE; HOMOLOGOUS RECOMBINATION; NONHUMAN; POLYMERASE CHAIN REACTION; PRIORITY JOURNAL; PROMOTER REGION; REPLICATION COMPETENT ADENOVIRUS; SENSITIVITY AND SPECIFICITY; SEROTYPE; STATISTICAL MODEL; VIRAL GENE DELIVERY SYSTEM; VIRUS CULTURE; VIRUS PARTICLE; VIRUS PURIFICATION; VIRUS RECOMBINANT;

ADENOVIRIDAE; ADENOVIRUS E1 PROTEINS; BIOLOGICAL ASSAY; CELL LINE; CELL LINE, TUMOR; GENE DELETION; GENETIC VECTORS; HUMANS; POLYMERASE CHAIN REACTION; REPRODUCIBILITY OF RESULTS; VIRUS REPLICATION;

EID: 33846894083     PISSN: 0264410X     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.vaccine.2006.12.011     Document Type: Article

References (24)

1. Graham F.L., Smiley J., Russell W.C., and Nairn R. Characteristics of a human cell line transformed by DNA from human adenovirus type 5. J Gen Virol 36 1 (1977) 59-74
2. Louis N., Evelegh C., and Graham F.L. Cloning and sequencing of the cellular-viral junctions from the human adenovirus type 5 transformed 293 cell line. Virology 233 2 (1997) 423-429
3. Zhu J., Grace M., Casale J., Chang A.T., Musco M.L., and Bordens R. Characterization of replication-competent adenovirus isolates from large-scale production of a recombinant adenoviral vector. Hum Gene Ther 10 1 (1999) 113-121
4. Lochmuller H., Jani A., Huard J., Prescott S., Simoneau M., Massie B., et al. Emergence of early region 1-containing replication-competent adenovirus in stocks of replication-defective adenovirus recombinants (delta E1 + delta E3) during multiple passages in 293 cells. Hum Gene Ther 5 12 (1994) 1485-1491
5. United States Food and Drug Administration & Biological Response Modifiers Advisory Committee; 21 July 2001.
6. Hermens W.T., and Verhaagen J. Adenoviral vector-mediated gene expression in the nervous system of immunocompetent Wistar and T cell-deficient nude rats: preferential survival of transduced astroglial cells in nude rats. Hum Gene Ther 8 9 (1997) 1049-1063
7. Chuah M.K., Collen D., and VandenDriessche T. Biosafety of adenoviral vectors. Curr Gene Ther 3 6 (2003) 527-543
8. United States Food and Drug Administration & Biological Response Modifiers Advisory Committee; 5 April 2001.
9. Fallaux F.J., Bout A., van der Velde I., van den Wollenberg D.J., Hehir K.M., Keegan J., et al. New helper cells and matched early region 1-deleted adenovirus vectors prevent generation of replication-competent adenoviruses. Hum Gene Ther 9 13 (1998) 1909-1917
10. United States Food and Drug Administration & Vaccines and Related Biological Products Advisory Committee, 16 November 2005, VRBPAC meeting: use of MDCK cells for manufacture of inactivated influenza vaccines; 2005.
11. Murakami P., Havenga M., Fawaz F., Vogels R., Marzio G., Pungor E., et al. Common structure of rare replication-deficient E1-positive particles in adenoviral vector batches. J Virol 78 12 (2004) 6200-6208
12. Seshidhar Reddy P., Ganesh S., Limbach M.P., Brann T., Pinkstaff A., Kaloss M., et al. Development of adenovirus serotype 35 as a gene transfer vector. Virology 311 2 (2003) 384-393
13. Vogels R., Zuijdgeest D., van Rijnsoever R., Hartkoorn E., Damen I., de Bethune M.P., et al. Replication-deficient human adenovirus type 35 vectors for gene transfer and vaccination: efficient human cell infection and bypass of preexisting adenovirus immunity. J Virol 77 15 (2003) 8263-8271
14. Holterman L., Vogels R., van der Vlugt R., Sieuwerts M., Grimbergen J., Kaspers J., et al. Novel replication-incompetent vector derived from adenovirus type 11 (Ad11) for vaccination and gene therapy: low seroprevalence and non-cross-reactivity with Ad5. J Virol 78 23 (2004) 13207-13215
15. Barouch D.H., Pau M.G., Custers J.H., Koudstaal W., Kostense S., Havenga M.J., et al. Immunogenicity of recombinant adenovirus serotype 35 vaccine in the presence of pre-existing anti-Ad5 immunity. J Immunol 172 10 (2004) 6290-6297
16. Ophorst O.J., Radosevic K., Havenga M.J., Pau M.G., Holterman L., Berkhout B., et al. Immunogenicity and protection of a recombinant human adenovirus serotype 35-based malaria vaccine against Plasmodium yoelii in mice. Infect Immun 74 1 (2006) 313-320
17. Barratt-Boyes S.M., Soloff A.C., Gao W., Nwanegbo E., Liu X., Rajakumar P.A., et al. Broad cellular immunity with robust memory responses to simian immunodeficiency virus following serial vaccination with adenovirus 5- and 35-based vectors. J Gen Virol 87 Pt 1 (2006) 139-149
18. Dion L.D., Fang J., and Garver Jr. R.I. Supernatant rescue assay vs. polymerase chain reaction for detection of wild type adenovirus-contaminating recombinant adenovirus stocks. J Virol Methods 56 1 (1996) 99-107
19. Dongling M.A., Newman A., Lucas W.T., Meloro R.N., Rudderow L., Hughes J.V., et al. Methods for detection and evaluation of replication competent adenovirus (RCA). Bioprocessing conference exclusive (2003) [Fall]
20. United States Food and Drug Administration. Viral safety evaluation of biotechnology products derived from cell lines of human of animal origin, Appendix 3. ICH Guidance for industry Q5A; 1998.
21. Shiver J.W., and Emini E.A. Recent advances in the development of HIV-1 vaccines using replication-incompetent adenovirus vectors. Annu Rev Med 55 (2004) 355-372
22. Havenga M., Vogels R., Zuijdgeest D., Radosevic K., Mueller S., Sieuwerts M., et al. Novel replication-incompetent adenoviral B-group vectors: high vector stability and yield in PER.C6 cells. J Gen Virol (2006) [published online ahead of publication]
23. Shabram P.W., Giroux D.D., Goudreau A.M., Gregory R.J., Horn M.T., Huyghe B.G., et al. Analytical anion-exchange HPLC of recombinant type-5 adenoviral particles. Hum Gene Ther 8 4 (1997) 453-465
24. United States Food and Drug Administration & Biological Response Modifiers Advisory Committee, Guidance for Human Somatic Cell Therapy and Gene Therapy; 1998.