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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hepatitis B Vaccine
• Intervention / Treatment: Biological: 20 µg dose hepatitis B vaccine

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 Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Suping Wang, PhD; Phone Number: +86-351-4135103; Email: supingwang@sxmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of Adverse Events After Vaccination	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

Collaborators and Investigators

• Sponsor: Shanxi Medical University
• Investigators: Principal Investigator: Suping Wang, PhD, Shanxi Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): February 20, 2022
• Primary Completion (Anticipated): November 25, 2022
• Study Completion (Anticipated): December 15, 2023

Study Registration Dates

• First Submitted: October 13, 2021
• First Submitted That Met QC Criteria: October 27, 2021
• First Posted (Actual): October 29, 2021

Study Record Updates

• Last Update Posted (Actual): December 6, 2021
• Last Update Submitted That Met QC Criteria: December 2, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Immunogenicity; College Students; Hepatitis B Vaccine; Long-term Immune Response; Booster Dose
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Hepatitis B; Hepatitis; Hepatitis A
• Other Study ID Numbers: DXSHB20211012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No