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

Sponsor

Changchun Zhuoyi Biological Co., Ltd (Other)

Overall Status

Completed

CT.gov ID

NCT05547815

Collaborator

(none)

149

Enrollment

Location

Arm

23.9

Actual Duration (Months)

6.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Evaluation of immune persistence after rabies vaccination in 150 people.

Condition or Disease	Intervention/Treatment	Phase
Rabies Antibody	Biological: 5 doses program	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

149 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Nov 11, 2019

Actual Primary Completion Date :

Dec 17, 2020

Actual Study Completion Date :

Nov 8, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

positive conversion rate evaluation (6 months) [6 months]
Evaluate the positive conversion rate 6 months after vaccination of rabies vaccine according to the 5-dose immunization program
antibody titer evaluation (6 months) [6 months]
Evaluate the antibody titer of serum neutralizing antibody 6 months after vaccination of rabies vaccine according to the 5-dose immunization program
positive conversion rate evaluation (12 months) [12 months]
Evaluate the positive conversion rate 12 months after vaccination of rabies vaccine according to the 5-dose immunization program
antibody titer evaluation (12 months) [12 months]
Evaluate the antibody titer of serum neutralizing antibody 12 months after vaccination of rabies vaccine according to the 5-dose immunization program

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Changchun Zhuoyi Biological Co., Ltd	Changchun	Jilin	China	130000

Sponsors and Collaborators

Changchun Zhuoyi Biological Co., Ltd

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Changchun Zhuoyi Biological Co., Ltd

ClinicalTrials.gov Identifier:

NCT05547815

Other Study ID Numbers:

ZY201909001

First Posted:

Sep 21, 2022

Last Update Posted:

Sep 21, 2022

Last Verified:

Sep 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Changchun Zhuoyi Biological Co., Ltd

rabies vaccine

antibody

persistence

Additional relevant MeSH terms:

Rabies

Study Results

No Results Posted as of Sep 21, 2022