PlaguePhase 2NCT02596308
Immunogenicity and Safety of Subunit Plague Vaccine
A Phase 2 study testing Plague vaccine 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 poses 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
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- Oct 2014to Jan 2015
- 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.
Show all 21Show fewer
- Women of reproductive age without contraception.
- Thrombocytopenia or other blood coagulation disorder, may cause taboo of intramuscular injection.
- Any prior administration of immunodepressant or corticosteroids, and antianaphylactic treatment, cytotoxic therapy in last 6 months.
- Difficult to collecting blood sample.
- Any prior administration of blood products in last 3 month.
- Any prior administration of other research medicines in last 1 month.
- 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.
- Rash on the injection site that may affect safety observation.
- Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives.
- Subject who must be excluded according to the exclusion criteria for the first dose.
- Any serious adverse events caused by vaccination.
- Hypersensitivity after vaccination (include urticarial or rash in 30 minutes after vaccination).Hypersensitivity after vaccination (include urticarial or rash in 30 minutes after vaccination).
- Other adverse reactions in the opinion of the investigator that affect continue vaccination (include: severely serious symptom of pain, swelling, Limitation of motion, continuous high fever, headache and other Systemic or local reactions).
Trial locations and contacts
1 site in 1 country.
China1 site
Jiangsu Provincial Center for Disease Control and Prevention
Nanjing, Jiangsu, 210009
About this study
Official title: Immunogenicity and Safety of Subunit Plague Vaccine Comprised by Fraction 1 Capsule (F1) and Virulence-Associated (V) Antigens: A Random Phase 2a 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 poses a serious threat to international security. Althought the killed whole-cell plague vaccine and live attenuated vaccine have 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,the recombinant subunit vaccines comprised by fraction 1 capsule(F1)and virulence-associated (V)antigens as the main composition have caused widely attention with providing greater protection than vaccines comprised of either subunit alone. This study was aimed to explor the safety and immunogenicity of a new type plague subunit vaccine which comprised natural F1 antigen and recombined V antigen (F1+rV).
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 diseases 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 poses 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 have the outbreak of the plague. It implies that safe and effective vaccine is urgently to developing. Althought the killed whole-cell plague vaccine and live attenuated vaccine have 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,the recombinant subunit vaccines comprised by fraction 1 capsule(F1)and virulence-associated (V)antigens as the main composition have caused widely attention with providing 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 by native F1 antigen and recombined V antigen (F1+rV).
- Conditions
- Plague
- Being tested
- Plague vaccine
- 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 vaccineBiological
Plague vaccine is comrised by native fraction 1 capsule (F1) and recombine virulence-associated (V) antigens.
| Study group | Role | What they receive |
|---|---|---|
| 15µg vaccine | Experimental | 15µg plague vaccine of 1.0ml in 120 adults aged 18-55 years old at day 0 and 28. Receives: Biological: Plague vaccine |
| 30µg vaccine | Experimental | 30µg plague vaccine of 1.0ml in 120 adults aged 18-55 years old at day 0 and 28. Receives: Biological: Plague vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate immunogenicity after vaccination.
the GMT of antibodies to F1 antigen at day 28 post-dose2
Measured: Day 28 post-dose 2
Proportion of subjects reporting solicited adverse reactions.
Proportion of subjects reporting solicited adverse events within 7 days post-each dose
Measured: Day 7 post-each dose
Secondary outcomes (8)
GMI of antibodies to F1 antigen.
Measured: Day 28 post-each dose
The seroconversion rate of antibodies to F1 antigen
Measured: Day 28 post-each dose
GMT of antibodies to F1 antigen at day 28
Measured: Day 28 post- dose1
GMT of antibodies to V antigen.
Measured: Day 28 post-each dose
GMI of antibodies to V antigen.
Measured: Day 28 post-each dose
The seroconversion rate of antibodies to V antigen.
Measured: Day 28 post-each dose
Proportion of subjects reporting unsolicited adverse events
Proportion of subjects reporting unsolicited adverse events within 28 days post-each dose
Measured: Day 28 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 56.
