Evaluation of a SARS-CoV-2 spike protein ectodomain subunit vaccine with a squalene emulsion adjuvant in rodents and rhesus macaques


Solomadin M. Tabynov K. Petrovsky N. Tabynov K.
2023Taylor and Francis Ltd.

Human Vaccines and Immunotherapeutics
2023#19Issue 2

COVID-19 vaccines have played an important role in reducing the impact of the current pandemic. Previously, we developed NARUVAX-C19 vaccine based on a recombinant Wuhan spike protein extracellular domain expressed in insect cells and formulated with a squalene emulsion adjuvant (Sepivac SWE™). The current study assessed the immunogenicity, efficacy, and safety of NARUVAX-C19 vaccine in rhesus macaques and hamsters. Macaques immunized intramuscularly with two doses of NARUVAX-C19 vaccine showed no adverse effects and demonstrated cellular immunity as assessed by T cell IFN-γ responses against spike protein, in addition to inducing a humoral response. Serum from immunized animals neutralized the homologous wild-type SARS-CoV-2 virus as well as the Alpha and Delta variants. In hamsters, immunization with NARUVAX-C19 vaccine protected against a heterologous challenge with the Delta virus, as reflected by reduced lung and nasal viral loads and lung pathology in immunized animals. Nevertheless, some NARUVAX-C19 vaccinated animals were still shown to transmit infection to naïve sentinel animals. Overall, NARUVAX-C19 vaccine induced broadly cross-neutralizing antibody and T cell IFN-γ responses in rhesus macaques and provided heterologous protection of hamsters against infection by the Delta virus variant. This data supports the utility of squalene emulsion-based adjuvanted recombinant vaccine in protection against SARS-CoV-2 and supports their continued clinical development.

adjuvant , COVID-19 , hamsters , immunogenicity , non-human primates , safety , SARS-CoV-2 , vaccine , viral transmission

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International Center for Vaccinology, Kazakh National Agrarian Research University (KazNARU), Almaty, Kazakhstan
School of Pharmacy, Karaganda Medical University, Karaganda, Kazakhstan
Preclinical Research Laboratory with Vivarium, M. Aikimbayev National Research Center for Especially Dangerous Infections, Almaty, Kazakhstan
T&TvaX LLC, Almaty, Kazakhstan
Vaxine Pty Ltd, Warradale, SA, Australia
Republican Allergy Center, Research Institute of Cardiology and Internal Medicine, Almaty, Kazakhstan

International Center for Vaccinology
School of Pharmacy
Preclinical Research Laboratory with Vivarium
T&TvaX LLC
Vaxine Pty Ltd
Republican Allergy Center

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