Observation on the Immune Persistence of People Aged 10-60 Years Old Immunized With Five Doses of Rabies Vaccine

September 18, 2022 updated by: Changchun Zhuoyi Biological Co., Ltd

Single Arm, Single Center Phase IV Clinical Trial to Evaluate the Immune Persistence and Safety of Freeze-dried Human Rabies Vaccine (Vero Cell)

Evaluation of immune persistence after rabies vaccination in 150 people.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

150 subjects aged 10-60 were recruited to inoculate the frozen human rabies vaccine (Vero cells) produced and marketed by Changchun Zhuoyi Biological Co., Ltd. in the whole process of 0, 3, 7, 14 and 28 day immunization. The immunogenicity persistence and safety of the test vaccine were evaluated 14 days, 6 months and 12 months after the whole process of vaccination.

Study Type

Interventional

Enrollment (Actual)

149

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 58 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 10-60 years old；
  • Temperature on the day of admission≤37.0 ° C (axillary temperature).

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental arm
5 doses of rabies vaccine
Biological: 5 doses program
Inoculate 5 doses of rabies vaccine, and collect blood at fixed time points to detect neutralizing antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
positive conversion rate evaluation (6 months)
Time Frame: 6 months
Evaluate the positive conversion rate 6 months after vaccination of rabies vaccine according to the 5-dose immunization program
6 months
antibody titer evaluation (6 months)
Time Frame: 6 months
Evaluate the antibody titer of serum neutralizing antibody 6 months after vaccination of rabies vaccine according to the 5-dose immunization program
6 months
positive conversion rate evaluation (12 months)
Time Frame: 12 months
Evaluate the positive conversion rate 12 months after vaccination of rabies vaccine according to the 5-dose immunization program
12 months
antibody titer evaluation (12 months)
Time Frame: 12 months
Evaluate the antibody titer of serum neutralizing antibody 12 months after vaccination of rabies vaccine according to the 5-dose immunization program
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changchun Zhuoyi Biological Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2019

Primary Completion (Actual)

December 17, 2020

Study Completion (Actual)

November 8, 2021

Study Registration Dates

First Submitted

September 13, 2022

First Submitted That Met QC Criteria

September 18, 2022

First Posted (Actual)

September 21, 2022

Study Record Updates

Last Update Posted (Actual)

September 21, 2022

Last Update Submitted That Met QC Criteria

September 18, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZY201909001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

all data of antibody titer .

IPD Sharing Time Frame

before December 2022.

IPD Sharing Access Criteria

public for all.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Clinical Study Report (CSR)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rabies

Clinical Trials on 5 doses program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belarus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe