Hepatitis E
Conditions
Keywords
hepatitis E, Immunogenicity, vaccine, safety
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.
Interventions
BIOLOGICALRecombinant (E. Coli) Hepatitis E Vaccine
Sponsors
Xiamen Innovax Biotech Co., Ltd
Xiamen Center for Disease Control and Prevention
Jun Zhang
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Outcome results
None listed