In vivo electroporation enhances the immunogenicity of an HIV-1 DNA vaccine candidate in healthy volunteers

PLoS ONE

Volumn 6, Issue 5, 2011, Pages

  Vasan, Sandhya ^a,b   Hurley, Arlene ^a,b   Schlesinger, Sarah J ^a,b   Hannaman, Drew ^c   Gardiner, David F ^a   Dugin, Daniel P ^a   Boente Carrera, Mar ^a   Vittorino, Roselle ^a   Caskey, Marina ^b   Andersen, Johanne ^b   Huang, Yaoxing ^a   Cox, Josephine H ^d   Tarragona Fiol, Tony ^d   Gill, Dilbinder K ^d   Cheeseman, Hannah ^d   Clark, Lorna ^d   Dally, Len ^e   Smith, Carol ^e   Schmidt, Claudia ^d   Park, Harriet H ^d   Kopycinski, Jakub T ^d   Gilmour, Jill ^d   Fast, Patricia ^d   Bernard, Robert ^c   Ho, David D ^a,b   more..

^a AARON DIAMOND AIDS RESEARCH CENTER   (United States)

^b ROCKEFELLER UNIVERSITY   (United States)

^c Ichor Medical Systems Inc   (United States)

^d INTERNATIONAL AIDS VACCINE INITIATIVE   (United States)

^e EMMES CORPORATION   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADVAX; CD4 ANTIGEN; CD8 ANTIGEN; DNA VACCINE; GAMMA INTERFERON; HUMAN IMMUNODEFICIENCY VIRUS VACCINE; INTERLEUKIN 2; MACROPHAGE INFLAMMATORY PROTEIN 1BETA; PLACEBO; TUMOR NECROSIS FACTOR ALPHA; UNCLASSIFIED DRUG; CYTOKINE;

ADULT; ARTHRALGIA; ARTICLE; CD4+ T LYMPHOCYTE; CD8+ T LYMPHOCYTE; CELLULAR IMMUNITY; CHILL; CONTROLLED STUDY; CYTOKINE RELEASE; DOUBLE BLIND PROCEDURE; DRUG DELIVERY SYSTEM; DRUG DOSE COMPARISON; DRUG SAFETY; DRUG TOLERABILITY; ELECTROPORATION; ENZYME LINKED IMMUNOSPOT ASSAY; FEMALE; FEVER; HEADACHE; HUMAN; HUMAN EXPERIMENT; HUMAN IMMUNODEFICIENCY VIRUS 1 INFECTION; IMMUNOGENICITY; IN VIVO STUDY; INJECTION SITE EDEMA; INJECTION SITE ERYTHEMA; INJECTION SITE INDURATION; INJECTION SITE PAIN; MALAISE; MALE; MYALGIA; NAUSEA AND VOMITING; NORMAL HUMAN; PHASE 1 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; RASH; SCAR FORMATION; SKIN DEFECT; TREATMENT OUTCOME; VOLUNTEER; ADOLESCENT; CLINICAL TRIAL; COMPARATIVE STUDY; CONTROLLED CLINICAL TRIAL; DRUG EFFECT; HUMAN IMMUNODEFICIENCY VIRUS 1; IMMUNOLOGY; INTRAMUSCULAR DRUG ADMINISTRATION; METHODOLOGY; MIDDLE AGED; SECRETION; STANDARD; T LYMPHOCYTE;

HUMAN IMMUNODEFICIENCY VIRUS 1;

ADOLESCENT; ADULT; AIDS VACCINES; CYTOKINES; DOUBLE-BLIND METHOD; ELECTROPORATION; FEMALE; HIV-1; HUMANS; IMMUNITY, CELLULAR; INJECTIONS, INTRAMUSCULAR; MALE; MIDDLE AGED; T-LYMPHOCYTES; VACCINES, DNA; YOUNG ADULT;

EID: 79956061128     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0019252     Document Type: Article

References (44)

