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Safety and immunogenicity of the bi-cistronic GLS-5310 COVID-19 DNA vaccine delivered with the GeneDerm suction device

2022; Elsevier BV; Volume: 128; Linguagem: Inglês

10.1016/j.ijid.2022.12.037

1878-3511

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,

Viral gastroenteritis research and epidemiology

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.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.GLS-5310 was well tolerated with no serious adverse events reported. Antibody and T cell responses were dose-independent. Anti-spike antibodies were induced in 95.5% of participants with an average geometric mean titer of ∼480 four weeks after vaccination and declined minimally through 48 weeks. Neutralizing antibodies were induced in 55.5% of participants with post-vaccination geometric mean titer of 28.4. T cell responses were induced in 97.8% of participants, averaging 716 site forming units/106 cells four weeks after vaccination, increasing to 1248 at week 24, and remaining greater than 1000 through 48 weeks.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.