Clinical trial NCT05099757: The Immunogenicity and Persistence of Booster Dose With Hepatitis B Vaccine in College Students
Official title: The Study on the Immunogenicity and Persistence of Booster Dose With Hepatitis B Vaccine in College Students
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hepatitis B Vaccine
Keywords: Hepatitis B Vaccine
Immunogenicity
Booster Dose
Long-term Immune Response
College Students
Lead sponsor: Shanxi Medical University
Sponsor class: OTHER
First posted: 2021-10-29
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Anti-HBs Seroconversion Rate at Months 1
timeFrame: Months 1
measure: Anti-HBs Seroconversion Rate at Months 3
timeFrame: Months 3
measure: Anti-HBs Seroconversion Rate at Months 7
timeFrame: Months 7
measure: Anti-HBs Seroconversion Rate at Months 12
timeFrame: Months 12
measure: Anti-HBs Seroconversion Rate at Months 18
timeFrame: Months 18
measure: Anti-HBs Seroconversion Rate at Months 24
timeFrame: Months 24
measure: Anti-HBs Seroconversion Rate at Months 30
timeFrame: Months 30
Secondary outcomes:
measure: Anti-HBs Concentration at Months 1
timeFrame: Months 1
measure: Anti-HBs Concentration at Months 3
timeFrame: Months 3
measure: Anti-HBs Concentration at Months 7
timeFrame: Months 7
measure: Anti-HBs Concentration at Months 12
timeFrame: Months 12
measure: Anti-HBs Concentration at Months 18
timeFrame: Months 18
measure: Anti-HBs Concentration at Months 24
timeFrame: Months 24
measure: Anti-HBs Concentration at Months 30
timeFrame: Months 30
Other outcomes:
measure: Occurrence of Adverse Events After Vaccination
timeFrame: Within 7 days after the vaccination
measure: Occurrence of Adverse Events After Vaccination
timeFrame: Within 28 days after vaccination
Locations:
Study officials:
affiliation: Shanxi Medical University
name: Suping Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References: