The stability and immunogenicity of formalin-inactivated Enterovirus A71 whole virion vaccine after ten years of low temperature storage.
J Microbiol Immunol Infect
; 56(6): 1121-1128, 2023 Dec.
Article
en En
| MEDLINE
| ID: mdl-37919172
ABSTRACT
BACKGROUND:
Vaccine stability is an important issue for vaccine development, which affects whether the vaccine product is effective within a certain period of time in each progress. Hand, foot, and mouth diseases (HFMD) is an epidemic disease in young children usually caused by Enterovirus A group viruses, and the Enterovirus A71 (EV-A71) had caused several pandemics and public health issues around the world. After two decades of research and development, formalin-inactivated EV-A71 (FI-EV-A71) vaccines are the first to complete the phase III clinical trials for protection against EV-A71 infection. Currently, the shelf life of FI-EV-A71 vaccine product is set to be within 18 months, but the stability and the effectiveness of the FI-EV-A71 whole virion when stored long-term at low temperature remains undetermined.METHODS:
Assessing the long-term storage properties of viral particles facilitates flexibility in manufacturing of vaccine products. In this study, the stability profiles of FI-EV-A71 vaccine lots and bulks after long-term of low temperature storage were analyzed by protein tests, particle measurement and animal immunization study.RESULTS:
After over ten years of storage, the reduction of protein concentration in the FI-EV-A71 bulk samples is less than 30 % and the antigenic content remained in a suspended, particulate state. Both the packed FI-EV-A71 final vaccine products and the FI-EV-A71 antigens adjuvant premix bulk could elicit strong neutralizing responses in mice.CONCLUSION:
After ten years of low temperature storage, the FI-EV-A71 vaccine still presents decent stability and good immunogenicity.Palabras clave
Texto completo:
1
Bases de datos:
MEDLINE
Asunto principal:
Vacunas Virales
/
Enterovirus
/
Enterovirus Humano A
/
Infecciones por Enterovirus
/
Enfermedad de Boca, Mano y Pie
Límite:
Animals
/
Child
/
Child, preschool
/
Humans
Idioma:
En
Revista:
J Microbiol Immunol Infect
Asunto de la revista:
ALERGIA E IMUNOLOGIA
/
MICROBIOLOGIA
Año:
2023
Tipo del documento:
Article
País de afiliación:
Taiwán