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A Phase Ⅳ Clinical Trial of the Recombinant Hepatitis E Vaccine (Escherichia Coli)

Primary Purpose

Hepatitis E

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Recombinant Hepatitis E Vaccine (Escherichia Coli)

About this trial

This is an interventional prevention trial for Hepatitis E focused on measuring hepatitis E

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Healthy people aged over 18 years old on the day of enrollment
Axillary temperature is below than 37.0 ℃
Blood pressure is not higher than 160/100 mmHg (with or without any medicine)
Judged as healthy and eligible for vaccination by the investigators through a self-reported medical history and some physical examinations.
Able to understand this study information and willing to comply with all study requirements.
Willing to participate in this study and sign informed consent form.

Exclusion Criteria:

Participated in any other clinical trial during the study period.
Use of any investigational product or non-registered product (drug or vaccine) within 30 days preceding the first dose of the study vaccine or plan to use during the study period.
Received immunosuppressed, immunoregulation therapy or corticosteroid systemic therapy for more than 14 days in the 6 months before entry, except local treatment.
Administration of any immunoglobulin or blood products within 3 months preceding the first dose of the study vaccine,or plan to use during the study period.
Administration of any inactivated vaccines within 14 days preceding the first dose of the study or attenuated live vaccines within 21 days preceding the first dose of the study.
Had a fever (axillary temperature over 38°C) within 3 days or acute illness requiring systemic antibiotics or antiviral treatment within 5 days before vaccination.
Immunodeficiency (such as HIV carriers), primary disease of important organs, malignant tumor, .or any immune disease (such as systemic lupus erythematosus, arthritis pauperum, splenectomy or functional asplenia or other disease which might affect immune response).
History of allergic disease or history of serious adverse events occurring after vaccination, i.e., allergy,urticaria, dyspnea, angioneurotic edema or abdominal pain.
Pregnant or breastfeeding
Allergic history to any component of this vaccine.
Other medical, psychological, social or occupational factors that, according to the investigators' judgment,might affect the individual's ability to obey the protocol or sign the informed consent.

Sites / Locations

Kaihua Center for Disease Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Experimental Group

Immunogenicity Control Group

Safety Control Group

Arm Description

Participants in this arm are aged over 65 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at o,1,6 month.

Participants in this arm are aged beteen 18-65 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at o,1,6 month.

Participants in this arm are aged over 65 years.

Outcomes

Primary Outcome Measures

Adverse reactions/events

Measure solicited local adverse reactions within 7 days after each vaccination; Measure solicited systematic adverse reactions within 7 days after each vaccination; Measure unsolicited adverse reactions within 30 days after vaccination; Measure serious adverse events occurred throughout the study

Secondary Outcome Measures

Anti-HEV antibody

Measure anti-HEV antibody in serum samples at 7 month to evaluate the immunogenicity of the Hepatitis E vaccine.

Full Information

NCT ID

NCT02417597

First Posted

April 11, 2015

Last Updated

May 17, 2016

Sponsor

Xiamen Innovax Biotech Co., Ltd

Collaborators

Xiamen University, Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02417597

Brief Title

A Phase Ⅳ Clinical Trial of the Recombinant Hepatitis E Vaccine (Escherichia Coli)

Official Title

Safety and Immunogenicity Study of the Recombinant Hepatitis E Vaccine(Escherichia Coli) in Healthy Volunteers Aged Over 65 Years

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Completed

Study Start Date

April 2015 (undefined)

Primary Completion Date

May 2016 (Actual)

Study Completion Date

May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Xiamen Innovax Biotech Co., Ltd

Collaborators

Xiamen University, Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This phase IV clinical study was designed to evaluate the safety and immunogenicity of the recombinant Hepatitis E vaccine(Hecolin®), manufactured by Xiamen Innovax Biotech CO., LTD., in healthy volunteers aged over 65 years of age at enrollment. The study volunteers will receive the 3 doses of Hecolin® administered intramuscularly according to a 0-1-6 month schedule.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis E

Keywords

hepatitis E

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

600 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental Group

Arm Type

Experimental

Arm Description

Participants in this arm are aged over 65 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at o,1,6 month.

Arm Title

Immunogenicity Control Group

Arm Type

Active Comparator

Arm Description

Participants in this arm are aged beteen 18-65 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at o,1,6 month.

Arm Title

Safety Control Group

Arm Type

No Intervention

Arm Description

Participants in this arm are aged over 65 years.

Intervention Type

Biological

Intervention Name(s)

Recombinant Hepatitis E Vaccine (Escherichia Coli)

Other Intervention Name(s)

Hecolin®

Intervention Description

Participants would intramuscularly receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) at 0, 1, 6 month.

Primary Outcome Measure Information:

Title

Adverse reactions/events

Description

Time Frame

up to 10 months

Secondary Outcome Measure Information:

Title

Anti-HEV antibody

Description

Measure anti-HEV antibody in serum samples at 7 month to evaluate the immunogenicity of the Hepatitis E vaccine.

Time Frame

7 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy people aged over 18 years old on the day of enrollment Axillary temperature is below than 37.0 ℃ Blood pressure is not higher than 160/100 mmHg (with or without any medicine) Judged as healthy and eligible for vaccination by the investigators through a self-reported medical history and some physical examinations. Able to understand this study information and willing to comply with all study requirements. Willing to participate in this study and sign informed consent form. Exclusion Criteria: Participated in any other clinical trial during the study period. Use of any investigational product or non-registered product (drug or vaccine) within 30 days preceding the first dose of the study vaccine or plan to use during the study period. Received immunosuppressed, immunoregulation therapy or corticosteroid systemic therapy for more than 14 days in the 6 months before entry, except local treatment. Administration of any immunoglobulin or blood products within 3 months preceding the first dose of the study vaccine,or plan to use during the study period. Administration of any inactivated vaccines within 14 days preceding the first dose of the study or attenuated live vaccines within 21 days preceding the first dose of the study. Had a fever (axillary temperature over 38°C) within 3 days or acute illness requiring systemic antibiotics or antiviral treatment within 5 days before vaccination. Immunodeficiency (such as HIV carriers), primary disease of important organs, malignant tumor, .or any immune disease (such as systemic lupus erythematosus, arthritis pauperum, splenectomy or functional asplenia or other disease which might affect immune response). History of allergic disease or history of serious adverse events occurring after vaccination, i.e., allergy,urticaria, dyspnea, angioneurotic edema or abdominal pain. Pregnant or breastfeeding Allergic history to any component of this vaccine. Other medical, psychological, social or occupational factors that, according to the investigators' judgment,might affect the individual's ability to obey the protocol or sign the informed consent.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhiping Chen

Organizational Affiliation

Zhejiang Provincial Center for Disease Control and Prevention

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kaihua Center for Disease Control and Prevention

City

Quzhou

State/Province

Zhejiang

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

31262585

Citation

Yu XY, Chen ZP, Wang SY, Pan HR, Wang ZF, Zhang QF, Shen LZ, Zheng XP, Yan CF, Lu M, Chen B, Zheng Y, Zhang J, Lv HK, Huang SJ. Safety and immunogenicity of hepatitis E vaccine in elderly people older than 65 years. Vaccine. 2019 Jul 26;37(32):4581-4586. doi: 10.1016/j.vaccine.2019.04.006. Epub 2019 Jun 28.

Results Reference

derived

Learn more about this trial

A Phase Ⅳ Clinical Trial of the Recombinant Hepatitis E Vaccine (Escherichia Coli)

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