Combination of MIDGE-Th1 DNA vaccines with the cationic lipid SAINT-18: Studies on formulation, biodistribution and vector clearance

Vaccine

Volumn 32, Issue 27, 2014, Pages 3460-3467

  Endmann, Anne ^a   Oswald, Detlef ^a   Riede, Oliver ^a   Talman, Eduard G ^b   Vos, Roelien E ^b   Schroff, Matthias ^a   Kleuss, Christiane ^a   Ruiters, Marcel H J ^b,c   Juhls, Christiane ^a  

^a MOLOGEN AG   (Germany)

^b Synvolux Therapeutics   (Netherlands)

^c UNIVERSITY MEDICAL CENTER GRONINGEN   (Netherlands)

Author keywords

Biodistribution; Cationic lipid; DNA vaccine; MIDGE Th1; SAINT 18; Transfection reagent

Indexed keywords

CATIONIC LIPID SAINT 18; DNA VACCINE; HEPATITIS B SURFACE ANTIGEN; IMMUNOGLOBULIN G1; IMMUNOGLOBULIN G2A; LIPID; LIPOPLEX; MIDGE TH1 DNA VACCINE; UNCLASSIFIED DRUG; 1-METHYL-4-(9-DIOLEYL)METHYLPYRIDINIUM; CATION; IMMUNOGLOBULIN G; PYRIDINIUM DERIVATIVE; VIRUS ANTIBODY;

ANIMAL EXPERIMENT; ANTIGEN EXPRESSION; ANTIGEN PRESENTATION; ARTICLE; CELL CULTURE; CONTROLLED STUDY; DNA IMMUNIZATION; DNA VECTOR; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG FORMULATION; FEMALE; GENETIC TRANSFECTION; IMMUNE RESPONSE; IMMUNOGENICITY; IN VITRO STUDY; LYMPH NODE; MALE; MOUSE; NONHUMAN; PARTICLE SIZE; PRIORITY JOURNAL; SURFACE CHARGE; ZETA POTENTIAL; ANIMAL; BAGG ALBINO MOUSE; BLOOD; CHEMISTRY; GENE VECTOR; IMMUNOLOGY; PHARMACOKINETICS; RAT; TH1 CELL; TISSUE DISTRIBUTION; WISTAR RAT;

ANIMALS; ANTIBODIES, VIRAL; CATIONS; FEMALE; GENETIC VECTORS; HEPATITIS B SURFACE ANTIGENS; IMMUNOGLOBULIN G; LYMPH NODES; MALE; MICE; MICE, INBRED BALB C; PYRIDINIUM COMPOUNDS; RATS; RATS, WISTAR; TH1 CELLS; TISSUE DISTRIBUTION; TRANSFECTION; VACCINES, DNA;

EID: 84901060529     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2014.03.048     Document Type: Article

References (42)

