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Immunogenicity and Safety of Subunit Plague Vaccine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02596308
Recruitment Status : Completed
First Posted : November 4, 2015
Last Update Posted : November 4, 2015
Sponsor:
Collaborator:
Lanzhou Institute of Biological Products Co., Ltd
Information provided by (Responsible Party):
Jiangsu Province Centers for Disease Control and Prevention

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 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).

Condition or disease Intervention/treatment Phase
Plague Biological: Plague vaccine Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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
Study Start Date : October 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Plague

Arm Intervention/treatment
Experimental: 15µg vaccine
15µg plague vaccine of 1.0ml in 120 adults aged 18-55 years old at day 0 and 28.
Biological: Plague vaccine
Plague vaccine is comrised by native fraction 1 capsule (F1) and recombine virulence-associated (V) antigens.

Experimental: 30µg vaccine
30µg plague vaccine of 1.0ml in 120 adults aged 18-55 years old at day 0 and 28.
Biological: Plague vaccine
Plague vaccine is comrised by native fraction 1 capsule (F1) and recombine virulence-associated (V) antigens.




Primary Outcome Measures :
  1. To evaluate immunogenicity after vaccination. [ Time Frame: Day 28 post-dose 2 ]
    the GMT of antibodies to F1 antigen at day 28 post-dose2

  2. 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


Secondary Outcome Measures :
  1. GMI of antibodies to F1 antigen. [ Time Frame: Day 28 post-each dose ]
  2. The seroconversion rate of antibodies to F1 antigen [ Time Frame: Day 28 post-each dose ]
  3. GMT of antibodies to F1 antigen at day 28 [ Time Frame: Day 28 post- dose1 ]
  4. GMT of antibodies to V antigen. [ Time Frame: Day 28 post-each dose ]
  5. GMI of antibodies to V antigen. [ Time Frame: Day 28 post-each dose ]
  6. The seroconversion rate of antibodies to V antigen. [ Time Frame: Day 28 post-each dose ]
  7. Proportion of subjects reporting unsolicited adverse events [ Time Frame: Day 28 post-each dose ]
    Proportion of subjects reporting unsolicited adverse events within 28 days post-each dose

  8. Proportion of subjects with serious adverse events (SAE)occurring throughout the trial [ Time Frame: Day 0 up to day 28 post-dose 2 ]
    Proportion of subjects with serious adverse events (SAE)occurring throughout the trial from day 0 to 56.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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, 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.

Exclusion Criteria for the second dose:

  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02596308


Locations
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China, Jiangsu
Jiangsu Provincial Center for Disease Control and Prevention
Nanjing, Jiangsu, China, 210009
Sponsors and Collaborators
Jiangsu Province Centers for Disease Control and Prevention
Lanzhou Institute of Biological Products Co., Ltd
Investigators
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Principal Investigator: Yuemei Hu, Bachelor Jiangsu Provincial Center for Diseases Control and Prevention
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jiangsu Province Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT02596308    
Other Study ID Numbers: JSVCT017
First Posted: November 4, 2015    Key Record Dates
Last Update Posted: November 4, 2015
Last Verified: November 2015
Keywords provided by Jiangsu Province Centers for Disease Control and Prevention:
Plague vaccine
Immunogenicity
Safety
Additional relevant MeSH terms:
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Plague
Yersinia Infections
Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections