Immunogenicity and Safety of Subunit Vaccine of Plague Vaccine With Two Immunization Regimens

NCT05330624 | Unknown Phase 2

• 1 other identifier: JSVCT083
• Study Type: interventional
• Target: 720
• 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 pose a serious threat to international security. Althought the killed whole-cell plague vaccine and live attenuated vaccine has 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, it have focused on recombinant subunit vaccines which were formed F1 and V antigens as the main composition provide 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 natural F1 antigen and recombined V antigen (F1+rV) in two immunization regimens.

Conditions

Plague

Keywords

Plague vaccine, Immunogenicity, Safety

Outcome Measures

Primary Outcomes (2)

• the GMT of antibodies to F1 antigen on Month 7 post-dose 1

  the GMT of antibodies to F1 antigen on Month 7 post-dose 1

  Month 7 post-dose 1

• the GMT of antibodies to rV antigen on Month 7 post-dose 1

  the GMT of antibodies to rV antigen on Month 7 post-dose 1

  Month 7 post-dose 1

Secondary Outcomes (54)

• The seroconversion of antibodies to F1 antigen on Month 7 post-dose 1

  Month 7 post-dose 1

• The GMFI of antibodies to F1 antigen on Month 7 post-dose 1

  Month 7 post-dose 1

• The seroconversion of antibodies to rV antigen on Month 7 post-dose 1

  Month 7 post-dose 1

• The GMFI of antibodies to rV antigen on Month 7 post-dose 1

  Month 7 post-dose 1

• The GMT of antibodies to F1 antigen on Month 1 post-dose 1

  Month 1 post-dose 1

Study Arms (2)

the D0- M1-M6 regimen

EXPERIMENTAL

Adults receive three doses of 1.0 ml plague vaccine at day 0, month 1, and month 6 (referred as the D0-M1-M6 regimen).

Biological: plague vaccine(F1+rV)

the D0- M2-M6 regimen

EXPERIMENTAL

Adults receive three doses of 1.0 ml plague vaccine at day 0, month 2, and month 6 (referred as the D0-M2-M6 regimen).

Biological: plague vaccine(F1+rV)

Interventions

plague vaccine(F1+rV) BIOLOGICAL

plague vaccine(F1+rV) (Lanzhou Institute of Biological Products Co.,Ltd) of 1.0ml, three doses

the D0- M1-M6 regimen; the D0- M2-M6 regimen

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, taboos of intramuscular injection and collection of blood.
• Difficulty in blood collection.
• Any prior administration of immunodepressant or corticosteroids, and antianaphylactic treatment, cytotoxic therapy in last 6 months.
• Any prior administration of blood products in last 3 month.
• Any prior administration of other research medicines in last 4 weeks.
• 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.
• Any condition that in the opinion of the investigator, may interferes the evaluation of study objectives.

Sponsors & Collaborators

• Jiangsu Province Centers for Disease Control and Prevention: lead

Study Sites (1)

Jiangsu Provincial Center for Diseases Control and Prevention

Nanjing, Jiangsu, 210009, China

Location

MeSH Terms

Conditions

Plague

Condition Hierarchy (Ancestors)

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

Study Officials

• Fengcai Zhu, Master

  Jiangsu Provincial Center for Diseases Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2022
• First Posted: April 15, 2022
• Study Start: May 8, 2020
• Primary Completion: May 20, 2022
• Study Completion: September 20, 2022
• Last Updated: April 15, 2022

Record last verified: 2022-04

Locations

CN (1)