NCT06314880

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

A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled Study to Evaluation the Safety, Tolerability, and Immunogenicity of Recombinant Meningococcal Group B Vaccine (E.Coli) in a Population Aged 3 Months-50 Years Old

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 3 Months – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a Phase I, single center, randomized, double-blind, placebo-controlled clinical trial conducted in Guangxi Province, China. The purpose of this study is to evaluate the safety and tolerability of the recombinant Group B meningococcal vaccine (E. coli) and explore its preliminary immunogenicity. Expected to include 300 subjects, divide them into 5 age groups of 18-50 years old, 6-17 years old, 2-5 years old, 6-23 months old, and 3-5 months old, and 2 dose groups, a total of 10 groups, with 30 people in each group. The experimental group and placebo control group are 20 people and 10 people, respectively.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant Meningococcal Group B Vaccine (E. Coli) (low-dose)	Each dose contains 60μg of MenB-fHBP-A and MenB-fHBP-B respectively. Administer one dose of 0.5mL each time. 20 people/group.
BIOLOGICAL	Recombinant Meningococcal Group B Vaccine (E. Coli) (hign-dose)	Each dose contains 100μg of MenB-fHBP-A and MenB-fHBP-B respectively. Administer one dose of 0.5mL each time. 20 people/group.
BIOLOGICAL	Placebo control	Placebo control. 20 people/group.

Timeline

• Start date: 2023-07-22
• Primary completion: 2024-12-30
• Completion: 2024-12-30
• First posted: 2024-03-18
• Last updated: 2024-04-03

Locations

1 site across 1 country: China