Immune response enhancement with GLS-5310 DNA primary vaccine against SARS-CoV-2 followed by administration of an mRNA vaccine heterologous boost.

Heterologous boost regimens are being increasingly considered against SARS-CoV-2. We report results for the 32 of 45 participants in the Phase 1 CoV2-001 clinical trial (Kim et al., Int J Iinfect Dis 2023, 128:112-120) who elected to receive an EUA-approved SARS-CoV-2 mRNA vaccine 6 to 8 months following a two-dose primary vaccination with the GLS-5310 bi-cistronic DNA vaccine given intradermally and followed by application of suction using the GeneDerm device. Receipt of EUA-approved mRNA vaccines after GLS-5310 vaccination was well-tolerated, with no reported adverse events. Immune responses were enhanced such that binding antibody titers, neutralizing antibody titers, and T-cell responses increased 1,187-fold, 110-fold, and 2.9-fold, respectively. This paper is the first description of the immune responses following heterologous vaccination with a DNA primary series and mRNA boost.
Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: The following authors are employees of GeneOne Life Science, Inc., the sponsor of the study and the developer of the GLS-5310 DNA vaccine against COVID-19 that is the subject of the paper. Christine R Roberts, Hyojin Lee, Areum Gil, Yeeun Oh, Ji eun Park, Bohyun Jeon, Ji Eun Lee, Deborah Kane, Sagar B Kudchodkar, Kar Muthumani, Young K Park *, Ijoo Kwon, Joel N Maslow *, * Young K Park and Joel N Maslow additionally own stock or stock options in GeneOne Life Science Inc. with a > $10,000 USD.
(Copyright © 2023 The Author(s). Published by Elsevier Ltd.. All rights reserved.)