Hepatitis E Clinical Trial
Official title:
Evaluation of Safety and Immunogenicity of Recombinant (E. Coli) Hepatitis E Vaccine(Hecolin®) in Seniors Aged Over 65 Years
Verified date | August 2018 |
Source | Xiamen University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 601 |
Est. completion date | December 7, 2015 |
Est. primary completion date | December 7, 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 16 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
China | Center for disease control and prevention in Xiamen haicang district | Xiamen | Fujian |
Lead Sponsor | Collaborator |
---|---|
Jun Zhang | Xiamen Center for Disease Control and Prevention, Xiamen Innovax Biotech Co., Ltd |
China,
Zhu FC, Zhang J, Zhang XF, Zhou C, Wang ZZ, Huang SJ, Wang H, Yang CL, Jiang HM, Cai JP, Wang YJ, Ai X, Hu YM, Tang Q, Yao X, Yan Q, Xian YL, Wu T, Li YM, Miao J, Ng MH, Shih JW, Xia NS. Efficacy and safety of a recombinant hepatitis E vaccine in healthy adults: a large-scale, randomised, double-blind placebo-controlled, phase 3 trial. Lancet. 2010 Sep 11;376(9744):895-902. doi: 10.1016/S0140-6736(10)61030-6. Epub 2010 Aug 20. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants with Serious and Non-Serious Adverse Events | Any adverse events reported within one month post each vaccination would be recorded, any serious adverse events reported throughout the study would be recorded. | From month 0-7 | |
Secondary | anti-HEV IgG seropositive rate | at month 7 | ||
Secondary | GMT of anti-HEV IgG | Serum sample would be collected at month 7, and geometric mean titer of anti-HEV IgG would be tested | 7 month after first vaccination |
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