Safety and comparative immunogenicity of an HIV-1 DNA vaccine in combination with plasmid interleukin 12 and impact of intramuscular electroporation for delivery

Journal of Infectious Diseases

Volumn 208, Issue 5, 2013, Pages 818-829

  Kalams, Spyros A ^a,b   Parker, Scott D ^c   Elizaga, Marnie ^d   Metch, Barbara ^d   Edupuganti, Srilatha ^e   Hural, John ^d   De Rosa, Stephen ^d   Carter, Donald K ^d   Rybczyk, Kyle ^a,b   Frank, Ian ^f   Fuchs, Jonathan ⁱ   Koblin, Beryl ^j   Kim, Denny H ^m   Joseph, Patrice ⁿ   Keefer, Michael C ^k   Baden, Lindsey R ^o   Eldridge, John ^l   Boyer, Jean ^g   Sherwat, Adam ^p   Cardinali, Massimo ^p   Allen, Mary ^p   Pensiero, Michael ^p   Butler, Chris ^p   Khan, Amir S ^h   Yan, Jian ^h   Sardesai, Niranjan Y ^h   Kublin, James G ^d   Weiner, David B ^g   more..

^a Infectious Diseases Division   (United States)

^b VANDERBILT UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

^d Fred Hutchinson Cancer Research Center   (United States)

^e EMORY UNIVERSITY   (United States)

^f School of Medicine   (United States)

^g UNIVERSITY OF PENNSYLVANIA   (United States)

^h Inovio Pharmaceuticals   (United States)

ⁱ San Francisco Department of Health   (United States)

^j NEW YORK BLOOD CENTER   (United States)

^k UNIVERSITY OF ROCHESTER SCHOOL OF MEDICINE AND DENTISTRY   (United States)

^l Profectus Biosciences   (United States)

^m ASTELLAS PHARMA GLOBAL DEVELOPMENT   (United States)

ⁿ Centers Institute of Infectious Diseases and Reproductive Health   (Haïti)

^o BRIGHAM AND WOMEN S HOSPITAL   (United States)

^p NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES   (United States)

more..

Author keywords

electroporation; plasmid cytokine adjuvant; vaccination

Indexed keywords

DNA VACCINE; ENVELOPE PROTEIN; GAG PROTEIN; HUMAN IMMUNODEFICIENCY VIRUS VACCINE; INTERLEUKIN 12; INTERLEUKIN 15; PENNVAX; PLACEBO; PLASMID DNA; POL PROTEIN; PROTEIN P40; PROTEIN P53; UNCLASSIFIED DRUG;

ADULT; ANTIBODY RESPONSE; ARTICLE; CD4+ T LYMPHOCYTE; CD8+ T LYMPHOCYTE; CELLULAR IMMUNITY; CONTROLLED STUDY; DRUG DELIVERY SYSTEM; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; ELECTROPORATION; FEMALE; HUMAN; HUMAN EXPERIMENT; IMMUNOGENICITY; IMMUNOREACTIVITY; INJECTION SITE PAIN; INJECTION SITE REACTION; MALE; MULTICENTER STUDY (TOPIC); NORMAL HUMAN; PERIPHERAL NEUROPATHY; PHASE 1 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; PROTEIN EXPRESSION; RANDOMIZED CONTROLLED TRIAL (TOPIC); VACCINATION;

EID: 84881623207     PISSN: 00221899     EISSN: None     Source Type: Journal    
DOI: 10.1093/infdis/jit236     Document Type: Article

References (44)

