Vaxfectin: A versatile adjuvant for plasmid DNA- and protein-based vaccines

Expert Opinion on Drug Delivery

Volumn 7, Issue 12, 2010, Pages 1433-1446

  Sullivan, Sean M ^a   Doukas, John ^a   Hartikka, Jukka ^a   Smith, Larry ^a   Rolland, Alain ^a  

^a VICAL INC   (United States)

Author keywords

adjuvant; cationic lipid; plasmid DNA; vaccine

Indexed keywords

APEX; IMMUNOLOGICAL ADJUVANT; INFLUENZA VACCINE; INTERLEUKIN 6; LIPOSOME; ONCEPT; PEPTIDE VACCINE; PLASMID DNA; UNCLASSIFIED DRUG; VAXFECTIN;

CLINICAL ASSESSMENT; CLINICAL TRIAL; DRUG ANALYSIS; DRUG DISTRIBUTION; EVAPORATION; HEADACHE; HUMAN; IMMUNE RESPONSE; IMMUNIZATION; IMMUNOGENICITY; MALAISE; MYALGIA; NONHUMAN; PAIN; REVIEW; T LYMPHOCYTE;

ADJUVANTS, IMMUNOLOGIC; ANIMALS; ANTIGENS, VIRAL; HUMANS; IMMUNIZATION, SECONDARY; PHOSPHATIDYLETHANOLAMINES; PLASMIDS; VACCINES, DNA; VACCINES, SUBUNIT; VIRAL VACCINES;

EID: 78649924914     PISSN: 17425247     EISSN: None     Source Type: Journal    
DOI: 10.1517/17425247.2010.538047     Document Type: Review

References (41)