1. Ulmer JB, Donnelly JJ, Parker SE, Rhodes GH, Felgner PL, et al. (1993) Heterologous protection against influenza by injection of DNA encoding a viral protein. Science 259: 1745-1749.
2. Donnelly JJ, Wahren B, Liu MA, (2005) DNA vaccines: progress and challenges. J Immunol 175 (2): 633-639.
3. Rice J, Ottensmeier CH, Stevenson FK, (2008) DNA vaccines: precision tools for activating effective immunity against cancer. Nat Rev Cancer 8: 108-120.
4. Wang R, Doolan DL, Le TP, Hedstrom RC, Coonan KM, et al. (1998) Induction of antigen-specific cytotoxic T lymphocytes in humans by a malaria DNA vaccine. Science 282: 476-480.
5. Rottinghaus ST, Poland GA, Jacobson RM, Barr LJ, Roy MJ, (2003) epatitis DNA vaccine induces protective antibody responses in human nonresponders to conventional vaccination. Vaccine 21: 4604-4608.
6. Catanzaro AT, Roederer M, Koup RA, Bailer RT, Enama ME, et al. (2007) Phase I clinical evaluation of a six-plasmid multiclade HIV-1 DNA candidate vaccine. Vaccine 25: 4085-4092.
7. Graham BS, Koup RA, Roederer M, Bailer RT, Enama ME, et al. (2006) Phase I Safety and Immunogenicity Evaluation of a Multiclade HIV-1 Candidate DNA Vaccine. J Infect Dis 194: 1650-1660.
8. Kutzler MA, Weiner DB, (2008) DNA vaccines: ready for prime time? Nat Rev Genet 9: 776-788.
9. McConkey SJ, Reece WH, Moorthy VS, Webster D, Dunachie S, et al. (2003) Enhanced T-cell immunogenicity of plasmid DNA vaccines boosted by recombinant modified vaccinia virus Ankara in humans. Nat Med 9: 729-735.
10. Harari A, Bart PA, Stöhr W, Tapia G, Garcia M, et al. (2008) An HIV-1 clade C DNA prime, NYVAC boost vaccine regimen induces reliable, polyfunctional, and long-lasting T cell responses. J Exp Med 205: 63-77.
11. Jaoko W, Nakwagala FN, Anzala O, Manyonyi GO, Birungi J, et al. (2008) Safety and immunogenicity of recombinant low-dosage HIV-1 A vaccine candidates vectored by plasmid pTHr DNA or modified vaccinia virus Ankara (MVA) in humans in East Africa. Vaccine 26: 2788-2795.
12. Goonetilleke N, Moore S, Dally L, Winstone N, Cebere I, et al. (2006) Induction of multifunctional human immunodeficiency virus type 1 (HIV-1)-specific T cells capable of proliferation in healthy subjects by using a prime-boost regimen of DNA- and modified vaccinia virus Ankara-vectored vaccines expressing HIV-1 Gag coupled to CD8+ T-cell epitopes. Virol 80: 4717-4728.
13. Wang S, Kennedy JS, West K, Montefiori DC, Coley S, et al. (2008) Cross-subtype antibody and cellular immune responses induced by a polyvalent DNA prime-protein boost HIV-1 vaccine in healthy human volunteers. Vaccine 26: 3947-3957.
14. Nwanegbo E, Vardas E, Gao W, Whittle H, Sun H, et al. (2004) Prevalence of neutralizing antibodies to adenoviral serotypes 5 and 35 in the adult populations of The Gambia, South Africa, and the United States. Clin Diagn Lab Immunol 11: 351-357.
15. Mast TC, Kierstead L, Gupta SB, Nikas AA, Kallas EG, et al. (2009) International epidemiology of human pre-existing adenovirus (Ad) type-5, type-6, type-26 and type-36 neutralizing antibodies: correlates of high Ad5 titers and implications for potential HIV vaccine trials. Vaccine 28: 950-957.
16. Santra S, Seaman MS, Xu L, Barouch DH, Lord CI, (2005) Replication-defective adenovirus serotype 5 vectors elicit durable cellular and humoral immune responses in nonhuman primates. J Virol 79: 6516-6522.
17. Schalk JA, Mooi FR, Berbers GA, van Aerts LA, Ovelgönne H, et al. (2006) Preclinical and clinical safety studies on DNA vaccines. Hum Vaccin 2: 45-53.
18. Manam S, Ledwith BJ, Barnum AB, Troilo PJ, Pauley CJ, (2000) Plasmid DNA vaccines: tissue distribution and effects of DNA sequence, adjuvants and delivery method on integration into host DNA. Intervirology 43: 273-281.
19. Mathiesen I, (1999) Electropermeabilization of skeletal muscle enhances gene transfer in vivo. Gene Ther 6: 508-14.
20. Widera G, Austin M, Rabussay D, Goldbeck C, Barnett SW, et al. (2000) Increased DNA vaccine delivery and immunogenicity by electroporation in vivo. J Immunol 164: 4635-40.
21. Babiuk S, Baca-Estrada ME, Foldvari M, Middleton DM, Rabussay D, et al. (2004) Increased gene expression and inflammatory cell infiltration caused by electroporation are both important for improving the efficacy of DNA vaccines. J Biotechnol 110: 1-10.
