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

Hepatitis E Clinical Trial

Official title:

Safety and Immunogenicity Study of the Recombinant Hepatitis E Vaccine(Escherichia Coli) in Healthy Volunteers Aged Over 65 Years

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02417597
• Other study ID #: PRO-HE-006
• Status: Completed
• Phase: Phase 4
• First received: April 11, 2015
• Last updated: May 17, 2016
• Start date: April 2015
• Est. completion date: May 2016

Study information

• Verified date: October 2015
• Source: Xiamen Innovax Biotech Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This phase IV clinical study was designed to evaluate the safety and immunogenicity of the recombinant Hepatitis E vaccine(Hecolin®), manufactured by Xiamen Innovax Biotech CO., LTD., in healthy volunteers aged over 65 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Healthy people aged over 18 years old on the day of enrollment

2. Axillary temperature is below than 37.0 ?

3. Blood pressure is not higher than 160/100 mmHg (with or without any medicine)

4. Judged as healthy and eligible for vaccination by the investigators through a self-reported 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. Participated in any other clinical trial during the study period.

2. 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.

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

4. 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.

5. 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.

6. 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.

7. 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).

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

9. Pregnant or breastfeeding

10. Allergic history to any component of this vaccine.

11. 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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis E

Intervention

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

Locations

Country	Name	City	State
China	Kaihua Center for Disease Control and Prevention	Quzhou	Zhejiang

Sponsors (3)

Lead Sponsor	Collaborator
Xiamen Innovax Biotech Co., Ltd	Beijing Wantai Biological Pharmacy Enterprise Co., Ltd., Xiamen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse reactions/events	Measure solicited local adverse reactions within 7 days after each vaccination; Measure solicited systematic adverse reactions within 7 days after each vaccination; Measure unsolicited adverse reactions within 30 days after vaccination; Measure serious adverse events occurred throughout the study	up to 10 months	Yes
Secondary	Anti-HEV antibody	Measure anti-HEV antibody in serum samples at 7 month to evaluate the immunogenicity of the Hepatitis E vaccine.	7 months	No