NCT05099757

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Shanxi Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatitis B Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	20 µg dose hepatitis B vaccine	one-dose, two-dose or three-dose, 20 µg per dose

Timeline

• Start date: 2022-02-20
• Primary completion: 2022-11-25
• Completion: 2023-12-15
• First posted: 2021-10-29
• Last updated: 2021-12-06