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

Volumn 7, Issue 1, 2012, Pages

  Kalams, Spyros A ^a   Parker, Scott ^b   Jin, Xia ^c   Elizaga, Marnie ^d   Metch, Barbara ^d   Wang, Maggie ^d   Hural, John ^d   Lubeck, Michael ^f   Eldridge, John ^g   Cardinali, Massimo ^e   Blattner, William A ^h   Sobieszczyk, Magda ⁱ   Suriyanon, Vinai ^j   Kalichman, Artur ^k   Weiner, David B ^l   Baden, Lindsey R ^m  

^a VANDERBILT UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

^c UNIVERSITY OF ROCHESTER MEDICAL CENTER   (United States)

^d Fred Hutchinson Cancer Research Center   (United States)

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

^f PFIZER INC   (United States)

^g Profectus BioSciences Inc   (United States)

^h UNIVERSITY OF MARYLAND   (United States)

ⁱ Columbia University School of Medicine ^*  (United States)

^j Chiang Mai Ram Hospital   (Thailand)

^k Centro de Referencia e Treinamento em DST AIDS   (Brazil)

^l UNIVERSITY OF PENNSYLVANIA   (United States)

^m BRIGHAM AND WOMEN S HOSPITAL   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ANTIBODY; DNA VACCINE; HIV 1 GAG P37 VACCINE; HUMAN IMMUNODEFICIENCY VIRUS VACCINE; IMMUNOLOGICAL ADJUVANT; INTERLEUKIN 12; INTERLEUKIN 12 ANTIBODY; INTERLEUKIN 15; INTERLEUKIN 15 ANTIBODY; PLACEBO; PLASMID VECTOR; UNCLASSIFIED DRUG; GAG PROTEIN; GAMMA INTERFERON;

ADULT; ANOREXIA; ANTIBODY TITER; APHTHOUS STOMATITIS; ARTHRALGIA; ARTICLE; BACKACHE; BLOOD CELL COUNT; BRAZIL; CD4+ LYMPHOCYTE COUNT; CELLULAR IMMUNITY; CHILL; COMBINATION CHEMOTHERAPY; CONTROLLED STUDY; DISEASE SEVERITY; DIZZINESS; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG DOSE COMPARISON; DRUG DOSE ESCALATION; DRUG INDUCED HEADACHE; DRUG MEGADOSE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; ELBOW PAIN; FATIGUE; FEMALE; GROUP SPECIFIC ANTIGEN GENE; HEART ATRIUM FIBRILLATION; HEMATOMA; HEMOGLOBIN BLOOD LEVEL; HUMAN; HUMAN EXPERIMENT; HUMORAL IMMUNITY; HYPERREFLEXIA; IMMUNOGENICITY; INJECTION SITE ERYTHEMA; INJECTION SITE HEMATOMA; INJECTION SITE INDURATION; INJECTION SITE PAIN; INJECTION SITE PAPULE; INJECTION SITE PRURITUS; INJECTION SITE PYREXIA; INJECTION SITE REACTION; INJECTION SITE SWELLING; INJECTION SITE TENDERNESS; LYMPHOCYTE COUNT; MALAISE; MALE; METRORRHAGIA; MONOTHERAPY; MULTICENTER STUDY; MUSCULOSKELETAL PAIN; MYALGIA; NAUSEA; NEUTROPENIA; NORMAL HUMAN; NOSE CONGESTION; PAIN; PHARYNGITIS; PHASE 1 CLINICAL TRIAL; PRESYNCOPE; PROTEINURIA; RANDOMIZED CONTROLLED TRIAL; RHINORRHEA; SIDE EFFECT; SNEEZING; THAILAND; THORAX PAIN; UNITED STATES; UPPER RESPIRATORY TRACT INFECTION; VACCINATION; VIRUS GENE; VIRUS STRAIN; VOMITING; ADOLESCENT; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; ENZYME LINKED IMMUNOSPOT ASSAY; HEALTH; HUMAN IMMUNODEFICIENCY VIRUS 1; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; IMMUNOLOGY; MIDDLE AGED; PLASMID; VIROLOGY;

