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Completed

NCT Number: NCT05547815

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

Evaluation of immune persistence after rabies vaccination in 150 people.

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Key information

Conditions

Rabies Antibody Infections Mononegavirales Infections RNA Virus Infections Rhabdoviridae Infections Virus Diseases

Age range

10 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Changchun Zhuoyi Biological Co., Ltd

Changchun, Jilin, 130000, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

5 doses program

Biological

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Changchun Zhuoyi Biological Co., Ltd

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Sep 21, 2022
Registry last updated
Sep 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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