Phase Ⅳ Clinical Trial of Recombinant Hepatitis E Vaccine（Hecolin®）
Phase 4
Completed
- Conditions
- Hepatitis E
- Interventions
- Biological: Recombinant (E. Coli) Hepatitis E Vaccine
- Registration Number
- NCT02189603
- Lead Sponsor
- Jun Zhang
- Brief Summary
The purpose of this study is to determine the safety and immunogenicity of the recombinant hepatitis E vaccine in people older than 65 years, and evaluate the efficacy of hepatitis E vaccine in this population.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 601
Inclusion Criteria
- Healthy people aged over 16 years old at the time of the first vaccination, normal intelligence and agree to sign the informed consent form.
- Healthy subjects as established by medical history and history-oriented clinical examination before entering into the study.
- Subjects will reside in the study region in the next 7 months.
- Free of history of hepatitis E.
- Can comply with the request of study.
- Axillary temperature is below 37 degree centigrade.
Exclusion Criteria
For dose 1:
- receiving other vaccine or immunoglobulin within two weeks;
- Having serious 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, genetic defect, HIV or other factors;
- Congenital malformation, eccyliosis or severe chronic 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Senior group(over 65 years old)-HE Recombinant (E. Coli) Hepatitis E Vaccine Anti-HEV IgG seronegative participants over 65 years old were enrolled. 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. Younger groups(16-65 years old) Recombinant (E. Coli) Hepatitis E Vaccine Participants aged 16-65 years old were enrolled. 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.
- Primary Outcome Measures
Name Time Method Number of Participants with Serious and Non-Serious Adverse Events From month 0-7 Any adverse events reported within one month post each vaccination would be recorded, any serious adverse events reported throughout the study would be recorded.
- Secondary Outcome Measures
Name Time Method anti-HEV IgG seropositive rate at month 7 GMT of anti-HEV IgG 7 month after first vaccination Serum sample would be collected at month 7, and geometric mean titer of anti-HEV IgG would be tested
Trial Locations
- Locations (1)
Center for disease control and prevention in Xiamen haicang district
🇨🇳Xiamen, Fujian, China