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

NCT02964910 | Completed Phase 4 Results DMC

• 1 other identifier: PRO-HE-009
• Study Type: interventional
• Target: 475
• Locations: 1 country
• Sites: 1

Brief Summary

This phase IV clinical study was designed to evaluate the immunogenicity and safety of Hecolin® in the chronic Hepatitis B patients on the clinical stability.

Conditions

Hepatitis E

Keywords

Hepatitis E

Outcome Measures

Primary Outcomes (2)

• Number of Participants Whose Anti-HEV Antibody Seroconverted at One Month After The Third Dose

  Measure the number of participants whose anti-HEV antibody seroconverted at month 7 to evaluate the immunogenicity of the Hepatitis E vaccine.

  Month 7

• Geometric Mean Concentrations of Anti-HEV Antibody at One Month After The Third Dose

  Measure the level of anti-HEV antibody in serum samples at month 7 to evaluate the immunogenicity of the Hepatitis E vaccine. Wu/ml：World Health Organization (WHO) units per ml. The WHO standard was used to calibrate the antibody quantitative reference.

  Month 7

Secondary Outcomes (8)

• Number of Participants With Changes in Liver Function Index Before and One Month After the First Dose

  Day 0-Month 1

• Number of Participants With Changes in Liver Function Index Before and One Month After the Third Dose

  Month 6-Month 7

• Number of Participants With Changes in Liver Function Index Before The First Dose and One Month After the Third Dose

  Day0-Month 7

• Number of Participants Who Experienced Any Adverse Reactions/Events

  Day 0-Month 7

• Number of Participants Who Experienced Solicited Adverse Reactions/Events

  Day 0-Day 7

Study Arms (2)

the chronic Hepatitis B patients

EXPERIMENTAL

Participants in this arm are aged over 30 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)

the healthy volunteer

ACTIVE COMPARATOR

Participants in this arm are aged over 30 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, 1, 6 month.

Also known as: Hecolin®

the chronic Hepatitis B patients; the healthy volunteer

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged over 30 years old on the day of enrollment
• Axillary temperature is below than 37.0 ℃.
• No administration of HEV vaccine before the study
• 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.
• Negative serological markers for hepatitis E
• ALT \< 1.5×ULN
• No spleen swelling,no cirrhosis and no hepatocellular carcinoma
• \. HBsAg(-)

You may not qualify if:

• With clinical evidence of malignant tumor
• History of severe cardio-cerebrovascular disease
• Administration of hepatotoxicity drugs before or during the study
• Pregnancy,breast-feeding or plan to be pregnant in 7 months later
• 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.
• 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 severe hypertension, cardiopathy,diabetes and hyperthyroidism)

Sponsors & Collaborators

• Xiamen Innovax Biotech Co., Ltd: lead

Study Sites (1)

Rushan Center for Disease Control and Prevention

Weihai, Shandong, China

Location

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

Results Point of Contact

• Title: Shandong Provincial Key Laboratory of Infectious Disease Control and Prevention
• Organization: Shandong Center for Disease Control and Prevention, Jinan, China

aqxuepi@163.com

0531-82679606

Study Officials

• Aiqiang Xu

  Shandong Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: November 9, 2016
• First Posted: November 16, 2016
• Study Start: August 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: December 1, 2017
• Last Updated: July 25, 2019
• Results First Posted: July 25, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)