Abstract
The rapid spread of SARS-CoV-2 with its mutating strains has posed a global threat to safety during this COVID-19 pandemic. Thus far, there are 123 candidate vaccines in human clinical trials and more than 190 candidates in preclinical development worldwide as per the WHO on 1 October 2021. The various types of vaccines that are currently approved for emergency use include viral vectors (e.g., adenovirus, University of Oxford/AstraZeneca, Gamaleya Sputnik V, and Johnson & Johnson), mRNA (Moderna and Pfizer-BioNTech), and whole inactivated (Sinovac Biotech and Sinopharm) vaccines. Amidst the emerging cases and shortages of vaccines for global distribution, it is vital to develop a vaccine candidate that recapitulates the severe and fatal progression of COVID-19 and further helps to cope with the current outbreak. Hence, we present the preclinical immunogenicity, protective efficacy, and safety evaluation of a whole-virion inactivated SARS-CoV-2 vaccine candidate (ERUCoV-VAC) formulated in aluminium hydroxide, in three animal models, BALB/c mice, transgenic mice (K18-hACE2), and ferrets. The hCoV-19/Turkey/ERAGEM-001/2020 strain was used for the safety evaluation of ERUCoV-VAC. It was found that ERUCoV-VAC was highly immunogenic and elicited a strong immune response in BALB/c mice. The protective efficacy of the vaccine in K18-hACE2 showed that ERUCoV-VAC induced complete protection of the mice from a lethal SARS-CoV-2 challenge. Similar viral clearance rates with the safety evaluation of the vaccine in upper respiratory tracts were also positively appreciable in the ferret models. ERUCoV-VAC has been authorized by the Turkish Medicines and Medical Devices Agency and has now entered phase 3 clinical development (NCT04942405). The name of ERUCoV-VAC has been changed to TURKOVAC in the phase 3 clinical trial.
Highlights
COVID-19 is caused by a novel positive-strand RNA coronavirus (SARS-CoV-2) belonging to the Coronaviridae family, along with severe acute respiratory syndrome (SARS)
Most of the current SARS-CoV-2 vaccines are based on the spike (S) protein to elicit an immune response against SARS-CoV-2 [7,38,39]
We presented the preclinical immunogenicity, protective efficacy, and safety evaluation of a whole-virion inactivated SARS-CoV-2 vaccine candidate (ERUCoV-VAC) formulated in aluminium hydroxide in three animal models: BALB/c mice, transgenic mice (K18-hACE2), and ferrets
Summary
COVID-19 is caused by a novel positive-strand RNA coronavirus (SARS-CoV-2) belonging to the Coronaviridae family, along with severe acute respiratory syndrome (SARS). The Middle East respiratory syndrome (MERS) coronavirus [1]. The SARS-CoV-2 RNA genome is approximately 30 kb and encodes four structural proteins: nucleocapsid (N), membrane (M), envelope (E), and spike (S) proteins, and its genome encodes 16 non-structural (nsp1–nsp16) and several accessory proteins [5,6]. The SARS-CoV-2 virus initiates the infection of the S protein into the human body through its interaction with the human angiotensin-converting enzyme 2 (ACE2) [7]. Due to the rapid spread of SARS-CoV-2 and the lack of pre-existing immunity, COVID-19 has posed a great threat to public health and safety [9]
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