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

October 7, 2023 updated by: Institute of Medical Biology, Chinese Academy of Medical Sciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

35000

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Yunnan
      • Kunming, Yunnan, China, 650118
        • Institute of Medical Biology -Chinese Academy of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes of hepatitis A antibody concentration
Time Frame: 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.
up to 43 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The frequency of all the adverse events in vaccine group and placebo group
Time Frame: up to 43 months
compare frequency of all the solicited events, unsolicited adverse events and serious adverse events between vaccine group and placebo group.
up to 43 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Medical Biology, Chinese Academy of Medical Sciences

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

August 28, 2013

First Submitted That Met QC Criteria

September 20, 2013

First Posted (Estimated)

September 25, 2013

Study Record Updates

Last Update Posted (Actual)

October 10, 2023

Last Update Submitted That Met QC Criteria

October 7, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • qiangmingsun123456!

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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