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Safety and immunogenicity of the bi-cistronic GLS-5310 COVID-19 DNA vaccine delivered with the GeneDerm suction device.
- Source :
-
International Journal of Infectious Diseases . Mar2023, Vol. 128, p112-120. 9p. - Publication Year :
- 2023
-
Abstract
- • This study reports the safety and immunogenicity of the GLS-5310 DNA vaccine through 48 weeks. • First clinical application of the GeneDerm suction device for DNA vaccine delivery. • GLS-5310 was well tolerated and without vaccine-associated severe adverse effects. • T cell responses of ∼1200 site forming units/106 peripheral blood mononuclear cells were maintained through 48 weeks. • T cell responses were many-fold higher than all other vaccine platforms. • Antibody responses were induced in 95.5% and maintained through 48 weeks. 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. [ABSTRACT FROM AUTHOR]
Details
- Language :
- English
- ISSN :
- 12019712
- Volume :
- 128
- Database :
- Academic Search Index
- Journal :
- International Journal of Infectious Diseases
- Publication Type :
- Academic Journal
- Accession number :
- 162009321
- Full Text :
- https://doi.org/10.1016/j.ijid.2022.12.037