Clinical trial NCT02189603: Phase Ⅳ Clinical Trial of Recombinant Hepatitis E Vaccine（Hecolin®）
Official title: Evaluation of Safety and Immunogenicity of Recombinant (E. Coli) Hepatitis E Vaccine（Hecolin®） in Seniors Aged Over 65 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis E
Keywords: hepatitis E
Immunogenicity
vaccine
safety
Lead sponsor: Xiamen University
Sponsor class: OTHER
Collaborators: name: Xiamen Innovax Biotech Co., Ltd
name: Xiamen Center for Disease Control and Prevention
First posted: 2014-07-14
Enrollment: 601
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants with Serious and Non-Serious Adverse Events
timeFrame: From month 0-7
Secondary outcomes:
measure: anti-HEV IgG seropositive rate
timeFrame: at month 7
measure: GMT of anti-HEV IgG
timeFrame: 7 month after first vaccination
Other outcomes:
Locations:
city: Xiamen
country: China
facility: Center for disease control and prevention in Xiamen haicang district
state: Fujian
Study officials:
References:
citation: 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.