Status:
UNKNOWN
Immunogenicity and Safety of Subunit Vaccine of Plague Vaccine With Two Immunization Regimens
Lead Sponsor:
Jiangsu Province Centers for Disease Control and Prevention
Conditions:
Plague
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief 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...
Detailed Description
Plague is a potentially fatal infection in humans caused by the bacterium Yersinia pestis, transmitted naturally from rodent reservoirs to humans via fleas. Human disease may also result from contact ...
Eligibility Criteria
Inclusion
- Healthy adults aged 18-55months old as established by medical history and clinical examination.
- The subjects' guardians are able to understand and sign the informed consent.
- Subjects who can and will comply with the requirements of the protocol.
- Subjects with temperature ≤37.0°C on axillary setting.
Exclusion
- Family history of seizures or progressive neurological disease.
- Subject who has a medical history of plague, or had been vaccination of plague vaccine.
- Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine.
- Any confirmed or suspected autoimmune diseases or immune deficiency disorders, including human immunodeficiency virus (HIV) infection.
- Dysgenopathy or severe chronic disease.
- Pregnant or lactating women, women of reproductive age without contraception.
- Thrombocytopenia or other blood coagulation disorder, taboos of intramuscular injection and collection of blood.
- Difficulty in blood collection.
- Any prior administration of immunodepressant or corticosteroids, and antianaphylactic treatment, cytotoxic therapy in last 6 months.
- Any prior administration of blood products in last 3 month.
- Any prior administration of other research medicines in last 4 weeks.
- Any prior administration of attenuated live vaccine in last 4 weeks.
- Any prior administration of subunit or inactivated vaccines in last 2 weeks.
- Had fever before vaccination, subjects with temperature \>37.0°C on axillary setting.
- Any condition that in the opinion of the investigator, may interferes the evaluation of study objectives.
- Exclusion Criteria for the other doses:
- Subject who must be excluded according to the exclusion criteria for the first dose
- Grade 3 or above systemic adverse reactions or unacceptable adverse reactions at injection site after the previous inoculation.
- Other reasons in the opinion of the investigator that affect continuing vaccination.
- Criteria for postponding of vaccination
- Recovered subject who be sick during the time window of vaccination whether to continue vaccination determined by the investigator according to the requirements of the protocol.
Key Trial Info
Start Date :
May 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 20 2022
Estimated Enrollment :
720 Patients enrolled
Trial Details
Trial ID
NCT05330624
Start Date
May 8 2020
End Date
September 20 2022
Last Update
April 15 2022
Active Locations (1)
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1
Jiangsu Provincial Center for Diseases Control and Prevention
Nanjing, Jiangsu, China, 210009