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 range18 Years – 55 Years

SexALL

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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…

What they're measuring

To evaluate immunogenicity after vaccination.

Timeframe: Day 28 post-dose 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

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2014-12