Environmental Risk Assessment of Clinical Trials Involving Modified Vaccinia Virus Ankara (MVA)-Based Vectors

Current Gene Therapy

Volumn 13, Issue 6, 2013, Pages 413-420

  Goossens, Martine ^a   Pauwels, Katia ^a   Willemarck, Nicolas ^a   Breyer, Didier ^a  

^a SCIENTIFIC INSTITUTE OF PUBLIC HEALTH   (Belgium)

Author keywords

Biosafety; Clinical trials; Environmental risk assessment; Gene therapy; GMO based vaccines; MVA based recombinant vectors

Indexed keywords

MODIFIED VACCINIA VIRUS ANKARA 5T4 VACCINE;

ARTICLE; BIOLOGICAL ACTIVITY; BIOSAFETY; CLINICAL EVALUATION; CLINICAL TRIAL (TOPIC); DRUG SAFETY; ENVIRONMENTAL IMPACT ASSESSMENT; GENETIC RECOMBINATION; GENETIC STABILITY; HAZARD ASSESSMENT; HUMAN; MOLECULAR DYNAMICS; RISK ASSESSMENT; TRANSGENIC ORGANISM; VACCINATION; VIRAL GENE THERAPY;

ANIMALS; CLINICAL TRIALS AS TOPIC; GENETIC THERAPY; GENETIC VECTORS; HAZARDOUS SUBSTANCES; HUMANS; RISK ASSESSMENT; VACCINATION; VACCINIA VIRUS; VIRAL VACCINES;

EID: 84891766215     PISSN: 15665232     EISSN: 18755631     Source Type: Journal    
DOI: 10.2174/156652321306140103221941     Document Type: Article

References (38)