1. Liu M.A. Immunologic basis of vaccine vectors. Immunity 2010, 33(October (4)):504-515.
2. Kutzler M.A., Weiner D.B. DNA vaccines: ready for prime time?. Nat Rev Genet 2008, 9(October (10)):776-788.
3. Ferraro B., Morrow M.P., Hutnick N.A., Shin T.H., Lucke C.E., Weiner D.B. Clinical applications of DNA vaccines: current progress. Clin Infect Dis 2011, 53(August (3)):296-302.
4. Fuller D.H., Loudon P., Schmaljohn C. Preclinical and clinical progress of particle-mediated DNA vaccines for infectious diseases. Methods 2006, 40(September (1)):86-97.
5. Luxembourg A., Evans C.F., Hannaman D. Electroporation-based DNA immunisation: translation to the clinic. Expert Opin Biol Ther 2007, 7(11):1647-1664.
6. Greenland J.R., Letvin N.L. Chemical adjuvants for plasmid DNA vaccines. Vaccine 2007, 25(May (19)):3731-3741.
7. Audouy S.A., de Leij L.F., Hoekstra D., Molema G. In vivo characteristics of cationic liposomes as delivery vectors for gene therapy. Pharm Res 2002, 19(11):1599-1605.
8. Moreno S., Lopez-Fuertes L., Vila-Coro A.J., Sack F., Smith C.A., Konig S.A., et al. DNA immunisation with minimalistic expression constructs. Vaccine 2004, 22(April (13-14)):1709-1716.
9. Lopez-Fuertes L., Perez-Jimenez E., Vila-Coro A.J., Sack F., Moreno S., Konig S.A., et al. DNA vaccination with linear minimalistic (MIDGE) vectors confers protection against Leishmania major infection in mice. Vaccine 2002, 21(December (3-4)):247-257.
10. Schirmbeck R., Konig-Merediz S.A., Riedl P., Kwissa M., Sack F., Schroff M., et al. Priming of immune responses to hepatitis B surface antigen with minimal DNA expression constructs modified with a nuclear localization signal peptide. J Mol Med 2001, 79(June (5-6)):343-350.
11. Zheng C., Juhls C., Oswald D., Sack F., Westfehling I., Wittig B., et al. Effect of different nuclear localization sequences on the immune responses induced by a MIDGE vector encoding bovine herpesvirus-1 glycoprotein D. Vaccine 2006, 24(May (21)):4625-4629.
12. Endmann A., Baden M., Weisermann E., Kapp K., Schroff M., Kleuss C., et al. Immune response induced by a linear DNA vector: influence of dose, formulation and route of injection. Vaccine 2010, 28(May (21)):3642-3649.
13. van der Woude I., Wagenaar A., Meekel A.A., ter Beest M.B., Ruiters M.H., Engberts J.B., et al. Novel pyridinium surfactants for efficient, nontoxic in vitro gene delivery. Proc Natl Acad Sci U S A 1997, 94(February (4)):1160-1165.
14. Sheets R.L., Stein J., Manetz T.S., Duffy C., Nason M., Andrews C. Biodistribution of DNA plasmid vaccines against HIV-1, Ebola, severe acute respiratory syndrome, or West Nile virus is similar, without integration, despite differing plasmid backbones or gene inserts. Toxicol Sci 2006, 91(2):610-619. [Epub 2006 March 28].
15. Tuomela M., Malm M., Wallen M., Stanescu I., Krohn K., Peterson P. Biodistribution and general safety of a naked DNA plasmid, GTU-MultiHIV, in a rat, using a quantitative PCR method. Vaccine 2005, 23(January (7)):890-896.
16. Gravier R., Dory D., Laurentie M., Bougeard S., Cariolet R., Jestin A. In vivo tissue distribution and kinetics of a pseudorabies virus plasmid DNA vaccine after intramuscular injection in swine. Vaccine 2007, 25(September (39-40)):6930-6938.
17. Parker S.E., Monteith D., Horton H., Hof R., Hernandez P., Vilalta A., et al. Safety of a GM-CSF adjuvant-plasmid DNA malaria vaccine. Gene Ther 2001, 8(13):1011-1023.
18. Pilling A.M., Harman R.M., Jones S.A., McCormack N.A., Lavender D., Haworth R. The assessment of local tolerance, acute toxicity, and DNA biodistribution following particle-mediated delivery of a DNA vaccine to minipigs. Toxicol Pathol 2002, 30(3):298-305.
19. Doukas J., Morrow J., Bellinger D., Hilgert T., Martin T., Jones D., et al. Nonclinical biodistribution, integration, and toxicology evaluations of an H5N1 pandemic influenza plasmid DNA vaccine formulated with Vaxfectin(R). Vaccine 2011, 29(July (33)):5443-5452.
20. Leamy V.L., Martin T., Mahajan R., Vilalta A., Rusalov D., Hartikka J., et al. Comparison of rabbit and mouse models for persistence analysis of plasmid-based vaccines. Hum Vaccin 2006, 2(May-June (3)):113-118.
21. Vilalta A., Mahajan R.K., Hartikka J., Leamy V., Martin T., Rusalov D., et al. II. Cationic lipid-formulated plasmid DNA-based Bacillus anthracis vaccine: evaluation of plasmid DNA persistence and integration potential. Hum Gene Ther 2005, 16(10):1151-1156.
22. Vilalta A., Mahajan R.K., Hartikka J., Rusalov D., Martin T., Bozoukova V., et al. I. Poloxamer-formulated plasmid DNA-based human cytomegalovirus vaccine: evaluation of plasmid DNA biodistribution/persistence and integration. Hum Gene Ther 2005, 16(October (10)):1143-1150.
