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

Hepatitis A Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01949857
• Other study ID #: qiangmingsun123456!
• Status: Completed
• Phase: Phase 4
• Start date: September 2013
• Est. completion date: June 2016

Study information

• Verified date: October 2023
• Source: Institute of Medical Biology, Chinese Academy of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35000
• Est. completion date: June 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Months to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A

Intervention

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).
• 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).
• 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
• 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.

Locations

Country	Name	City	State
China	Institute of Medical Biology -Chinese Academy of Medical Sciences	Kunming	Yunnan

Sponsors (2)

Lead Sponsor	Collaborator
Institute of Medical Biology, Chinese Academy of Medical Sciences	Jiangsu Province Centers for Disease Control and Prevention

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	up to 43 months