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      A Single Dose of Self-Transcribing and Replicating RNA Based SARS-CoV-2 Vaccine Produces Protective Adaptive Immunity In Mice.

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      Molecular Therapy

      American Society of Gene & Cell Therapy

      SARS-CoV-2, conventional mRNA, self-amplifying RNA, STARRTM, LUNAR®-COV19, COVID-19, Vaccine, Coronavirus

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          Abstract

          A self-transcribing and replicating RNA (STARR TM) based vaccine (LUNAR®-COV19) has been developed to prevent SARS-CoV-2 infection. The vaccine encodes an alphavirus-based replicon and the SARS-CoV-2 full length spike glycoprotein. Translation of the replicon produces a replicase complex that amplifies and prolong SARS-CoV-2 spike glycoprotein expression. A single prime vaccination in mice led to robust antibody responses, with neutralizing antibody titers increasing up to day 60. Activation of cell mediated immunity produced a strong viral antigen specific CD8 + T lymphocyte response. Assaying for intracellular cytokine staining for IFN-γ and IL-4 positive CD4 + T helper lymphocytes as well as anti-spike glycoprotein IgG2a/IgG1 ratios supported a strong Th1 dominant immune response. Finally, single LUNAR-COV19 vaccination at both 2 μg and 10 μg doses completely protected human ACE2 transgenic mice from both mortality and even measurable infection following wild-type SARS-CoV-2 challenge. Our findings collectively suggest the potential of LUNAR-COV19 as a single dose vaccine.

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          Abstract

          The LUNAR COV-19 SARS-CoV-2 vaccine is a self-replicating RNA based vaccine that increases antigen expression and also duration of expression. This increased antigen expression combined with the self-activation of the innate immune system produces a low single dose vaccine that yields protective immunity against SARS-CoV-2 virus infection.

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          Author and article information

          Journal
          Mol Ther
          Mol Ther
          Molecular Therapy
          American Society of Gene & Cell Therapy
          1525-0016
          1525-0024
          5 April 2021
          5 April 2021
          Affiliations
          [1 ]Viral Research and Experimental Medicine Center (ViREMiCS), SingHealth Duke-NUS Academic Medical Center, Singapore
          [2 ]Program in Emerging Infectious Diseases, Duke-NUS Medical School, Singapore
          [3 ]Department of Infectious Disease, Singapore General Hospital
          [4 ]Arcturus Therapeutics, Inc., 10628 Science Center Drive, San Diego CA 92121
          Author notes
          [5 ]Correspondence to: Dr. Sean M. Sullivan;
          [∗]

          Equal contribution

          Article
          S1525-0016(21)00188-X
          10.1016/j.ymthe.2021.04.001
          8019652
          © 2021.

          Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.

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