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Immunogenicity and Safety of Inactivated and Live Attenuated Hepatitis A Vaccines

Primary Purpose

Hepatitis A

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Attenuated Hepatitis A Vaccine, H2 Strain
Inactivated Hepatitis A Vaccine, Lu8 Strain
Group A Meningococcal Polysaccharide vaccine
Sponsored by
Jiangsu Province Centers for Disease Control and Prevention
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

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

  • Jiangsu Provincial Center for Disease Control and Prevention
  • Institute of Medical Biology -Chinese Academy of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Attenuated Hepatitis A Vaccine, H2 Strain

Inactivated Hepatitis A Vaccine, Lu8 Strain

Group A Meningococcal Polysaccharide vaccine

Arm Description

Health subjects received attenuated Hepatitis A vaccine intramuscularly in the deltoid region.

Health subjects received inactivated Hepatitis A vaccine intramuscularly in the deltoid region.

Health subjects received Group A Meningococcal Polysaccharide vaccine intramuscularly in the deltoid region.

Outcomes

Primary Outcome Measures

Changes of hepatitis A antibody concentration
Changes of anti Hepatitis A antibody geometric mean concentrations at pre-vaccination, month 1,12, 24, 36, and 1 months after the booster vaccination.

Secondary Outcome Measures

Incidence of adverse events
Compare incidence of all the solicited events(AEs), unsolicited AEs and serious AEs within 28 days post-vaccination.

Full Information

First Posted
October 25, 2015
Last Updated
November 6, 2015
Sponsor
Jiangsu Province Centers for Disease Control and Prevention
Collaborators
Institute of Medical Biology, Chinese Academy of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02601040
Brief Title
Immunogenicity and Safety of Inactivated and Live Attenuated Hepatitis A Vaccines
Official Title
Phase IV Clinical Trial to Assess the Safety, Immunogenicity,Three-year Immune Persistence of Inactivated Hepatitis A Vaccine (HAV) and Live Attenuated HAV Vaccine in Health Chinese Children and Adult
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The main purpose of this study was to evaluate the safety and immunogenicity of Immunogenicity of Inactivated and Live Attenuated Hepatitis A Vaccines 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
Safety, Immunogenicity, Vaccine, Hepatitis A

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
13500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Attenuated Hepatitis A Vaccine, H2 Strain
Arm Type
Experimental
Arm Description
Health subjects received attenuated Hepatitis A vaccine intramuscularly in the deltoid region.
Arm Title
Inactivated Hepatitis A Vaccine, Lu8 Strain
Arm Type
Experimental
Arm Description
Health subjects received inactivated Hepatitis A vaccine intramuscularly in the deltoid region.
Arm Title
Group A Meningococcal Polysaccharide vaccine
Arm Type
Placebo Comparator
Arm Description
Health subjects received Group A Meningococcal Polysaccharide vaccine intramuscularly in the deltoid region.
Intervention Type
Biological
Intervention Name(s)
Attenuated Hepatitis A Vaccine, H2 Strain
Intervention Description
6.50 lgCCID50/ml in babies aged 18-35 months\6.50 lgCCID50/ml in children aged 3-16 years \6.50 lgCCID50/ml in adults aged 17 up to 65 years old
Intervention Type
Biological
Intervention Name(s)
Inactivated Hepatitis A Vaccine, Lu8 Strain
Intervention Description
320EU/Vial in babies aged 18-35 months \320EU/Vial in children aged 3-16 years \640EU/Vial in adults aged 17 up to 65 years old\boost at month 6\two-dose
Intervention Type
Biological
Intervention Name(s)
Group A Meningococcal Polysaccharide vaccine
Intervention Description
30µg Group A Meningococcal Polysaccharide vaccine in subjects aged 18 months-65 years old
Primary Outcome Measure Information:
Title
Changes of hepatitis A antibody concentration
Description
Changes of anti Hepatitis A antibody geometric mean concentrations at pre-vaccination, month 1,12, 24, 36, and 1 months after the booster vaccination.
Time Frame
37 months
Secondary Outcome Measure Information:
Title
Incidence of adverse events
Description
Compare incidence of all the solicited events(AEs), unsolicited AEs and serious AEs within 28 days post-vaccination.
Time Frame
28 days

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
Jingsi Yang, PhD
Organizational Affiliation
Institude of Medical Biology, Chinese Academy of Medical Sciences
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Fubao Ma
Organizational Affiliation
Jiangsu Provincial Center for Disease Control and Prevention
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Qiangming Sun, PhD
Organizational Affiliation
Institude of Medical Biology, Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Guodong Kang
Organizational Affiliation
Jiangsu Provincial Center for Disease Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jiangsu Provincial Center for Disease Control and Prevention
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
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

Citations:
PubMed Identifier
34222044
Citation
Wang X, Luo J, Ma F, Kang G, Ding Z, Pan Y, Zhao Y, Chen J, Feng K, Yan L, Zhang J, Li L, Lan Q, Li D, Yang X, Li G, Yang J, Sun Q. The Safety, Immunogenicity, and Immunopersistence of Hepatitis A Vaccine in HBs-Ag-Positive Participants: A Retrospective Study. Front Cell Infect Microbiol. 2021 Jun 17;11:672221. doi: 10.3389/fcimb.2021.672221. eCollection 2021.
Results Reference
derived

Learn more about this trial

Immunogenicity and Safety of Inactivated and Live Attenuated Hepatitis A Vaccines

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