1. Drexler I, Staib C, Sutter G. Modified vaccinia virus Ankara as antigen delivery system: how can we best use its potential? Curr Opin Biotechnol 2004; 15(6): 506-12.
2. Gomez CE, Najera JL, Krupa M, Esteban M. The poxvirus vectors MVA and NYVAC as gene delivery systems for vaccination against infectious diseases and cancer. Curr Gene Ther 2008; 8(2): 97-120.
3. Larocca C, Schlom J. Viral Vector-Based Therapeutic Cancer Vaccines. The Cancer J 2011; 17(5): 359-71.
4. Meyer H, Sutter G, Mayr A. Mapping of deletions in the genome of the highly attenuated vaccinia virus MVA and their influence on virulence. J Gen Virol 1991; 72 (Pt 5): 1031-8.
5. Verheust C, Goossens M, Pauwels K, Breyer D. Biosafety aspects of modified vaccinia virus Ankara (MVA)-based vectors used for gene therapy or vaccination. Vaccine 2012; 30(16): 2623-32.
6. Moss B. Poxviridae: the virus and their repication. In: Knipe D & Howley P, Eds. Field's virology, 4. Lippincot Williams & Wilkins: Philadelphia 2001; pp. 2849-2883.
7. Mayr A, Stickl H, Muller HK, Danner K, Singer H. The smallpox vaccination strain MVA: marker, genetic structure, experience gained with the parenteral vaccination and behavior in organisms with a debilitated defence mechanism (author's transl). Zentralbl Bakteriol B 1978; 167(5-6): 375-90.
8. Stickl H, Hochstein-Mintzel V, Mayr A, Huber HC, Schafer H, Holzner A. MVA vaccination against smallpox: clinical tests with an attenuated live vaccinia virus strain (MVA) (author's transl). Dtsch Med Wochenschr 1974; 99(47): 2386-92.
9. Mahnel H, Mayr A. Experiences with immunization against orthopox viruses of humans and animals using vaccine strain MVA (author's transl). Berl Munch Tierarztl Wochenschr 1994; 107(8): 253-6.
10. Parrino J, Graham BS. Smallpox vaccines: Past, present, and future. J Allergy Clin Immunol 2006; 118(6): 1320-6.
11. European Medicines Agency. Available at: http://www.ema. europa.eu/ema//index.jsp?curl=pages/medicines/human/medicines/ 002596/smops/Positive/human_smop_000518.jsp&mid=WC0b01a c058001d127. (accessed 26.07.13)
12. Sneyers M, Goossens M. Approved gene therapy clinical trials in Belgium. Available at: http://www.biosafety.be/GT/Regulatory/ Table_1.html (accessed 26.07.13)
13. EC. Commission Decision 2002/623/EC of 24 July 2002 establishing guidance notes supplementing Annex II to Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC. Off J Eur Commun, L200 of 30.07.2002.
14. Suter M, Meisinger-Henschel C, Tzatzaris M, et al. Modified vaccinia Ankara strains with identical coding sequences actually represent complex mixtures of viruses that determine the biological properties of each strain. Vaccine 2009; 27(52): 7442-50.
15. Kennedy JS, Greenberg RN. IMVAMUNE: modified vaccinia Ankara strain as an attenuated smallpox vaccine. Expert Rev Vaccines 2009; 8(1): 13-24.
16. Cottingham MG, Carroll MW. Recombinant MVA vaccines: dispelling the myths. Vaccine 2013; 4247-51
17. Wang Z, Martinez J, Zhou W, et al. Modified H5 promoter improves stability of insert genes while maintaining immunogenicity during extended passage of genetically engineered MVA vaccines. Vaccine 2010; 28(6): 1547-57.
18. Wyatt LS, Earl PL, Xiao W, et al. Elucidating and Minimizing the Loss by Recombinant Vaccinia Virus of Human Immunodeficiency Virus Gene Expression Resulting from Spontaneous Mutations and Positive Selection. J Virol 2009; 83(14): 7176-84.
19. Ramirez JC, Gherardi MM, Esteban M. Biology of attenuated modified vaccinia virus Ankara recombinant vector in mice: virus fate and activation of B-and T-cell immune responses in comparison with the Western Reserve strain and advantages as a vaccine. J Virol 2000; 74(2): 923-33.
20. Tan X, Chun S, Pablo J, Felgner P, Liang X, Davies DH. Failure of the smallpox vaccine to develop a skin lesion in vaccinia virusnaive individuals is related to differences in antibody profiles before vaccination, not after. Clin Vaccine Immunol 2012; 19(3): 418-28.
21. Sparkes JD, Fenje P. The effect of residual moisture in lyophilized smallpox vaccine on its stability at different temperatures. Bull World Health Organ 1972; 46(6): 729-34.
22. Drumond BP, Leite JA, da Fonseca FG, Bonjardim CA, Ferreira PC, Kroon E. Brazilian Vaccinia virus strains are genetically divergent and differ from the Lister vaccine strain. Microbes and Infection 2008; 10(2): 185-97.
23. Stittelaar KJ, Kuiken T, de Swart RL, et al. Safety of modified vaccinia virus Ankara (MVA) in immune-suppressed macaques. Vaccine 2001; 19(27): 3700-9.
24. Okeke MI, Nilssen O, Traavik T. Modified vaccinia virus Ankara multiplies in rat IEC-6 cells and limited production of mature virions occurs in other mammalian cell lines. J Gen Virol 2006; 87(Pt 1): 21-7.
25. Hanke T, McMichael AJ, Dennis MJ, et al. Biodistribution and persistence of an MVA-vectored candidate HIV vaccine in SIVinfected rhesus macaques and SCID mice. Vaccine 2005; 23(12): 1507-14.
26. Hanke T, McMichael AJ, Samuel RV, et al. Lack of toxicity and persistence in the mouse associated with administration of candidate DNA-and modified vaccinia virus Ankara (MVA)-based HIV vaccines for Kenya. Vaccine 2002; 21(1-2): 108-14.
27. Rheinbaben F, Gebel J, Exner M, & Schmidt M. Environmental resistance, disinfection, and sterilization of poxviruses. In: A.A. Mercer, A. Schmidt, & O. Weber, Eds. Poxviruses. Birkhäuser Verlag Basel/Switzerland: 2007; pp. 397-405.
28. Bergmans H, Logie C, Van Maanen K, Hermsen H, Meredyth M, Van der Vlugt C. Identification of potentially hazardous human gene products in GMO risk assessment. Environ Biosafety Res 2008; 71-9.
29. Earl PL, Cotter C, Moss B, et al. Design and evaluation of multigene, multi-clade HIV-1 MVA vaccines. Vaccine 2009; 27(42): 5885-95.
30. Meisinger-Henschel C, Schmidt M, Lukassen S, Linke B, Krause L, Konietzny S, Goesmann A, Howley P, Chaplin P, Suter M, Hausmann J. Genomic sequence of chorioallantois vaccinia virus Ankara, the ancestor of modified vaccinia virus Ankara. J Gen Virol 2007; 88(Pt 12): 3249-59.
31. Meisinger-Henschel C, Spath M, Lukassen S, et al. Introduction of the six major genomic deletions of modified vaccinia virus Ankara (MVA) into the parental vaccinia virus is not sufficient to reproduce an MVA-like phenotype in cell culture and in mice. J Virol 2010; 84(19): 9907-19.
32. Carroll MW, Moss B. Host range and cytopathogenicity of the highly attenuated MVA strain of vaccinia virus: propagation and generation of recombinant viruses in a nonhuman mammalian cell line. Virology 1997; 238(2): 198-211.
33. Wyatt LS, Carroll MW, Czerny CP, Merchlinsky M, Sisler JR, Moss B. Marker Rescue of the Host Range Restriction Defects of Modified Vaccinia Virus Ankara. Virology 1998; 251(2): 334-42.
34. Hansen H, Okeke MI, Nilssen O, Traavik T. Recombinant viruses obtained from co-infection in vitro with a live vaccinia-vectored influenza vaccine and a naturally occurring cowpox virus display different plaque phenotypes and loss of the transgene. Vaccine 2004; 23(4): 499-506.
35. Okeke MI, Nilssen O, Moens U, Tryland M, Traavik T. In vitro host range, multiplication and virion forms of recombinant viruses obtained from co-infection in vitro with a vaccinia-vectored influenza vaccine and a naturally occurring cowpox virus isolate. Virol J 2009; 6: 55.
36. Gomez CE, Najera JL, Domingo-Gil E, Ochoa-Callejero L, Gonzalez-Aseguinolaza G, Esteban M. Virus distribution of the attenuated MVA and NYVAC poxvirus strains in mice. J Gen Virol 2007; 88(Pt 9): 2473-8.
37. Schenk-Braat EA, van Mierlo MM, Wagemaker G, Bangma CH, Kaptein LC. An inventory of shedding data from clinical gene therapy trials. J Gene Med 2007; 9(10): 910-21.
38. European Medicines Agency. ICH Considerations: General principles to address virus and vector shedding. EMEA/CHMP/ ICH/449035/2009.