Abstract
New generation plasmid DNA vaccines may be a safe, fast and simple emergency vaccine platform for preparedness against emerging viral pathogens. Applying platform optimization strategies, we tested the pre-clinical immunogenicity and protective effect of a candidate DNA plasmid vaccine specific for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The DNA vaccine induced spike-specific binding IgG and neutralizing antibodies in mice, rabbits, and rhesus macaques together with robust Th1 dominant cellular responses in small animals. Intradermal and intramuscular needle-free administration of the DNA vaccine yielded comparable immune responses. In a vaccination-challenge study of rhesus macaques, the vaccine demonstrated protection from viral replication in the lungs following intranasal and intratracheal inoculation with SARS-CoV-2. In conclusion, the candidate plasmid DNA vaccine encoding the SARS-CoV-2 spike protein is immunogenic in different models and confers protection against lung infection in nonhuman primates. Further evaluation of this DNA vaccine candidate in clinical trials is warranted.
Highlights
Coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), emerged in Wuhan, China around December 2019
The DNA vaccine candidate hereafter referred to as pNTC-Spike, expresses an unmodified, wild-type full-length SARS-CoV-2 spike protein derived from the Wuhan-hu-1 reference strain
We developed a SARS-CoV-2-specific plasmid DNA vaccine candidate using platform optimization strategies to improve vaccine safety, antigen expression, potency, and immunogenicity
Summary
Coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), emerged in Wuhan, China around December 2019 It has since caused a global pandemic that has to date, resulted in over 160 million confirmed infections and 3.5 million deaths (WHO COVID-19 Weekly Epidemiological Update; 1 June 2021), the numbers are likely underestimated[1]. The DNA vaccine modality is generally regarded as safe and is immunogenic in many different mammalian species including man[2,3]. Inducing both broad antibody and cellular immune responses, DNA vaccines have the potential to reduce both infection and disease. The plasmid DNA does not induce vector-specific antibodies, permitting multiple booster vaccinations including mixed modality primeboost strategies[5]
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