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

Hepatitis B Clinical Trial

Official title:

Safety and Immunogenicity Study of the Recombinant Hepatitis E Vaccine(Escherichia Coli) Coadministration With Recombinant Hepatitis B Vaccine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02584543
• Other study ID #: PRO-HE-007
• Status: Completed
• Phase: Phase 4
• First received: October 21, 2015
• Last updated: December 1, 2017
• Start date: October 2015
• Est. completion date: August 25, 2016

Study information

• Verified date: December 2017
• Source: Xiamen Innovax Biotech Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a open label, randomized phase VI study, to assess the safety and immunogenicity of co-administration of Hepatitis E vaccine with Hepatitis B vaccine. The concomitant group (n =300) received Hepatitis B vaccine concomitantly with Hepatitis E vaccine at day 1 and months 1 and 6; The nonconcomitant group (n =150) received Hepatitis E vaccine at at day 1 and months 1 and 6. Another nonconcomitant group (n=150) received Hepatitis B vaccine at at day 1 and months 1 and 6.

Anti-HEV IgG and HBsAb were determined. Injection-site and systemic adverse events (AEs) were monitored for 30 days after any vaccination; serious AEs were monitored throughout the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 602
• Est. completion date: August 25, 2016
• Est. primary completion date: August 25, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

• Negative in HBsAg,HBsAb and HBcAb.

• 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.

Exclusion Criteria:

• Pregnant or breastfeeding or planning on getting pregnant in the future 7 months

• 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, exceptlocal 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.

• Plan to participate in any other clinical trial during the study period

• Administration of HEV vaccine before the study.

• 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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis E

Intervention

Biological:
• HEV vaccine

• HBV vaccine

Locations

Country	Name	City	State
China	Beijing Chaoyang District CDC	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xiamen Innovax Biotech Co., Ltd

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	7 months
Secondary	Immunogenicity	Measure anti-HEV antibody in serum samples at 7 month to evaluate the immunogenicity of the Hepatitis E vaccine. And measure the HBsAb in serum samples at 7 month to evaluate the immunogenicity of Hepatitis B vaccine.	7 months