Clinical Trial of Recombinant Hepatitis E Vaccine

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Xiamen Innovax Biotech Co., Ltd
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
National Institute of Diagnostics and Vaccine Development in infectious disease
Jiangsu Provincial Center for Disease Control and Prevention
Information provided by (Responsible Party):
Jun Zhang, Xiamen University
ClinicalTrials.gov Identifier:
NCT01014845
First received: November 13, 2009
Last updated: February 21, 2014
Last verified: February 2014
  Purpose

The primary purpose of this study is to determine whether the preventive hepatitis E are effective in the prevention of hepatitis E occurring at least 30 days after the administration of the third dose of vaccine.

The secondary purpose of this study is to to evaluate the safety and immunogenicity and immunopersistence of the study vaccine.

The initial study is planed to be ended on month 19 and the results were analysed and used for registration purpose. The extended study will be continued to assess the long-term efficacy, immunogenicity and safety.


Condition Intervention Phase
Hepatitis E
Biological: hepatitis E vaccine
Biological: Hepatitis B vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 3, Randomized, Double-blind, Placebo (Hepatitis B Vaccine) Controlled Clinical Trial of Recombinant (E. Coli) Hepatitis E Vaccine

Resource links provided by NLM:


Further study details as provided by Xiamen University:

Primary Outcome Measures:
  • Rate of confirmed hepatitis E cases [ Time Frame: One year since one month post the third injection ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • IgG anti-HEV seroconversion rate [ Time Frame: On one month post the third injection ] [ Designated as safety issue: No ]
  • Persistency of IgG anti-HEV [ Time Frame: One year ] [ Designated as safety issue: No ]

Enrollment: 112604
Study Start Date: August 2007
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hepatitis E vaccine
Hepatitis E vaccine, containing 30mcg of HEV239 recombinant antigen adsorbed to alum adjuvant suspended in 0.5ml phosphate buffer, was given at 0, 1, 6m for three doses.
Biological: hepatitis E vaccine
Intramuscularly given at 0, 1, 6m for three doses.
Other Name: Hecolin
Placebo Comparator: HBV vaccine
Hepatitis B vaccine, containing 5mcg of HBsAg recombinant antigen adsorbed to alum adjuvant suspended in 0.5ml phosphate buffer, was given at 0, 1, 6m for three doses.
Biological: Hepatitis B vaccine
Intramuscularly given at 0, 1, 6m for three doses.

Detailed Description:

Participants were randomly allocated into two groups, one received Hepatitis E vaccine and the other received hepatitis B vaccine. The study was carried out with two stages. In the first stage (phase 3a), 2 645 subjects was enrolled and actively monitored for solicited adverse events for 1 month after each injection. Serum samples from all the subjects were collected on day 0, 7m, 13m, 19m and timely after then to evaluate the immunogenicity and immuno-persistency. In the second stage (phase 3b), another 109 959 subjects was enrolled and monitored for solicited adverse events for 1 month after each injection. Serum samples from 9764 subjects among the phase 3b participants were collected on day 0, 7m, 19m and timely after then to evaluate the immunogenicity and immuno-persistency. Serious adverse events during the trial were followed up.

Suspected hepatitis cases were identified through an established active hepatitis surveillance system. The sentinels of the system comprised all the healthcare facilities in the field. Suspected hepatitis was defined as when patients presented with systemic symptoms such as fatigue and/or loss of appetite for more than 3 days with alanine aminotransferase (ALT) exceeding 2.5 fold upper limit of normal range (ULN). Paired sera were obtained from these patients at the time of presentation and 2-6 weeks later. Sera were tested for the HEV antibodies and HEV-RNA.

  Eligibility

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy people aged from 16 years to 65 years old at the time of the first vaccination, normal intelligence and agree to sign the informed consent form.
  • Subjects will reside in the study region in the next 19 months.
  • Free of history of hepatitis B or hepatitis E.
  • Can comply with the request of study.
  • Axillary temperature is below 37 degree centigrade.

Exclusion Criteria:

For dose 1:

  • Having other vaccine or immunoglobulin within two weeks;
  • Having allergic history to vaccine and medicine
  • Eclampsia, epilepsy, encephalopathy and history of mental disease or family;
  • Thrombocytopenia or other disturbance of blood coagulation which would lead to muscle injection taboo;
  • Fixed or suspected deficiency of immunologic function, containing immunosuppressant treatment(radiation therapy, chemical treatment, steroid hormone, antimetabolites, cytotoxic drugs), genetic defect(e.g. fabism), HIV or other factors;
  • congenital malformation, eccyliosis or severe chronic disease(e.g. Down Syndrome, diabetes, sickle cell anemia or mental disease);
  • fixed or suspected other disease including fever, active infection, liver and kidney disease, angiocardiopathy, malignancy, acute and chronic disease;
  • joining other clinical study undergoing;
  • women pregnant or in lactation.

For dose 2 or 3:

  • Severe allergy for dose 1 or 2;
  • Severe adverse reaction associated with last vaccination;
  • New occurrence of symptoms meet dose 1 exclusion criteria after the first dose.
  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: NCT01014845

Locations
China, Jiangsu
Dongtai Center for Disease Control and Prevention
Dongtai, Jiangsu, China, 224200
Sponsors and Collaborators
Xiamen University
Xiamen Innovax Biotech Co., Ltd
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
National Institute of Diagnostics and Vaccine Development in infectious disease
Jiangsu Provincial Center for Disease Control and Prevention
Investigators
Study Director: Jun Zhang, M.D. National Institute of Diagnostics and Vaccine Development in infectious disease, Xiamen University
Principal Investigator: Feng-Cai Zhu, M.D. Jiangsu Provincial Center for Disease Control and Prevention, China
  More Information

Publications:

Responsible Party: Jun Zhang, professor, Xiamen University
ClinicalTrials.gov Identifier: NCT01014845     History of Changes
Other Study ID Numbers: Pro-HE-003, 2006AA02A209
Study First Received: November 13, 2009
Last Updated: February 21, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Xiamen University:
hepatitis E
vaccine
efficacy

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

ClinicalTrials.gov processed this record on September 18, 2014