Safety and efficacy of DNA vaccines: Plasmids vs. minicircles

Human Vaccines and Immunotherapeutics

Volumn 10, Issue 5, 2014, Pages 1306-1308

  Stenler, Sofia ^a   Blomberg, Pontus ^a,b   Smith, C I Edvard ^a  

^a KAROLINSKA INSTITUTE   (Sweden)

^b KAROLINSKA UNIVERSITY HOSPITAL   (Sweden)

Author keywords

DNA vaccination; Nonviral gene therapy; Pneumatic delivery; Supercoil; Topoisoforms; Vaccine; Vector safety

Indexed keywords

DNA VACCINE; MINICIRCLE DNA; PLASMID DNA;

BIOASSAY; CD8+ T LYMPHOCYTE; DNA IMMUNIZATION; DRUG EFFICACY; DRUG SAFETY; GENE CASSETTE; GENE DELIVERY SYSTEM; GENE EXPRESSION; HUMAN; MOLECULAR BIOLOGY; NOTE;

EID: 84901412115     PISSN: 21645515     EISSN: 2164554X     Source Type: Journal    
DOI: 10.4161/hv.28077     Document Type: Note

References (25)

1. Quaak SG, Haanen JB, Beijnen JH, Nuijen B. Naked plasmid DNA formulation: effect of different disaccharides on stability after lyophilisation. AAPS PharmSciTech 2010; 11:344-50; PMID:20204715; http://dx.doi.org/10.1208/s12249- 010-9391-2
2. FDA. U.S. Department of Health and Human Services, Food and Drug Administration: Guidance for Industry: Guidance for Human Somatic Cell Therapy and Gene Therapy. 1998.
3. Darquet AM, Cameron B, Wils P, Scherman D, Crouzet J. A new DNA vehicle for nonviral gene delivery: supercoiled minicircle. Gene Ther 1997; 4:1341-9; PMID:9472558; http://dx.doi.org/10.1038/sj.gt.3300540
4. Bigger BW, Tolmachov O, Collombet JM, Fragkos M, Palaszewski I, Coutelle C. An araC-controlled bacterial cre expression system to produce DNA minicircle vectors for nuclear and mitochondrial gene therapy. J Biol Chem 2001; 276:23018-27; PMID:11304530; http://dx.doi.org/10.1074/jbc.M010873200
5. Chen ZY, He CY, Ehrhardt A, Kay MA. Minicircle DNA vectors devoid of bacterial DNA result in persistent and high-level transgene expression in vivo. Mol Ther 2003; 8:495-500; PMID:12946323; http://dx.doi.org/10.1016/S1525- 0016(03)00168-0
6. Chen ZY, He CY, Kay MA. Improved production and purification of minicircle DNA vector free of plasmid bacterial sequences and capable of persistent transgene expression in vivo. Hum Gene Ther 2005; 16:126-31; PMID:15703495; http://dx.doi.org/10.1089/hum.2005.16.126
7. Kay MAHC, He CY, Chen ZY. A robust system for production of minicircle DNA vectors. Nat Biotechnol 2010; 28:1287-9; PMID:21102455; http://dx.doi.org/ 10.1038/nbt.1708
8. Mayrhofer P, Blaesen M, Schleef M, Jechlinger W. Minicircle-DNA production by site specific recombination and protein-DNA interaction chromatography. J Gene Med 2008; 10:1253-69; PMID:18767031; http://dx.doi.org/ 10.1002/jgm.1243
9. Stenler S, Wiklander OP, Badal-Tejedor M, Turunen J, Nordin JZ, Hallengärd D, Wahren B, Andaloussi SE, Rutland MW, Smith CE, et al. Micro-minicircle Gene Therapy: Implications of Size on Fermentation, Complexation, Shearing Resistance, and Expression. Mol Ther Nucleic Acids 2014; 2:e140; PMID:24399204; http://dx.doi.org/10.1038/mtna.2013.67
10. WHO. The WHO Expert Committee on Biological Standardization 56th report: Number 941. Geneva: World Health Organization, 2007.
11. FDA. U.S. Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research: Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications. 2007.
