Hepatitis E is characteristic by sporadic and local epidemic around the world, and mainly infects adults aged 15 to 40 years old, resulting in the infection rate ranged from 1% to 15%. The investigational hepatitis E vaccine is a recombinant aluminium-adjuvant hepatitis E vaccine. This is a single center, randomized, blinding, parallel-controlled phase Ib clinical trial. This study will determine the safety and immunogenicity of the investigational recombinant hepatitis E vaccine in healthy adults between 16 and 65 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
60
three doses, 30μg/0.5ml per dose
30μg/0.5ml Hepatitis E vaccine developed by Xiamen innovax biotech Co.,Ltd.,three doses, 30μg/0.5ml per dose
Jiangsu Provincial Center for Diseases Control and Prevention
Nanjing, Jiangsu, China
Occurrence of adverse reactions after vaccination
Occurrence of adverse reactions within 7 days after each vaccination with the Recombinant Hepatitis E vaccine.
Time frame: within 7 days after each vaccination
The geometric mean concentration of antibody against Hepatitis E responses to the Hepatitis E vaccine
Antibody against Hepatitis E responses to the Hepatitis E vaccine at 7 months after the first vaccination
Time frame: 7 months after the first vaccination
Occurrence of adverse events after each vaccination
Occurrence of adverse events within 28 days after each vaccination with the Hepatitis E vaccine.
Time frame: within 28 days after each vaccination
Occurrence of serious adverse events after the vaccination.
Occurrence of serious adverse events within 12 months after the first vaccination with the Hepatitis E vaccine.
Time frame: within 12 months after the first vaccination
The positive rates of antibody against Hepatitis E responses to the Hepatitis E vaccine.
The positive rates of antibody against Hepatitis E responses to the Hepatitis E vaccine at 7 months after the first vaccination.
Time frame: 7 months after the first vaccination
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