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

Sponsor

Chinese Academy of Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT01949857

Collaborator

Jiangsu Province Centers for Disease Control and Prevention (Other)

35,000

Enrollment

Location

Arms

Duration (Months)

1061.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis A	Biological: Attenuated HAV Vaccine, H2 Strain Biological: Attenuated HAV Vaccine, L-A-1 Strain Biological: Inactivated HAV Vaccine, Lu8 Strain Biological: Inactivated HAV Vaccine, TZ84 Strain	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

35000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Prevention

Official Title:

Phase 4 Clinical Trial to Assess the Safety, Immunogenicity,Three-year Immune Persistence of Inactivated Hepatitis A Vaccine (HAV) and Live Attenuated HAV Vaccine

Study Start Date :

Sep 1, 2013

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Biological: 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). Other Names: Hepatitis A (Live) Vaccine, Freeze-dried
Experimental: 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).	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). Other Names: Hepatitis A Vaccine
Experimental: 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	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 Other Names: Hepatitis A Vaccine, Inactivated
Experimental: 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	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. Other Names: Hepatitis A Vaccine, Inactivated

Outcome Measures

Primary Outcome Measures

changes of hepatitis A antibody concentration [up to 43 months]
1. Changes of anti-HAV antibody geometric mean concentrations at pre-vaccination, month 1,12, 24, 36, and 1 months after the booster vaccination.

Secondary Outcome Measures

The frequency of all the adverse events in vaccine group and placebo group [up to 43 months]
compare frequency of all the solicited events, unsolicited adverse events and serious adverse events between vaccine group and placebo group.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Months to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute of Medical Biology -Chinese Academy of Medical Sciences	Kunming	Yunnan	China	650118

Sponsors and Collaborators

Chinese Academy of Medical Sciences
Jiangsu Province Centers for Disease Control and Prevention

Investigators

Study Chair: Qihan Li, Ph.D., Institude of Medical Biology, Chinese Academy of Medical Sciences
Study Chair: Jingsi Yang, Institude of Medical Biology, Chinese Academy of Medical Sciences
Principal Investigator: Qiangming Sun, Ph.D., Institude of Medical Biology, Chinese Academy of Medical Sciences
Study Director: Fubao Ma, Jiangsu Provincial Center for Disease Control and Prevention