ANIMALIA; HUMAN IMMUNODEFICIENCY VIRUS 1; MACACA;

ADJUVANTS, IMMUNOLOGIC; ADOLESCENT; ADULT; AIDS VACCINES; ENZYME-LINKED IMMUNOSPOT ASSAY; FEMALE; GAG GENE PRODUCTS, HUMAN IMMUNODEFICIENCY VIRUS; HEALTH; HIV INFECTIONS; HIV-1; HUMANS; INTERFERON-GAMMA; INTERLEUKIN-12; INTERLEUKIN-15; MALE; MIDDLE AGED; PLASMIDS; VACCINATION; VACCINES, DNA; YOUNG ADULT;

EID: 84855361060     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0029231     Document Type: Article

References (48)

1. Kutzler MA, Weiner DB, (2008) DNA vaccines: ready for prime time? Nat Rev Genet 9: 776-788.
2. Casimiro DR, Bett AJ, Fu TM, Davies ME, Tang A, et al. (2004) Heterologous human immunodeficiency virus type 1 priming-boosting immunization strategies involving replication-defective adenovirus and poxvirus vaccine vectors. J Virol 78: 11434-11438.
3. Liu J, O'Brien KL, Lynch DM, Simmons NL, La Porte A, et al. (2009) Immune control of an SIV challenge by a T-cell-based vaccine in rhesus monkeys. Nature 457: 87-91.
4. Shiver JW, Fu TM, Chen L, Casimiro DR, Davies ME, et al. (2002) Replication-incompetent adenoviral vaccine vector elicits effective anti-immunodeficiency-virus immunity. Nature 415: 331-335.
5. Wilson NA, Reed J, Napoe GS, Piaskowski S, Szymanski A, et al. (2006) Vaccine-induced cellular immune responses reduce plasma viral concentrations after repeated low-dose challenge with pathogenic simian immunodeficiency virus SIVmac239. J Virol 80: 5875-5885.
6. Chattergoon M, Boyer J, Weiner DB, (1997) Genetic immunization: a new era in vaccines and immune therapeutics. FASEB J 11: 753-763.
7. Bansal A, Jackson B, West K, Wang S, Lu S, et al. (2008) Multifunctional T-cell characteristics induced by a polyvalent DNA prime/protein boost human immunodeficiency virus type 1 vaccine regimen given to healthy adults are dependent on the route and dose of administration. J Virol 82: 6458-6469.
8. Graham BS, Koup RA, Roederer M, Bailer RT, Enama ME, et al. (2006) Phase 1 safety and immunogenicity evaluation of a multiclade HIV-1 DNA candidate vaccine. J Infect Dis 194: 1650-1660.
9. Mwau M, Cebere I, Sutton J, Chikoti P, Winstone N, et al. (2004) A human immunodeficiency virus 1 (HIV-1) clade A vaccine in clinical trials: stimulation of HIV-specific T-cell responses by DNA and recombinant modified vaccinia virus Ankara (MVA) vaccines in humans. J Gen Virol 85: 911-919.
10. Tavel JA, Martin JE, Kelly GG, Enama ME, Shen JM, et al. (2007) Safety and immunogenicity of a Gag-Pol candidate HIV-1 DNA vaccine administered by a needle-free device in HIV-1-seronegative subjects. J Acquir Immune Defic Syndr 44: 601-605.
11. Donnelly JJ, Friedman A, Martinez D, Montgomery DL, Shiver JW, et al. (1995) Preclinical efficacy of a prototype DNA vaccine: enhanced protection against antigenic drift in influenza virus. Nat Med 1: 583-587.
12. Catanzaro AT, Koup RA, Roederer M, Bailer RT, Enama ME, et al. (2006) Phase 1 safety and immunogenicity evaluation of a multiclade HIV-1 candidate vaccine delivered by a replication-defective recombinant adenovirus vector. J Infect Dis 194: 1638-1649.
13. Casimiro DR, Chen L, Fu TM, Evans RK, Caulfield MJ, et al. (2003) Comparative immunogenicity in rhesus monkeys of DNA plasmid, recombinant vaccinia virus, and replication-defective adenovirus vectors expressing a human immunodeficiency virus type 1 gag gene. J Virol 77: 6305-6313.
