Back to resultsImmunogenicity and Safety of Subunit Vaccine of Plague Vaccine With Two Immunization Regimens
Primary Purpose
Plague
Status
Active
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
plague vaccine(F1+rV)
Sponsored by
About this trial
This is an interventional prevention trial for Plague focused on measuring Plague vaccine, Immunogenicity, Safety
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Jiangsu Provincial Center for Diseases Control and Prevention
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
the D0- M1-M6 regimen
the D0- M2-M6 regimen
Arm Description
Adults receive three doses of 1.0 ml plague vaccine at day 0, month 1, and month 6 (referred as the D0-M1-M6 regimen).
Adults receive three doses of 1.0 ml plague vaccine at day 0, month 2, and month 6 (referred as the D0-M2-M6 regimen).
Outcomes
Primary Outcome Measures
the GMT of antibodies to F1 antigen on Month 7 post-dose 1
the GMT of antibodies to F1 antigen on Month 7 post-dose 1
the GMT of antibodies to rV antigen on Month 7 post-dose 1
the GMT of antibodies to rV antigen on Month 7 post-dose 1
Secondary Outcome Measures
The seroconversion of antibodies to F1 antigen on Month 7 post-dose 1
The seroconversion of antibodies to F1 antigen on Month 7 post-dose 1
The GMFI of antibodies to F1 antigen on Month 7 post-dose 1
The GMFI of antibodies to F1 antigen on Month 7 post-dose 1
The seroconversion of antibodies to rV antigen on Month 7 post-dose 1
The seroconversion of antibodies to rV antigen on Month 7 post-dose 1
The GMFI of antibodies to rV antigen on Month 7 post-dose 1
the GMFI of antibodies to rV antigen on Month 7 post-dose 1
The GMT of antibodies to F1 antigen on Month 1 post-dose 1
The GMT of antibodies to F1 antigen on Month 1 post-dose 1
The GMT of antibodies to rV antigen on Month 1 post-dose 1
The GMT of antibodies to rV antigen on Month 1 post-dose 1
The seroconversion of antibodies to F1 antigen on Month1 post-dose 1
The seroconversion of antibodies to F1 antigen on Month1 post-dose 1
The seroconversion of antibodies to rV antigen on Month1 post-dose 1
The seroconversion of antibodies to rV antigen on Month1 post-dose 1
The GMFI of antibodies to F1 antigen on Month 1 post-dose 1
The GMFI of antibodies to F1 antigen on Month 1 post-dose 1
The GMFI of antibodies to rV antigen on Month 1 post-dose 1
The GMFI of antibodies to rV antigen on Month 1 post-dose 1
The GMT of antibodies to F1 antigen on Month 2 post-dose 1
The GMT of antibodies to F1 antigen on Month 2 post-dose 1
The GMT of antibodies to rV antigen on Month 2 post-dose 1
The GMT of antibodies to rV antigen on Month 2 post-dose 1
The seroconversion of antibodies to F1 antigen on Month 2 post-dose 1
The seroconversion of antibodies to F1 antigen on Month 2 post-dose 1
The seroconversion of antibodies to rV antigen on Month 2 post-dose 1
The seroconversion of antibodies to rV antigen on Month 2 post-dose 1
The GMFI of antibodies to F1 antigen on Month 2 post-dose 1
The GMFI of antibodies to F1 antigen on Month 2 post-dose 1
The GMFI of antibodies to rV antigen on Month 2 post-dose 1
The GMFI of antibodies to rV antigen on Month 2 post-dose 1
The GMT of antibodies to F1 antigen on Month 3 post-dose 1
The GMT of antibodies to F1 antigen on Month 3 post-dose 1
The GMT of antibodies to rV antigen on Month 3 post-dose 1
The GMT of antibodies to rV antigen on Month 3 post-dose 1
The seroconversion of antibodies to F1 antigen on Month 3 post-dose 1
The seroconversion of antibodies to F1 antigen on Month 3 post-dose 1
The seroconversion of antibodies to rV antigen on Month 3 post-dose 1
The seroconversion of antibodies to rV antigen on Month 3 post-dose 1
The GMFI of antibodies to F1 antigen on Month 3 post-dose 1
The GMFI of antibodies to F1 antigen on Month 3 post-dose 1
The GMFI of antibodies to rV antigen on Month 3 post-dose 1
The GMFI of antibodies to rV antigen on Month 3 post-dose 1
The GMT of antibodies to F1 antigen on Month 6 post-dose 1
The GMT of antibodies to F1 antigen on Month 6 post-dose 1