23. Panjaworayan N., Roessner S.K., Firth A.E., Brown C.M. HBVRegDB: annotation, comparison, detection and visualization of regulatory elements in hepatitis B virus sequences. Virol J 2007, 4:136.
24. Wasungu L., Hoekstra D. Cationic lipids, lipoplexes and intracellular delivery of genes. J Control Release 2006, 116(November (2)):255-264.
25. van den Berg J.H., Oosterhuis K., Hennink W.E., Storm G., van der Aa L.J., Engbersen J.F., et al. Shielding the cationic charge of nanoparticle-formulated dermal DNA vaccines is essential for antigen expression and immunogenicity. J Control Release 2010, 141(January (2)):234-240.
26. Garzon M.R., Berraondo P., Crettaz J., Ochoa L., Vera M., Lasarte J.J., et al. Induction of gp120-specific protective immune responses by genetic vaccination with linear polyethylenimine-plasmid complex. Vaccine 2005, 23(February (11)):1384-1392.
27. Hartikka J., Bozoukova V., Ferrari M., Sukhu L., Enas J., Sawdey M., et al. Vaxfectin enhances the humoral immune response to plasmid DNA-encoded antigens. Vaccine 2001, 19(15-16):1911-1923.
28. Reyes L., Hartikka J., Bozoukova V., Sukhu L., Nishioka W., Singh G., et al. Vaxfectin enhances antigen specific antibody titers and maintains Th1 type immune responses to plasmid DNA immunization. Vaccine 2001, 19(27):3778-3786.
29. Jimenez G.S., Planchon R., Wei Q., Rusalov D., Geall A., Enas J., et al. Vaxfectin-formulated influenza DNA vaccines encoding NP and M2 viral proteins protect mice against lethal viral challenge. Hum Vaccin 2007, 3(September-October (5)):157-164.
30. Porter K.R., Ewing D., Chen L., Wu S.J., Hayes C.G., Ferrari M., et al. Immunogenicity and protective efficacy of a vaxfectin-adjuvanted tetravalent dengue DNA vaccine. Vaccine 2012, 30(January (2)):336-341.
31. Smith L.R., Wloch M.K., Ye M., Reyes L.R., Boutsaboualoy S., Dunne C.E., et al. Phase 1 clinical trials of the safety and immunogenicity of adjuvanted plasmid DNA vaccines encoding influenza A virus H5 hemagglutinin. Vaccine 2010, 28(March (13)):2565-2572.
32. Tros de Ilarduya C., Sun Y., Duzgunes N. Gene delivery by lipoplexes and polyplexes. Eur J Pharm Sci 2010, 40(June (3)):159-170.
33. Brave A., Gudmundsdotter L., Sandstrom E., Haller B.K., Hallengard D., Maltais A.K., et al. Biodistribution, persistence and lack of integration of a multigene HIV vaccine delivered by needle-free intradermal injection and electroporation. Vaccine 2010, 28(November (51)):8203-8209.
34. Dolter K.E., Evans C.F., Ellefsen B., Song J., Boente-Carrera M., Vittorino R., et al. Immunogenicity, safety, biodistribution and persistence of ADVAX, a prophylactic DNA vaccine for HIV-1, delivered by in vivo electroporation. Vaccine 2011, 29(January (4)):795-803.
35. Condon C., Watkins S.C., Celluzzi C.M., Thompson K., Falo L.D. DNA-based immunization by in vivo transfection of dendritic cells. Nat Med 1996, 2(October (10)):1122-1128.
36. Raz E., Carson D.A., Parker S.E., Parr T.B., Abai A.M., Aichinger G., et al. Intradermal gene immunization: the possible role of DNA uptake in the induction of cellular immunity to viruses. Proc Natl Acad Sci U S A 1994, 91(September (20)):9519-9523.
37. Davis H.L., Millan C.L., Watkins S.C. Immune-mediated destruction of transfected muscle fibers after direct gene transfer with antigen-expressing plasmid DNA. Gene Ther 1997, 4(March (3)):181-188.
38. Garg S., Oran A., Wajchman J., Sasaki S., Maris C.H., Kapp J.A., et al. Genetic tagging shows increased frequency and longevity of antigen-presenting, skin-derived dendritic cells in vivo. Nat Immunol 2003, 4(September (9)):907-912.
39. Porgador A., Irvine K.R., Iwasaki A., Barber B.H., Restifo N.P., Germain R.N. Predominant role for directly transfected dendritic cells in antigen presentation to CD8+ T cells after gene gun immunization. J Exp Med 1998, 188(September (6)):1075-1082.
40. Oussoren C., Velinova M., Scherphof G., van der Want J.J., van Rooijen N., Storm G. Lymphatic uptake and biodistribution of liposomes after subcutaneous injection. IV. Fate of liposomes in regional lymph nodes. Biochim Biophys Acta 1998, 1370(March (2)):259-272.
41. Oussoren C., Zuidema J., Crommelin D.J., Storm G. Lymphatic uptake and biodistribution of liposomes after subcutaneous injection. II. Influence of liposomal size, lipid composition and lipid dose. Biochim Biophys Acta 1997, 1328(September (2)):261-272.
42. Vangasseri D.P., Cui Z., Chen W., Hokey D.A., Falo L.D., Huang L. Immunostimulation of dendritic cells by cationic liposomes. Mol Membr Biol 2006, 23(September-October):385-395.