22. Liu J, Kjeken R, Mathiesen I, Barouch DH, (2008) Recruitment of antigen-presenting cells to the site of inoculation and augmentation of human immunodeficiency virus type 1 DNA vaccine immunogenicity by in vivo electroporation. J Virol 82: 5643-5649.
23. Babiuk S, Baca-Estrada ME, Foldvari M, Storms M, Rabussay D et al, (2002) Electroporation improves the efficacy of DNA vaccines in large animals. Vaccine 20: 3399-3408.
24. Luxembourg A, Hannaman D, Ellefsen B, Nakamura G, Bernard R, (2006) Enhancement of immune responses to an HBV DNA vaccine by electroporation. Vaccine 24: 4490-4493.
25. Li Z, Zhang H, Fan X, Zhang Y, Huang J, et al. (2006) DNA electroporation prime and protein boost strategy enhances humoral immunity of tuberculosis DNA vaccines in mice and non-human primates. Vaccine 24: 4565-4568.
26. Hooper JW, Golden JW, Ferro AM, King AD, (2007) Smallpox DNA vaccine delivered by novel skin electroporation device protects mice against intranasal poxvirus challenge. Vaccine 25: 1814-1823.
27. Luckay A, Sidhu MK, Kjeken R, Megati S, Chong SY, et al. (2007) Effect of plasmid DNA vaccine design and in vivo electroporation on the resulting vaccine-specific immune responses in rhesus macaques. J Virol 81: 5257-5269.
28. Dobaño C, Widera G, Rabussay D, Doolan DL, (2007) Enhancement of antibody and cellular immune responses to malaria DNA vaccines by in vivo electroporation. Vaccine 25: 6635-6645.
29. Hirao LA, Wu L, Khan AS, Hokey DA, Yan J, et al. (2008) Combined effects of IL-12 and electroporation enhances the potency of DNA vaccination in macaques. Vaccine 26: 3112-3120.
30. Livingston BD, Little SF, Luxembourg A, Ellefsen B, Hannaman D, (2010) Comparative performance of a licensed anthrax vaccine versus electroporation based delivery of a PA encoding DNA vaccine in rhesus macaques. Vaccine 28 (4): 1056-1061.
31. Rosati M, Valentin A, Jalah R, Patel V, von Gegerfelt A, et al. (2008) Increased immune responses in rhesus macaques by DNA vaccination combined with electroporation. Vaccine 26 (40): 5223-5229.
32. Chen MW, Cheng TJ, Huang Y, Jan JT, Ma SH, Yu AL, et al. (2008) A consensus-hemagglutinin-based DNA vaccine that protects mice against divergent H5N1 influenza viruses. Proc Natl Acad Sci U SA 105: 13538-13543.
33. Sersa G, Miklavcic D, Cemazar M, Rudolf Z, Pucihar G, Snoj M, (2008) Electrochemotherapy in treatment of tumours. Eur J Surg Oncol 34: 232-240.
34. Stevenson FK, Ottensmeier CH, Johnson P, Zhu D, Buchan SL, et al. (2004) DNA vaccines to attack cancer. Proc Natl Acad Sci U S A 101 (Suppl 2): 14646-14652.
35. Low L, Mander A, McCann K, Dearnaley D, Tjelle T, et al. (2009) DNA vaccination with electroporation induces increased antibody responses in patients with prostate cancer. Hum Gene Ther 20: 1269-1278.
36. Huang Y, Chen Z, Zhang W, Gurner D, Song Y, et al. (2008) 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 47: 403-411.
37. Vasan S, Schlesinger SJ, Huang Y, Hurley A, Lombardo A, et al. (2010) Phase 1 Safety and Immunogenicity Evaluation of ADVAX, a Multigenic, DNA-based Clade C/B' HIV-1 Candidate Vaccine. PLOS One 5 (1): e8617, p1-7.
38. McCormack S, Stöhr W, Barber T, Bart PA, Harari A, et al. (2008) EV02: a Phase I trial to compare the safety and immunogenicity of HIV DNA-C prime-NYVAC-C boost to NYVAC-C alone. Vaccine 26: 3162-3174.
39. Chong SY, Egan MA, Kutzler MA, Megati S, Masood A, et al. (2007) Comparative ability of plasmid IL-12 and IL-15 to enhance cellular and humoral immune responses elicited by a SIVgag plasmid DNA vaccine and alter disease progression following SHIV89.6P challenge in rhesus macaques. Vaccine 25: 4967-4982.
40. Weiskopf D, Weinberger B, Grubeck-Loebenstein B, (2009) The aging of the immune system. Transpl Int 22: 1041-1050.
41. Asmuth DM, Brown EL, DiNubile MJ, Sun X, del Rio C, et al. (2010) Comparative cell-mediated immunogenicity of DNA/DNA, DNA/adenovirus type 5 (Ad5), or Ad5/Ad5 HIV-1 clade B gag vaccine prime-boost regimens. J Infect Dis 201: 132-141.
42. Betts MR, Nason MC, West SM, De Rosa SC, Migueles SA, et al. (2006) HIV nonprogressors preferentially maintain highly functional HIV-specific CD8+ T-cells. Blood 107: 4781-4789.
43. Letvin NL, Mascola JR, Sun Y, Gorgone DA, Buzby AP, et al. (2006) Preserved CD4+ central memory T cells and survival in vaccinated SIV-challenged monkeys. Science 312: 1530-1533.
44. Vasan S, Schlesinger SJ, Arrode G, (2007) T-Cell Immune Responses to HIV-1. Front Biosci 12: 2330-2343.