Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03365921
Recruitment Status : Completed
First Posted : December 7, 2017
Last Update Posted : May 7, 2020
Sponsor:
Collaborator:
Jiangsu Province Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Xiamen Innovax Biotech Co., Ltd

Brief Summary:
This study is to evaluate lot-lot consistency of Recombinant Hepatitis E Vaccine (Escherichia Coli) Hecolin®.

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

Detailed Description:
This study is a mono-center, randomization, double-blind clinical trial in healthy subjects between 18 to 50. Under the premise of full informed consent, 360 subjects that meet the requirement of clinical trial in the age of 18-50 will be divided into 3 groups and injected 3 consecutive batches of Hecolin® separately. The main outcome measures are the immunogenicity evaluation and safety surveillance after inoculation according to prescribed immunization procedure.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 360 participants
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
Actual Study Start Date : October 27, 2018
Actual Primary Completion Date : June 16, 2019
Actual Study Completion Date : June 16, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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 :
  1. 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.



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.


Layout table for eligibility information
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.


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


Locations
Layout table for location information
China, Jiangsu
Dongtai City Center for Disease Control and Prevention
Dongtai, Jiangsu, China, 224200
Sponsors and Collaborators
Xiamen Innovax Biotech Co., Ltd
Jiangsu Province Centers for Disease Control and Prevention
Investigators
Layout table for investigator information
Principal Investigator: Yuemei Hu Jiangsu Provincial Center for Disease Prevention and Control
Layout table for additonal information
Responsible Party: Xiamen Innovax Biotech Co., Ltd
ClinicalTrials.gov Identifier: NCT03365921    
Other Study ID Numbers: PRO-HE-010
First Posted: December 7, 2017    Key Record Dates
Last Update Posted: May 7, 2020
Last Verified: April 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis A
Hepatitis E
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections