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Immunogenicity and Safety of Subunit Plague Vaccine

Primary Purpose

Plague

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Plague vaccine
Sponsored by
Jiangsu Province Centers for Disease Control and Prevention
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Plague focused on measuring Plague vaccine, Immunogenicity, Safety

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Jiangsu Provincial Center for Disease Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

15µg vaccine

30µg vaccine

Arm Description

15µg plague vaccine of 1.0ml in 120 adults aged 18-55 years old at day 0 and 28.

30µg plague vaccine of 1.0ml in 120 adults aged 18-55 years old at day 0 and 28.

Outcomes

Primary Outcome Measures

To evaluate immunogenicity after vaccination.
the GMT of antibodies to F1 antigen at day 28 post-dose2
Proportion of subjects reporting solicited adverse reactions.
Proportion of subjects reporting solicited adverse events within 7 days post-each dose

Secondary Outcome Measures

GMI of antibodies to F1 antigen.
The seroconversion rate of antibodies to F1 antigen
GMT of antibodies to F1 antigen at day 28
GMT of antibodies to V antigen.
GMI of antibodies to V antigen.
The seroconversion rate of antibodies to V antigen.
Proportion of subjects reporting unsolicited adverse events
Proportion of subjects reporting unsolicited adverse events within 28 days 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.

Full Information

First Posted
November 2, 2015
Last Updated
November 2, 2015
Sponsor
Jiangsu Province Centers for Disease Control and Prevention
Collaborators
Lanzhou Institute of Biological Products Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02596308
Brief Title
Immunogenicity and Safety of Subunit Plague Vaccine
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 Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu Province Centers for Disease Control and Prevention
Collaborators
Lanzhou Institute of Biological Products Co., Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plague
Keywords
Plague vaccine, Immunogenicity, Safety

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
15µg vaccine
Arm Type
Experimental
Arm Description
15µg plague vaccine of 1.0ml in 120 adults aged 18-55 years old at day 0 and 28.
Arm Title
30µg vaccine
Arm Type
Experimental
Arm Description
30µg plague vaccine of 1.0ml in 120 adults aged 18-55 years old at day 0 and 28.
Intervention Type
Biological
Intervention Name(s)
Plague vaccine
Intervention Description
Plague vaccine is comrised by native fraction 1 capsule (F1) and recombine virulence-associated (V) antigens.
Primary Outcome Measure Information:
Title
To evaluate immunogenicity after vaccination.
Description
the GMT of antibodies to F1 antigen at day 28 post-dose2
Time Frame
Day 28 post-dose 2
Title
Proportion of subjects reporting solicited adverse reactions.
Description
Proportion of subjects reporting solicited adverse events within 7 days post-each dose
Time Frame
Day 7 post-each dose
Secondary Outcome Measure Information:
Title
GMI of antibodies to F1 antigen.
Time Frame
Day 28 post-each dose
Title
The seroconversion rate of antibodies to F1 antigen
Time Frame
Day 28 post-each dose
Title
GMT of antibodies to F1 antigen at day 28
Time Frame
Day 28 post- dose1
Title
GMT of antibodies to V antigen.
Time Frame
Day 28 post-each dose
Title
GMI of antibodies to V antigen.
Time Frame
Day 28 post-each dose
Title
The seroconversion rate of antibodies to V antigen.
Time Frame
Day 28 post-each dose
Title
Proportion of subjects reporting unsolicited adverse events
Description
Proportion of subjects reporting unsolicited adverse events within 28 days post-each dose
Time Frame
Day 28 post-each dose
Title
Proportion of subjects with serious adverse events (SAE)occurring throughout the trial
Description
Proportion of subjects with serious adverse events (SAE)occurring throughout the trial from day 0 to 56.
Time Frame
Day 0 up to day 28 post-dose 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuemei Hu, Bachelor
Organizational Affiliation
Jiangsu Provincial Center for Diseases Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jiangsu Provincial Center for Disease Control and Prevention
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
29927704
Citation
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.
Results Reference
derived

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Immunogenicity and Safety of Subunit Plague Vaccine

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