PlaguePhase 2NCT05330624
Immunogenicity and Safety of Subunit Vaccine of Plague Vaccine With Two Immunization Regimens
A Phase 2 study testing plague vaccine(F1+rV) in people with Plague, run by Jiangsu Province Centers for Disease Control and Prevention at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Plague
- What is being tested?
- plague vaccine(F1+rV)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 720 participants
- Where
- 1 siteChina
- Study dates
- 8 May 2020to 20 Sep 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Jiangsu Provincial Center for Diseases Control and Prevention
Nanjing, Jiangsu, 210009
About this study
Official title: Immunogenicity and Safety of Subunit Vaccine of Plague Vaccine (F1+ rV) With Two Immunization Regimens: A Random Phase 2b Clinical Trial
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.
Read the 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.
- Conditions
- Plague
- Being tested
- plague vaccine(F1+rV)
- Keywords
- Plague vaccine, Immunogenicity, Safety
- Medical subject headings
- Plague
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plague vaccine(F1+rV)Biological
plague vaccine(F1+rV) (Lanzhou Institute of Biological Products Co.,Ltd) of 1.0ml, three doses
| Study group | Role | What they receive |
|---|---|---|
| the D0- M1-M6 regimen | Experimental | 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). Receives: Biological: plague vaccine(F1+rV) |
| the D0- M2-M6 regimen | Experimental | 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). Receives: Biological: plague vaccine(F1+rV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Month 7 post-dose 1
Secondary outcomes (54)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Month 1 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
Measured: Month 1 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Month 12 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
Measured: Month 12 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Month 18 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
Measured: Month 18 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Month 24 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
Measured: Month 24 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
Measured: 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
Measured: 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
Measured: 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
Measured: Month 24 post-dose 1
Proportion of subjects reporting adverse events
Proportion of subjects reporting adverse events within 30 days post-each dose
Measured: Day 30 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.
Measured: Day 0 up to month 12 post dose 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start8 May 2020
- Primary completion20 May 2022 (estimated)
- Study completion20 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PlagueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 720 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Province Centers for Disease Control and Prevention
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Fengcai Zhu, Master, Principal investigator, Jiangsu Provincial Center for Diseases Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05330624
- Sponsor's protocol ID
- JSVCT083
- Status last verified
- Apr 2022
- First submitted
- 8 Apr 2022
- Last updated
- 15 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of Subunit Vaccine of Plague Vaccine (F1+ rV) With Two Immunization Regimens: A Random Phase 2b Clinical Trial
- ClinicalTrials.gov ID
- NCT05330624
- Acronym / sponsor ID
- JSVCT083
- Conditions
- Plague
- Keywords
- Plague vaccine, Immunogenicity, Safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 720 participants (actual)
- Lead sponsor
- Jiangsu Province Centers for Disease Control and PreventionResearch network
- Study start
- 8 May 2020 (actual)
- Primary completion
- 20 May 2022 (estimated)
- Study completion
- 20 Sep 2022 (estimated)
- First posted
- 15 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the D0- M1-M6 regimen | Experimental | Biological: plague vaccine(F1+rV)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). |
| the D0- M2-M6 regimen | Experimental | Biological: plague vaccine(F1+rV)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). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| plague vaccine(F1+rV)plague vaccine(F1+rV) (Lanzhou Institute of Biological Products Co.,Ltd) of 1.0ml, three doses | Biological | the D0- M1-M6 regimen, the D0- M2-M6 regimen |
Primary outcome
the GMT of antibodies to F1 antigen on Month 7 post-dose 1
Time frame: 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
Time frame: Month 7 post-dose 1
the GMT of antibodies to rV antigen on Month 7 post-dose 1
54 secondary outcomes
The seroconversion of antibodies to F1 antigen on Month 7 post-dose 1
Time frame: Month 7 post-dose 1
The GMFI of antibodies to F1 antigen on Month 7 post-dose 1
Time frame: Month 7 post-dose 1
The seroconversion of antibodies to rV antigen on Month 7 post-dose 1
Time frame: Month 7 post-dose 1
The GMFI of antibodies to rV antigen on Month 7 post-dose 1
Time frame: Month 7 post-dose 1
The GMT of antibodies to F1 antigen on Month 1 post-dose 1
Time frame: Month 1 post-dose 1
The GMT of antibodies to rV antigen on Month 1 post-dose 1
Time frame: Month 1 post-dose 1
The seroconversion of antibodies to F1 antigen on Month1 post-dose 1
Time frame: Month 1 post-dose 1
The seroconversion of antibodies to rV antigen on Month1 post-dose 1
Time frame: Month 1 post-dose 1
The GMFI of antibodies to F1 antigen on Month 1 post-dose 1
Time frame: Month 1 post-dose 1
The GMFI of antibodies to rV antigen on Month 1 post-dose 1
Time frame: Month 1 post-dose 1
The GMT of antibodies to F1 antigen on Month 2 post-dose 1
Time frame: Month 2 post-dose 1
The GMT of antibodies to rV antigen on Month 2 post-dose 1
Time frame: Month 2 post-dose 1
The seroconversion of antibodies to F1 antigen on Month 2 post-dose 1
Time frame: Month 2 post-dose 1
The seroconversion of antibodies to rV antigen on Month 2 post-dose 1
Time frame: Month 2 post-dose 1
The GMFI of antibodies to F1 antigen on Month 2 post-dose 1
Time frame: Month 2 post-dose 1
The GMFI of antibodies to rV antigen on Month 2 post-dose 1
Time frame: Month 2 post-dose 1
The GMT of antibodies to F1 antigen on Month 3 post-dose 1
Time frame: Month 3 post-dose 1
The GMT of antibodies to rV antigen on Month 3 post-dose 1
Time frame: Month 3 post-dose 1
The seroconversion of antibodies to F1 antigen on Month 3 post-dose 1
Time frame: Month 3 post-dose 1
The seroconversion of antibodies to rV antigen on Month 3 post-dose 1
Time frame: Month 3 post-dose 1
The GMFI of antibodies to F1 antigen on Month 3 post-dose 1
Time frame: Month 3 post-dose 1
The GMFI of antibodies to rV antigen on Month 3 post-dose 1
Time frame: Month 3 post-dose 1
The GMT of antibodies to F1 antigen on Month 6 post-dose 1
Time frame: Month 6 post-dose 1
The GMT of antibodies to rV antigen on Month 6 post-dose 1
Time frame: Month 6 post-dose 1
The seroconversion of antibodies to F1 antigen on Month 6 post-dose 1
Time frame: Month 6 post-dose 1
The seroconversion of antibodies to rV antigen on Month 6 post-dose 1
Time frame: Month 6 post-dose 1
The GMFI of antibodies to F1 antigen on Month 6 post-dose 1
Time frame: Month 6 post-dose 1
The GMFI of antibodies to rV antigen on Month 6 post-dose 1
Time frame: Month 6 post-dose 1
The GMT of antibodies to F1 antigen on Month 9 post-dose 1
Time frame: Month 9 post-dose 1
The GMT of antibodies to rV antigen on Month 9 post-dose 1
Time frame: Month 9 post-dose 1
The seroconversion of antibodies to F1 antigen on Month 9 post-dose 1
Time frame: Month 9 post-dose 1
The seroconversion of antibodies to rV antigen on Month 9 post-dose 1
Time frame: Month 9 post-dose 1
The GMFI of antibodies to F1 antigen on Month 9 post-dose 1
Time frame: Month 9 post-dose 1
The GMFI of antibodies to rV antigen on Month 9 post-dose 1
Time frame: Month 9 post-dose 1
The GMT of antibodies to F1 antigen on Month12 post-dose 1
Time frame: Month 12 post-dose 1
The GMT of antibodies to rV antigen on Month12 post-dose 1
Time frame: Month 12 post-dose 1
The seroconversion of antibodies to F1 antigen on Month 12 post-dose 1
Time frame: Month 12 post-dose 1
The seroconversion of antibodies to rV antigen on Month 12 post-dose 1
Time frame: Month 12 post-dose 1
The GMFI of antibodies to F1 antigen on Month 12 post-dose 1
Time frame: Month 12 post-dose 1
The GMFI of antibodies to rV antigen on Month 12 post-dose 1
Time frame: Month 12 post-dose 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fengcai Zhu, Master principal investigator
Jiangsu Provincial Center for Diseases Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing plague vaccine(F1+rV) in people with Plague, run by Jiangsu Province Centers for Disease Control and Prevention at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the GMT of antibodies to F1 antigen on Month 7 post-dose 1 (time frame: Month 7 post-dose 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2022.