A Study on the Recombinant Hepatitis E Vaccine (Escherichia Coli) (Accelerated Vaccination Schedule)

A Study on Immunogenicity of Recombinant Hepatitis E Vaccine (Escherichia Coli) Hecolin® Using Accelerated Vaccination Schedule in Adults (Aged Over 18 Years)

This phase IV clinical study was designed to evaluate the immunogenicity and safety of the recombinant Hepatitis E vaccine (Hecolin®), manufactured by Xiamen Innovax Biotech CO., LTD., in healthy adults (over 18 years) with accelerated vaccination schedule. The study volunteers will receive the 3 doses of Hecolin® administered intramuscularly according to a 0-7-21 days schedule or a 0-1-6 month schedule.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 125
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Quzhou, Zhejiang, China, 324200
      • Changshan Center for Disease Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Aged over 18 years old on the day of enrollment, including 18 years old;
2. Axillary temperature is below than 37.0 ℃;
3. Negative serological markers for hepatitis E and liver function are normal or no clinical significance;
4. Judged as healthy and eligible for vaccination by the investigators through a selfreported 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. Pregnancy,breast-feeding or plan to be pregnant in 7 months;
2. Administration of Hepatitis E Vaccine before the study;
3. Participate in any other clinical trial during the study period;
4. 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;
5. Received immunosuppressed, immunoregulation therapy or corticosteroid systemic therapy for more than 14 days in the 6 months before entry, except local treatment;
6. 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;
7. 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;
8. Had a fever (axillary temperature over 38°C) within 3 days or acute illness, or use systemic antibiotics or antiviral treatment within 5 days before vaccination;
9. 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), liver and kidney disease and other chronic disease history;
10. History of allergic disease or history of serious adverse events occurring after vaccination, i.e., allergy,urticaria, dyspnea, angioneurotic edema or abdominal pain. Allergic history to any component of this vaccine.
11. Asthma that needed emergency treatment, hospitalization, oral or intravenous corticosteroid to keep stable in the past two years;
12. Combining another severe internal medicine disease(such as cardiopathy,diabetes and hyperthyroidism)
13. Anormal coagulation function or coagulopathy diagnosed by doctor;
14. Epilepsy(not including alcohol epilepsy within 3 years prior to abstinence and simple epilepsy that do without curing within 3 years prior to the study )
15. Anomal psychology or mind affecting the individual's ability to obey the study requirement;
16. 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: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: the Accelerated Vaccination Schedule Group; Participants in this arm are aged over 18 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at 0,7,21 day.	Biological: Recombinant Hepatitis E Vaccine (Escherichia Coli); Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 7, 21 days.; Other Names: Hecolin®; Biological: Recombinant Hepatitis E Vaccine (Escherichia Coli); Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month.; Other Names: Hecolin®
Active Comparator: the Standard Vaccination Schedule Group; Participants in this arm are aged over 18 years and would receive three doses of Recombinant Hepatitis E Vaccine (Escherichia Coli)(Hecolin®) at 0,1,6 month.	Biological: Recombinant Hepatitis E Vaccine (Escherichia Coli); Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 7, 21 days.; Other Names: Hecolin®; Biological: Recombinant Hepatitis E Vaccine (Escherichia Coli); Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month.; Other Names: Hecolin®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anti-HEV antibody of Experimental Group	Measure anti-HEV antibody in serum samples at 51st day to evaluate the immunogenicity of the Hepatitis E vaccine.	up to 2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse reactions/events of Experimental Group and Control Group	Measure solicited local adverse reactions/events within 7 days after each vaccination; Measure solicited systematic adverse reactions/events within 7 days after each vaccination; Measure unsolicited adverse reactions/events within 30 days after vaccination; Measure serious adverse events occurred throughout the study（up to 7 months）.	up to 7 months
Anti-HEV antibody of Experimental Group	Measure anti-HEV antibody in serum samples at 21st day,28st day and month 7 to evaluate the immunogenicity of the Hepatitis E vaccine.	up to 7 months
Anti-HEV antibody of Control Group	Measure anti-HEV antibody in serum samples at month 1,2,7 to evaluate the immunogenicity of the Hepatitis E vaccine.	up to 7 months

Collaborators and Investigators

• Sponsor: Xiamen Innovax Biotech Co., Ltd

Publications and helpful links

General Publications

• Chen Z, Lin S, Duan J, Luo Y, Wang S, Gan Z, Yi H, Wu T, Huang S, Zhang Q, Lv H. Immunogenicity and safety of an accelerated hepatitis E vaccination schedule in healthy adults: a randomized, controlled, open-label, phase IV trial. Clin Microbiol Infect. 2019 Sep;25(9):1133-1139. doi: 10.1016/j.cmi.2019.01.015. Epub 2019 Jan 31.

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2017
• Primary Completion (Actual): July 15, 2018
• Study Completion (Actual): November 28, 2018

Study Registration Dates

• First Submitted: May 14, 2017
• First Submitted That Met QC Criteria: May 25, 2017
• First Posted (Actual): May 30, 2017

Study Record Updates

• Last Update Posted (Actual): February 21, 2019
• Last Update Submitted That Met QC Criteria: February 19, 2019
• Last Verified: February 1, 2019

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; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: PRO-HE-008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No