Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine (Phase Ib)

Summary

The purpose of this phase Ib study is to evaluate the safety of a Sabin Inactivated Poliovirus Vaccine (sIPV) in adults and children, and the safety and immunogenicity of it in infants. 20 adults aged 18\~45 years and 20 children aged 4 years were only administered one dose of sIPV with high D antigen content. 20 infants aged 2 months (60\~90 days) were administered three doses of sIPV with high D antigen content, on the month 0, 1, 2 schedule. Serum samples were collected before the 1st dose and 30 days after the 3rd dose vaccination to assess the immunogenicity in infants. Adverse events occurring within 30 days after each dose were collected to assess the safety.

Timeline

Start

2017-11-24

Primary completion

2018-03-09

Completion

2018-12-28

Publications

• Jia S, Tang R, Li G, Hu Y, Liang Q. The effect of maternal poliovirus antibodies on the immune responses of infants to poliovirus vaccines. BMC Infect Dis. 2020 Aug 31;20(1):641. doi: 10.1186/s12879-020-05348-1.

Drugs

Indications