The GMT of antibodies to rV antigen on Month 6 post-dose 1
The GMT of antibodies to rV antigen on Month 6 post-dose 1
The seroconversion of antibodies to F1 antigen on Month 6 post-dose 1
The seroconversion of antibodies to F1 antigen on Month 6 post-dose 1
The seroconversion of antibodies to rV antigen on Month 6 post-dose 1
The seroconversion of antibodies to rV antigen on Month 6 post-dose 1
The GMFI of antibodies to F1 antigen on Month 6 post-dose 1
The GMFI of antibodies to F1 antigen on Month 6 post-dose 1
The GMFI of antibodies to rV antigen on Month 6 post-dose 1
The GMFI of antibodies to rV antigen on Month 6 post-dose 1
The GMT of antibodies to F1 antigen on Month 9 post-dose 1
The GMT of antibodies to F1 antigen on Month 9 post-dose 1
The GMT of antibodies to rV antigen on Month 9 post-dose 1
The GMT of antibodies to rV antigen on Month 9 post-dose 1
The seroconversion of antibodies to F1 antigen on Month 9 post-dose 1
The seroconversion of antibodies to F1 antigen on Month 9 post-dose 1
The seroconversion of antibodies to rV antigen on Month 9 post-dose 1
The seroconversion of antibodies to rV antigen on Month 9 post-dose 1
The GMFI of antibodies to F1 antigen on Month 9 post-dose 1
The GMFI of antibodies to F1 antigen on Month 9 post-dose 1
The GMFI of antibodies to rV antigen on Month 9 post-dose 1
The GMFI of antibodies to rV antigen on Month 9 post-dose 1
The GMT of antibodies to F1 antigen on Month12 post-dose 1
The GMT of antibodies to F1 antigen on Month12 post-dose 1
The GMT of antibodies to rV antigen on Month12 post-dose 1
The GMT of antibodies to rV antigen on Month12 post-dose 1
The seroconversion of antibodies to F1 antigen on Month 12 post-dose 1
The seroconversion of antibodies to F1 antigen on Month 12 post-dose 1
The seroconversion of antibodies to rV antigen on Month 12 post-dose 1
The seroconversion of antibodies to rV antigen on Month 12 post-dose 1
The GMFI of antibodies to F1 antigen on Month 12 post-dose 1
The GMFI of antibodies to F1 antigen on Month 12 post-dose 1
The GMFI of antibodies to rV antigen on Month 12 post-dose 1
The GMFI of antibodies to rV antigen on Month 12 post-dose 1
The GMT of antibodies to F1 antigen on Month18 post-dose 1
The GMT of antibodies to F1 antigen on Month18 post-dose 1
The GMT of antibodies to rV antigen on Month18 post-dose 1
The GMT of antibodies to rV antigen on Month18 post-dose 1
The seroconversion of antibodies to F1 antigen on Month 18 post-dose 1
The seroconversion of antibodies to F1 antigen on Month 18 post-dose 1
The seroconversion of antibodies to rV antigen on Month 18 post-dose 1
The seroconversion of antibodies to rV antigen on Month 18 post-dose 1
The GMFI of antibodies to F1 antigen on Month 18 post-dose 1
The GMFI of antibodies to F1 antigen on Month 18 post-dose 1
The GMFI of antibodies to rV antigen on Month 18 post-dose 1
The GMFI of antibodies to rV antigen on Month 18 post-dose 1
The GMT of antibodies to F1 antigen on Month24 post-dose 1
The GMT of antibodies to F1 antigen on Month24 post-dose 1
The GMT of antibodies to rV antigen on Month24 post-dose 1
The GMT of antibodies to rV antigen on Month24 post-dose 1
The seroconversion of antibodies to F1 antigen on Month 24 post-dose 1
The seroconversion of antibodies to F1 antigen on Month 24 post-dose 1
The seroconversion of antibodies to rV antigen on Month 24 post-dose 1
The seroconversion of antibodies to rV antigen on Month 24 post-dose 1
The GMFI of antibodies to F1 antigen on Month 24 post-dose 1
The GMFI of antibodies to F1 antigen on Month 24 post-dose 1
The GMFI of antibodies to rV antigen on Month 24 post-dose 1
The GMFI of antibodies to rV antigen on Month 24 post-dose 1
Proportion of subjects reporting adverse events
Proportion of subjects reporting adverse events within 30 days post-each dose
Proportion of subjects with serious adverse events (SAE)occurring throughout the trial
Proportion of subjects with serious adverse events (SAE)occurring throughout the trial from day 0 to month 12.
