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Completed

NCT Number: NCT05549908

Vaccine Prevention of Rabies Adopts 4-shot Immunization Method

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)

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Key information

Conditions

Rabies Human Antibody Titer

Age range

10 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Changchun Zhuoyi Biological Co., Ltd

Changchun, Jilin, 130000, China

About this study

It is to prove that the freeze-dried human rabies vaccine (Vero cell) in the population aged 10-60 years, the four dose vaccination program is not inferior to the five dose vaccination program, and the safty、antibody positive conversion rate and geometric mean concentration of the four dose group of the test vaccine are not inferior to the five dose program group 14 days after the first dose vaccination.

To compare the immunogenicity of people aged 10-60 years old who were vaccinated 6 and 12 months after the whole vaccination, so as to evaluate the antibody positive rate and GMT 6 and 12 months after the test vaccine was vaccinated.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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

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

Rabies vaccine

Biological

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

Primary outcomes

  1. Antibody positive conversion rate of experimental groups

    Time frame: 3 months

    • Compare the Antibody positive conversion rate between two experimental groups 14 days after the first dose of inoculation.

  2. Antibody positive conversion rate of 4 doses groups

    Time frame: 3 months

    -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. Compare the GMT between two experimental groups

    Time frame: 3 months

    • Compare the GMT between two experimental groups 14 days after the first dose of inoculation.

  4. Geometric Mean Titer (GMT) of 4 doses groups

    Time frame: 3 months

    • Compare the GMT between the SPEEDA 4 doses group and the experimental 4 doses group 14 days after the first dose inoculation.

  5. Safety within 30 minutes

    Time frame: 3 months

    • Incidence rate of any local and systemic adverse events (AE) within 30 minutes after each dose of inoculation;

  6. Safety within 0-7 days

    Time frame: 3 months

    • Incidence rate of collected AE within 0-7 days after each dose of inoculation;

  7. Safety within 6 months

    Time frame: 9months

    • Incidence rate of all serious adverse events (SAE) within 6 months from the first dose of inoculation to the full course of inoculation.

Secondary outcomes

  1. Antibody test of 7 days.

    Time frame: 3 months

    • Antibody test 7 days after the first dose of inoculation.

  2. Antibody test after whole vaccination.

    Time frame: 3 months

    • Antibody test 14days after the whole vaccination.

  3. Persistent observation within 12 months

    Time frame: 16 months

    • Antibody test in different points within 12 months after the whole vaccination.

Sponsors and collaborators

Lead sponsor

Changchun Zhuoyi Biological Co., Ltd

Other

Registry information

Official study title

Randomized, Blind, Phase III Clinical Trial to Evaluate the Immunogenicity and Safety of Freeze-dried Human Rabies Vaccine (Vero Cell) Inoculated in 4-dose Program (2-1-1)

Important dates

Study start
2020
Primary completion
2021
Study completion
2023
First posted
Sep 22, 2022
Registry last updated
Mar 13, 2024

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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