The Immunogenicity and Safety of Inactivated and Live Attenuated Hepatitis A Vaccines

NCT ID: NCT01949857

Last Updated: 2023-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 35000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2016-06-30

Brief Summary

The purpose of this Phase 4 trial is to assess the safety, immunogenicity, three-year immune persistence of inactivated hepatitis A vaccine (HAV) and live attenuated HAV vaccine.

Detailed Description

Hepatitis A refers to liver inflammation caused by infection with the hepatitis A virus. HAV is is one of the most common hepatitis viruses that can cause hepatitis in China. The data from the phase 1, 2 and 3 trials suggested that both inactivated hepatitis A vaccine and live attenuated hepatitis A vaccine had a clinically acceptable safety and good immunogenicity for healthy Chinese people.

Conditions

Hepatitis A

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Attenuated HAV Vaccine, H2 Strain

6.50 lgCCID50/ml in babies aged 18-35 months\\6.50 lgCCID50/ml in children aged 3-15 years \\6.50 lgCCID50/ml in adults aged 16 up to 65 years old

Group Type: EXPERIMENTAL

Attenuated HAV Vaccine, H2 Strain

Intervention Type: BIOLOGICAL

6.50 lgCCID50/Vial in babies aged 18-35 months\\6.50 lgCCID50/Vial in children aged 3-15 years \\6.50 lgCCID50/Vial in adults aged 16 up to 65 years old, only one dose (1Vial/dose).

Attenuated HAV Vaccine, L-A-1 Strain

6.50 lgCCID50/Vial in babies aged 18-35 months\\6.50 lgCCID50/Vial in children aged 3-15 years \\6.50 lgCCID50/Vial in adults aged 16 up to 65 years old, only one dose (1Vial/dose).

Group Type: EXPERIMENTAL

Attenuated HAV Vaccine, L-A-1 Strain

Intervention Type: BIOLOGICAL

6.50 lgCCID50/Vial in babies aged 18-35 months\\6.50 lgCCID50/Vial in children aged 3-15 years \\6.50 lgCCID50/Vial in adults aged 16 up to 65 years old, only one dose (1Vial/dose).

Inactivated HAV Vaccine, Lu8 Strain

320EU/Vial in babies aged 18-35 months\\320EU/Vial in children aged 3-15 years \\640EU/Vial in adults aged 16 up to 65 years old\\boost at month 6\\two-dose

Group Type: EXPERIMENTAL

Inactivated HAV Vaccine, Lu8 Strain

Intervention Type: BIOLOGICAL

320EU/Vial in babies aged 18-35 months\\320EU/Vial in children aged 3-15 years \\640EU/Vial in adults aged 16 up to 65 years old\\boost at month 6\\two-dose

Inactivated HAV Vaccine, TZ84 Strain

250U/Vial in babies aged 18-35 months\\250U/Vial in children aged 3-15 years \\500U/Vial in adults aged 16 up to 65 years old\\boost at month 6\\two-dose

Group Type: EXPERIMENTAL

Inactivated HAV Vaccine, TZ84 Strain

Intervention Type: BIOLOGICAL

250U/Vial in babies aged 18-35 months\\250U/Vial in children aged 3-15 years \\500U/Vial in adults aged 16 up to 65 years old\\boost at month 6\\two-dose.

Interventions

Attenuated HAV Vaccine, H2 Strain

6.50 lgCCID50/Vial in babies aged 18-35 months\\6.50 lgCCID50/Vial in children aged 3-15 years \\6.50 lgCCID50/Vial in adults aged 16 up to 65 years old, only one dose (1Vial/dose).

Intervention Type: BIOLOGICAL

Attenuated HAV Vaccine, L-A-1 Strain

6.50 lgCCID50/Vial in babies aged 18-35 months\\6.50 lgCCID50/Vial in children aged 3-15 years \\6.50 lgCCID50/Vial in adults aged 16 up to 65 years old, only one dose (1Vial/dose).

Intervention Type: BIOLOGICAL

Inactivated HAV Vaccine, Lu8 Strain

320EU/Vial in babies aged 18-35 months\\320EU/Vial in children aged 3-15 years \\640EU/Vial in adults aged 16 up to 65 years old\\boost at month 6\\two-dose

Intervention Type: BIOLOGICAL

Inactivated HAV Vaccine, TZ84 Strain

250U/Vial in babies aged 18-35 months\\250U/Vial in children aged 3-15 years \\500U/Vial in adults aged 16 up to 65 years old\\boost at month 6\\two-dose.

Intervention Type: BIOLOGICAL

Other Intervention Names

Hepatitis A (Live) Vaccine, Freeze-dried; Hepatitis A Vaccine; Hepatitis A Vaccine, Inactivated; Hepatitis A Vaccine, Inactivated

Eligibility Criteria

Inclusion Criteria

• Only subjects fulfilling all of the following criteria will be eligible for the study:

• People aged from 18 months to 65 years old.
• The subjects or subjects' guardians are able to understand and sign the informed consent
• The subjects or subjects' guardians allow to comply with the requirements of the protocol
• Subjects with temperature <=37.0°C on axillary setting
• The subjects have signed informed consent already

Exclusion Criteria

• Subjects will not be eligible for the study if any of the following criteria is met:

• Subject who has a medical history of serious disease including Tumor, autoimmune disease, progressive atherosclerosis diseases or complications of diabetes, chronic obstructive pulmonary disease (copd), kidney disease, congestive heart failure etc.
• Have a history of neurological symptoms or signs
• Have medical history or family history relating to allergies, seizures, epilepsy, brain and spirit etc.
• Suffering from serious chronic diseases
• Suffering from known or suspected of diseases including respiratory diseases, acute infection , mothers have HIV infection, cardiovascular disease, severe hypertension, skin diseases, malignant tumor
• Allergic to any ingredient in research, history of allergies to any vaccination (always), especially for people allergic to high protein food like eggs and milk
• Any prior known or suspected damage or abnormal immune function. As for patients who are treated with immune inhibitors or immune enhancer medicine, accept with immunoglobin, blood products and plasma extraction within 3 months
• Any prior diseases including human immunodeficiency virus infection or related
• Bleeding constitution or prolong bleeding time situation
• Accept hepatitis A vaccination within a month
• Received vaccines, other immune globulin, any research drug injections in the past 4 weeks
• People who had any acute illness, needed systemic antibiotics or antiviral treatment in the past 7 days
• Caught a fever with axillary temperature 38°C or higher in past 3 days
• Take part in another clinical researchers
• Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent
• Pregnancy test result is positive

• Minimum Eligible Age: 18 Months
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jiangsu Province Centers for Disease Control and Prevention

NETWORK

Sponsor Role: collaborator

Institute of Medical Biology, Chinese Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Qihan Li, Ph.D.

Role: STUDY_CHAIR

Institude of Medical Biology, Chinese Academy of Medical Sciences

Jingsi Yang

Role: STUDY_CHAIR

Institude of Medical Biology, Chinese Academy of Medical Sciences

Qiangming Sun, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Institude of Medical Biology, Chinese Academy of Medical Sciences

Fubao Ma

Role: STUDY_DIRECTOR

Jiangsu Provincial Center for Disease Control and Prevention

Locations

Institute of Medical Biology -Chinese Academy of Medical Sciences

Kunming, Yunnan, China

Countries

China

Other Identifiers

qiangmingsun123456!

Identifier Type: -

Identifier Source: org_study_id