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

NCT ID: NCT02964910

Last Updated: 2019-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 475 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2017-12-31

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.

Detailed Description

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 the chronic Hepatitis B patients on the clinical stability and aged over 30 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.

Conditions

Hepatitis E

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

the chronic Hepatitis B patients

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.

Group Type: EXPERIMENTAL

Recombinant Hepatitis E Vaccine (Escherichia Coli)

Intervention Type: BIOLOGICAL

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

the healthy volunteer

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.

Group Type: ACTIVE_COMPARATOR

Recombinant Hepatitis E Vaccine (Escherichia Coli)

Intervention Type: BIOLOGICAL

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

Interventions

Recombinant Hepatitis E Vaccine (Escherichia Coli)

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

Intervention Type: BIOLOGICAL

Other Intervention Names

Hecolin®

Eligibility Criteria

Inclusion Criteria

1. Aged over 30 years old on the day of enrollment

2. Axillary temperature is below than 37.0 ℃.

3. No administration of HEV vaccine before the study

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.

7. Negative serological markers for hepatitis E

1. ALT < 1.5×ULN

2. No spleen swelling,no cirrhosis and no hepatocellular carcinoma

1. HBsAg(-)

Exclusion Criteria

1. With clinical evidence of malignant tumor

2. History of severe cardio-cerebrovascular disease

3. Administration of hepatotoxicity drugs before or during the study

4. Pregnancy,breast-feeding or plan to be pregnant in 7 months later

5. Participated in any other clinical trial during the study period.

6. 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.

7. Received immunosuppressed, immunoregulation therapy or corticosteroid systemic therapy for more than 14 days in the 6 months before entry, except local treatment.

8. 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.

9. 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.

10. 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.

11. 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).

12. History of allergic disease or history of serious adverse events occurring after vaccination, i.e., allergy,urticaria, dyspnea, angioneurotic edema or abdominal pain.

13. Allergic history to any component of this vaccine.

14. Asthma that needed emergency treatment, hospitalization, oral or intravenous corticosteroid to keep stable in the past two years.

15. Combining another severe internal medicine disease(such as severe hypertension, cardiopathy,diabetes and hyperthyroidism)

16. Anomal coagulation function or coagulopathy diagnosed by doctor

17. 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 )

18. Anomal psychology or mind affecting the individual's ability to obey the study requie

19. 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.

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Xiamen Innovax Biotech Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aiqiang Xu

Role: PRINCIPAL_INVESTIGATOR

Shandong Provincial Center for Disease Control and Prevention

Locations

Rushan Center for Disease Control and Prevention

Weihai, Shandong, China

Countries

China

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

PRO-HE-009

Identifier Type: -

Identifier Source: org_study_id