Vaccine Prevention of Rabies Adopts 4-shot Immunization Method

Changchun Zhuoyi Biological

Status and phase: Completed; Phase 3

Conditions: Rabies Human; Antibody Titer

Treatments: Biological: rabies vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT05549908

ZY201905001

Details and patient eligibility

About

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)

Full description

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.

Enrollment: 1,800 patients

Sex: All

Ages: 10 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,800 participants in 3 patient groups

Experimental 4 doses

Experimental group

Description:

Inoculate experimental vaccine according to 2-1-1 immunization procedure

Treatment:

Biological: rabies vaccine

Experimental 5 doses

Experimental group

Description:

Inoculate experimental vaccine according to 1-1-1-1-1 immunization procedure

Treatment:

Biological: rabies vaccine

SPEEDA® 4 doses

Active Comparator group

Description:

Inoculate SPEEDA® according to 2-1-1 immunization procedure

Treatment:

Biological: rabies vaccine