T/CAV 001-2023 Active

Main technical content: 1. Organize and summarize vaccine types, immunology-related terms, pharmaceutical research-related terms, and non-clinical trial research-related terms for pre-clinical vaccine research, and construct a classification framework for pre-clinical vaccine research terminology. 2. Retrieve relevant domestic and international literature, laws and regulations, and other materials to compare, summarize, and refine vaccine pre-clinical research terminology and its definitions, and formulate a standard for vaccine pre-clinical research terminology. 3. Discuss and revise the terminology to finalize the standard for vaccine pre-clinical research. This document defines vaccine pre-clinical research terminology in China and provides definitions and explanations, including 54 vaccine pre-clinical research terms. These include: - 9 vaccine-type-related terms (inactivated vaccines, live attenuated vaccines, recombinant vector vaccines, subunit vaccines, recombinant protein vaccines, DNA vaccines, mRNA vaccines, combination vaccines, conjugate vaccines); - 18 immunology-related terms (primary immunity, booster immunity, sequential immunity, innate immunity, adaptive immunity, humoral immunity, cellular immunity, mucosal immunity, antigen, immunogenicity, antigenicity, antibody, neutralizing antibody, antibody-dependent cell-mediated cytotoxicity, complement-dependent cytotoxicity, cytokines, interferon); - 13 pharmaceutical-related terms (raw materials, excipients, bacterial (viral) strains, cell seeds, primary cell banks, master cell banks, working cell banks, adjuvants, nucleic acid delivery systems, virus-like particles, semi-finished products, finished products, batches); - 14 non-clinical research-related terms (efficacy studies, lethal dose, toxicity studies, genetic toxicity, reproductive toxicity, long-term toxicity, carcinogenicity, detoxification studies, laboratory animals, animal experiments, animal welfare, animal ethics, humane