Reflections on establishment and application of reference materials for antibody evaluation in vaccine clinical trials
10.13200/j.cnki.cjb.004632
- VernacularTitle:疫苗临床试验抗体评价用标准物质建立及应用的思考
- Author:
Yiping WANG
1
Author Information
1. *The Center of Reference Standards and Standardization, National Institutes for Food and Drug Control, Beijing 102629, China
- Publication Type:Journal Article
- Keywords:
Vaccines;
Clinical trials;
Immunogenicity;
Antibody;
Reference materials
- From:
Chinese Journal of Biologicals
2026;39(01):123-128
- CountryChina
- Language:Chinese
-
Abstract:
Reference materials play a significant role in enhancing the comparability and accuracy of clinical immunogenicity test results for vaccines. The World Health Organization(WHO) and China have issued many antibody reference standards for evaluating antibody induced by vaccines in clinical phase and infectious disease pathogen infections, which provide a critical material basis for the quantitative detection of antibodies induced by vaccines in clinical phase and serological surveillance. In 2022, the WHO published manuals for the preparation of reference materials, such as “WHO manual for the preparation of reference materials for use as secondary standards in antibody testing”, to improve the development level of antibody reference materials. Recently, the General Chapter 0237 the Preparation and Establishment of National Biological Reference Standards in Chinese Pharmacopoeia 2025 Volume Ⅲ has been revised referring to the WHO manuals mentioned above, and puts forward relevant requirements for the key points of the development of biological reference materials including antibody reference materials, emphasizing the preset criterion, statistical models and uncertainty. It calls for attention to commutability and stability studies and monitoring based on the lifecycle of reference materials. This paper summarizes relevant guidelines and pharmacopoeia requirements, and proposes suggestions for the establishment and application of antibody reference materials in clinical trials for human vaccines in China.
