Prevention of Rabies With Four Doses of Rabies Vaccine

Randomized, Blind and Positive Control Design: a Phase III Clinical Trial to Evaluate the Consistency Between Batches of 5 Doses of Freeze-dried Rabies Vaccine (Vero Cell) and the Immunogenicity and Safety of 4 Doses of Vaccine (1-1-1-1)

To evaluate the non inferiority of the immunogenicity of the test vaccine inoculated according to the four dose immunization program over the five dose immunization program and the batches consistency of immunogenicity according to five dose immunization procedures.

Study Overview

• Status: Enrolling by invitation
• Conditions: Rabies Human; Antibody
• Intervention / Treatment: Biological: immunization procedures

Detailed Description

• In the population aged 10-60 years, evaluate the non inferiority of the immunogenicity of the test vaccine inoculated according to the four dose immunization program (0, 3, 7, 14/28 days) over the five dose immunization program (0, 3, 7, 14, 28 days)；
• To evaluate the consistency of immunogenicity between batches of freeze-dried human rabies vaccine (Vero cell) inoculated according to five dose immunization procedures (0, 3, 7, 14, 28 days).

• Study Type: Interventional
• Enrollment (Estimated): 2100
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Li Miao; Phone Number: 18686674382; Email: 943749635@qq.com

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China, 130000
      • Changchun Zhuoyi Biological Co., Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• People aged 10-60；
• Body temperature on the day of enrollment<37.3℃ (axillary temperature)

Exclusion Criteria:

• Have a history of rabies vaccine immunization or use of rabies virus passive immunization agents；
• People with congenital or acquired immunodeficiency or other autoimmune diseases；
• Female urine pregnancy test is positive, or during pregnancy and lactation, or she has a birth plan during the study period;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 4 doses; Inoculate rabies vaccine according to 1-1-1-1 immunization procedure	Biological: immunization procedures; The subjects were vaccinated with rabies vaccine according to different immunization procedures
Experimental: 5 doses; Inoculate rabies vaccine according to 1-1-1-1-1 immunization procedure	Biological: immunization procedures; The subjects were vaccinated with rabies vaccine according to different immunization procedures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive conversion rate of 14 days	- 14 days after the first dose of inoculation, the positive conversion rate of serum neutralizing antibody.	6 months
Antibody Geometric Mean Titer (GMT) of 14 days	- 14 days after the first dose of inoculation, the Geometric Mean Titer (GMT) of serum neutralizing antibody .	6 months
Positive conversion rate of 42 days	- The seroconversion rate of serum neutralizing antibody that 42 days after the first dose of inoculation.	6 months
Advertise Events (AE) incidence within 1 month	- The distribution of AE incidence in different time periods (including all, within 30 minutes, 0-3 days, 0-7 days, 8-30 days) after each dose of inoculation;	6 months
Serious Adverse Events (SAE) incidence within 6 months	- Incidence rate of SAE within 6 months from the first dose of inoculation to the full course of inoculation.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antibody test of 28 days	Detection of serum neutralizing antibody 28 days after the first dose of inoculation	6 months
Antibody GMT of 42 days	The serum neutralized antibody GMT 42 days after the first dose of inoculation;	6 months
Antibody test within 12 months	The serum neutralizing antibody was detected in 3 timepoints within 12 months after the whole vaccination.	18months

Collaborators and Investigators

• Sponsor: Changchun Zhuoyi Biological Co., Ltd
• Investigators: Study Director: Li Miao, Changchun Zhuoyi Biological Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2022
• Primary Completion (Estimated): May 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: September 14, 2022
• First Submitted That Met QC Criteria: September 16, 2022
• First Posted (Actual): September 19, 2022

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Mononegavirales Infections; Rhabdoviridae Infections; Rabies
• Other Study ID Numbers: ZY202106001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: safety and antibody results.
• IPD Sharing Time Frame: before December 2024.
• IPD Sharing Access Criteria: public to all.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No