Hepatitis B Vaccine
Conditions
Keywords
Hepatitis B Vaccine, Immunogenicity, Booster Dose, Long-term Immune Response, College Students
Brief summary
The anti-HBs produced after hepatitis B vaccination will decrease over time. College students are vaccinated with hepatitis B vaccine at birth, and their antibodies may have decreased significantly. In addition, college students are sexually active population, which has a high risk of HBV infection. It is necessary to study the anti-HBs level of college students, and analyze the strengthening immunization for this special group. This study will analyze the immunogenicity, immune persistence, and safety of booster dose of intramuscular 20 µg recombinant hepatitis B vaccines. Different booster vaccination including one-dose (0 month), two-dose (0, 1 months), or three-dose (0, 1, and 6 months) was given according to the antibody production level after booster vaccination among college students.
Detailed description
Participants are given booster dose of one-dose (0 month), two-dose (0, 1 months), or three-dose (0, 1, and 6 months) 20 µg recombinant hepatitis B vaccine according to the antibody production level. HBsAg and anti-HBs will be tested during the study period. Adverse reactions will be recorded after vaccination.
Interventions
BIOLOGICAL20 µg dose hepatitis B vaccine
one-dose, two-dose or three-dose, 20 µg per dose
Sponsors
Shanxi Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged of 18 years or above * Serologically negative for hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (anti-HBs) at enrollment * Sign informed consent, willing to participate in this study
Exclusion criteria
* Being pregnant * Intolerance or allergy to any component of the vaccine * Participants with severe acute or chronic diseases (such as liver disease, blood disease, cancer), acute onset of chronic diseases and fever
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anti-HBs Seroconversion Rate at Months 30 | Months 30 | Anti-HBs Seroconversion Rate at Months 30 |
| Anti-HBs Seroconversion Rate at Months 3 | Months 3 | Anti-HBs Seroconversion Rate at Months 3 |
| Anti-HBs Seroconversion Rate at Months 7 | Months 7 | Anti-HBs Seroconversion Rate at Months 7 |
| Anti-HBs Seroconversion Rate at Months 12 | Months 12 | Anti-HBs Seroconversion Rate at Months 12 |
| Anti-HBs Seroconversion Rate at Months 18 | Months 18 | Anti-HBs Seroconversion Rate at Months 18 |
| Anti-HBs Seroconversion Rate at Months 1 | Months 1 | Anti-HBs Seroconversion Rate at Months 1 |
| Anti-HBs Seroconversion Rate at Months 24 | Months 24 | Anti-HBs Seroconversion Rate at Months 24 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anti-HBs Concentration at Months 30 | Months 30 | Anti-HBs Concentration at Months 30 |
| Anti-HBs Concentration at Months 12 | Months 12 | Anti-HBs Concentration at Months 12 |
| Anti-HBs Concentration at Months 18 | Months 18 | Anti-HBs Concentration at Months 18 |
| Anti-HBs Concentration at Months 24 | Months 24 | Anti-HBs Concentration at Months 24 |
| Anti-HBs Concentration at Months 1 | Months 1 | Anti-HBs Concentration at Months 1 |
| Anti-HBs Concentration at Months 3 | Months 3 | Anti-HBs Concentration at Months 3 |
| Anti-HBs Concentration at Months 7 | Months 7 | Anti-HBs Concentration at Months 7 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Adverse Events After Vaccination | Within 7 days after the vaccination | Occurrence of Adverse Events After Vaccination |
Contacts
Primary ContactSuping Wang, PhD
Outcome results
None listed