A Phase I safety study of plasmid DNA immunization targeting carcinoembryonic antigen in colorectal cancer patients

Vaccine

Volumn 29, Issue 39, 2011, Pages 6817-6822

  Staff, Caroline ^a   Mozaffari, Fariba ^a   Haller, B Kristian ^a,b   Wahren, Britta ^b   Liljefors, Maria ^a  

^a KAROLINSKA UNIVERSITY HOSPITAL   (Sweden)

^b KAROLINSKA INSTITUTE   (Sweden)

Author keywords

CEA; Colorectal cancer; DNA vaccine

Indexed keywords

CANCER VACCINE; CARCINOEMBRYONIC ANTIGEN 66; CYCLOPHOSPHAMIDE; DNA VACCINE; EPITOPE; PLASMID DNA; RECOMBINANT GRANULOCYTE MACROPHAGE COLONY STIMULATING FACTOR; UNCLASSIFIED DRUG;

ADJUVANT THERAPY; ADULT; AGED; ANOREXIA; ARTHRALGIA; ARTICLE; AUTOIMMUNITY; CANCER ADJUVANT THERAPY; CANCER IMMUNIZATION; CANCER PATIENT; CANCER RADIOTHERAPY; CANCER SURGERY; CHEST TIGHTNESS; CLINICAL ARTICLE; COLORECTAL CANCER; CONTROLLED CLINICAL TRIAL; DIARRHEA; DIZZINESS; DNA IMMUNIZATION; DRUG DELIVERY SYSTEM; DRUG ERUPTION; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TARGETING; DRUG TOLERABILITY; FATIGUE; FEMALE; HEMATURIA; HUMAN; INJECTION SITE CONTUSION; INJECTION SITE EDEMA; INJECTION SITE ERYTHEMA; INJECTION SITE INDURATION; INJECTION SITE PAIN; INJECTION SITE PRURITUS; INJECTION SITE REACTION; INJECTION SITE WARMTH; JET INJECTION; JET INJECTOR; MALE; MYALGIA; NAUSEA; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; SHIVERING; SIDE EFFECT; SWELLING; UNSPECIFIED SIDE EFFECT; VEIN THROMBOSIS;

AGED; CANCER VACCINES; CARCINOEMBRYONIC ANTIGEN; COLORECTAL NEOPLASMS; CYCLOPHOSPHAMIDE; DRUG DELIVERY SYSTEMS; DRUG EVALUATION; ERYTHEMA; FEMALE; FOLLOW-UP STUDIES; GPI-LINKED PROTEINS; GRANULOCYTE-MACROPHAGE COLONY-STIMULATING FACTOR; HUMANS; INJECTIONS, INTRADERMAL; INJECTIONS, INTRAMUSCULAR; MALE; MIDDLE AGED; PLASMIDS; RECOMBINANT PROTEINS; VACCINATION; VACCINES, DNA;

EID: 80052301905     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2010.12.063     Document Type: Article

References (34)