1. Tang D-C, DeVit M, Rouse BT. Genetic immunization is a simple method for eliciting an immune response. Nature 1992;356:152-54
2. Ulmer JB, Donnelly JJ, Packer SE, et al. Heterologus protection against influenza by injeciton of DNA encoding a viral protein. Science 1993;259:1745-49
3. Hartikka J, Bozoukova V, Ferrari M, et al. Vaxfectin enhances the humoral immune response to plasmid DNA-encoded antigens. Vaccine 2001;19:1911-23
4. Hartikka J, Bozoukova V, Yang CK, et al. Vaxfectin, a cationic lipid-based adjuvant for protein-based influenza vaccines. Vaccine 2009;27:6399-403
5. Reddy R, Nair S, Brynestad K, Rouse BT. Liposomes as antigen delivery systems in viral immunity. Semin Immunol 1992;4:91-6
6. Chikh sG, Schutze-Redelmeier MP. Liposomal delivery of CTL epitopes to dendritic cells. Biosci Rep 2002;22:339-53
7. Reyes L, Hartikka J, Bozoukova V, et al. Vaxfectin enhances antigen specific antibody titers and maintains Th1 type immune responses to plasmid DNA immunization. Vaccine 2001;19:3778-86
8. Sedegah M, Rogers WO, Belmonte A, et al. Vaxfectin enhances immunogenicity and protective efficacy of P. yoelii circumsporozoite DNA vaccines. Vaccine 2006;24:1921-7
9. Sedegah M, Rogers WO, Belmonte M, et al. Vaxfectin enhances both antibody and in vitro T cell responses to each component of a 5-gene Plasmodium falciparum plasmid DNA vaccine mixture administered at low doses. Vaccine 2010;28:3055-65
10. Locher CP, Witt SA, Ashlock BM, et al. Human immunodeficiency virus type 2 DNA vaccine provides partial protection from acute baboon infection. Vaccine 2004;22:2261-72
11. Pan CH, Jimenez GS, Nair N, et al. Use of Vaxfectin adjuvant with DNA vaccine encoding the measles virus hemagglutinin and fusion proteins protects juvenile and infant rhesus macaques against measles virus. Clin Vaccine Immunol 2008;15:1214-21
12. Jimenez GS, Planchon R, Wei Q, et al. Vaxfectin-formulated influenza DNA vaccines encoding NP and M2 viral proteins protect mice against lethal viral challenge. Hum Vaccin 2007;3:157-64
13. Lalor PA, Webby RJ, Morrow J, et al. Plasmid DNA-based vaccines protect mice and ferrets against lethal challenge with A/Vietnam/1203/04 (H5N1) influenza virus. J Infect Dis 2008;197:1643-52
14. Ye M, Wei Q, Kristin R, et al. Rapid development of a Vaxfectin-adjuvanted DNA vaccine encoding pandemic swine-origin influenza A virus A (H1N1) hemagglutinin. Gene Ther Regul 2009;4:44-55
15. Vilalta A, Jimenez G, Rusalov D, et al. Vaccination with polymerase chain reaction-generated linear expression cassettes protects mice against lethal influenza A challenge. Hum Gene Ther 2007;18:763-71
16. Doukas J, Morrow J, Bellinger D, et al. Nonclinical biodistribution, integration, and toxicology evaluations of an H5N1 pandemic influenza plasmid DNA vaccine formulated with Vaxfectin Submitted
17. Sheets RL, Stein J, Manetz TS, et al. Toxicological safety evaluation of DNA plasmid vaccines against HIV-1, Ebola, Severe Acute Respiratory Syndrome, or West Nile virus is similar despite differing plasmid backbones or gene-inserts. Toxicol Sci 2006;91:620-30 (Pubitemid 43827314)
18. Vilalta A, Mahajan RK, Hartikka J, et al. II. Cationic lipid-formulated plasmid DNA-based Bacillus anthracis vaccine: evaluation of plasmid DNA persistence and integration potential. Hum Gene Ther 2005;16:1151-6
19. Vilalta A, Mahajan RK, Hartikka J, et al. I. Poloxamer-formulated plasmid DNA-based human cytomegalovirus vaccine: evaluation of plasmid DNA biodistribution/persistence and integration. Hum Gene Ther 2005;16:1143-50
20. Martin T, Parker SE, Hedstrom R, et al. Plasmid DNA malaria vaccine: the potential for genomic integration after intramuscular injection. Hum Gene Ther 1999;10:759-68
21. Nichols WW, Ledwith BJ, Manam SV, Troilo PJ. Potential DNA vaccine integration into host cell genome. Ann NY Acad Sci 1995;772:30-9
22. Smith LR, Wloch MK, Ye M, et al. Phase 1 clinical trials of the safety and immunogenicity of adjuvanted plasmid DNA vaccines encoding influenza A virus H5 hemagglutinin. Vaccine 2010;28:2565-72
23. Guidance for Industry Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines. 2007. Available from: . gov/CbER/gdlns/panfluvac. pdf. [Accessed 12 January 2009]
24. Keitel WA, Atmar RL. Preparing for a possible pandemic: influenza A/H5N1 vaccine development. Curr Opin Pharmacol 2007;7:484-90
25. Soares MM, Mehta V, Finn OJ. Three different vaccines based on the 140-amino acid MUC1 peptide with seven tandemly repeated tumor-specific epitopes elicit distinct immune effector mechanisms in wild-type versus MUC1-transgenic mice with different potential for tumor rejection. J Immunol 2001;166:6555-63
26. Raz E, Tighe H, Sato Y, et al. Preferential induction of a Th1 immune response and inhibition of specific IgE antibody formation by plasmid DNA immunization. Proc Natl Acad Sci USA 1996;93:5141-5
27. Vilalta A, Shlapobersky M, Wei Q, et al. Analysis of biomarkers after intramuscular injection of Vaxfectin-formulated hCMV gB plasmid DNA. Vaccine 2009;27:7409-17
28. Restifo NP. Building better vaccines: how apoptotic cell death can induce inflammation and activate innate and adaptive immunity. Curr Opin Immunol 2000;12:597-603
29. Shlapobersky M, Wei Q, Sullivan S, Vilalta A. Vaxfectin-adjuvanted seasonal influenza protein vaccine: correlation of systemic and local immunological markers with formulation parameters. Vaccine 2009;27:6404-10
30. Beutler BA. TLRs and innate immunity. Blood 2009;113:1399-407
31. Gavin AL, Hoebe K, Duong B, et al. Adjuvant-enhanced antibody responses in the absence of toll-like receptor signaling. Science 2006;314:1936-8
32. Rao JB, Chamberlain RS, Bronte V, et al. IL-12 is an effective adjuvant to recombinant vaccinia virus-based tumor vaccines: enhancement by simultaneous B7-1 expression. J Immunol 1996;156:3357-65
33. Waldmann TA, Tagaya Y. The multifaceted regulation of interleukin-15 expression and the role of this cytokine in NK cell differentiation and host response to intracellular pathogens. Annu Rev Immunol 1999;17:19-49
34. Judge AD, Zhang X, Fujii H, et al. Interleukin 15 controls both proliferation and survival of a subset of memory-phenotype CD8(+) T cells. J Exp Med 2002;196:935-46
35. DSouza S, Rosseels V, Denis O, et al. Improved tuberculosis DNA vaccines by formulation in cationic lipids. Infect Immun 2002;70:3681-8
36. Nukuzuma C, Ajiro N, Wheeler CJ, Konishi E. Enhancing effect of vaxfectin on the ability of a Japanese encephalitis DNA vaccine to induce neutralizing antibody in mice. Viral Immunol 2003;16:183-9
37. Margalith M, Vilalta A. Sustained protective rabies neutralizing antibody titers after administration of cationic lipid-formulated pDNA vaccine. Genet Vaccines Ther 2006;4:2-7
38. Romano M, DSouza S, Adnet PY, et al. Priming but not boosting with plasmid DNA encoding mycolyl-transferase Ag85A from Mycobacterium tuberculosis increases the survival time of Mycobacterium bovis BCG vaccinated mice against low dose intravenous challenge with M. tuberculosis H37Rv. Vaccine 2006;24:3353-64
39. Sankar V, Baccaglini L, Sawdey M, et al. Salivary gland delivery of pDNA-cationic lipoplexes elicits systemic immune responses. Oral Dis 2002;8:275-81
40. Hermanson G, Whitlow V, Parker S, et al. A cationic lipid-formulated plasmid DNA vaccine confers sustained antibody-mediated protection against aerosolized anthrax spores. Proc Natl Acad Sci USA 2004;101:13601-6
41. Hahn UK, Aichler M, Boehm R, Beyer W. Comparison of the immunological memory after DNA vaccination and protein vaccination against anthrax in sheep. Vaccine 2006;24:4595-7