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

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

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.

Study Overview

• Status: Completed
• Conditions: Hepatitis E
• Intervention / Treatment: Biological: Recombinant Hepatitis E Vaccine (Escherichia Coli)

• Study Type: Interventional
• Enrollment (Actual): 600
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Quzhou, Zhejiang, China
      • Kaihua Center for Disease Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Participated in any other clinical trial during the study period.
2. 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.
3. Received immunosuppressed, immunoregulation therapy or corticosteroid systemic therapy for more than 14 days in the 6 months before entry, except local treatment.
4. 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.
5. 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.
6. 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.
7. 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).
8. History of allergic disease or history of serious adverse events occurring after vaccination, i.e., allergy,urticaria, dyspnea, angioneurotic edema or abdominal pain.
9. Pregnant or breastfeeding
10. Allergic history to any component of this vaccine.
11. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; 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.	Biological: Recombinant Hepatitis E Vaccine (Escherichia Coli); Participants would intramuscularly receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) at 0, 1, 6 month.; Other Names: Hecolin®
Active Comparator: Immunogenicity Control Group; 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.	Biological: Recombinant Hepatitis E Vaccine (Escherichia Coli); Participants would intramuscularly receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) at 0, 1, 6 month.; Other Names: Hecolin®
No Intervention: Safety Control Group; Participants in this arm are aged over 65 years.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	up to 10 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anti-HEV antibody	Measure anti-HEV antibody in serum samples at 7 month to evaluate the immunogenicity of the Hepatitis E vaccine.	7 months

Collaborators and Investigators

• Sponsor: Xiamen Innovax Biotech Co., Ltd
• Collaborators: Xiamen University; Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: April 11, 2015
• First Submitted That Met QC Criteria: April 14, 2015
• First Posted (Estimate): April 15, 2015

Study Record Updates

• Last Update Posted (Estimate): May 18, 2016
• Last Update Submitted That Met QC Criteria: May 17, 2016
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: hepatitis E
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Liver Diseases; Hepatitis, Viral, Human; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Enterovirus Infections; Picornaviridae Infections; Enterobacteriaceae Infections; Hepatitis; Hepatitis A; Escherichia coli Infections; Hepatitis E
• Other Study ID Numbers: PRO-HE-006