1. Hokey DA, Weiner DB. DNA vaccines for HIV: challenges and opportunities. Springer Semin Immunopathol 2006; 28:267-79.
2. Catanzaro AT, Roederer M, Koup RA, et al. Phase I clinical evaluation of a six-plasmid multiclade HIV-1 DNA candidate vaccine. Vaccine 2007; 25:4085-92.
3. Graham BS, Koup RA, Roederer M, et al. Phase 1 safety and immunogenicity evaluation of a multiclade HIV-1 DNA candidate vaccine. J Infect Dis 2006; 194:1650-60.
4. Kutzler MA, Weiner DB. DNAvaccines: ready for prime time Nat Rev Genet 2008; 9:776-88.
5. MacGregor RR, Boyer JD, Ugen KE, et al. First human trial of a DNAbased vaccine for treatment of human immunodeficiency virus type 1 infection: safety and host response. J Infect Dis 1998; 178:92-100.
6. MacGregor RR, Ginsberg R, Ugen KE, et al. T-cell responses induced in normal volunteers immunized with a DNA-based vaccine containing HIV-1 env and rev. AIDS 2002; 16:2137-43.
7. Muthumani K, Zhang D, Dayes NS, et al. Novel engineered HIV-1 East African Clade-A gp160 plasmid construct induces strong humoral and cell-mediated immune responses in vivo. Virology 2003; 314:134-46.
8. Chapman BS, Thayer RM, Vincent KA, Haigwood NL. Effect of intron A from human cytomegalovirus (Towne) immediate-early gene on heterologous expression in mammalian cells. Nucleic Acids Res 1991; 19:3979-86.
9. Haigwood NL, Pierce CC, Robertson MN, et al. Protection from pathogenic SIV challenge using multigenic DNAvaccines. Immunol Lett 1999; 66:183-8.
10. Baden LR, Blattner WA, Morgan C, et al. Timing of plasmid cytokine (IL-2/Ig) administration affects HIV-1 vaccine immunogenicity in HIV-seronegative subjects. J Infect Dis 2011; 204:1541-9.
11. Barouch DH, Santra S, Schmitz JE, et al. Control of viremia and prevention of clinical AIDS in rhesus monkeys by cytokine-augmented DNA vaccination. Science 2000; 290:486-92.
12. Morrow MP, Pankhong P, Laddy DJ, et al. Comparative ability of IL-12 and IL-28B to regulate Treg populations and enhance adaptive cellular immunity. Blood 2009; 113:5868-77.
13. Kraynyak KA, Kutzler MA, Cisper NJ, et al. Plasmid-encoded interleukin-15 receptor alpha enhances specific immune responses induced by a DNAvaccine in vivo. Hum Gene Ther 2009; 20:1143-56.
14. Trinchieri G. Interleukin-12: a proinflammatory cytokine with immunoregulatory functions that bridge innate resistance and antigen-specific adaptive immunity. Annu Rev Immunol 1995; 13:251-76.
15. Wolf SF, Temple PA, Kobayashi M, et al. Cloning of cDNA for natural killer cell stimulatory factor, a heterodimeric cytokine with multiple biologic effects on T and natural killer cells. J Immunol 1991; 146:3074-81.
16. Giri JG, Anderson DM, Kumaki S, Park LS, Grabstein KH, Cosman D. IL-15, a novel T cell growth factor that shares activities and receptor components with IL-2. J Leukoc Biol 1995; 57:763-6.
17. Grabstein KH, Eisenman J, Shanebeck K, et al. Cloning of a T cell growth factor that interacts with the beta chain of the interleukin-2 receptor. Science 1994; 264:965-8.
18. Rochman Y, Spolski R, Leonard WJ. New insights into the regulation of T cells by gamma(c) family cytokines. Nat Rev Immunol 2009; 9:480-90.
19. Becker TC, Wherry EJ, Boone D, et al. Interleukin 15 is required for proliferative renewal of virus-specific memory CD8 T cells. J Exp Med 2002; 195:1541-8.
20. Wherry EJ, Becker TC, Boone D, Kaja MK, Ma A, Ahmed R. Homeostatic proliferation but not the generation of virus specific memory CD8 T cells is impaired in the absence of IL-15 or IL-15Ralpha. Adv Exp Med Biol 2002; 512:165-75.
21. Wherry EJ, Teichgraber V, Becker TC, et al. Lineage relationship and protective immunity of memory CD8 T cell subsets. Nat Immunol 2003; 4:225-34.
22. Cemazar M, Golzio M, Sersa G, Rols MP, Teissie J. Electrically-assisted nucleic acids delivery to tissues in vivo: where do we stand Curr Pharm Des 2006; 12:3817-25.
23. Favard C, Dean DS, Rols MP. Electrotransfer as a non viral method of gene delivery. Curr Gene Ther 2007; 7:67-77.
