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Development of a novel EV-A71 monoclonal antibody for monitoring vaccine potency
Thi-Hong-Loc Le1,2, Tzu-Yu Weng1, Hua Yen1
1National Institute of Infectious Diseases and Vaccinology, National Health Research Institutes, Zhunan, Miaoli, Taiwan.
Insights
A new monoclonal antibody, NHRI2016-1, can assess Enterovirus A71 (EV-A71) vaccine stability and potency. This tool helps ensure effective hand, foot, and mouth disease (HFMD) vaccines for children.
Area of Science:
- Virology
- Immunology
- Vaccinology
Background:
- Enterovirus A71 (EV-A71) causes severe hand, foot, and mouth disease (HFMD) in children.
- Existing EV-A71 vaccines face stability challenges from environmental factors.
- There is a need for reliable tools to assess EV-A71 vaccine quality during development.
Purpose of the Study:
- To develop a monoclonal antibody (mAb) for evaluating EV-A71 vaccine potency and effectiveness.
- To establish a method for assessing the stability of EV-A71 vaccine antigens.
- To correlate in vitro vaccine antigen assessment with in vivo immunogenicity.
Main Methods:
- Development of a specific monoclonal antibody, NHRI2016-1.
- Utilizing NHRI2016-1 in in vitro immunoassays for antigen recognition.
- Conducting rat experiments to assess antibody induction by vaccine antigens.
Main Results:
- NHRI2016-1 specifically recognizes effective EV-A71 antigens in vitro.
- Rat experiments demonstrated that effective antigens induced neutralizing antibodies, while ineffective ones did not.
- The mAb shows potential for linking in vitro potency to in vivo immunogenicity.
Conclusions:
- NHRI2016-1 is a promising tool for characterizing EV-A71 vaccines.
- This mAb can aid in monitoring the potency and effectiveness of EV-A71 vaccines.
- The developed assay offers a method to ensure vaccine quality and stability.
Abstract:
Enterovirus A71 (EV-A71) is one of the major causes of hand, foot, and mouth disease (HFMD), primarily affecting children under five. It can lead to neurological and cardiac complications, or even death, in some cases. Inactivated monovalent vaccines have been licensed in China and Taiwan; however, the stability of EV-A71 vaccines is often compromised by factors such as extreme temperatures or ultraviolet (UV) irradiation. Currently, no commercially available tools can assess the stability of EV-A71 throughout vaccine development. In this study, we report the development of a monoclonal antibody (mAb), NHRI2016-1, which can be used in in vitro immunoassays to evaluate EV-A71 vaccine potency and effectiveness. NHRI2016-1 exclusively recognizes effective EV-A71 antigens in in vitro potency assays. Similarly, rat experiment confirmed that effective vaccine antigens could induce neutralizing antibodies, while ineffective antigens could not. Thus, NHRI2016-1 shows potential for correlating in vitro potency with in vivo immunogenicity of EV-A71 vaccine antigens. These data suggest that NHRI2016-1 could be a promising tool for characterizing EV-A71 vaccines and monitoring vaccine potency.