12. EMEA. Comittee for Veterinary medicinal products: Notes for Guidance: DNA-vaccines nonamplifiable in eukaryotic cells for veterinary use. In: Products TEAftEfM, ed., 2000.
13. Brinster RL, Chen HY, Trumbauer ME, Yagle MK, Palmiter RD. Factors affecting the efficiency of introducing foreign DNA into mice by microinjecting eggs. Proc Natl Acad Sci U S A 1985; 82:4438-42; PMID:3892534; http://dx.doi.org/10.1073/pnas.82.13.4438
14. Hitchcock AG, Sergeant JA, Rahman SF, Tharia HA, Blom H. Scale-Up of a Plasmid DNA Purification Process. BioProcess International 2010; 8:46-54
15. Vahlsing HL, Yankauckas MA, Sawdey M, Gromkowski SH, Manthorpe M. Immunization with plasmid DNA using a pneumatic gun. J Immunol Methods 1994; 175:11-22; PMID:7930633; http://dx.doi.org/10.1016/0022-1759(94)90327-1
16. Wang R, Epstein J, Baraceros FM, Gorak EJ, Charoenvit Y, Carucci DJ, Hedstrom RC, Rahardjo N, Gay T, Hobart P, et al. Induction of CD4(+) T cell-dependent CD8(+) type 1 responses in humans by a malaria DNA vaccine. Proc Natl Acad Sci U S A 2001; 98:10817-22; PMID:11526203; http://dx.doi.org/10.1073/ pnas.181123498
17. Hallengärd D, Bråve A, Isaguliants M, Blomberg P, Enger J, Stout R, King A, Wahren B. A combination of intradermal jet-injection and electroporation overcomes in vivo dose restriction of DNA vaccines. Genet Vaccines Ther 2012; 10:5; PMID:22873174; http://dx.doi.org/10.1186/1479-0556-10- 5
18. Kano Y, Miyashita T, Nakamura H, Kuroki K, Nagata A, Imamoto F. In vivo correlation between DNA supercoiling and transcription. Gene 1981; 13:173-84; PMID:6263758; http://dx.doi.org/10.1016/0378-1119(81)90006-8
19. Cupillard L, Juillard V, Latour S, Colombet G, Cachet N, Richard S, Blanchard S, Fischer L. Impact of plasmid supercoiling on the efficacy of a rabies DNA vaccine to protect cats. Vaccine 2005; 23:1910-6; PMID:15734063; http://dx.doi.org/10.1016/j.vaccine.2004.10.018
20. nd, Gilbert BE, Zechiedrich L. Supercoiled Minivector DNA resists shear forces associated with gene therapy delivery. Gene Ther 2012; 19:94-100; PMID:21633394; http://dx.doi.org/10.1038/gt.2011.77
21. Zhao N, Fogg JM, Zechiedrich L, Zu Y. Transfection of shRNA-encoding Minivector DNA of a few hundred base pairs to regulate gene expression in lymphoma cells. Gene Ther 2011; 18:220-4; PMID:20962872; http://dx.doi.org/10. 1038/gt.2010.123
22. Cai Y, Rodriguez S, Hebel H. DNA vaccine manufacture: scale and quality. Expert Rev Vaccines 2009; 8:1277-91; PMID:19722898; http://dx.doi.org/10.1586/ erv.09.84
23. Dietz WM, Skinner NE, Hamilton SE, Jund MD, Heitfeld SM, Litterman AJ, Hwu P, Chen ZY, Salazar AM, Ohlfest JR, et al. Minicircle DNA is superior to plasmid DNA in eliciting antigen-specific CD8+ T-cell responses. Mol Ther 2013; 21:1526-35; PMID:23689601; http://dx.doi.org/10.1038/mt.2013.85
24. Chen ZY, Riu E, He CY, Xu H, Kay MA. Silencing of episomal transgene expression in liver by plasmid bacterial backbone DNA is independent of CpG methylation. Mol Ther 2008; 16:548-56; PMID:18253155; http://dx.doi.org/10.1038/ sj.mt.6300399
25. Riu E, Chen ZY, Xu H, He CY, Kay MA. Histone modifications are associated with the persistence or silencing of vector-mediated transgene expression in vivo. Mol Ther 2007; 15:1348-55; PMID:17457320; http://dx.doi.org/10.1038/sj.mt. 6300177