Safety and Immunogenicity of Freeze-dried Rabies Vaccine（MRC-5 Cell) in Chinese Humans

Beijing Center for Disease Prevention and Control

Status and phase: Completed; Phase 3

Conditions: Safety, Immunogenicity

Treatments: Biological: 2.5IU/ml rabies vaccine(MRC-5 cell) in humans aged 10-20 years old; Biological: 2.5IU/ml rabies vaccine(MRC-5 cell) in humans aged 51-60 years old; Biological: 2.5IU/ml rabies vaccine(MRC-5 cell) in humans aged 21-50 years old; Biological: 2.5IU/ml rabies vaccine(vero cell) in humans aged 21-50 years old; Biological: 2.5IU/ml rabies vaccine(vero cell) in humans aged 51-60 years old; Biological: 2.5IU/ml rabies vaccine(vero cell) in humans aged 10-20 years old

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02288286

BJCDCP-11

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and immunogenicity of freeze-dried rabies vaccine (MRC-5 cells)in different age health human populations, according to the traditional Essen methods (1-1-1-1-1) vaccination.

Enrollment: 1,200 patients

Sex: All

Ages: 10 to 60 years old

Volunteers: Accepts Healthy Volunteers

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 receving 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,200 participants in 6 patient groups, including a placebo group

2.5IU/ml in humans aged 10-20 years old

Experimental group

Description:

freeze-dried rabies vaccines(MRC-5 cell) of 2.5IU/ml in 200 humans aged 10-20 years old on days 0,3,7,14,28

Treatment:

Biological: 2.5IU/ml rabies vaccine(MRC-5 cell) in humans aged 10-20 years old

2.5IU/ml in humans aged 21-50

Experimental group

Description:

freeze-dried rabies vaccines(MRC-5 cell) of 2.5IU/ml in 200 humans aged 21-50 years old on days 0,3,7,14,28

Treatment:

Biological: 2.5IU/ml rabies vaccine(MRC-5 cell) in humans aged 21-50 years old

2.5IU/ml in humans aged 51-60

Experimental group

Description:

freeze-dried rabies vaccines(MRC-5 cell) of 2.5IU/ml in 200 humans aged 51-60 years old on days 0,3,7,14,28

Treatment:

Biological: 2.5IU/ml rabies vaccine(MRC-5 cell) in humans aged 51-60 years old

2.5IU/ml in humans(from 10-20 years old)

Placebo Comparator group

Description:

freeze-dried rabies vaccines(vero cell) of 2.5IU/ml in 200 humans aged 10-20 years old on days 0,3,7,14,28

Treatment:

Biological: 2.5IU/ml rabies vaccine(vero cell) in humans aged 10-20 years old

2.5IU/ml in humans(from 21-50 years old)

Placebo Comparator group

Description:

freeze-dried rabies vaccines(vero cell) of 2.5IU/ml in 200 humans aged 21-50 years old on days 0,3,7,14,28

Treatment:

Biological: 2.5IU/ml rabies vaccine(vero cell) in humans aged 21-50 years old

2.5IU/ml in humans(from 51-60 years old)

Placebo Comparator group

Description:

freeze-dried rabies vaccines(vero cell) of 2.5IU/ml in 200 humans aged 51-60 years old on days 0,3,7,14,28

Treatment:

Biological: 2.5IU/ml rabies vaccine(vero cell) in humans aged 51-60 years old