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

Xiamen Innovax Biotech

Status and phase: Completed; Phase 4

Conditions: Hepatitis E

Treatments: Biological: Recombinant Hepatitis E Vaccine (Escherichia Coli)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02964910

PRO-HE-009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 475 patients

Sex: All

Ages: 30+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria(all volunteers):

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

Inclusion Criteria(experiment group):

1. ALT < 1.5×ULN
2. No spleen swelling,no cirrhosis and no hepatocellular carcinoma

Inclusion Criteria(control group):

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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475 participants in 2 patient groups

the chronic Hepatitis B patients

Experimental group

Description:

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.

Treatment:

Biological: Recombinant Hepatitis E Vaccine (Escherichia Coli)

the healthy volunteer

Active Comparator group

Description:

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.

Treatment:

Biological: Recombinant Hepatitis E Vaccine (Escherichia Coli)