Human Vaccines & Immunotherapeutics (Jun 2017)

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

  • A. N. Meleshko,
  • N. A. Petrovskaya,
  • N. Savelyeva,
  • K. P. Vashkevich,
  • S. N. Doronina,
  • N. V. Sachivko

DOI
https://doi.org/10.1080/21645515.2017.1285477
Journal volume & issue
Vol. 13, no. 6
pp. 1398 – 1403

Abstract

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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.

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