14. Bett AJ, Dubey SA, Mehrotra DV, Guan L, Long R, et al. (2010) Comparison of T cell immune responses induced by vectored HIV vaccines in non-human primates and humans. Vaccine.
15. Cox KS, Clair JH, Prokop MT, Sykes KJ, Dubey SA, et al. (2008) DNA gag/adenovirus type 5 (Ad5) gag and Ad5 gag/Ad5 gag vaccines induce distinct T-cell response profiles. J Virol 82: 8161-8171.
16. Koup RA, Roederer M, Lamoreaux L, Fischer J, Novik L, et al. (2010) Priming immunization with DNA augments immunogenicity of recombinant adenoviral vectors for both HIV-1 specific antibody and T-cell responses. PLoS One 5: e9015.
17. Goepfert PAea (2010) Phase 1 safety and immunogenicity testing of DNA and recombinant modified vaccinia Ankara vaccines expressing HIV-1 Virus-Like Particles. J Infect Dis.
18. Barouch DH, Santra S, Schmitz JE, Kuroda MJ, Fu TM, et al. (2000) Control of viremia and prevention of clinical AIDS in rhesus monkeys by cytokine-augmented DNA vaccination. Science 290: 486-492.
19. Morrow MP, Pankhong P, Laddy DJ, Schoenly KA, Yan J, et al. (2009) Comparative ability of IL-12 and IL-28B to regulate Treg populations and enhance adaptive cellular immunity. Blood 113: 5868-5877.
20. Kraynyak KA, Kutzler MA, Cisper NJ, Laddy DJ, Morrow MP, et al. (2009) Plasmid-encoded interleukin-15 receptor alpha enhances specific immune responses induced by a DNA vaccine in vivo. Hum Gene Ther 20: 1143-1156.
21. Trinchieri G, (1995) Interleukin-12: a proinflammatory cytokine with immunoregulatory functions that bridge innate resistance and antigen-specific adaptive immunity. Annu Rev Immunol 13: 251-276.
22. Wolf SF, Temple PA, Kobayashi M, Young D, Dicig M, et al. (1991) Cloning of cDNA for natural killer cell stimulatory factor, a heterodimeric cytokine with multiple biologic effects on T and natural killer cells. J Immunol 146: 3074-3081.
23. Sartori A, Ma X, Gri G, Showe L, Benjamin D, et al. (1997) Interleukin-12: an immunoregulatory cytokine produced by B cells and antigen-presenting cells. Methods 11: 116-127.
24. Freeman AF, Holland SM, (2007) Persistent bacterial infections and primary immune disorders. Curr Opin Microbiol 10: 70-75.
25. Holland SM, (2007) Interferon gamma, IL-12, IL-12R and STAT-1 immunodeficiency diseases: disorders of the interface of innate and adaptive immunity. Immunol Res 38: 342-346.
26. MacLennan C, Fieschi C, Lammas DA, Picard C, Dorman SE, et al. (2004) Interleukin (IL)-12 and IL-23 are key cytokines for immunity against Salmonella in humans. J Infect Dis 190: 1755-1757.
27. Giri JG, Anderson DM, Kumaki S, Park LS, Grabstein KH, et al. (1995) IL-15, a novel T cell growth factor that shares activities and receptor components with IL-2. J Leukoc Biol 57: 763-766.
28. Grabstein KH, Eisenman J, Shanebeck K, Rauch C, Srinivasan S, et al. (1994) Cloning of a T cell growth factor that interacts with the beta chain of the interleukin-2 receptor. Science 264: 965-968.
29. Rochman Y, Spolski R, Leonard WJ, (2009) New insights into the regulation of T cells by gamma(c) family cytokines. Nat Rev Immunol 9: 480-490.
30. Becker TC, Wherry EJ, Boone D, Murali-Krishna K, Antia R, et al. (2002) Interleukin 15 is required for proliferative renewal of virus-specific memory CD8 T cells. J Exp Med 195: 1541-1548.