Full Information
NCT ID
NCT05330624
First Posted
April 8, 2022
Last Updated
April 8, 2022
Sponsor
Jiangsu Province Centers for Disease Control and Prevention
1. Study Identification
Unique Protocol Identification Number
NCT05330624
Brief Title
Immunogenicity and Safety of Subunit Vaccine of Plague Vaccine With Two Immunization Regimens
Official Title
Immunogenicity and Safety of Subunit Vaccine of Plague Vaccine (F1+ rV) With Two Immunization Regimens: A Random Phase 2b Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 8, 2020 (Actual)
Primary Completion Date
May 20, 2022 (Anticipated)
Study Completion Date
September 20, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu Province Centers for Disease Control and Prevention
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 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.
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 with blood or tissues of infected animals or exposure to aerosolized droplets containing bacteria. Pneumonic plague is typically diagnosed in humans with with high mortality. It has a long history for plague as an agent of biowarfare, and pose a serious threat to international security. In human history, there were three outbreaks of plague all over the world, about 200 million people died from the disease. The increasing trend of plague epidemic in recent years, some regions and countries in the world still has the outbreak of the plague. It implied that safety and safe and effective vaccine is urgently to developing.
Althought the killed whole-cell plague vaccine and live attenuated vaccine has been licensed, these vaccines cause significant adverse reactions, including fever, headache, malaise, lymphadenopathy, erythema and induration at the injection site with high degree of immune variability. They are rarely used today because of toxicities, limited evidence for efficacy to prevent plague, and limited commercial availability. Based on the researches 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. In the primary phase 2a clinical trial, 30μg formulation showed a stronger and sustained immune response. This study was aim to exploring the safety and immunogenicity of a new type plague subunit vaccine which comprised 30μg natural F1 antigen and 30μg recombined V antigen (F1+rV) in two immunization regimens.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plague
Keywords
Plague vaccine, Immunogenicity, Safety
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
720 (Actual)
8. Arms, Groups, and Interventions
Arm Title
the D0- M1-M6 regimen
Arm Type
Experimental
Arm Description
Adults receive three doses of 1.0 ml plague vaccine at day 0, month 1, and month 6 (referred as the D0-M1-M6 regimen).
Arm Title
the D0- M2-M6 regimen
Arm Type
Experimental
Arm Description
Adults receive three doses of 1.0 ml plague vaccine at day 0, month 2, and month 6 (referred as the D0-M2-M6 regimen).
