Vaccine Reaction
Conditions
Brief summary
To investigate the immunogenicity of HB vaccine with different series among primary immune adults aged 25-55, to assess potential alternative approaches for HB immunization.
Detailed description
By comparing the immunization effect of hepatitis B vaccine with other different types of hepatitis B vaccines using seris procedure, information on the immunization effect of 60 micrograms of hepatitis B vaccine in adults was obtained, which will provide a scientific basis for the development of a rapid immunization procedure for adults with large doses of hepatitis B vaccine and for the improvement of the immunization strategy for hepatitis B in adults.
Interventions
BIOLOGICAL20μg Engerix-B hepatitis B vaccine
BIOLOGICAL20μg Kangtai hepatitis B vaccine
BIOLOGICAL60μg Kangtai hepatitis B vaccine
BIOLOGICAL20μg CHO
Sponsors
Wu Jiang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* aged 25-55 years * negative for HBsAg,anti-HBs, and anti-HBc without prior HBV or HAV vaccination
Exclusion criteria
* a history of vaccine component allergies * autoimmune diseases * immunodeficiency * vaccinations received within the past month * acute illnesses within the past week * fever (axillary temperature exceeding 38°C) within the past three days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anti-HBs | at the second month after the final injection of each arm | Titers of hepatitis B virus surface antibody |
Countries
China
Outcome results
None listed