Prevention of Rabies With Four Doses of Rabies Vaccine

Phase 3

• Conditions: Antibody; Rabies Human
• Interventions: Biological: immunization procedures

• Registration Number: NCT05545371
• Lead Sponsor: Changchun Zhuoyi Biological Co., Ltd

Brief Summary

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.

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 Timeline

• Study Start: 2022-06-18
• Study First Submitted: 2022-09-14
• Study First Submitted QC: 2022-09-16
• Study First Posted: 2022-09-19
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-09
• Last Update Posted: 2024-07-10
• Primary Completion: 2024-11-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 2100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
5 doses	immunization procedures	Inoculate rabies vaccine according to 1-1-1-1-1 immunization procedure
4 doses	immunization procedures	Inoculate rabies vaccine according to 1-1-1-1 immunization procedure

Primary Outcome Measures

Name	Time	Method
Serious Adverse Events (SAE) incidence within 6 months	12 months	- Incidence rate of SAE within 6 months from the first dose of inoculation to the full course of inoculation.
Positive conversion rate of 14 days	6 months	- 14 days after the first dose of inoculation, the positive conversion rate of serum neutralizing antibody.
Positive conversion rate of 42 days	6 months	- The seroconversion rate of serum neutralizing antibody that 42 days after the first dose of inoculation.
Advertise Events (AE) incidence within 1 month	6 months	- 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;
Antibody Geometric Mean Titer (GMT) of 14 days	6 months	- 14 days after the first dose of inoculation, the Geometric Mean Titer (GMT) of serum neutralizing antibody .

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Changchun Zhuoyi Biological Co., Ltd; 🇨🇳 Changchun, Jilin, China