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

Shanxi Medical University

Status and phase: Unknown; Phase 4

Conditions: Hepatitis B Vaccine

Treatments: Biological: 20 µg dose hepatitis B vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT05099757

DXSHB20211012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

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

Experimental group

Description:

20 µg recombinant hepatitis B vaccine with one, two or three injections at month 0, months 0, 1 or 0, 1, and 6

Treatment:

Biological: 20 µg dose hepatitis B vaccine