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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2013 by Chinese Academy of Medical Sciences
Sponsor:
Collaborator:
Jiangsu Province Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Qiangming Sun, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01949857
First received: August 28, 2013
Last updated: September 20, 2013
Last verified: September 2013
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Chinese Academy of Medical Sciences:

Primary Outcome Measures:
  • changes of hepatitis A antibody concentration [ Time Frame: up to 43 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: up to 43 months ] [ Designated as safety issue: Yes ]
    compare frequency of all the solicited events, unsolicited adverse events and serious adverse events between vaccine group and placebo group.


Estimated Enrollment: 6000
Study Start Date: September 2013
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: Hepatitis A Vaccine, Inactivated

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.

  Eligibility

Ages Eligible for Study:   18 Months to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01949857

Contacts
Contact: Qiangming Sun, Ph.D. 86-871-68335165 qiangmingsun@gmail.com

Locations
China, Yunnan
Institute of Medical Biology -Chinese Academy of Medical Sciences Not yet recruiting
Kunming, Yunnan, China, 650118
Contact: Qiangming Sun, Ph.D.    86-871-68335165    qiangmingsun@gmail.com   
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
  More Information

No publications provided

Responsible Party: Qiangming Sun, Molecular Epidemiology Joint Laboratory, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01949857     History of Changes
Other Study ID Numbers: qiangmingsun123456!
Study First Received: August 28, 2013
Last Updated: September 20, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Chinese Academy of Medical Sciences:
Hepatitis A
Vaccine
Safety
efficacy

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections

ClinicalTrials.gov processed this record on August 28, 2014