The Safety Research of Freeze-dried Rabies Vaccine（MRC-5 Cell) in Chinese Humans

A Safety Study of Freeze-dried Rabies Vaccine(MRC-5 Cell)in Chinese Humans From 10-60 Years Old

The purpose of this study is to evaluate the safety of Freeze-dried Rabies Vaccine （MRC-5 Cell) in healthy humans aged from 10-60 years old, according to the traditional Essen methods (1-1-1-1-1) vaccination.

Study Overview

• Status: Completed
• Conditions: Healthy; Rabies
• Intervention / Treatment: Biological: 2.5IU/ml in rabies vaccine （MRC-5 Cell) humans aged 10-20 years old; Biological: 2.5IU/ml rabies vaccine （MRC-5 Cell) in humans aged 21-60 years old; Biological: 2.5IU/ml rabies vaccine （MRC-5 Cell) in humans(from 10-20 years old); Biological: 2.5IU/ml rabies vaccine （MRC-5 Cell) in humans(from 21-60 years old)

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 58 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 10-60 years old healthy people with normal intelligence
• Obtain informed consent from the participants or their guardians, and signed informed consent
• The participants or their guardians can comply with the requirements of clinical trial scheme
• The axillary temperature is 37.0 ℃ or less

Exclusion Criteria:

• participants who vaccinated with rabies vaccine before
• participants who used anti-rabies passive immunization agents
• participants who were Suspect or have a history of injury which is hurted by warm-blooded mammals
• Female who was pregnant, or in the lactation period, or have Pregnant plans in the clinical trial.
• participants who have allergy history, especially those who are allergic to neomycin,or had serious adverse reactions ever, Such as allergies, hives, difficulty breathing, angioneurotic edema, or abdominal pain and so on.
• participants who had been diagnosed or suspected to have immunodeficiency or Autoimmune diseases,or have Immune system disorders.
• participants who have Thyroidectomy History,or had been treated because of Thyroid disease in the past year.
• participants who had abnormal clotting which is diagnosed by doctor(such as clotting factor deficiency, coagulation disorders, platelet abnormalities),or who had coagulopathy.
• Participants who had history of epilepsy, seizures or convulsions ,or family history of mental illness.
• Participants who is asplenia, or functional asplenia, and asplenia or splenic resection under any circumstances.
• Participants who had immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids in the past six months. (It does not include Corticosteroid spray treatment Of allergic rhinitis, Surface treatment with corticosteroids because of acute uncomplicated dermatitis)
• Participants who had Received blood products in the past 3 months
• Participants who had Received other investigational drug in the past one month.
• Participants who had received Live attenuated vaccine 14 days before the clinical trial.
• Participants who had received Subunit vaccines and inactivated vaccines 7days before the clinical trial.
• Participants who was having the prevent or the treatment of Antituberculosis.
• Participants who had fever 3 days before receiving the Vaccine.( Axillary temperature is above 38℃)
• Participants who was suffering from severe chronic.( Such as Down's syndrome, diabetes, sickle cell anemia or neurological disorder, Guillain-Barre syndrome);
• Participants who was diagnosed or suspected to be suffering from some disease, such as Respiratory diseases, acute infection, Chronic of active stage，Cardiovascular Disease, Severe hypertension, Skin disease ,or the mother or her children was HIV-infected, besides the participants were during the Treatment period of malignant tumors,.
• According to the researchers, there are other factors that are not suitable for Participants to join the clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 2.5IU/ml in humans aged 10-20 years old; freeze-dried rabies vaccine(MRC-5 cell) of 2.5IU/ml in 20 humans aged 10-20 years old on day 0,3,7,14,28	Biological: 2.5IU/ml in rabies vaccine （MRC-5 Cell) humans aged 10-20 years old; Freeze-dried Rabies Vaccine（MRC-5 Cell) of 2.5IU/ml,5 doses,4 weeks interval
Experimental: 2.5IU/ml in humans aged 21-60 years old; freeze-dried rabies vaccine(MRC-5 cell) of 2.5IU/ml in 20 humans aged 21-60 years old on day 0,3,7,14,28	Biological: 2.5IU/ml rabies vaccine （MRC-5 Cell) in humans aged 21-60 years old; Freeze-dried Rabies Vaccine（MRC-5 Cell) of 2.5IU/ml,5 doses,4 weeks interval
Active Comparator: 2.5IU/ml in humans(from 10-20 years old); freeze-dried rabies vaccine(vero cell) of 2.5IU/ml in 20 humans aged 10-20 years old on day 0,3,7,14,28	Biological: 2.5IU/ml rabies vaccine （MRC-5 Cell) in humans(from 10-20 years old); Freeze-dried Rabies Vaccine（vero Cell) of 2.5IU/ml,5 doses,4 weeks interval
Active Comparator: 2.5IU/ml in humans(from 21-60 years old); freeze-dried rabies vaccine(vero cell) of 2.5IU/ml in 20 humans aged 21-60 years old on day 0,3,7,14,28	Biological: 2.5IU/ml rabies vaccine （MRC-5 Cell) in humans(from 21-60 years old); Freeze-dried Rabies Vaccine（vero Cell) of 2.5IU/ml,5 doses,4 weeks interval

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
evaluate the safety of freeze-dried rabies vaccine (MRC-5 cell) in chinese humans Adverse reactions associated with vaccine	Adverse reactions associated with vaccine	within the first 4 weeks after the first vaccination

Collaborators and Investigators

• Sponsor: Beijing Center for Disease Control and Prevention
• Collaborators: Beijing Minhai Biotechnology Co., Ltd

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: October 30, 2014
• First Submitted That Met QC Criteria: October 31, 2014
• First Posted (Estimate): November 2, 2014

Study Record Updates

• Last Update Posted (Estimate): January 20, 2016
• Last Update Submitted That Met QC Criteria: January 19, 2016
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: safety; rabies vaccine; MRC-5 cell
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Mononegavirales Infections; Rhabdoviridae Infections; Rabies; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: BJCDCP-10