Phase I clinical trial of idiotypic DNA vaccine administered as a complex with polyethylenimine to patients with B-cell lymphoma
2017; Taylor & Francis; Volume: 13; Issue: 6 Linguagem: Inglês
10.1080/21645515.2017.1285477
ISSN2164-554X
AutoresAlexander Meleshko, N. A. Petrovskaya, Natalia Savelyeva, Katsiaryna Vashkevich, S. N. Doronina, N. V. Sachivko,
Tópico(s)Immune Cell Function and Interaction
ResumoWe 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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