Safety, Tolerability, and Immunogenicity of Recombinant Meningococcal Group B Vaccine (E.Coli)

NCT06314880 | Recruiting Phase 1

• 1 other identifier: 2022112701
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The research objective is to evaluate the safety and tolerability of the recombinant Group B meningococcal vaccine (E. coli) and explore its preliminary immunogenicity.

Conditions

Healthy Volunteers

Keywords

Recombinant Meningococcal Group B Vaccine (E. Coli)

Outcome Measures

Primary Outcomes (5)

• The incidence rate of all AEs within 0-30 days after each dose of vaccination

  All AEs occurrence within 0-30 days after each dose of vaccination (occurrences, number of cases, incidence rate, and relationship with vaccination)

  within 0-30 days after vaccination

• The incidence rate of solicited AEs within 30 minutes after each dose of vaccination

  All solicited AEs occurrence within 30 minutes after each dose of vaccination (occurrences, number of cases, incidence rate, and relationship with vaccination)

  within 30 minutes after vaccination

• The incidence rate of solicited AEs within 0-14 days after each dose of vaccination

  All solicited AEs occurrence within 0-14 days after each dose of vaccination (occurrences, number of cases, incidence rate, and relationship with vaccination)

  within 0-14 days vaccination

• The incidence rate of unsolicited AEs within 0-30 days after each dose of vaccination

  All unsolicited AEs occurrence within 0-30 days after each dose of vaccination (occurrences, number of cases, incidence rate, and relationship with vaccination)

  within 0-30 days vaccination

• The incidence rate of grade 3 and higher AEs within 0-30 days after each dose of vaccination

  All grade 3 and higher AEs occurrence within 0-30 days after each dose of vaccination (occurrences, number of cases, incidence rate, and relationship with vaccination)

  within 0-30 days vaccination

Study Arms (5)

18-50 years old

EXPERIMENTAL

60 people per age group. The first 15 subjects in the 18-50 age group will serve as sentinels, with 10 in the experimental group and 5 in the control group.

Biological: Recombinant Meningococcal Group B Vaccine (E. Coli) (low-dose); Biological: Recombinant Meningococcal Group B Vaccine (E. Coli) (hign-dose); Biological: Placebo control

6-17 years old

EXPERIMENTAL

60 people per age group. Divided into high-dose group, low-dose group, and placebo group.

Biological: Recombinant Meningococcal Group B Vaccine (E. Coli) (low-dose); Biological: Recombinant Meningococcal Group B Vaccine (E. Coli) (hign-dose); Biological: Placebo control

2-5 years old

EXPERIMENTAL

60 people per age group. Divided into high-dose group, low-dose group, and placebo group.

Biological: Recombinant Meningococcal Group B Vaccine (E. Coli) (low-dose); Biological: Recombinant Meningococcal Group B Vaccine (E. Coli) (hign-dose); Biological: Placebo control

6-23 months old

EXPERIMENTAL

60 people per age group. Divided into high-dose group, low-dose group, and placebo group.

Biological: Recombinant Meningococcal Group B Vaccine (E. Coli) (low-dose); Biological: Recombinant Meningococcal Group B Vaccine (E. Coli) (hign-dose); Biological: Placebo control

3-5 months old

EXPERIMENTAL

60 people per age group. Divided into high-dose group, low-dose group, and placebo group.

Biological: Recombinant Meningococcal Group B Vaccine (E. Coli) (low-dose); Biological: Recombinant Meningococcal Group B Vaccine (E. Coli) (hign-dose); Biological: Placebo control

Interventions

Recombinant Meningococcal Group B Vaccine (E. Coli) (low-dose) BIOLOGICAL

Each dose contains 60μg of MenB-fHBP-A and MenB-fHBP-B respectively. Administer one dose of 0.5mL each time. 20 people/group.