1. Parkin D.M., Bray F., Ferlay J., Pisani P. Global cancer statistics, 2002. CA Cancer J Clin 2005, 55(March-April (2)):74-108.
2. Weitz J., Koch M., Debus J., Hohler T., Galle P.R., Buchler M.W. Colorectal cancer. Lancet 2005, 365(January (9454)):153-165.
3. Tebbutt N.C., Cattell E., Midgley R., Cunningham D., Kerr D. Systemic treatment of colorectal cancer. Eur J Cancer 2002, 38(May (7)):1000-1015.
4. Benson A.B. New approaches to the adjuvant therapy of colon cancer. Oncologist 2006, 11(October (9)):973-980.
5. Moertel C.G., Fleming T.R., Macdonald J.S., Haller D.G., Laurie J.A., Tangen C.M., et al. Fluorouracil plus levamisole as effective adjuvant therapy after resection of stage III colon carcinoma: a final report. Ann Intern Med 1995, 122(March (5)):321-326.
6. Adjuvant radiotherapy for rectal cancer: a systematic overview of 8,507 patients from 22 randomised trials. Lancet 2001, 358(October (9290)):1291-1304.
7. Hammarstrom S. The carcinoembryonic antigen (CEA) family: structures, suggested functions and expression in normal and malignant tissues. Semin Cancer Biol 1999, 9(April (2)):67-81.
8. Berinstein N.L. Carcinoembryonic antigen as a target for therapeutic anticancer vaccines: a review. J Clin Oncol 2002, 20(April (8)):2197-2207.
9. Mosolits S., Nilsson B., Mellstedt H. Towards therapeutic vaccines for colorectal carcinoma: a review of clinical trials. Expert Rev Vaccines 2005, 4(June (3)):329-350.
10. Samanci A., Yi Q., Fagerberg J., Strigard K., Smith G., Ruden U., et al. Pharmacological administration of granulocyte/macrophage-colony-stimulating factor is of significant importance for the induction of a strong humoral and cellular response in patients immunized with recombinant carcinoembryonic antigen. Cancer Immunol Immunother 1998, 47(November (3)):131-142.
11. Fioretti D., Iurescia S., Fazio V.M., Rinaldi M. DNA vaccines: developing new strategies against cancer. J Biomed Biotechnol. 2010, 2010. Article ID: 174378.
12. Ulmer J.B., Wahren B., Liu M.A. Gene-based vaccines: recent technical and clinical advances. Trends Mol Med 2006, 12(May (5)):216-222.
13. Anderson RS Plasmid DNA and viral vector-based vaccines for the treatment of cancer. Vaccine 2007, 25(Suppl. 2):B24-B34.
14. Cui Z. DNA vaccine. Adv Genet 2005, 54:257-289.
15. Conry R.M., Allen K.O., Lee S., Moore S.E., Shaw D.R., LoBuglio A.F. Human autoantibodies to carcinoembryonic antigen (CEA) induced by a vaccinia-CEA vaccine. Clin Cancer Res 2000, 6(January (1)):34-41.
16. Conry R.M., Curiel D.T., Strong T.V., Moore S.E., Allen K.O., Barlow D.L., et al. Safety and immunogenicity of a DNA vaccine encoding carcinoembryonic antigen and hepatitis B surface antigen in colorectal carcinoma patients. Clin Cancer Res 2002, 8(September (9)):2782-2787.
17. Lund L.H., Andersson K., Zuber B., Karlsson A., Engstrom G., Hinkula J., et al. Signal sequence deletion and fusion to tetanus toxoid epitope augment antitumor immune responses to a human carcinoembryonic antigen (CEA) plasmid DNA vaccine in a murine test system. Cancer Gene Ther 2003, 10(May (5)):365-376.
18. Lutsiak M.E., Semnani R.T., De Pascalis R., Kashmiri S.V., Schlom J., Sabzevari H. Inhibition of CD4(+)25+ T regulatory cell function implicated in enhanced immune response by low-dose cyclophosphamide. Blood 2005, 105(April (7)):2862-2868.
19. Ruter J., Barnett B.G., Kryczek I., Brumlik M.J., Daniel B.J., Coukos G., et al. Altering regulatory T cell function in cancer immunotherapy: a novel means to boost the efficacy of cancer vaccines. Front Biosci 2009, 14:1761-1770.
20. Hallermalm K., Johansson S., Brave A., Ek M., Engstrom G., Boberg A., et al. Pre-clinical evaluation of a CEA DNA prime/protein boost vaccination strategy against colorectal cancer. Scand J Immunol 2007, 66(July (1)):43-51.
21. Dalerba P., Maccalli C., Casati C., Castelli C., Parmiani G. Immunology and immunotherapy of colorectal cancer. Crit Rev Oncol Hematol 2003, 46(April (1)):33-57.
22. Ullenhag G.J., Frodin J.E., Jeddi-Tehrani M., Strigard K., Eriksson E., Samanci A., et al. Durable carcinoembryonic antigen (CEA)-specific humoral and cellular immune responses in colorectal carcinoma patients vaccinated with recombinant CEA and granulocyte/macrophage colony-stimulating factor. Clin Cancer Res 2004, 10(May (10)):3273-3281.
23. Webster R.G., Robinson H.L. DNA vaccines: a review of developments. BioDrugs 1997, 8(October (4)):273-292.
24. Liu M.A., Ulmer J.B. Human clinical trials of plasmid DNA vaccines. Adv Genet 2005, 55:25-40.
25. MacGregor R.R., Boyer J.D., Ugen K.E., Lacy K.E., Gluckman S.J., Bagarazzi M.L., et al. First human trial of a DNA-based vaccine for treatment of human immunodeficiency virus type 1 infection: safety and host response. J Infect Dis 1998, 178(July (1)):92-100.
26. Marshall J.L., Gulley J.L., Arlen P.M., Beetham P.K., Tsang K.Y., Slack R., et al. Phase I study of sequential vaccinations with fowlpox-CEA(6D)-TRICOM alone and sequentially with vaccinia-CEA(6D)-TRICOM, with and without granulocyte-macrophage colony-stimulating factor, in patients with carcinoembryonic antigen-expressing carcinomas. J Clin Oncol 2005, 23(February (4)):720-731.
27. Gurunathan S., Klinman D.M., Seder R.A. DNA vaccines: immunology, application, and optimization*. Annu Rev Immunol 2000, 18:927-974.
28. Brave A., Ljungberg K., Boberg A., Rollman E., Isaguliants M., Lundgren B., et al. Multigene/multisubtype HIV-1 vaccine induces potent cellular and humoral immune responses by needle-free intradermal delivery. Mol Ther 2005, 12(December (6)):1197-1205.
29. Johansson S., Ek M., Wahren B., Stout R., Liu M., Hallermalm K. Intracellular targeting of CEA results in Th1-type antibody responses following intradermal genetic vaccination by a needle-free jet injection device. Sci World J 2007, 7:987-999.
30. Mitragotri S. Current status and future prospects of needle-free liquid jet injectors. Nat Rev Drug Discov 2006, 5(July (7)):543-548.
31. Sheets R.L., Stein J., Manetz T.S., Duffy C., Nason M., Andrews C., et al. Biodistribution of DNA plasmid vaccines against HIV-1, Ebola, Severe Acute Respiratory Syndrome, or West Nile virus is similar, without integration, despite differing plasmid backbones or gene inserts. Toxicol Sci 2006, 91(June (2)):610-619.
32. Sandstrom E., Nilsson C., Hejdeman B., Brave A., Bratt G., Robb M., et al. Broad immunogenicity of a multigene, multiclade HIV-1 DNA vaccine boosted with heterologous HIV-1 recombinant modified vaccinia virus Ankara. J Infect Dis 2008, 198(November (10)):1482-1490.
33. Ledwith B.J., Manam S., Troilo P.J., Barnum A.B., Pauley C.J., Griffiths T.G., et al. Plasmid DNA vaccines: investigation of integration into host cellular DNA following intramuscular injection in mice. Intervirology 2000, 43(4-6):258-272.
34. Brave A., Hallengard D., Gudmundsdotter L., Stout R., Walters R., Wahren B., et al. Late administration of plasmid DNA by intradermal electroporation efficiently boosts DNA-primed T and B cell responses to carcinoembryonic antigen. Vaccine 2009, 27(June (28)):3692-3696.