ArticleInternational journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases2023
Safety and immunogenicity of the bi-cistronic GLS-5310 COVID-19 DNA vaccine delivered with the GeneDerm suction device.
Article in International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
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Who cites it
8 citing papers in PubMed, 19 citations in OpenAlex.
- Trial
- Delivery of DNA-encoded vaccines and proteins in mice using cutaneous suction-mediated transfection.FEBS open bio · 2026Article
- The Role of the CLIC/GEEC Endocytic Pathway for Mechanophysical Transfection of DNA.The journal of gene medicine · 2025Review
- A label-free nanowell-based impedance sensor for ten-minute SARS-CoV-2 detection.Sensors & diagnostics · 2025Article
- Beyond the Needle: Innovative Microneedle-Based Transdermal Vaccination.Medicines (Basel, Switzerland) · 2025Review
- Advances in nucleic acid-based cancer vaccines.Journal of biomedical science · 2025Review
- B and T Cell Bi-Cistronic Multiepitopic Vaccine Induces Broad Immunogenicity and Provides Protection Against SARS-CoV-2.Vaccines · 2024Article
- Article
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Authors and funding
24 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesThe 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.
designA 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.
resultsGLS-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
conclusionGLS-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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