To Evaluate the Immunogenicity and Safety of Two Different Immunization Schedules of Rabies Vaccine (Vero Cell)

Phase 3

Completed

• Conditions: Rabies Human
• Interventions: Biological: Experimental vaccine; Biological: Control vaccine

• Registration Number: NCT06177249
• Lead Sponsor: Hualan Biological Bacterin Co. Ltd.

Brief Summary

To evaluate the safety and immunogenicity of lyophilized human rabies vaccine (Vero cell) developed by Hualan Biological in healthy people aged 9 to 65 years with two different immunization schedules.

Detailed Description

The trial to assess the rabies vaccine (Vero cells) in healthy group of 9 \~ 65 years old after inoculation, the first dose after 14 days and 14 days after inoculation 5 agent group turn antibody positive rate of bad effect on 5 agent in the control group; The safety profile, seroconversion rate, and geometric mean concentration of the four-dose vaccine were noninferior to those of the five-dose regimen at 14 days after the first dose. More people aged 9-65 in the first agent free after 7 days, 14 days and 14 days after inoculation, 5 patients and 5 doses in the control group, four patients and 5 doses group antibody positive rate, GMC and GMC growth multiples have differences. To evaluate whether the seroconversion rate of subjects in the 4-dose experimental group reached 100% 14 days after the whole course of vaccination.

Study Timeline

• Status Verified: 2015-03
• Study Start: 2015-03-15
• Primary Completion: 2015-12-16
• Study Completion: 2016-05-01
• Study First Submitted: 2023-12-07
• Study First Submitted QC: 2023-12-19
• Last Update Submitted: 2023-12-19
• Study First Posted: 2023-12-20
• Last Update Posted: 2023-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1956

Inclusion Criteria

• 9 to 65 years old healthy residents;
• volunteered for the experiment and signed informed consent;
• the subjects or their guardians can comply with the requirements of the clinical trial protocol;
• have not received rabies vaccination at any time;
• nearly six months has not been mammals bite, scratch;
• not participating in clinical trials of other drugs;
• No use of human immunoglobulin or other products in the past six months.

Exclusion Criteria

First needle exclusion:

• have allergies, convulsions, seizures, mental and nervous system, such as history, or family history of epilepsy;
• Allergic to the main ingredient of the investigational vaccine;
• known to people with poor immune function damage or the tumor, spleen;
• Axillary temperature >38.0℃ within 7 days due to acute febrile illness;
• Patients with axillary body temperature > 37.0℃;
• Severe chronic diseases such as congenital malformation, developmental disorder or severe cardiovascular disease, diabetes mellitus, hypertension that cannot be stabilized by drugs, liver and kidney diseases, and malignant tumors;
• patients with acute and chronic infectious diseases, active infections, severe asthma, infectious skin diseases;
• pregnant and lactating women; Any circumstances that the investigator believes may affect the assessment of the trial.

Subsequent needle exclusions:

• any serious adverse event causally related to vaccination;
• new findings that meet the "first dose exclusion criteria";
• the researchers think that may affect test evaluation of any situation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental vaccines	Experimental vaccine	An additional group of 652 people received the trial vaccine in a 0 -, 7 -, and 21-day schedule (two first doses for a total of four doses). Blood samples were collected at 0, 7/14 and 35/42 days for antibody detection, and all subjects were systematically observed for safety.
Experimental vaccines and vaccine	Control vaccine	A total of 1956 subjects were randomly divided into three groups at a ratio of 1:1:1, 652 subjects in each group were vaccinated with the test vaccine or the control vaccine on a schedule of 0, 3, 7, 14, 28 days (a total of 5 doses). Blood samples were collected from the subjects for antibody detection on 0, 7/14, 35/42 days, respectively.
Experimental vaccines and vaccine	Experimental vaccine	A total of 1956 subjects were randomly divided into three groups at a ratio of 1:1:1, 652 subjects in each group were vaccinated with the test vaccine or the control vaccine on a schedule of 0, 3, 7, 14, 28 days (a total of 5 doses). Blood samples were collected from the subjects for antibody detection on 0, 7/14, 35/42 days, respectively.

Primary Outcome Measures

Name	Time	Method
1956 subjects accept the observation of systemic adverse reactions according to Guidelines for grading standard of adverse reaction of clinical trial of vaccine used for prevention.	Vaccinations 31 days to 180 days	Fever, allergy, headache, fatigue, nausea and vomiting, diarrhea, muscle pain, arthralgia and so on were observed
1956 subjects accept the observation of local adverse reaction according to Guidelines for grading standard of adverse reaction of clinical trial of vaccine used for prevention	Vaccinations 31 days to 180 days	Tenderness, pruritus, induration, redness, swelling and its degree of size and disturbance of body activity at the inoculation site

Secondary Outcome Measures

Name	Time	Method
The immunogenicity was tested by immunofluorescence staining	Blood samples were collected on day 0, 7, 14 and 35 in the 4-dose group	The rabies virus antibody was detected by immunofluorescence focus method. The positive rate was defined as the serum antibody concentration ≥0.5IU/ml

Trial Locations

Locations (1)

Xia Shengli; 🇨🇳 Zhengzhou, Henan, China