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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05547815

Enrollment

149

Registered

2022-09-21

Start date

2019-11-11

Completion date

2021-11-08

Last updated

2022-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antibody, Rabies

Keywords

rabies vaccine, antibody, persistence

Brief summary

Evaluation of immune persistence after rabies vaccination in 150 people.

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.

Interventions

BIOLOGICAL5 doses program

Inoculate 5 doses of rabies vaccine, and collect blood at fixed time points to detect neutralizing antibody

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

10 Years to 60 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026