Intervention Type
Biological
Intervention Name(s)
plague vaccine(F1+rV)
Intervention Description
plague vaccine(F1+rV) (Lanzhou Institute of Biological Products Co.,Ltd) of 1.0ml, three doses
Primary Outcome Measure Information:
Title
the GMT of antibodies to F1 antigen on Month 7 post-dose 1
Description
the GMT of antibodies to F1 antigen on Month 7 post-dose 1
Time Frame
Month 7 post-dose 1
Title
the GMT of antibodies to rV antigen on Month 7 post-dose 1
Description
the GMT of antibodies to rV antigen on Month 7 post-dose 1
Time Frame
Month 7 post-dose 1
Secondary Outcome Measure Information:
Title
The seroconversion of antibodies to F1 antigen on Month 7 post-dose 1
Description
The seroconversion of antibodies to F1 antigen on Month 7 post-dose 1
Time Frame
Month 7 post-dose 1
Title
The GMFI of antibodies to F1 antigen on Month 7 post-dose 1
Description
The GMFI of antibodies to F1 antigen on Month 7 post-dose 1
Time Frame
Month 7 post-dose 1
Title
The seroconversion of antibodies to rV antigen on Month 7 post-dose 1
Description
The seroconversion of antibodies to rV antigen on Month 7 post-dose 1
Time Frame
Month 7 post-dose 1
Title
The GMFI of antibodies to rV antigen on Month 7 post-dose 1
Description
the GMFI of antibodies to rV antigen on Month 7 post-dose 1
Time Frame
Month 7 post-dose 1
Title
The GMT of antibodies to F1 antigen on Month 1 post-dose 1
Description
The GMT of antibodies to F1 antigen on Month 1 post-dose 1
Time Frame
Month 1 post-dose 1
Title
The GMT of antibodies to rV antigen on Month 1 post-dose 1
Description
The GMT of antibodies to rV antigen on Month 1 post-dose 1
Time Frame
Month 1 post-dose 1
Title
The seroconversion of antibodies to F1 antigen on Month1 post-dose 1
Description
The seroconversion of antibodies to F1 antigen on Month1 post-dose 1
Time Frame
Month 1 post-dose 1
Title
The seroconversion of antibodies to rV antigen on Month1 post-dose 1
Description
The seroconversion of antibodies to rV antigen on Month1 post-dose 1
Time Frame
Month 1 post-dose 1
Title
The GMFI of antibodies to F1 antigen on Month 1 post-dose 1
Description
The GMFI of antibodies to F1 antigen on Month 1 post-dose 1
Time Frame
Month 1 post-dose 1
Title
The GMFI of antibodies to rV antigen on Month 1 post-dose 1
Description
The GMFI of antibodies to rV antigen on Month 1 post-dose 1
Time Frame
Month 1 post-dose 1
Title
The GMT of antibodies to F1 antigen on Month 2 post-dose 1
Description
The GMT of antibodies to F1 antigen on Month 2 post-dose 1
Time Frame
Month 2 post-dose 1
Title
The GMT of antibodies to rV antigen on Month 2 post-dose 1
Description
The GMT of antibodies to rV antigen on Month 2 post-dose 1
Time Frame
Month 2 post-dose 1
Title
The seroconversion of antibodies to F1 antigen on Month 2 post-dose 1
Description
The seroconversion of antibodies to F1 antigen on Month 2 post-dose 1
Time Frame
Month 2 post-dose 1
Title
The seroconversion of antibodies to rV antigen on Month 2 post-dose 1
Description
The seroconversion of antibodies to rV antigen on Month 2 post-dose 1
Time Frame
Month 2 post-dose 1
Title
The GMFI of antibodies to F1 antigen on Month 2 post-dose 1
Description
The GMFI of antibodies to F1 antigen on Month 2 post-dose 1
Time Frame
Month 2 post-dose 1
Title
The GMFI of antibodies to rV antigen on Month 2 post-dose 1
Description
The GMFI of antibodies to rV antigen on Month 2 post-dose 1
Time Frame
Month 2 post-dose 1
Title
The GMT of antibodies to F1 antigen on Month 3 post-dose 1
Description
The GMT of antibodies to F1 antigen on Month 3 post-dose 1
Time Frame