Measured: Day 0 up to day 28 post-dose 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2015 (estimated)
- Study startOct 2014
- Primary completionDec 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Province Centers for Disease Control and Prevention
- Sponsor type
- Research network
- Collaborators
- Lanzhou Institute of Biological Products Co., Ltd
- Responsible party
- Sponsor
- Investigators
- Yuemei Hu, Bachelor, Principal investigator, Jiangsu Provincial Center for Diseases Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02596308
- Sponsor's protocol ID
- JSVCT017
- Status last verified
- Nov 2015
- First submitted
- 2 Nov 2015
- Last updated
- 4 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Hu J, Jiao L, Hu Y, Chu K, Li J, Zhu F, Li T, Wu Z, Wei D, Meng F, Wang B. One year immunogenicity and safety of subunit plague vaccine in Chinese healthy adults: An extended open-label study. Hum Vaccin Immunother. 2018;14(11):2701-2705. doi: 10.1080/21645515.2018.1486154. Epub 2018 Jul 11.
PubMed 29927704
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of Subunit Plague Vaccine Comprised by Fraction 1 Capsule (F1) and Virulence-Associated (V) Antigens: A Random Phase 2a Clinical Trial
- ClinicalTrials.gov ID
- NCT02596308
- Acronym / sponsor ID
- JSVCT017
- Conditions
- Plague
- Keywords
- Plague vaccine, Immunogenicity, Safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Jiangsu Province Centers for Disease Control and PreventionResearch network
- Collaborators
- Lanzhou Institute of Biological Products Co., Ltd
- Study start
- Oct 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 4 Nov 2015 (estimated)
- 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 poses a serious threat to international security. Althought the killed whole-cell plague vaccine and live attenuated vaccine have 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,the recombinant subunit vaccines comprised by fraction 1 capsule(F1)and virulence-associated (V)antigens as the main composition have caused widely attention with providing greater protection than vaccines comprised of either subunit alone. This study was aimed to explor the safety and immunogenicity of a new type plague subunit vaccine which comprised natural F1 antigen and recombined V antigen (F1+rV).
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 diseases 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 poses 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 have the outbreak of the plague. It implies that safe and effective vaccine is urgently to developing. Althought the killed whole-cell plague vaccine and live attenuated vaccine have 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,the recombinant subunit vaccines comprised by fraction 1 capsule(F1)and virulence-associated (V)antigens as the main composition have caused widely attention with providing 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 by native F1 antigen and recombined V antigen (F1+rV).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 15µg vaccine | Experimental | Biological: Plague vaccine15µg plague vaccine of 1.0ml in 120 adults aged 18-55 years old at day 0 and 28. |
| 30µg vaccine | Experimental | Biological: Plague vaccine30µg plague vaccine of 1.0ml in 120 adults aged 18-55 years old at day 0 and 28. |
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 (21 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 vaccinePlague vaccine is comrised by native fraction 1 capsule (F1) and recombine virulence-associated (V) antigens. | Biological | 15µg vaccine, 30µg vaccine |
Primary outcome
To evaluate immunogenicity after vaccination.
Time frame: Day 28 post-dose 2
the GMT of antibodies to F1 antigen at day 28 post-dose2
Proportion of subjects reporting solicited adverse reactions.
Time frame: Day 7 post-each dose
Proportion of subjects reporting solicited adverse events within 7 days post-each dose
8 secondary outcomes
GMI of antibodies to F1 antigen.
Time frame: Day 28 post-each dose
The seroconversion rate of antibodies to F1 antigen
Time frame: Day 28 post-each dose
GMT of antibodies to F1 antigen at day 28
Time frame: Day 28 post- dose1
GMT of antibodies to V antigen.
Time frame: Day 28 post-each dose
GMI of antibodies to V antigen.
Time frame: Day 28 post-each dose
The seroconversion rate of antibodies to V antigen.
Time frame: Day 28 post-each dose
Proportion of subjects reporting unsolicited adverse events
Time frame: Day 28 post-each dose
Proportion of subjects with serious adverse events (SAE)occurring throughout the trial
Time frame: Day 0 up to day 28 post-dose 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2015.
- Derived from this study: PubMed 29927704Hu J, Jiao L, Hu Y, Chu K, Li J, Zhu F, Li T, Wu Z, Wei D, Meng F, Wang B. One year immunogenicity and safety of subunit plague vaccine in Chinese healthy adults: An extended open-label study. Hum Vaccin Immunother. 2018;14(11):2701-2705. doi: 10.1080/21645515.2018.1486154. Epub 2018 Jul 11.
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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.
Yuemei Hu, Bachelor 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 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 21 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: finished, as of the sponsor's last update on 4 Nov 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To evaluate immunogenicity after vaccination. (time frame: Day 28 post-dose 2). 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?
On the ClinicalTrials.gov record for NCT02596308, which also lists 1 linked publication.
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 4 Nov 2015; AzTrials last refreshed its copy on 7 Nov 2026.