title: Phase I clinical trial of idiotypic DNA vaccine administered as a complex with polyethylenimine to patients with B-cell lymphoma.
abstract: We report on the design of a phase I, non-randomized, open-label study of idiotypic DNA vaccination in patients with B-cell non-Hodgkin's lymphoma (ISRCTN31090206). The study uses DNA fusion gene vaccination encoding patient-specific single chain variable fragment, or idiotype, linked to an immunostimulatory sequence. Two types of immunostimulatory sequence are being explored: potato virus X coat protein and human chemokine MIP3α. Linear polyethylenimine with low molecular weight (8 kDa) is used as a synthetic vehicle for vaccine delivery. Humoral and T-cellular immune responses to vaccination will be measured by ELISA and ELISPOT, respectively. The primary study endpoints are safety, tolerability and immunogenicity of DNA-PEI vaccination.
authors.affiliation: a Belarusian Research Center for Pediatric Oncology, Hematology and Immunology , Minsk , Belarus.
authors.forename: A N
authors.initials: AN
authors.lastname: Meleshko
authors.affiliation: b N.N. Alexandrov National Cancer Centre of Belarus , Minsk , Belarus.
authors.forename: N A
authors.initials: NA
authors.lastname: Petrovskaya
authors.affiliation: c Cancer Sciences Unit, Faculty of Medicine, University of Southampton , Southampton , UK.
authors.forename: N
authors.initials: N
authors.lastname: Savelyeva
authors.affiliation: a Belarusian Research Center for Pediatric Oncology, Hematology and Immunology , Minsk , Belarus.
authors.forename: K P
authors.initials: KP
authors.lastname: Vashkevich
authors.affiliation: a Belarusian Research Center for Pediatric Oncology, Hematology and Immunology , Minsk , Belarus.
authors.forename: S N
authors.initials: SN
authors.lastname: Doronina
authors.affiliation: b N.N. Alexandrov National Cancer Centre of Belarus , Minsk , Belarus.
authors.forename: N V
authors.initials: NV
authors.lastname: Sachivko
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage / Q000009:adverse effects* / Q000235:genetics; D000293:Adolescent; D000328:Adult; D000368:Aged; D001323:Autoantibodies / Q000097:blood; D036022:Capsid Proteins / Q000008:administration & dosage / Q000009:adverse effects / Q000235:genetics; D054418:Chemokine CCL20 / Q000008:administration & dosage / Q000009:adverse effects / Q000235:genetics; D017321:Clinical Trials, Phase I as Topic; D004797:Enzyme-Linked Immunosorbent Assay; D058501:Enzyme-Linked Immunospot Assay; D005260:Female; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000235:genetics / Q000276:immunology; D016393:Lymphoma, B-Cell / Q000628:therapy*; D008228:Lymphoma, Non-Hodgkin / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011094:Polyethyleneimine / Q000008:administration & dosage / Q000009:adverse effects*; D017863:Potexvirus / Q000235:genetics; D013601:T-Lymphocytes / Q000276:immunology; D019444:Vaccines, DNA / Q000008:administration & dosage / Q000276:immunology*; D055815:Young Adult
chemical_list: D000276:Adjuvants, Immunologic; D001323:Autoantibodies; D036022:Capsid Proteins; D054418:Chemokine CCL20; D007140:Immunoglobulin Fab Fragments; D019444:Vaccines, DNA; D011094:Polyethyleneimine
keywords: DNA vaccine; cancer vaccine; idiotype; lymphoma; polyethylenimine