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

• DOI: 10.1016/j.ijid.2022.12.037
• Publication Date: 2022-12-31T00:41:41Z
• Authors: Woo Joo Kim; Christine C. Roberts; Joon Young Song; Jin Gu Yoon; Hye Seong; Hak-Jun Hyun; Hyojin Lee; Areum Gil; Yeeun Oh; Ji-eun Park; Bohyun Jeon; Ji-Eun Lee; Sang Kyu Choi; Sun Kyung Yoon; Sunhee Lee; Byoungguk Kim; Deborah Kane; Susan Spruill; Sagar B. Kudchodkar; Kar Muthumani; Young K. Park; Ijoo Kwon; Moonsup Jeong; Joel N. Maslow
• Keywords: Regimen

The CoV2-001 phase I randomized trial evaluated the safety and immunogenicity of GLS-5310 bi-cistronic DNA vaccine through 48 weeks follow-up.A total 45 vaccine-naïve participants were recruited between December 31, 2020, March 30, 2021. GLS-5310, encoding for SARS-CoV-2 spike open reading frame 3a (ORF3a) proteins, was administered intradermally at 0.6 mg or 1.2 per dose, followed by application GeneDerm suction device as part a two-dose regimen spaced either 8 12 vaccinations.GLS-5310 well tolerated with no serious adverse events reported. Antibody T cell responses dose-independent. Anti-spike antibodies induced in 95.5% an average geometric mean titer ∼480 four after vaccination declined minimally weeks. Neutralizing 55.5% post-vaccination 28.4. 97.8% participants, averaging 716 site forming units/106 cells vaccination, increasing to 1248 week 24, remaining greater than 1000 weeks.GLS-5310 high levels binding T-cell responses. similar other vaccines, whereas many-fold non-DNA vaccines.