Vaccine Prevention of Rabies Adopts 4-shot Immunization Method

Randomized, Blind, Phase III Clinical Trial to Evaluate the Immunogenicity and Safety of Freeze-dried Human Rabies Vaccine (Vero Cell) Inoculated in 4-dose Program (2-1-1)

A phase III clinical trial to evaluate the immunogenicity and safety of freeze-dried human rabies vaccine (Vero cell) developed by Changchun Zhuoyi Biological Co., Ltd. inoculated in a 4-dose procedure (2-1-1)

Study Overview

• Status: Completed
• Conditions: Rabies Human; Antibody Titer
• Intervention / Treatment: Biological: rabies vaccine

Detailed Description

It is to prove that the freeze-dried human rabies vaccine (Vero cell) in the population aged 10-60 years, the four dose vaccination program is not inferior to the five dose vaccination program, and the safty、antibody positive conversion rate and geometric mean concentration of the four dose group of the test vaccine are not inferior to the five dose program group 14 days after the first dose vaccination.

To compare the immunogenicity of people aged 10-60 years old who were vaccinated 6 and 12 months after the whole vaccination, so as to evaluate the antibody positive rate and GMT 6 and 12 months after the test vaccine was vaccinated.

• Study Type: Interventional
• Enrollment (Actual): 1800
• Phase: Phase 3

Contacts and Locations

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:

• The age is 10-60 years old;
• Underarm temperature ≤ 37.0 ℃.

Exclusion Criteria:

• Have a history of rabies vaccine immunization or use of rabies virus passive immunization agents；
• Has been diagnosed with congenital or acquired immunodeficiency disease；
• Pregnancy (including positive urine pregnancy test) or lactation, planned pregnancy preparation within 2 months.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental 4 doses; Inoculate experimental vaccine according to 2-1-1 immunization procedure	Biological: rabies vaccine; The subjects were vaccinated with rabies vaccines with different immunization procedures, and the safety and immunogenicity were compared
Experimental: Experimental 5 doses; Inoculate experimental vaccine according to 1-1-1-1-1 immunization procedure	Biological: rabies vaccine; The subjects were vaccinated with rabies vaccines with different immunization procedures, and the safety and immunogenicity were compared
Active Comparator: SPEEDA® 4 doses; Inoculate SPEEDA® according to 2-1-1 immunization procedure	Biological: rabies vaccine; The subjects were vaccinated with rabies vaccines with different immunization procedures, and the safety and immunogenicity were compared

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antibody positive conversion rate of experimental groups	- Compare the Antibody positive conversion rate between two experimental groups 14 days after the first dose of inoculation.	3 months
Antibody positive conversion rate of 4 doses groups	-Compare the Antibody positive conversion rate between the SPEEDA 4 doses group and experimental 4 doses group 14 days after the first dose of inoculation.	3 months
Compare the GMT between two experimental groups	- Compare the GMT between two experimental groups 14 days after the first dose of inoculation.	3 months
Geometric Mean Titer (GMT) of 4 doses groups	- Compare the GMT between the SPEEDA 4 doses group and the experimental 4 doses group 14 days after the first dose inoculation.	3 months
Safety within 30 minutes	- Incidence rate of any local and systemic adverse events (AE) within 30 minutes after each dose of inoculation;	3 months
Safety within 0-7 days	- Incidence rate of collected AE within 0-7 days after each dose of inoculation;	3 months
Safety within 6 months	- Incidence rate of all serious adverse events (SAE) within 6 months from the first dose of inoculation to the full course of inoculation.	9months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antibody test of 7 days.	- Antibody test 7 days after the first dose of inoculation.	3 months
Antibody test after whole vaccination.	- Antibody test 14days after the whole vaccination.	3 months
Persistent observation within 12 months	- Antibody test in different points within 12 months after the whole vaccination.	16 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2020
• Primary Completion (Actual): October 31, 2021
• Study Completion (Actual): April 20, 2023

Study Registration Dates

• First Submitted: September 14, 2022
• First Submitted That Met QC Criteria: September 18, 2022
• First Posted (Actual): September 22, 2022

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: February 1, 2023

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: ZY201905001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all results.
• IPD Sharing Time Frame: before December 2023.
• IPD Sharing Access Criteria: public for all.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No