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

Hepatitis B Vaccine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05099757
• Other study ID #: DXSHB20211012
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: February 20, 2022
• Est. completion date: December 15, 2023

Study information

• Verified date: December 2021
• Source: Shanxi Medical University
• Contact: Suping Wang, PhD
• Phone: +86-351-4135103
• Email: supingwang[@]sxmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: December 15, 2023
• Est. primary completion date: November 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B Vaccine

Intervention

Biological:
• 20 µg dose hepatitis B vaccine
one-dose, two-dose or three-dose, 20 µg per dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanxi Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Occurrence of Adverse Events After Vaccination	Occurrence of Adverse Events After Vaccination	Within 7 days after the vaccination
Other	Occurrence of Adverse Events After Vaccination	Occurrence of Adverse Events After Vaccination	Within 28 days after vaccination
Primary	Anti-HBs Seroconversion Rate at Months 1	Anti-HBs Seroconversion Rate at Months 1	Months 1
Primary	Anti-HBs Seroconversion Rate at Months 3	Anti-HBs Seroconversion Rate at Months 3	Months 3
Primary	Anti-HBs Seroconversion Rate at Months 7	Anti-HBs Seroconversion Rate at Months 7	Months 7
Primary	Anti-HBs Seroconversion Rate at Months 12	Anti-HBs Seroconversion Rate at Months 12	Months 12
Primary	Anti-HBs Seroconversion Rate at Months 18	Anti-HBs Seroconversion Rate at Months 18	Months 18
Primary	Anti-HBs Seroconversion Rate at Months 24	Anti-HBs Seroconversion Rate at Months 24	Months 24
Primary	Anti-HBs Seroconversion Rate at Months 30	Anti-HBs Seroconversion Rate at Months 30	Months 30
Secondary	Anti-HBs Concentration at Months 1	Anti-HBs Concentration at Months 1	Months 1
Secondary	Anti-HBs Concentration at Months 3	Anti-HBs Concentration at Months 3	Months 3
Secondary	Anti-HBs Concentration at Months 7	Anti-HBs Concentration at Months 7	Months 7
Secondary	Anti-HBs Concentration at Months 12	Anti-HBs Concentration at Months 12	Months 12
Secondary	Anti-HBs Concentration at Months 18	Anti-HBs Concentration at Months 18	Months 18
Secondary	Anti-HBs Concentration at Months 24	Anti-HBs Concentration at Months 24	Months 24
Secondary	Anti-HBs Concentration at Months 30	Anti-HBs Concentration at Months 30	Months 30