18-50 years old; 2-5 years old; 3-5 months old; 6-17 years old; 6-23 months old

Recombinant Meningococcal Group B Vaccine (E. Coli) (hign-dose) BIOLOGICAL

Each dose contains 100μg of MenB-fHBP-A and MenB-fHBP-B respectively. Administer one dose of 0.5mL each time. 20 people/group.

18-50 years old; 2-5 years old; 3-5 months old; 6-17 years old; 6-23 months old

Placebo control BIOLOGICAL

Placebo control. 20 people/group.

18-50 years old; 2-5 years old; 3-5 months old; 6-17 years old; 6-23 months old

Eligibility Criteria

• Age: 3 Months - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age range from 3 months to 50 years old, legal guardian and/or individual can provide legal identification;
• The subjects and/or their legal guardians have the ability to understand the research procedures, agree to participate in the study (and/or their legal guardians agree to the child's participation in the study), and sign an informed consent form;
• The subjects and/or their legal guardians are able to participate in all planned follow-up visits;
• On the day of enrollment, the axillary temperature was less than 37.3 ℃;
• Standards for certain groups of people:
• Subjects ≥ 2 years old: laboratory test indicators (as specified in the protocol) within the normal range, or those with abnormalities but no clinical significance (evaluated by clinical doctors);
• Female participants of childbearing age: Agree to take effective contraceptive measures within 6 months from enrollment to full vaccination.

You may not qualify if:

• Have received any Group B meningococcal vaccine in the past;
• A history of invasive diseases caused by meningococcus or gonococci;
• Pregnant or lactating women;
• Have any history of severe allergies to vaccines or drugs in the past, such as allergic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura;
• Suffering from serious heart disease, liver disease, kidney disease, congenital malformations, developmental disorders, and genetic defects (including but not limited to Down syndrome, moderate to severe thalassemia, etc.) that may interfere with the progress or completion of the study;
• Diagnosed as having congenital or acquired immunodeficiency, or suspected of having serious chronic or systemic diseases that may interfere with the conduct or completion of the study, such as active tuberculosis, hepatitis B, hepatitis C, human immunodeficiency virus (HIV), syphilis infection, etc;
• Individuals with encephalopathy, uncontrolled epilepsy, seizures, and other progressive neurological disorders, or a history or family history of mental illness;
• Suffering from contraindications for intramuscular injection such as thrombocytopenia, any coagulation disorders, or receiving anticoagulant therapy;
• Received immunosuppressive therapy within 3 months prior to vaccination, such as continuous use of systemic glucocorticoid therapy for more than 2 weeks, such as prednisone or similar drugs\>5mg/day (note: local and inhaled/nebulized steroids can be used);
• Asplenia or splenectomy, functional asplenia caused by any circumstances;
• Subjects with hypertension (systolic blood pressure ≥ 140mmHg and/or diastolic blood pressure ≥ 90mmHg, suitable for adults);
• Suffering from acute illness or in the acute phase of chronic illness, or using antipyretic, analgesic, and antiallergic drugs (such as acetaminophen, ibuprofen, aspirin, etc.) three days before the first dose of vaccination;
• Within 7 days (≤ 7 days) prior to enrollment, received inactivated vaccines, and within 14 days (≤ 14 days) received live attenuated vaccines;
• Has received blood or blood related products or immunoglobulin (hepatitis B immunoglobulin is acceptable) within 3 months prior to enrollment;
• Premature infants (gestational age\<37 weeks), low birth weight infants (birth weight\<2500g), and infants with a history of abnormal labor (only applicable to the 3-5 month and 6-23 month age groups);

Sponsors & Collaborators

• Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd: lead

Study Sites (1)

Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention

Nanning, Guangxi, 530028, China

RECRUITING

MeSH Terms

Conditions

Escherichia coli Infections

Condition Hierarchy (Ancestors)

Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Lin Du

  Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

  STUDY CHAIR

Central Study Contacts

Wenjian Fang

CONTACT

+86-18611630252; fangwenjian@zhifeishengwu.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: March 18, 2024
• Study Start: July 22, 2023
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: April 3, 2024

Record last verified: 2024-02

Locations

CN (1)