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

NCT05330624 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 720

Last updated 2022-04-15

No results posted yet for this study

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.

Conditions

  • Plague

Interventions

BIOLOGICAL

plague vaccine(F1+rV)

plague vaccine(F1+rV) (Lanzhou Institute of Biological Products Co.,Ltd) of 1.0ml, three doses

Sponsors & Collaborators

  • Jiangsu Province Centers for Disease Control and Prevention

    lead NETWORK

Principal Investigators

  • Fengcai Zhu, Master · Jiangsu Provincial Center for Diseases Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05330624 on ClinicalTrials.gov