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

Sponsor

Shanxi Medical University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05099757

Collaborator

(none)

150

Enrollment

Arm

21.8

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis B Vaccine	Biological: 20 µg dose hepatitis B vaccine	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Feb 20, 2022

Anticipated Primary Completion Date :

Nov 25, 2022

Anticipated Study Completion Date :

Dec 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 20 µg at month 0, months 0, 1 or 0, 1, and 6 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 one-dose, two-dose or three-dose, 20 µg per dose

Arm

Intervention/Treatment

Experimental: 20 µg at month 0, months 0, 1 or 0, 1, and 6

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

one-dose, two-dose or three-dose, 20 µg per dose

Outcome Measures

Primary Outcome Measures

Anti-HBs Seroconversion Rate at Months 1 [Months 1]
Anti-HBs Seroconversion Rate at Months 1
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 24 [Months 24]
Anti-HBs Seroconversion Rate at Months 24
Anti-HBs Seroconversion Rate at Months 30 [Months 30]
Anti-HBs Seroconversion Rate at Months 30

Secondary Outcome Measures

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
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 30 [Months 30]
Anti-HBs Concentration at Months 30

Other Outcome Measures

Occurrence of Adverse Events After Vaccination [Within 7 days after the vaccination]
Occurrence of Adverse Events After Vaccination
Occurrence of Adverse Events After Vaccination [Within 28 days after vaccination]
Occurrence of Adverse Events After Vaccination

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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