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

A Meleshko

N Petrovskaya

N Savelyeva

K Vashkevich

S Doronina

N Sachivko

^{Belarusian Research Center for Pediatric Oncology, Hematology and Immunology, Minsk, Belarus}

^{N.N. Alexandrov National Cancer Centre of Belarus, Minsk, Belarus}

^{Cancer Sciences Unit, Faculty of Medicine, University of Southampton, Southampton, UK}

CONTACT A. N. Meleshko, PhD yb.tut@okhselem, Head of Genetic Biotechnology Laboratory, Belarusian Research Center for Pediatric Oncology, Hematology and Immunology, 223053, Minsk region v. Borovlyani, Frunzenskaya st., 43, Belarus

Received 2016 Dec 5; Revised 2017 Jan 6; Accepted 2017 Jan 17.

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: cancer vaccine, DNA vaccine, idiotype, lymphoma, polyethylenimine

ABSTRACT

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