Vaccine Prevention of Rabies Adopts 4-shot Immunization Method

Rabies Human Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05549908
• Other study ID #: ZY201905001
• Status: Completed
• Phase: Phase 3
• Start date: July 22, 2020
• Est. completion date: April 20, 2023

Study information

• Verified date: February 2023
• Source: Changchun Zhuoyi Biological Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1800
• Est. completion date: April 20, 2023
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Rabies
• Rabies Human

Intervention

Biological:
• rabies vaccine
The subjects were vaccinated with rabies vaccines with different immunization procedures, and the safety and immunogenicity were compared

Locations

Country	Name	City	State
China	Changchun Zhuoyi Biological Co., Ltd	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Changchun Zhuoyi Biological Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Compare the GMT between two experimental groups	- Compare the GMT between two experimental groups 14 days after the first dose of inoculation.	3 months
Primary	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
Primary	Safety within 30 minutes	- Incidence rate of any local and systemic adverse events (AE) within 30 minutes after each dose of inoculation;	3 months
Primary	Safety within 0-7 days	- Incidence rate of collected AE within 0-7 days after each dose of inoculation;	3 months
Primary	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	Antibody test of 7 days.	- Antibody test 7 days after the first dose of inoculation.	3 months
Secondary	Antibody test after whole vaccination.	- Antibody test 14days after the whole vaccination.	3 months
Secondary	Persistent observation within 12 months	- Antibody test in different points within 12 months after the whole vaccination.	16 months