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

NCT01949857 | Completed Phase 4 DMC

• 1 other identifier: qiangmingsun123456!
• Study Type: interventional
• Target: 35,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis A

Keywords

Hepatitis A; Vaccine; Safety; efficacy

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 43 months

Secondary Outcomes (1)

• The frequency of all the adverse events in vaccine group and placebo group

  up to 43 months

Study Arms (4)

Attenuated HAV Vaccine, H2 Strain

EXPERIMENTAL

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

Attenuated HAV Vaccine, L-A-1 Strain

EXPERIMENTAL

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

Inactivated HAV Vaccine, Lu8 Strain

EXPERIMENTAL

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

Inactivated HAV Vaccine, TZ84 Strain

EXPERIMENTAL

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

Interventions

Attenuated HAV Vaccine, H2 Strain 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).

Also known as: Hepatitis A (Live) Vaccine, Freeze-dried

Attenuated HAV Vaccine, H2 Strain

Attenuated HAV Vaccine, L-A-1 Strain 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).

Also known as: Hepatitis A Vaccine

Attenuated HAV Vaccine, L-A-1 Strain

Inactivated HAV Vaccine, Lu8 Strain 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

Also known as: Hepatitis A Vaccine, Inactivated

Inactivated HAV Vaccine, Lu8 Strain

Inactivated HAV Vaccine, TZ84 Strain 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.

Also known as: Hepatitis A Vaccine, Inactivated

Inactivated HAV Vaccine, TZ84 Strain

Eligibility Criteria

• Age: 18 Months - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Medical Biology, Chinese Academy of Medical Sciences: lead
• Jiangsu Province Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Institute of Medical Biology -Chinese Academy of Medical Sciences

Kunming, Yunnan, 650118, China

Location

MeSH Terms

Conditions

Hepatitis A

Interventions

Hepatitis A Vaccines; Vaccines; Freeze Drying

Condition Hierarchy (Ancestors)

Hepatitis, Viral, Human; Virus Diseases; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Viral Hepatitis Vaccines; Viral Vaccines; Biological Products; Complex Mixtures; Cryopreservation; Tissue Preservation; Histocytological Preparation Techniques; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Preservation, Biological; Therapeutics; Investigative Techniques

Study Officials

• 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

  STUDY CHAIR

• Qiangming Sun, Ph.D.

  Institude of Medical Biology, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Fubao Ma

  Jiangsu Provincial Center for Disease Control and Prevention

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2013
• First Posted: September 25, 2013
• Study Start: September 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: June 1, 2016
• Last Updated: October 10, 2023

Record last verified: 2023-10

Locations

CN (1)