Phase 1 studies of the safety and immunogenicity of electroporated HER2/CEA DNA vaccine followed by adenoviral boost immunization in patients with solid tumors

Journal of Translational Medicine

Volumn 11, Issue 1, 2013, Pages

  Diaz Montero, Claudia Marcela ^a,e   Chiappori, Alberto ^b   Aurisicchio, Luigi ^c,g   Bagchi, Ansuman ^d   Clark, Jason ^d,h   Dubey, Sheri ^d   Fridman, Arthur ^d   Fabregas, Jesus C ^e   Marshall, John ^f   Scarselli, Elisa ^c,i   La Monica, Nicola ^d   Ciliberto, Gennaro ^c,k   Montero, Alberto J ^a,e  

^a MEDICAL UNIVERSITY OF SOUTH CAROLINA   (United States)

^b H LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE   (United States)

^c IRBM   (Italy)

^d MERCK RESEARCH LABORATORIES   (United States)

^e UNIVERSITY OF MIAMI   (United States)

^f GEORGETOWN UNIVERSITY   (United States)

^g Takis   (Italy)

^h Experimental Station   (United States)

ⁱ

^j Italy

^k NATIONAL CANCER INSTITUTE   (Italy)

more..

Author keywords

Adenoviral vaccine; Cell mediated immune response; DNA vaccine; Electroporation; Prime boost; Solid tumors

Indexed keywords

BACTERIAL TOXIN; CARCINOEMBRYONIC ANTIGEN; CREATININE; DNA VACCINE; EPIDERMAL GROWTH FACTOR RECEPTOR 2; ESCHERICHIA COLI HEAT LABILE TOXIN; UNCLASSIFIED DRUG; V930 VACCINE; V932 VACCINE; VIRUS VACCINE;

ABDOMINAL PAIN; ADENOCARCINOMA; ADULT; AGED; ANTIBODY RESPONSE; ANTIBODY TITER; ANTIGEN EXPRESSION; ARTHRALGIA; ARTICLE; BLADDER CANCER; BREAST CANCER; CANCER IMMUNIZATION; CANCER PATIENT; CANCER STAGING; CELLULAR IMMUNITY; CLINICAL ARTICLE; COHORT ANALYSIS; COLORECTAL CANCER; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CREATININE BLOOD LEVEL; DIARRHEA; DIZZINESS; DRUG DOSE COMPARISON; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG FATALITY; DRUG MEGADOSE; DRUG SAFETY; DRUG TOLERABILITY; DYSPNEA; ELECTROPORATION; ENZYME LINKED IMMUNOSPOT ASSAY; FATIGUE; FEMALE; HOT FLUSH; HUMAN; IMMUNOGENICITY; INFECTION; INJECTION SITE CONTUSION; INJECTION SITE ERYTHEMA; INJECTION SITE PAIN; INJECTION SITE PAPULE; INJECTION SITE RASH; INJECTION SITE REACTION; INJECTION SITE SWELLING; INSOMNIA; KIDNEY CANCER; LOW DRUG DOSE; LUNG NON SMALL CELL CANCER; MALE; MCGILL PAIN QUESTIONNAIRE; MULTICENTER STUDY; MUSCULOSKELETAL PAIN; NAUSEA; OPEN STUDY; OUTCOME ASSESSMENT; OVARY CANCER; PANCREAS CANCER; PHASE 1 CLINICAL TRIAL; PROTEIN EXPRESSION; RISK BENEFIT ANALYSIS; SIDE EFFECT; SKIN DISEASE; SOLID TUMOR; SQUAMOUS CELL CARCINOMA; TREATMENT DURATION; VOMITING;

ADENOVIRIDAE; AGED; CANCER VACCINES; CARCINOEMBRYONIC ANTIGEN; ENZYME-LINKED IMMUNOSORBENT ASSAY; FEMALE; GENES, ERBB-2; GENETIC VECTORS; HUMANS; MALE; MIDDLE AGED; NEOPLASMS; PLASMIDS; VACCINES, DNA;

EID: 84874978904     PISSN: None     EISSN: 14795876     Source Type: Journal    
DOI: 10.1186/1479-5876-11-62     Document Type: Article

References (48)

