NCT05549908

Brief 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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,800

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jul 2020

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 22, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 22, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2023

Completed
Last Updated

March 13, 2024

Status Verified

February 1, 2023

Enrollment Period

1.3 years

First QC Date

September 14, 2022

Last Update Submit

March 11, 2024

Conditions

Rabies HumanAntibody Titer

Outcome Measures

Primary Outcomes (7)

  • 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 Outcomes (3)

  • Antibody test of 7 days.

    3 months

  • Antibody test after whole vaccination.

    3 months

  • Persistent observation within 12 months

    16 months

Study Arms (3)

Experimental 4 doses

EXPERIMENTAL

Inoculate experimental vaccine according to 2-1-1 immunization procedure

Biological: rabies vaccine

Experimental 5 doses

EXPERIMENTAL

Inoculate experimental vaccine according to 1-1-1-1-1 immunization procedure

Biological: rabies vaccine

SPEEDA® 4 doses

ACTIVE COMPARATOR

Inoculate SPEEDA® according to 2-1-1 immunization procedure

Biological: rabies vaccine

Interventions

rabies vaccineBIOLOGICAL

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

Experimental 4 dosesExperimental 5 dosesSPEEDA® 4 doses

Eligibility Criteria

Age10 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changchun Zhuoyi Biological Co., Ltd

Changchun, Jilin, 130000, China

Location

Related Publications (1)

  • Jin F, Zhu L, Wang Y, Qin G, Tian Y, Xie Y, Jin H, Zhang Y, Wang L, Li J, Wu Z, Sheng Y, Shi L, Yang G, Zhao Z, Chen L, Chen P, Jiang Z, Yu J, Gao Z, Li Q, Wu X, Miao L. Randomized, blind, controlled phase III clinical trial: Assessing the immunogenicity and safety of freeze-dried human rabies vaccine (vero cell) with a 4-dose regimen (2-1-1) in a 10-60 year-old demographic. Vaccine. 2024 Oct 3;42(23):126059. doi: 10.1016/j.vaccine.2024.06.026. Epub 2024 Jun 27.

    PMID: 38937182DERIVED

MeSH Terms

Interventions

Rabies Vaccines

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Li Miao, Dr

    Changchun Zhuoyi Biological Co., Ltd

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2022

First Posted

September 22, 2022

Study Start

July 22, 2020

Primary Completion

October 31, 2021

Study Completion

April 20, 2023

Last Updated

March 13, 2024

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will share

all results.

Shared Documents
STUDY PROTOCOL
Time Frame
before December 2023.
Access Criteria
public for all.

Locations

CN(1)