Development of enterovirus 71 vaccines: from the lab bench to Phase III clinical trials

Area of Science:

• Virology
• Vaccinology
• Epidemiology

Background:

• Enterovirus 71 (EV71) causes widespread epidemics, particularly impacting the Western Pacific Region.
• Young children under 3 years old are the most vulnerable population to EV71-associated diseases.
• Several Asian countries are actively researching and developing EV71 vaccines.

Purpose of the Study:

• To review the development and clinical trial status of inactivated whole-virus EV71 candidate vaccines.
• To assess the efficacy, safety, and immunogenicity of these candidate vaccines.

Main Methods:

• Clinical trials were conducted on five inactivated whole-virus EV71 candidate vaccines.
• Vaccines were developed in mainland China (C4 genotype), Taiwan (B4 genotype), and Singapore (B2 genotype).
• Phase III clinical trials were completed for three vaccines developed in mainland China.

Main Results:

• The tested EV71 vaccines demonstrated good efficacy.
• Satisfactory safety profiles were observed across the candidate vaccines.
• High immunogenicity was achieved with the evaluated EV71 vaccines.

Conclusions:

• Inactivated EV71 vaccines are nearing availability as the first vaccines against EV71.
• These vaccines are expected to provide crucial protection against EV71 epidemics.
• The development represents a significant advancement in combating EV71 in the Western Pacific Region.