1. Frohlich MW. Sipuleucel-T for the treatment of advanced prostate cancer. Semin Oncol 2012, 39:245-252. 10.1053/j.seminoncol.2012.02.004, 22595047.
2. Wesley J, Whitmore J, Trager J, Sheikh N. An overview of sipuleucel-T: autologous cellular immunotherapy for prostate cancer. Hum Vaccine & immunotherapeutics 2012, 8(4):520-527. Epub 2012 Feb 28, 10.4161/hv.19188, 3192102, 21998244.
3. Prieto PA, Yang JC, Sherry RM, Hughes MS, Kammula US, White DE, Levy CL, Rosenberg SA, Phan GQ. CTLA-4 blockade with ipilimumab: long-term follow-up of 177 patients with metastatic melanoma. Clin Canc Res: J Am Assoc Canc Res 2012, 18:2039-2047.
4. Robert C, Thomas L, Bondarenko I, O'Day S, Weber J, Garbe C, Lebbe C, Baurain J-F, Testori A, Grob J-J. Ipilimumab plus dacarbazine for previously untreated metastatic melanoma. N Engl J Med 2011, 364:2517-2526. 10.1056/NEJMoa1104621, 21639810.
5. Rosenberg SA, Yang JC, Restifo NP. Cancer immunotherapy: moving beyond current vaccines. Nat Med 2004, 10:909-915. 10.1038/nm1100, 1435696, 15340416.
6. Aurisicchio L, Ciliberto G. Genetic cancer vaccines: current status and perspectives. Expert Opin Biol Ther 2012, 12:1043-1058. 10.1517/14712598.2012.689279, 22577875.
7. Williams JA, Carnes AE, Hodgson CP. Plasmid DNA vaccine vector design: impact on efficacy, safety and upstream production. Biotechnol Adv 2009, 27:353-370. 2693335, 19233255.
8. Plog MS, Guyre CA, Roberts BL, Goldberg M, St George JA, Perricone MA. Preclinical safety and biodistribution of adenovirus-based cancer vaccines after intradermal delivery. Hum Gene Ther 2006, 17:705-716. 10.1089/hum.2006.17.705, 16839270.
9. Cappelletti M, Zampaglione I, Rizzuto G, Ciliberto G, La Monica N, Fattori E. Gene electro-transfer improves transduction by modifying the fate of intramuscular DNA. J Gene Med 2003, 5:324-332. 10.1002/jgm.352, 12692866.
10. Fattori E, La Monica N, Ciliberto G, Toniatti C. Electro-gene-transfer: a new approach for muscle gene delivery. Somat Cell Mol Genet 2002, 27:75-83. 10.1023/A:1022927822244, 12774942.
11. Zampaglione I, Simon AJ, Capone S, Finnefrock AC, Casimiro DR, Kath GS, Tang A, Folgori A, La Monica N, Shiver J. Genetic vaccination by gene electro-transfer in non-human primates. J Drug Del Sci Tech 2006, 16:85.
12. Hojman P. Basic principles and clinical advancements of muscle electrotransfer. Curr Gene Ther 2010, 10:128-138. 10.2174/156652310791110994, 20222860.
13. Facciabene A, Aurisicchio L, Elia L, Palombo F, Mennuni C, Ciliberto G, La Monica N. Vectors encoding carcinoembryonic antigen fused to the B subunit of heat-labile enterotoxin elicit antigen-specific immune responses and antitumor effects. Vaccine 2007, 26:47-58. 10.1016/j.vaccine.2007.10.060, 18055074.
14. Letvin NL, Mascola JR, Sun Y, Gorgone DA, Buzby AP, Xu L, Yang ZY, Chakrabarti B, Rao SS, Schmitz JE. Preserved CD4+ central memory T cells and survival in vaccinated SIV-challenged monkeys. Science 2006, 312:1530-1533. 10.1126/science.1124226, 2365913, 16763152.
15. Shiver JW, Fu TM, Chen L, Casimiro DR, Davies ME, Evans RK, Zhang ZQ, Simon AJ, Trigona WL, Dubey SA. Replication-incompetent adenoviral vaccine vector elicits effective anti-immunodeficiency-virus immunity. Nature 2002, 415:331-335. 10.1038/415331a, 11797011.
16. Stephenson J. Defective adenoviruses as novel vaccines for the Flaviviridae. Clin Diagn Virol 1998, 10:187-194. 10.1016/S0928-0197(98)00038-5, 9741645.
17. Tims T, Briggs DJ, Davis RD, Moore SM, Xiang Z, Ertl HC, Fu ZF. Adult dogs receiving a rabies booster dose with a recombinant adenovirus expressing rabies virus glycoprotein develop high titers of neutralizing antibodies. Vaccine 2000, 18:2804-2807. 10.1016/S0264-410X(00)00088-8, 10812222.
