Safety and immunogenicity of the bi-cistronic GLS-5310 COVID-19 DNA vaccine delivered with the GeneDerm suction device
Woo Joo Kim, Christine C. Roberts, Joon Young Song, Jin Gu Yoon, Hye Seong, Hakjun Hyun, Hyojin Lee, Areum Gil, Ye-Eun Oh, Ji-Eun Park, Bohyun Jeon, Ji-Eun Lee, Sang Kyu Choi, Sun Kyung Yoon, Sun-Hee Lee, Byoungguk Kim, D. M. Kane, Susan E. Spruill, Sagar B. Kudchodkar, Kar Muthumani, Young K. Park, Ijoo Kwon, Moonsup Jeong, Joel N. Maslow
Abstract
OBJECTIVES: The CoV2-001 phase I randomized trial evaluated the safety and immunogenicity of the GLS-5310 bi-cistronic DNA vaccine through 48 weeks of follow-up. DESIGN: A total of 45 vaccine-naïve participants were recruited between December 31, 2020, and March 30, 2021. GLS-5310, encoding for the SARS-CoV-2 spike and open reading frame 3a (ORF3a) proteins, was administered intradermally at 0.6 mg or 1.2 mg per dose, followed by application of the GeneDerm suction device as part of a two-dose regimen spaced either 8 or 12 weeks between vaccinations. RESULTS: cells four weeks after vaccination, increasing to 1248 at week 24, and remaining greater than 1000 through 48 weeks. CONCLUSION: GLS-5310 administered with the GeneDerm suction device was well tolerated and induced high levels of binding antibodies and T-cell responses. Antibody responses were similar to other DNA vaccines, whereas T cell responses were many-fold greater than DNA and non-DNA vaccines.