The Immunogenicity and Persistence of Booster Dose With Hepatitis B Vaccine in College Students

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Study on the Immunogenicity and Persistence of Booster Dose With Hepatitis B Vaccine in College Students

Conditions
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Hepatitis B Vaccine

Intervention / Treatment
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* Biological: 20 µg dose hepatitis B vaccine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 20 µg at month 0, months 0, 1 or 0, 1, and 6<br>20 µg recombinant hepatitis B vaccine with one, two or three injections at month 0, months 0, 1 or 0, 1, and 6 | Biological: 20 µg dose hepatitis B vaccine<br>* one-dose, two-dose or three-dose, 20 µg per dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-HBs Seroconversion Rate at Months 1 | Anti-HBs Seroconversion Rate at Months 1 | Months 1 | 
| Anti-HBs Seroconversion Rate at Months 3 | Anti-HBs Seroconversion Rate at Months 3 | Months 3 | 
| Anti-HBs Seroconversion Rate at Months 7 | Anti-HBs Seroconversion Rate at Months 7 | Months 7 | 
| Anti-HBs Seroconversion Rate at Months 12 | Anti-HBs Seroconversion Rate at Months 12 | Months 12 | 
| Anti-HBs Seroconversion Rate at Months 18 | Anti-HBs Seroconversion Rate at Months 18 | Months 18 | 
| Anti-HBs Seroconversion Rate at Months 24 | Anti-HBs Seroconversion Rate at Months 24 | Months 24 | 
| Anti-HBs Seroconversion Rate at Months 30 | Anti-HBs Seroconversion Rate at Months 30 | Months 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-HBs Concentration at Months 1 | Anti-HBs Concentration at Months 1 | Months 1 | 
| Anti-HBs Concentration at Months 3 | Anti-HBs Concentration at Months 3 | Months 3 | 
| Anti-HBs Concentration at Months 7 | Anti-HBs Concentration at Months 7 | Months 7 | 
| Anti-HBs Concentration at Months 12 | Anti-HBs Concentration at Months 12 | Months 12 | 
| Anti-HBs Concentration at Months 18 | Anti-HBs Concentration at Months 18 | Months 18 | 
| Anti-HBs Concentration at Months 24 | Anti-HBs Concentration at Months 24 | Months 24 | 
| Anti-HBs Concentration at Months 30 | Anti-HBs Concentration at Months 30 | Months 30 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis B Vaccine, Immunogenicity, Booster Dose, Long-term Immune Response, College Students