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

This study is not yet open for participant recruitment.
Verified December 2017 by Xiamen Innovax Biotech Co., Ltd
Sponsor:
ClinicalTrials.gov Identifier:
NCT03365921
First Posted: December 7, 2017
Last Update Posted: December 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Jiangsu Province Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Xiamen Innovax Biotech Co., Ltd
  Purpose
This study is to evaluate lot-lot consistency of Recombinant Hepatitis E Vaccine (Escherichia Coli) Hecolin®.

Condition Intervention Phase
Hepatitis E Biological: Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month. Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: An Randomized, Double-blinded Trial of Recombinant Hepatitis E Vaccine (Escherichia Coli) Hecolin® to Evaluate Lot-to-lot Consistency

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Seroconversion rate and GMC of anti-HEV IgG at Month 7. [ Time Frame: 7 months ]
    Measure anti-HEV IgG in serum samples at 7 month to evaluate the immunogenicity of the Hepatitis E vaccine.


Secondary Outcome Measures:
  • Adverse reactions/events of all subjects [ Time Frame: up to 7 months ]
    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.


Estimated Enrollment: 360
Anticipated Study Start Date: December 2017
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hepatitis E vaccine lot 1 Biological: Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month.
Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month.
Experimental: Hepatitis E vaccine lot 2 Biological: Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month.
Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month.
Experimental: Hepatitis E vaccine lot 3 Biological: Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month.
Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 1. Aged over 18 years old to 50 years old on the day of enrollment 2. Axillary temperature is below than 37.0 ℃. 3.Negative serological markers for hepatitis E 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.

Exclusion Criteria:

  1. Pregnancy,breast-feeding or plan to be pregnant in 7 months;
  2. Administration of Hepatitis E Vaccine before the study;
  3. Participate in any other clinical trial during the study period;
  4. 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;
  5. Received immunosuppressed, immunoregulation therapy or corticosteroid systemic therapy for more than 14 days in the 6 months before entry, except local treatment;
  6. 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;
  7. 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;
  8. Had a fever (axillary temperature over 38°C) within 3 days or acute illness, or use systemic antibiotics or antiviral treatment within 5 days before vaccination;
  9. 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), liver and kidney disease and other chronic disease history;
  10. History of allergic disease or history of serious adverse events occurring after vaccination, i.e., allergy,urticaria, dyspnea, angioneurotic edema or abdominal pain. Allergic history to any component of this vaccine.

12. Asthma that needed emergency treatment, hospitalization, oral or intravenous corticosteroid to keep stable in the past two years; 12. Combining another severe internal medicine disease(such as cardiopathy,diabetes and hyperthyroidism) 13. Anormal coagulation function or coagulopathy diagnosed by doctor; 14. 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 ) 15. Anomal psychology or mind affecting the individual's ability to obey the study requirement; 16. 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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03365921


Contacts
Contact: Qiufen Zhang (+86)0592-6536555 qiufen_zhang@innovax.cn

Sponsors and Collaborators
Xiamen Innovax Biotech Co., Ltd
Jiangsu Province Centers for Disease Control and Prevention
Investigators
Principal Investigator: Yuemei Hu Jiangsu Provincial Center for Disease Prevention and Control
  More Information

Responsible Party: Xiamen Innovax Biotech Co., Ltd
ClinicalTrials.gov Identifier: NCT03365921     History of Changes
Other Study ID Numbers: PRO-HE-010
First Submitted: December 1, 2017
First Posted: December 7, 2017
Last Update Posted: December 7, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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