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. 2017 Jun 3;13(6):1-6.
doi: 10.1080/21645515.2017.1285477. Epub 2017 Mar 8.

Phase I clinical trial of idiotypic DNA vaccine administered as a complex with polyethylenimine to patients with B-cell lymphoma

A N Meleshko  1 , N A Petrovskaya  2 , N Savelyeva  3 , K P Vashkevich  1 , S N Doronina  1 , N V Sachivko  2
Affiliations

Phase I clinical trial of idiotypic DNA vaccine administered as a complex with polyethylenimine to patients with B-cell lymphoma

A N Meleshko et al. Hum Vaccin Immunother. .

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.

Keywords: DNA vaccine; cancer vaccine; idiotype; lymphoma; polyethylenimine.

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Figures

Figure 1.
Figure 1.
Constructions of DNA-vaccines. HL2 – helical linker 2: AEAAAKEAAAKEAAAK, LP – leader peptide, ATG и TAA – start- and stop-codons for protein translation, Restriction sites: Rs1 – BamHI or KpnI, Rs2 – SalI or HindIII, Rs3 – NotI, Rs4 – NdeI.
Figure 2.
Figure 2.
Overall treatment plan.
See this image and copyright information in PMC

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