Safety and immunogenicity of the bi-cistronic GLS-5310 COVID-19 DNA vaccine delivered with the GeneDerm suction deviceopen access
- Authors
- Kim, Woo Joo; Roberts, Christine C.; Song, Joon Young; Yoon, Jin Gu; Seong, Hye; Hyun, Hak-Jun; Lee, Hyojin; Gil, Areum; Oh, Yeeun; Park, Ji-eun; Jeon, Bohyun; Lee, Ji-Eun; Choi, Sang Kyu; Yoon, Sun Kyung; Lee, Sunhee; Kim, Byoungguk; Kane, Deborah; Spruill, Susan; Kudchodkar, Sagar B.; Muthumani, Kar; Park, Young K.; Kwon, Ijoo; Jeong, Moonsup; Maslow, Joel N.
- Issue Date
- Mar-2023
- Publisher
- Elsevier BV
- Keywords
- SARS-CoV-2; T cell immune response; DNA vaccine; ORF3a; Suction mediated in vivo transfection; Persistence of immune response
- Citation
- International Journal of Infectious Diseases, v.128, pp 112 - 120
- Pages
- 9
- Indexed
- SCIE
SCOPUS
- Journal Title
- International Journal of Infectious Diseases
- Volume
- 128
- Start Page
- 112
- End Page
- 120
- URI
- https://scholarworks.korea.ac.kr/kumedicine/handle/2021.sw.kumedicine/62423
- DOI
- 10.1016/j.ijid.2022.12.037
- ISSN
- 1201-9712
1878-3511
- 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
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.
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.
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Collections - 2. Clinical Science > Department of Infectious Diseases > 1. Journal Articles
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