Immunogenicity and Safety of Subunit Plague Vaccine

NCT02596308 | Completed Phase 2

• 1 other identifier: JSVCT017
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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).

Conditions

Plague

Keywords

Plague vaccine; Immunogenicity; Safety

Outcome Measures

Primary Outcomes (2)

• To evaluate immunogenicity after vaccination.

  the GMT of antibodies to F1 antigen at day 28 post-dose2

  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

  Day 7 post-each dose

Secondary Outcomes (8)

• GMI of antibodies to F1 antigen.

  Day 28 post-each dose

• The seroconversion rate of antibodies to F1 antigen

  Day 28 post-each dose

• GMT of antibodies to F1 antigen at day 28

  Day 28 post- dose1

• GMT of antibodies to V antigen.

  Day 28 post-each dose

• GMI of antibodies to V antigen.

  Day 28 post-each dose

Study Arms (2)

15µg vaccine

EXPERIMENTAL

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

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.

Biological: Plague vaccine

Interventions

Plague vaccine BIOLOGICAL

Plague vaccine is comrised by native fraction 1 capsule (F1) and recombine virulence-associated (V) antigens.

15µg vaccine; 30µg vaccine

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu Province Centers for Disease Control and Prevention: lead
• Lanzhou Institute of Biological Products Co., Ltd: collaborator

Study Sites (1)

Jiangsu Provincial Center for Disease Control and Prevention

Nanjing, Jiangsu, 210009, China

Location

Related Publications (1)

• 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.

  PMID: 29927704 DERIVED

MeSH Terms

Conditions

Plague

Interventions

Plague Vaccine

Condition Hierarchy (Ancestors)

Yersinia Infections; Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Yuemei Hu, Bachelor

  Jiangsu Provincial Center for Diseases Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2015
• First Posted: November 4, 2015
• Study Start: October 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: January 1, 2015
• Last Updated: November 4, 2015

Record last verified: 2015-11

Locations

CN (1)