31. Wherry EJ, Becker TC, Boone D, Kaja MK, Ma A, et al. (2002) 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 512: 165-175.
32. Wherry EJ, Teichgraber V, Becker TC, Masopust D, Kaech SM, et al. (2003) Lineage relationship and protective immunity of memory CD8 T cell subsets. Nat Immunol 4: 225-234.
33. Schneider R, Campbell M, Nasioulas G, Felber BK, Pavlakis GN, (1997) Inactivation of the human immunodeficiency virus type 1 inhibitory elements allows Rev-independent expression of Gag and Gag/protease and particle formation. J Virol 71: 4892-4903.
34. Schwartz S, Campbell M, Nasioulas G, Harrison J, Felber BK, et al. (1992) Mutational inactivation of an inhibitory sequence in human immunodeficiency virus type 1 results in Rev-independent gag expression. J Virol 66: 7176-7182.
35. Schwartz S, Felber BK, Pavlakis GN, (1992) Distinct RNA sequences in the gag region of human immunodeficiency virus type 1 decrease RNA stability and inhibit expression in the absence of Rev protein. J Virol 66: 150-159.
36. Moodie Z, Price L, Gouttefangeas C, Mander A, Janetzki S, et al. (2010) Response definition criteria for ELISPOT assays revisited. Cancer Immunol Immunother 59: 1489-1501.
37. Agresti A, Coull BA, (1996) Order-restricted tests for stratified comparisons of binomial proportions. Biometrics 52: 1103-1111.
38. Abrams D, Levy Y, Losso MH, Babiker A, Collins G, et al. (2009) Interleukin-2 therapy in patients with HIV infection. N Engl J Med 361: 1548-1559.
39. Rodolfo M, Colombo MP, (1999) Interleukin-12 as an adjuvant for cancer immunotherapy. Methods 19: 114-120.
40. Atkins MB, Robertson MJ, Gordon M, Lotze MT, DeCoste M, et al. (1997) Phase I evaluation of intravenous recombinant human interleukin 12 in patients with advanced malignancies. Clin Cancer Res 3: 409-417.
41. Leonard JP, Sherman ML, Fisher GL, Buchanan LJ, Larsen G, et al. (1997) Effects of single-dose interleukin-12 exposure on interleukin-12-associated toxicity and interferon-gamma production. Blood 90: 2541-2548.
42. Schadeck EB, Sidhu M, Egan MA, Chong SY, Piacente P, et al. (2006) A dose sparing effect by plasmid encoded IL-12 adjuvant on a SIVgag-plasmid DNA vaccine in rhesus macaques. Vaccine 24: 4677-4687.
43. 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 SHIV(89.6P) challenge in rhesus macaques. Vaccine 25: 4967-4982.
44. Boyer JD, Robinson TM, Kutzler MA, Vansant G, Hokey DA, et al. (2007) Protection against simian/human immunodeficiency virus (SHIV) 89.6P in macaques after coimmunization with SHIV antigen and IL-15 plasmid. Proc Natl Acad Sci U S A 104: 18648-18653.
45. Frahm N, Korber BT, Adams CM, Szinger JJ, Draenert R, et al. (2004) Consistent cytotoxic-T-lymphocyte targeting of immunodominant regions in human immunodeficiency virus across multiple ethnicities. J Virol 78: 2187-2200.
46. 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.
47. 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.
48. Hirao LA, Wu L, Satishchandran A, Khan AS, Draghia-Akli R, et al. (2010) Comparative Analysis of Immune Responses Induced by Vaccination With SIV Antigens by Recombinant Ad5 Vector or Plasmid DNA in Rhesus Macaques. Mol Ther 18: 1568-1576.