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

Autor:	Kim WJ; Division of Infectious Diseases, Guro Hospital, Vaccine Innovation Center, Korea University, College of Medicine, Seoul, Republic of Korea., Roberts CC; GeneOne Life Science, Inc., Seoul, Republic of Korea., Song JY; Division of Infectious Diseases, Guro Hospital, Vaccine Innovation Center, Korea University, College of Medicine, Seoul, Republic of Korea., Yoon JG; Division of Infectious Diseases, Guro Hospital, Vaccine Innovation Center, Korea University, College of Medicine, Seoul, Republic of Korea., Seong H; Division of Infectious Diseases, Guro Hospital, Vaccine Innovation Center, Korea University, College of Medicine, Seoul, Republic of Korea., Hyun HJ; Division of Infectious Diseases, Guro Hospital, Vaccine Innovation Center, Korea University, College of Medicine, Seoul, Republic of Korea., Lee H; GeneOne Life Science, Inc., Seoul, Republic of Korea., Gil A; GeneOne Life Science, Inc., Seoul, Republic of Korea., Oh Y; GeneOne Life Science, Inc., Seoul, Republic of Korea., Park JE; GeneOne Life Science, Inc., Seoul, Republic of Korea., Jeon B; GeneOne Life Science, Inc., Seoul, Republic of Korea., Lee JE; GeneOne Life Science, Inc., Seoul, Republic of Korea., Choi SK; Division of Vaccine clinical Research, Center for Vaccine Research, National Institute of Infectious Diseases, National Institute of Health Korea Disease Korean Control and Prevention Agency, Cheongju-si, Republic of Korea., Yoon SK; Division of Vaccine clinical Research, Center for Vaccine Research, National Institute of Infectious Diseases, National Institute of Health Korea Disease Korean Control and Prevention Agency, Cheongju-si, Republic of Korea., Lee S; Division of Vaccine clinical Research, Center for Vaccine Research, National Institute of Infectious Diseases, National Institute of Health Korea Disease Korean Control and Prevention Agency, Cheongju-si, Republic of Korea., Kim B; Division of Vaccine clinical Research, Center for Vaccine Research, National Institute of Infectious Diseases, National Institute of Health Korea Disease Korean Control and Prevention Agency, Cheongju-si, Republic of Korea., Kane D; GeneOne Life Science, Inc., Seoul, Republic of Korea., Spruill S; Applied Statistics and Consulting, Spruce Pine, USA., Kudchodkar SB; GeneOne Life Science, Inc., Seoul, Republic of Korea., Muthumani K; GeneOne Life Science, Inc., Seoul, Republic of Korea., Park YK; GeneOne Life Science, Inc., Seoul, Republic of Korea., Kwon I; GeneOne Life Science, Inc., Seoul, Republic of Korea., Jeong M; GeneOne Life Science, Inc., Seoul, Republic of Korea., Maslow JN; GeneOne Life Science, Inc., Seoul, Republic of Korea; Department of Medicine, Morristown Medical Center, Morristown, USA. Electronic address: jmaslow@genels.us.
Jazyk:	angličtina
Zdroj:	International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases [Int J Infect Dis] 2023 Mar; Vol. 128, pp. 112-120. Date of Electronic Publication: 2022 Dec 31.
DOI:	10.1016/j.ijid.2022.12.037
Abstrakt:	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: 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/10 6 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. Competing Interests: Declaration of competing interest CCR, HL, AG, YO, J-EP, BJ, J-EL, DK, SBK, KM, IK, MJ, YKP, JNM are employees of GeneOne Life Science, Inc. (Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.)
Databáze:	MEDLINE
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