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Clinical Trial of Recombinant Hepatitis E Vaccine

This study has been completed.
Sponsor:
Collaborators:
Xiamen Innovax Biotech Co., Ltd
Beijing Wantai Biological Pharmacy Enterprise Co.,Ltd
National Institute of Diagnostics and Vaccine Development in infectious disease
Information provided by:
Xiamen University
ClinicalTrials.gov Identifier:
NCT01014845
First received: November 13, 2009
Last updated: November 16, 2009
Last verified: November 2009
History of Changes

November 13, 2009
November 16, 2009
August 2007
June 2009   (final data collection date for primary outcome measure)
Rate of confirmed hepatitis E cases [ Time Frame: One year since one month post the third injection ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01014845 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Clinical Trial of Recombinant Hepatitis E Vaccine
A Phase 3, Randomized, Double-blind, Placebo (Hepatitis B Vaccine) Controlled Clinical Trial of Recombinant (E. Coli) Hepatitis E Vaccine

This study is a prospective, randomized, double-blind, placebo (hepatitis B vaccine) controlled phase 3 clinical trial. The vaccination schedule is 0, 1, 6 month. Subjects were randomly allocated into two groups, one received Hepatitis E vaccine and the other received hepatitis B vaccine. The study is carried out with two stages. In the first stage (phase 3a), about 2000 subjects will be enrolled and solicited monitored for adverse events for 1 month after each injection. Serum samples from all subjects were collected on day 0, 7m, 13m and 19m to evaluate the immunogenicity and immuno-persistency. In the second stage (phase 3b), another 100,000 subjects will be enrolled and be unsolicited monitored for adverse events for 1 month after each injection. Serum samples from about 10,000 subjects were collected on day 0 and 7m to evaluate the immunogenicity. All subjects were followed up for acute hepatitis and severe adverse events during the trial.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Hepatitis E
Biological: hepatitis E vaccine
30mcg/dose, on 0,1,6m schedule
Other Name: Hecolin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
122179
June 2009
June 2009   (final data collection date for primary outcome measure)

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.
Both
16 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01014845
Pro-HE-003, 2006AA02A209
Yes
Jun Zhang, National Institute of Diagnostics and Vaccine Development in infectious disease,Xiamen University
Xiamen University
  • Xiamen Innovax Biotech Co., Ltd
  • Beijing Wantai Biological Pharmacy Enterprise Co.,Ltd
  • National Institute of Diagnostics and Vaccine Development in infectious disease
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
Xiamen University
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP