Host: The Japanese Society of Toxicology
Name : The 49th Annual Meeting of the Japanese Society of Toxicology
Date : June 30, 2022 - July 02, 2022
Vaccines have demonstrated a highly positive benefit/risk profile and greatly contributed to public health in the modern era. However, unlike chemically synthetized small molecules or therapeutic monoclonal antibodies, there is little if any specific guidance available from regulatory agencies upon first-in-human (FIH) trials specific to vaccines*. In general, there are limitations in the ability of animal and in vitro studies to predict safety in humans because vaccines induce immune response. If similar vaccines exist, preclinical safety data of the candidate as well as clinical experiences of similar vaccines can be provided to support the proposed first-in-human dose*, **. DS-5670a is a lipid-nano particle mRNA vaccine, encoding receptor-binding domain (RBD) of the spike (S) glycoprotein of SARS-CoV-2, which is being developed as prophylactic vaccine against COVID-19. Before we initiated a FIH study, a couple of LNP-mRNA vaccines against COVID-19 had already published their clinical results including dose levels evaluated as well as information on safety and efficacy in their early clinical development. Based on the preclinical efficacy and safety results of DS-5670a as well as clinical data from those COVID-19 LNP-mRNA vaccines, we designed a dose range for our FIH study. Now we confirmed that DS-5670a induced immunogenicity with no major safety issues in this FIH study.
*: Nature biotechnology 28.9 (2010): 910-916.
**: WHO: Guidelines on the nonclinical evaluation of vaccine adjuvants and adjuvanted vaccines (2013).
