This study is conducted among people aged 18-50 in Dandong City, an area with a high incidence of hepatitis A in recent years. 1000 qualified pariticipants with signed informed consent will be screened for anti-HAV antibodies by collecting blood sample of 3ml. One dose of hepatitis A vaccine will be administrated to all the pariticipants. Negative anti-HAV antibodies-negative subjects will recieve the second dose of hepatitis A vaccination, and 400 of them will be randomly selected and assigned to 4 groups with different interval of vaccination(6 month, 18 months, 36 months and 60 months). Blood samples will be collected before vaccination of each dose and on 28 days after each dose of vaccination to anti-HAV antibody test. Safety data will be collected within 28 days after each vaccination with a smartphone mini-program.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,092
The hepatitis A vaccine contains 500 SU inactivated hepatitis A virus per dose in 1mL of aluminum hydroxide solution. For anti-HAV antibody-negative participants, two dose of hepatitis A vaccine will be given with vaccination interval of 6 month, 18 months, 36 months, and 60 months, respectively.
Liaoning Center for Disease Control and Prevention
Shenyang, Liaoning, China
The seroconversion rate of anti-HAV antibody 28 days after two dose of vaccination of hepatitis A vaccine with an interval of 6 month
Time frame: 28 days after two dose of vaccination of hepatitis A vaccine
Incidence of adverse reaction within 28 days after one dose of vaccination
Time frame: 28 days after one dose of vaccination
The seroconversion rate of anti-HAV antibody 28 days after two dose of vaccination of hepatitis A vaccine with an interval of 18 month, 36 months, and 60 months
Time frame: 28 days after two dose of vaccination
The seropositive rate, GMC and GMI of anti-HAV antibody 28 days after two dose of vaccination of hepatitis A vaccine with an interval of 6 months, 18 month, 36 months, and 60 months
Time frame: 28th day after two dose of vaccination
The seropositive rate, GMC and GMI of anti-HAV antibody 28 days after one dose of vaccination of hepatitis A vaccine with an interval of 6 months, 18 month, 36 months, and 60 months
Time frame: 28 days after one dose of vaccination
The seropositive rate, GMC and GMI of anti-HAV antibody 28 days after two dose of vaccination of hepatitis A vaccine with an interval of 6 months, 18 month, 36 months, and 60 months among people with underlying conditions
Time frame: 28 days after two dose of vaccination
The seropositive rate of anti-HAV antibody before vaccination
Time frame: before vaccination
Incidence of adverse reaction within 7 days after one dose of vaccination
Time frame: 7 days after one dose of vaccination
Incidence of adverse reaction within 28 days after two dose of vaccination
Time frame: 28 days after two dose of vaccination
Incidence of adverse reaction within 28 days after one dose of vaccination among different group of people
Time frame: 28 days after one dose of vaccination among
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