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

NCT03168412 | Completed Phase 4

• 1 other identifier: PRO-HE-008
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatitis E

Keywords

Hepatitis E

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Adverse reactions/events of Experimental Group and Control Group

  up to 7 months

• Anti-HEV antibody of Experimental Group

  up to 7 months

• Anti-HEV antibody of Control Group

  up to 7 months

Study Arms (2)

the Accelerated Vaccination Schedule Group

EXPERIMENTAL

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)

the Standard Vaccination Schedule Group

ACTIVE COMPARATOR

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)

Interventions

Recombinant Hepatitis E Vaccine (Escherichia Coli) BIOLOGICAL

Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 7, 21 days.

Also known as: Hecolin®

the Accelerated Vaccination Schedule Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged over 18 years old on the day of enrollment, including 18 years old;
• Axillary temperature is below than 37.0 ℃;
• Negative serological markers for hepatitis E and liver function are normal or no clinical significance;
• Judged as healthy and eligible for vaccination by the investigators through a selfreported 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.

You may not qualify if:

• Pregnancy,breast-feeding or plan to be pregnant in 7 months;
• Administration of Hepatitis E Vaccine before the study;
• Participate 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, or use 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), liver and kidney disease and other chronic disease history;
• 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.
• Asthma that needed emergency treatment, hospitalization, oral or intravenous corticosteroid to keep stable in the past two years;
• Combining another severe internal medicine disease(such as cardiopathy,diabetes and hyperthyroidism)
• Anormal coagulation function or coagulopathy diagnosed by doctor;
• 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 )
• Anomal psychology or mind affecting the individual's ability to obey the study requirement;

Sponsors & Collaborators

• Xiamen Innovax Biotech Co., Ltd: lead

Study Sites (1)

Changshan Center for Disease Control and Prevention

Quzhou, Zhejiang, 324200, China

Location

Related Publications (1)

• 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.

  PMID: 30711651 DERIVED

MeSH Terms

Conditions

Hepatitis E

Interventions

hecolin

Condition Hierarchy (Ancestors)

Hepatitis, Viral, Human; Virus Diseases; Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Zhiping Chen

  Zhejiang Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2017
• First Posted: May 30, 2017
• Study Start: May 25, 2017
• Primary Completion: July 15, 2018
• Study Completion: November 28, 2018
• Last Updated: February 21, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)