18. Harro C, Sun X, Stek JE, Leavitt RY, Mehrotra DV, Wang F, Bett AJ, Casimiro DR, Shiver JW, DiNubile MJ. Safety and immunogenicity of the Merck adenovirus serotype 5 (MRKAd5) and MRKAd6 human immunodeficiency virus type 1 trigene vaccines alone and in combination in healthy adults. Clin Vaccine Immunol 2009, 16:1285-1292. 10.1128/CVI.00144-09, 2745015, 19605598.
19. McElrath MJ, De Rosa SC, Moodie Z, Dubey S, Kierstead L, Janes H, Defawe OD, Carter DK, Hural J, Akondy R. HIV-1 vaccine-induced immunity in the test-of-concept Step Study: a case-cohort analysis. Lancet 2008, 372:1894-1905. 10.1016/S0140-6736(08)61592-5, 2774110, 19012957.
20. Cox KS, Clair JH, Prokop MT, Sykes KJ, Dubey SA, Shiver JW, Robertson MN, Casimiro DR. DNA gag/adenovirus type 5 (Ad5) gag and Ad5 gag/Ad5 gag vaccines induce distinct T-cell response profiles. J Virol 2008, 82:8161-8171. 10.1128/JVI.00620-08, 2519591, 18524823.
21. Asmuth DM, Brown EL, DiNubile MJ, Sun X, del Rio C, Harro C, Keefer MC, Kublin JG, Dubey SA, Kierstead LS. 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 2010, 201:132-141. 10.1086/648591, 19929694.
22. Peruzzi D, Gavazza A, Mesiti G, Lubas G, Scarselli E, Conforti A, Bendtsen C, Ciliberto G, La Monica N, Aurisicchio L. A vaccine targeting telomerase enhances survival of dogs affected by B-cell lymphoma. Mol Ther: ASGT 2010, 18:1559-1567.
23. Wei CJ, Boyington JC, McTamney PM, Kong WP, Pearce MB, Xu L, Andersen H, Rao S, Tumpey TM, Yang ZY, Nabel GJ. Induction of broadly neutralizing H1N1 influenza antibodies by vaccination. Science 2010, 329:1060-1064. 10.1126/science.1192517, 20647428.
24. Churchyard GJ, Morgan C, Adams E, Hural J, Graham BS, Moodie Z, Grove D, Gray G, Bekker LG, McElrath MJ. 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(8):e21225. 10.1371/journal.pone.0021225, 3152265, 21857901.
25. Gluck S, Arteaga CL, Osborne CK. Optimizing chemotherapy-free survival for the ER/HER2-positive metastatic breast cancer patient. Clin Canc Res: JAm Assoc Canc Res 2011, 17:5559-5561.
26. Jones KL, Buzdar AU. Evolving novel anti-HER2 strategies. Lancet Oncol 2009, 10:1179-1187. 10.1016/S1470-2045(09)70315-8, 19959074.
27. Kuespert K, Pils S, Hauck CR. CEACAMs: their role in physiology and pathophysiology. Curr Opin Cell Biol 2006, 18:565-571. 10.1016/j.ceb.2006.08.008, 16919437.
28. Mennuni C, Calvaruso F, Facciabene A, Aurisicchio L, Storto M, Scarselli E, Ciliberto G, La Monica N. Efficient induction of T-cell responses to carcinoembryonic antigen by a heterologous prime-boost regimen using DNA and adenovirus vectors carrying a codon usage optimized cDNA. Int J Cancer 2005, 117:444-455. 10.1002/ijc.21188, 15906358.
29. Mori F, Giannetti P, Peruzzi D, Lazzaro D, Giampaoli S, Kaufman HL, Ciliberto G, La Monica N, Aurisicchio L. A therapeutic cancer vaccine targeting carcinoembryonic antigen in intestinal carcinomas. Hum Gene Ther 2009, 20:125-136. 10.1089/hum.2008.116, 18937552.
30. Facciabene A, Aurisicchio L, Elia L, Palombo F, Mennuni C, Ciliberto G, La Monica N. DNA and adenoviral vectors encoding carcinoembryonic antigen fused to immunoenhancing sequences augment antigen-specific immune response and confer tumor protection. Hum Gene Ther 2006, 17:81-92. 10.1089/hum.2006.17.81, 16409127.
31. Aurisicchio L, Peruzzi D, Conforti A, Dharmapuri S, Biondo A, Giampaoli S, Fridman A, Bagchi A, Winkelmann CT, Gibson R. Treatment of mammary carcinomas in HER-2 transgenic mice through combination of genetic vaccine and an agonist of Toll-like receptor 9. Clin Canc Res: J Am Assoc Canc Res 2009, 15:1575-1584.
32. Cipriani B, Fridman A, Bendtsen C, Dharmapuri S, Mennuni C, Pak I, Mesiti G, Forni G, Monaci P, Bagchi A. Therapeutic vaccination halts disease progression in BALB-neuT mice: the amplitude of elicited immune response is predictive of vaccine efficacy. Hum Gene Ther 2008, 19:670-680. 10.1089/hum.2007.127, 18533895.
