Trial record 116 of 504 for:    hepatitis b | Open Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2015 by Xiamen Innovax Biotech Co., Ltd
Sponsor:
Information provided by (Responsible Party):
Xiamen Innovax Biotech Co., Ltd
ClinicalTrials.gov Identifier:
NCT02584543
First received: October 21, 2015
Last updated: November 2, 2015
Last verified: October 2015
  Purpose

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.


Condition Intervention Phase
Hepatitis E
Hepatitis B
Biological: HEV vaccine
Biological: HBV vaccine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity Study of the Recombinant Hepatitis E Vaccine(Escherichia Coli) Coadministration With Recombinant Hepatitis B Vaccine

Resource links provided by NLM:


Further study details as provided by Xiamen Innovax Biotech Co., Ltd:

Primary Outcome Measures:
  • Adverse reactions/events [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]
    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


Secondary Outcome Measures:
  • Immunogenicity [ Time Frame: 7 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 600
Study Start Date: October 2015
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HEV vaccine and HBV vaccine Co-administration group Biological: HEV vaccine Biological: HBV vaccine
Active Comparator: HEV vaccine control group Biological: HEV vaccine
Active Comparator: HBV vaccine control group Biological: HBV vaccine

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02584543

Contacts
Contact: Huirong Pan (+86) 05926536555 huirong_pan@innovax.cn

Locations
China, Beijing
Beijing Chaoyang District CDC Recruiting
Beijing, Beijing, China
Contact: Zheng Zhang    (+86)01067773663    anggie_zhzh@126.com   
Sponsors and Collaborators
Xiamen Innovax Biotech Co., Ltd
Investigators
Principal Investigator: Zheng Zhang Beijing Chaoyang District CDC
  More Information

Responsible Party: Xiamen Innovax Biotech Co., Ltd
ClinicalTrials.gov Identifier: NCT02584543     History of Changes
Other Study ID Numbers: PRO-HE-007 
Study First Received: October 21, 2015
Last Updated: November 2, 2015
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis E
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 21, 2016