Rabies Human
Conditions
Keywords
Antibody Titer
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.
Interventions
BIOLOGICALControl 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.
BIOLOGICALExperimental 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.
Sponsors
Henan Center for Disease Control and Prevention
Hualan Biological Bacterin Co. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
double blind
Intervention model description
Lyophilized rabies vaccine for human use (Vero cell) and control vaccine
Eligibility
Sex/Gender
ALL
Age
9 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Every needle 30 days after vaccination | Tenderness, pruritus, induration, redness, swelling and its degree of size and disturbance of body activity at the inoculation site |
| 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. | Every needle 30 days after vaccination | Fever, allergy, headache, fatigue, nausea and vomiting, diarrhea, muscle pain, arthralgia and so on were observed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The immunogenicity was tested by immunofluorescence staining | 5 agent group gathering subjects were 0, 7, 14, 42 days of blood samples | The rabies virus antibody was detected by immunofluorescence focus method. The positive rate was defined as the serum antibody concentration ≥0.5IU/ml |
Countries
China
Outcome results
None listed