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

Primary Purpose

Hepatitis A

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Attenuated HAV Vaccine, H2 Strain
Attenuated HAV Vaccine, L-A-1 Strain
Inactivated HAV Vaccine, Lu8 Strain
Inactivated HAV Vaccine, TZ84 Strain
Sponsored by
Institute of Medical Biology, Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatitis A focused on measuring Hepatitis A, Vaccine, Safety, efficacy

Eligibility Criteria

18 Months - 65 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Institute of Medical Biology -Chinese Academy of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Attenuated HAV Vaccine, H2 Strain

Attenuated HAV Vaccine, L-A-1 Strain

Inactivated HAV Vaccine, Lu8 Strain

Inactivated HAV Vaccine, TZ84 Strain

Arm Description

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

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).

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

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

Outcomes

Primary Outcome Measures

changes of hepatitis A antibody concentration
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
compare frequency of all the solicited events, unsolicited adverse events and serious adverse events between vaccine group and placebo group.

Full Information

First Posted
August 28, 2013
Last Updated
October 7, 2023
Sponsor
Institute of Medical Biology, Chinese Academy of Medical Sciences
Collaborators
Jiangsu Province Centers for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT01949857
Brief Title
The Immunogenicity and Safety of Inactivated and Live Attenuated Hepatitis A Vaccines
Acronym
HAV
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 Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Medical Biology, Chinese Academy of Medical Sciences
Collaborators
Jiangsu Province Centers for Disease Control and Prevention

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis A
Keywords
Hepatitis A, Vaccine, Safety, efficacy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
35000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Attenuated HAV Vaccine, H2 Strain
Arm Type
Experimental
Arm Description
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
Arm Title
Attenuated HAV Vaccine, L-A-1 Strain
Arm Type
Experimental
Arm Description
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).
Arm Title
Inactivated HAV Vaccine, Lu8 Strain
Arm Type
Experimental
Arm Description
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
Arm Title
Inactivated HAV Vaccine, TZ84 Strain
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
Attenuated HAV Vaccine, H2 Strain
Other Intervention Name(s)
Hepatitis A (Live) Vaccine, Freeze-dried
Intervention Description
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
Intervention Name(s)
Attenuated HAV Vaccine, L-A-1 Strain
Other Intervention Name(s)
Hepatitis A Vaccine
Intervention Description
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
Intervention Name(s)
Inactivated HAV Vaccine, Lu8 Strain
Other Intervention Name(s)
Hepatitis A Vaccine, Inactivated
Intervention Description
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
Intervention Name(s)
Inactivated HAV Vaccine, TZ84 Strain
Other Intervention Name(s)
Hepatitis A Vaccine, Inactivated
Intervention Description
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.
Primary Outcome Measure Information:
Title
changes of hepatitis A antibody concentration
Description
1. Changes of anti-HAV antibody geometric mean concentrations at pre-vaccination, month 1,12, 24, 36, and 1 months after the booster vaccination.
Time Frame
up to 43 months
Secondary Outcome Measure Information:
Title
The frequency of all the adverse events in vaccine group and placebo group
Description
compare frequency of all the solicited events, unsolicited adverse events and serious adverse events between vaccine group and placebo group.
Time Frame
up to 43 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qihan Li, Ph.D.
Organizational Affiliation
Institude of Medical Biology, Chinese Academy of Medical Sciences
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jingsi Yang
Organizational Affiliation
Institude of Medical Biology, Chinese Academy of Medical Sciences
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Qiangming Sun, Ph.D.
Organizational Affiliation
Institude of Medical Biology, Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fubao Ma
Organizational Affiliation
Jiangsu Provincial Center for Disease Control and Prevention
Official's Role
Study Director
Facility Information:
Facility Name
Institute of Medical Biology -Chinese Academy of Medical Sciences
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650118
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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