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

NCT ID: NCT06177249

Last Updated: 2023-12-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1956 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-15
• Study Completion Date: 2016-05-01

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.

Conditions

Rabies Human

Keywords

Antibody Titer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: QUADRUPLE

Study Groups

Experimental vaccines and 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.

Group Type: ACTIVE_COMPARATOR

Control vaccine

Intervention Type: BIOLOGICAL

A group of 652 subjects were vaccinated with the control vaccine at 0, 3, 7, 14 and 28 days (5 doses in total). Blood samples were collected from the subjects at 0, 7/14 and 35/42 days for antibody detection.

Experimental vaccine

Intervention Type: BIOLOGICAL

A total of 652 subjects received 5 doses of the vaccine at 0, 3, 7, 14 and 28 days. Blood samples were collected on 0, 7/14 and 35/42 days for antibody detection.

experimental vaccines

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.

Group Type: ACTIVE_COMPARATOR

Experimental vaccine

Intervention Type: BIOLOGICAL

A total of 652 subjects received 5 doses of the vaccine at 0, 3, 7, 14 and 28 days. Blood samples were collected on 0, 7/14 and 35/42 days for antibody detection.

Interventions

Control vaccine

A group of 652 subjects were vaccinated with the control vaccine at 0, 3, 7, 14 and 28 days (5 doses in total). Blood samples were collected from the subjects at 0, 7/14 and 35/42 days for antibody detection.

Intervention Type: BIOLOGICAL

Experimental vaccine

A total of 652 subjects received 5 doses of the vaccine at 0, 3, 7, 14 and 28 days. Blood samples were collected on 0, 7/14 and 35/42 days for antibody detection.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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;
• the researchers think that may affect test evaluation of any situation.

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Henan Center for Disease Control and Prevention

OTHER_GOV

Sponsor Role: collaborator

Hualan Biological Bacterin Co. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Xia Shengli

Zhengzhou, Henan, China

Countries

China

Other Identifiers

2014L00266

Identifier Type: -

Identifier Source: org_study_id