Month 3 post-dose 1
Title
The GMT of antibodies to rV antigen on Month 3 post-dose 1
Description
The GMT of antibodies to rV antigen on Month 3 post-dose 1
Time Frame
Month 3 post-dose 1
Title
The seroconversion of antibodies to F1 antigen on Month 3 post-dose 1
Description
The seroconversion of antibodies to F1 antigen on Month 3 post-dose 1
Time Frame
Month 3 post-dose 1
Title
The seroconversion of antibodies to rV antigen on Month 3 post-dose 1
Description
The seroconversion of antibodies to rV antigen on Month 3 post-dose 1
Time Frame
Month 3 post-dose 1
Title
The GMFI of antibodies to F1 antigen on Month 3 post-dose 1
Description
The GMFI of antibodies to F1 antigen on Month 3 post-dose 1
Time Frame
Month 3 post-dose 1
Title
The GMFI of antibodies to rV antigen on Month 3 post-dose 1
Description
The GMFI of antibodies to rV antigen on Month 3 post-dose 1
Time Frame
Month 3 post-dose 1
Title
The GMT of antibodies to F1 antigen on Month 6 post-dose 1
Description
The GMT of antibodies to F1 antigen on Month 6 post-dose 1
Time Frame
Month 6 post-dose 1
Title
The GMT of antibodies to rV antigen on Month 6 post-dose 1
Description
The GMT of antibodies to rV antigen on Month 6 post-dose 1
Time Frame
Month 6 post-dose 1
Title
The seroconversion of antibodies to F1 antigen on Month 6 post-dose 1
Description
The seroconversion of antibodies to F1 antigen on Month 6 post-dose 1
Time Frame
Month 6 post-dose 1
Title
The seroconversion of antibodies to rV antigen on Month 6 post-dose 1
Description
The seroconversion of antibodies to rV antigen on Month 6 post-dose 1
Time Frame
Month 6 post-dose 1
Title
The GMFI of antibodies to F1 antigen on Month 6 post-dose 1
Description
The GMFI of antibodies to F1 antigen on Month 6 post-dose 1
Time Frame
Month 6 post-dose 1
Title
The GMFI of antibodies to rV antigen on Month 6 post-dose 1
Description
The GMFI of antibodies to rV antigen on Month 6 post-dose 1
Time Frame
Month 6 post-dose 1
Title
The GMT of antibodies to F1 antigen on Month 9 post-dose 1
Description
The GMT of antibodies to F1 antigen on Month 9 post-dose 1
Time Frame
Month 9 post-dose 1
Title
The GMT of antibodies to rV antigen on Month 9 post-dose 1
Description
The GMT of antibodies to rV antigen on Month 9 post-dose 1
Time Frame
Month 9 post-dose 1
Title
The seroconversion of antibodies to F1 antigen on Month 9 post-dose 1
Description
The seroconversion of antibodies to F1 antigen on Month 9 post-dose 1
Time Frame
Month 9 post-dose 1
Title
The seroconversion of antibodies to rV antigen on Month 9 post-dose 1
Description
The seroconversion of antibodies to rV antigen on Month 9 post-dose 1
Time Frame
Month 9 post-dose 1
Title
The GMFI of antibodies to F1 antigen on Month 9 post-dose 1
Description
The GMFI of antibodies to F1 antigen on Month 9 post-dose 1
Time Frame
Month 9 post-dose 1
Title
The GMFI of antibodies to rV antigen on Month 9 post-dose 1
Description
The GMFI of antibodies to rV antigen on Month 9 post-dose 1
Time Frame
Month 9 post-dose 1
Title
The GMT of antibodies to F1 antigen on Month12 post-dose 1
Description
The GMT of antibodies to F1 antigen on Month12 post-dose 1
Time Frame
Month 12 post-dose 1
Title
The GMT of antibodies to rV antigen on Month12 post-dose 1
Description
The GMT of antibodies to rV antigen on Month12 post-dose 1
Time Frame
Month 12 post-dose 1
Title
The seroconversion of antibodies to F1 antigen on Month 12 post-dose 1
Description
The seroconversion of antibodies to F1 antigen on Month 12 post-dose 1
Time Frame
Month 12 post-dose 1
Title
