Immunogenicity and Safety of Subunit Plague Vaccine (NCT02596308) | Clinical Trial Compass
CompletedPhase 2
Immunogenicity and Safety of Subunit Plague Vaccine
China240 participantsStarted 2014-10
Plain-language 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. 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).
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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, 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 temp…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To evaluate immunogenicity after vaccination.
Timeframe: Day 28 post-dose 2
2
Proportion of subjects reporting solicited adverse reactions.
Timeframe: Day 7 post-each dose
Trial details
NCT IDNCT02596308
SponsorJiangsu Province Centers for Disease Control and Prevention