24. Gothelf A, Mir LM, Gehl J. Electrochemotherapy: results of cancer treatment using enhanced delivery of bleomycin by electroporation. Cancer Treat Rev 2003; 29:371-87.
25. Liu J, Kjeken R, Mathiesen I, Barouch DH. Recruitment of antigenpresenting cells to the site of inoculation and augmentation of human immunodeficiency virus type 1 DNA vaccine immunogenicity by in vivo electroporation. J Virol 2008; 82:5643-9.
26. Luckay A, Sidhu MK, Kjeken R, et al. Effect of plasmid DNA vaccine design and in vivo electroporation on the resulting vaccine-specific immune responses in rhesus macaques. J Virol 2007; 81:5257-69.
27. Huang Y, Chen Z, ZhangW, et al. Design, construction, and characterization of a dual-promoter multigenic DNA vaccine directed against an HIV-1 subtype C/B' recombinant. J Acquir Immune Defic Syndr 2008; 47:403-11.
28. Sardesai NY, Weiner DB. Electroporation delivery of DNA vaccines: prospects for success. Curr Opin Immunol 2011; 23:421-9.
29. Kalams SA, Parker S, Jin X, et al. Safety and immunogenicity of an HIV-1 gag DNA vaccine with or without IL-12 and/or IL-15 plasmid cytokine adjuvant in healthy, HIV-1 uninfected adults. PLoS One 2012; 7:e29231.
30. McElrath MJ, De Rosa SC, Moodie Z, et al. HIV-1 vaccine-induced immunity in the test-of-concept Step Study: a case-cohort analysis. Lancet 2008; 372:1894-905.
31. Liao HX, Sutherland LL, Xia SM, et al. A group M consensus envelope glycoprotein induces antibodies that neutralize subsets of subtype B and C HIV-1 primary viruses. Virology 2006; 353:268-82.
32. Goepfert PA, Tomaras GD, Horton H, et al. Durable HIV-1 antibody and T-cell responses elicited by an adjuvanted multi-protein recombinant vaccine in uninfected human volunteers. Vaccine 2007; 25:510-8.
33. Tomaras GD, Yates NL, Liu P, et al. Initial B-cell responses to transmitted human immunodeficiency virus type 1: virion-binding immunoglobulin M (IgM) and IgG antibodies followed by plasma anti-gp41 antibodies with ineffective control of initial viremia. J Virol 2008; 82:12449-63.
34. Montefiori DC. Measuring HIV neutralization in a luciferase reporter gene assay. Methods Mol Biol 2009; 485:395-405.
35. Hirao LA, Wu L, Khan AS, et al. Combined effects of IL-12 and electroporation enhances the potency of DNA vaccination in macaques. Vaccine 2008; 26:3112-20.
36. Wang R, Doolan DL, Le TP, et al. Induction of antigen-specific cytotoxic T lymphocytes in humans by a malaria DNA vaccine. Science 1998; 282:476-80.
37. De Rosa SC, Thomas EP, Bui J, et al. HIV-DNA priming alters T cell responses to HIV-adenovirus vaccine even when responses to DNA are undetectable. J Immunol 2011; 187:3391-401.
38. Churchyard GJ, Morgan C, Adams E, et al. A phase IIA randomized clinical trial of a multiclade HIV-1 DNA prime followed by a multiclade rAd5 HIV-1 vaccine boost in healthy adults (HVTN204). PLoS One 2011; 6:e21225.
39. Goepfert PA, Elizaga ML, Sato A, et al. Phase 1 safety and immunogenicity testing of DNA and recombinant modified vaccinia Ankara vaccines expressing HIV-1 virus-like particles. J Infect Dis 2011; 203: 610-9.
40. Rosati M, Bergamaschi C, Valentin A, et al. DNA vaccination in rhesus macaques induces potent immune responses and decreases acute and chronic viremia after SIVmac251 challenge. Proc Natl Acad Sci USA 2009; 106:15831-6.
41. Winstone N, Wilson AJ, Morrow G, et al. Enhanced control of pathogenic Simian immunodeficiency virus SIVmac239 replication in macaques immunized with an interleukin-12 plasmid and a DNA prime-viral vector boost vaccine regimen. J Virol 2011; 85:9578-87.
42. Schadeck EB, Sidhu M, Egan MA, et al. A dose sparing effect by plasmid encoded IL-12 adjuvant on a SIVgag-plasmid DNA vaccine in rhesus macaques. Vaccine 2006; 24:4677-87.
43. Hirao LA, Wu L, Satishchandran A, et al. Comparative analysis of immune responses induced by vaccination with SIV antigens by recombinant Ad5 vector or plasmid DNA in rhesus macaques. Mol Ther 2010; 18:1568-76.
44. Vasan S, Hurley A, Schlesinger SJ, et al. In vivo electroporation enhances the immunogenicity of an HIV-1 DNA vaccine candidate in healthy volunteers. PLoS One 2011; 6:e19252.