The seroconversion of antibodies to rV antigen on Month 12 post-dose 1
Description
The seroconversion of antibodies to rV antigen on Month 12 post-dose 1
Time Frame
Month 12 post-dose 1
Title
The GMFI of antibodies to F1 antigen on Month 12 post-dose 1
Description
The GMFI of antibodies to F1 antigen on Month 12 post-dose 1
Time Frame
Month 12 post-dose 1
Title
The GMFI of antibodies to rV antigen on Month 12 post-dose 1
Description
The GMFI of antibodies to rV antigen on Month 12 post-dose 1
Time Frame
Month 12 post-dose 1
Title
The GMT of antibodies to F1 antigen on Month18 post-dose 1
Description
The GMT of antibodies to F1 antigen on Month18 post-dose 1
Time Frame
Month 18 post-dose 1
Title
The GMT of antibodies to rV antigen on Month18 post-dose 1
Description
The GMT of antibodies to rV antigen on Month18 post-dose 1
Time Frame
Month 18 post-dose 1
Title
The seroconversion of antibodies to F1 antigen on Month 18 post-dose 1
Description
The seroconversion of antibodies to F1 antigen on Month 18 post-dose 1
Time Frame
Month 18 post-dose 1
Title
The seroconversion of antibodies to rV antigen on Month 18 post-dose 1
Description
The seroconversion of antibodies to rV antigen on Month 18 post-dose 1
Time Frame
Month 18 post-dose 1
Title
The GMFI of antibodies to F1 antigen on Month 18 post-dose 1
Description
The GMFI of antibodies to F1 antigen on Month 18 post-dose 1
Time Frame
Month 18 post-dose 1
Title
The GMFI of antibodies to rV antigen on Month 18 post-dose 1
Description
The GMFI of antibodies to rV antigen on Month 18 post-dose 1
Time Frame
Month 18 post-dose 1
Title
The GMT of antibodies to F1 antigen on Month24 post-dose 1
Description
The GMT of antibodies to F1 antigen on Month24 post-dose 1
Time Frame
Month 24 post-dose 1
Title
The GMT of antibodies to rV antigen on Month24 post-dose 1
Description
The GMT of antibodies to rV antigen on Month24 post-dose 1
Time Frame
Month 24 post-dose 1
Title
The seroconversion of antibodies to F1 antigen on Month 24 post-dose 1
Description
The seroconversion of antibodies to F1 antigen on Month 24 post-dose 1
Time Frame
Month 24 post-dose 1
Title
The seroconversion of antibodies to rV antigen on Month 24 post-dose 1
Description
The seroconversion of antibodies to rV antigen on Month 24 post-dose 1
Time Frame
Month 24 post-dose 1
Title
The GMFI of antibodies to F1 antigen on Month 24 post-dose 1
Description
The GMFI of antibodies to F1 antigen on Month 24 post-dose 1
Time Frame
Month 24 post-dose 1
Title
The GMFI of antibodies to rV antigen on Month 24 post-dose 1
Description
The GMFI of antibodies to rV antigen on Month 24 post-dose 1
Time Frame
Month 24 post-dose 1
Title
Proportion of subjects reporting adverse events
Description
Proportion of subjects reporting adverse events within 30 days post-each dose
Time Frame
Day 30 post-each dose
Title
Proportion of subjects with serious adverse events (SAE)occurring throughout the trial
Description
Proportion of subjects with serious adverse events (SAE)occurring throughout the trial from day 0 to month 12.
Time Frame
Day 0 up to month 12 post dose 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fengcai Zhu, Master
Organizational Affiliation
Jiangsu Provincial Center for Diseases Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jiangsu Provincial Center for Diseases Control and Prevention
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
12. IPD Sharing Statement
Learn more about this trial
Immunogenicity and Safety of Subunit Vaccine of Plague Vaccine With Two Immunization Regimens
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