drugset / Trial / NCT05330624

Immunogenicity and Safety of Subunit Vaccine of Plague Vaccine With Two Immunization Regimens

NCT05330624 ↗

RandomizedParallel-groupOpen-labelPrevention

Summary

Plague is a potentially fatal infection in humans caused by the bacterium Yersinia pestis. Pneumonic plague is typically diagnosed in humans with high mortality. It has a long history for plague as an agent of biowarfare, and pose a serious threat to international security. Althought the killed whole-cell plague vaccine and live attenuated vaccine has been licensed. They are rarely used today because of toxicities, limited evidence for efficacy to prevent plague, and limited commercial availability. In the last twenty years, it have focused on recombinant subunit vaccines which were formed F1 and V antigens as the main composition provide greater protection than vaccines comprised of either subunit alone. This study was aim to exploring the safety and immunogenicity of a new type plague subunit vaccine which comprised natural F1 antigen and recombined V antigen (F1+rV) in two immunization regimens.

Timeline

Start
2020-05-08
Primary completion
2022-05-20
Completion
2022-09-20

Drugs

EvaluationDrugModalityDoseRoute
Subject plague vaccine(F1+rV) Vaccine 1 ml —

Indications