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

AN Meleshko, NA Petrovskaya… - Human vaccines & …, 2017 - Taylor & Francis
AN Meleshko, NA Petrovskaya, N Savelyeva, KP Vashkevich, SN Doronina, NV Sachivko
Human vaccines & immunotherapeutics, 2017Taylor & Francis
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 …
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.
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