33. Koblin BA, Casapia M, Morgan C, Qin L, Wang ZM, Defawe OD, Baden L, Goepfert P, Tomaras GD, Montefiori DC. Safety and immunogenicity of an HIV adenoviral vector boost after DNA plasmid vaccine prime by route of administration: a randomized clinical trial. PLoS One 2011, 6:e24517. 10.1371/journal.pone.0024517, 3171485, 21931737.
34. Mander AP, Thompson SG. Two-stage designs optimal under the alternative hypothesis for phase II cancer clinical trials. Contemp Clin Trials 2010, 31:572-578. 10.1016/j.cct.2010.07.008, 3049867, 20678585.
35. Stevenson FK, Ottensmeier CH, Rice J. DNA vaccines against cancer come of age. Curr Opin Immunol 2010, 22:264-270. 10.1016/j.coi.2010.01.019, 20172703.
36. Rice J, Ottensmeier CH, Stevenson FK. DNA vaccines: precision tools for activating effective immunity against cancer. Nat Rev Cancer 2008, 8:108-120. 10.1038/nrc2326, 18219306.
37. Diaz-Montero CM, Salem ML, Nishimura MI, Garrett-Mayer E, Cole DJ, Montero AJ. Increased circulating myeloid-derived suppressor cells correlate with clinical cancer stage, metastatic tumor burden, and doxorubicin-cyclophosphamide chemotherapy. Cancer Immunol Immunother 2009, 58:49-59. 10.1007/s00262-008-0523-4, 3401888, 18446337.
38. Montero AJ, Diaz-Montero CM, Kyriakopoulos CE, Bronte V, Mandruzzato S. Myeloid-derived suppressor cells in cancer patients: a clinical perspective. J Immunother 2012, 35:107-115. 10.1097/CJI.0b013e318242169f, 22306898.
39. Huber ML, Haynes L, Parker C, Iversen P. Interdisciplinary critique of sipuleucel-T as immunotherapy in castration-resistant prostate cancer. J Natl Cancer Inst 2012, 104:273-279. 10.1093/jnci/djr514, 3283534, 22232132.
40. Paller CJ, Antonarakis ES. Sipuleucel-T for the treatment of metastatic prostate cancer: promise and challenges. Hum Vaccine & immunotherapeutics 2012, 8(4):509-519. Epub 2012 Apr 1, 3192102, 21998244.
41. Kantoff PW, Higano CS, Shore ND, Berger ER, Small EJ, Penson DF, Redfern CH, Ferrari AC, Dreicer R, Sims RB. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med 2010, 363:411-422. 10.1056/NEJMoa1001294, 20818862.
42. Geldmacher A, Freier A, Losch FO, Walden P. Therapeutic vaccination for cancer immunotherapy: antigen selection and clinical responses. Hum Vaccin 2011, 7:115-119. 3062245, 21263227.
43. Madan RA, Bilusic M, Heery C, Schlom J, Gulley JL. Clinical evaluation of TRICOM vector therapeutic cancer vaccines. Semin Oncol 2012, 39:296-304. 10.1053/j.seminoncol.2012.02.010, 22595052.
44. Mohebtash M, Tsang KY, Madan RA, Huen NY, Poole DJ, Jochems C, Jones J, Ferrara T, Heery CR, Arlen PM. A pilot study of MUC-1/CEA/TRICOM poxviral-based vaccine in patients with metastatic breast and ovarian cancer. Clin Cancer Res 2011, 17:7164-7173. 10.1158/1078-0432.CCR-11-0649, 3227395, 22068656.
45. Nemunaitis J, Nemunaitis M, Senzer N, Snitz P, Bedell C, Kumar P, Pappen B, Maples PB, Shawler D, Fakhrai H. Phase II trial of Belagenpumatucel-L, a TGF-beta2 antisense gene modified allogeneic tumor vaccine in advanced non small cell lung cancer (NSCLC) patients. Cancer Gene Ther 2009, 16:620-624. 10.1038/cgt.2009.15, 19287371.
46. Bedikian AY, Richards J, Kharkevitch D, Atkins MB, Whitman E, Gonzalez R. A phase 2 study of high-dose Allovectin-7 in patients with advanced metastatic melanoma. Melanoma Res 2010, 20:218-226.
47. Quoix E, Ramlau R, Westeel V, Papai Z, Madroszyk A, Riviere A, Koralewski P, Breton JL, Stoelben E, Braun D. Therapeutic vaccination with TG4010 and first-line chemotherapy in advanced non-small-cell lung cancer: a controlled phase 2B trial. Lancet Oncol 2011, 12:1125-1133. 10.1016/S1470-2045(11)70259-5, 22019520.
48. Brunsvig PF, Kyte JA, Kersten C, Sundstrom S, Moller M, Nyakas M, Hansen GL, Gaudernack G, Aamdal S. Telomerase peptide vaccination in NSCLC: a phase II trial in stage III patients vaccinated after chemoradiotherapy and an 8-year update on a phase I/II trial. Clin Cancer Res 2011, 17:6847-6857. 10.1158/1078-0432.CCR-11-1385, 21918169.