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Status unknownNCT05099757Updated Dec 6, 2021

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

A Phase 4 interventional study of 20 µg dose hepatitis B vaccine in Hepatitis B Vaccine, sponsored by Shanxi Medical University. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-12-06.

Sponsored by Shanxi Medical University · Phase 4, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Dec 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
150
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hepatitis B Vaccine

Keywords

  • Hepatitis B Vaccine
  • Immunogenicity
  • Booster Dose
  • Long-term Immune Response
  • College Students
03

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's planned enrollment of 150 is above the median of 100 across 1,886 interventional studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

Shanxi Medical University is the lead sponsor of 10 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • 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

Interventions

  • Biological20 µg dose hepatitis B vaccine

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

06

What researchers measure

Primary outcomes

  1. Anti-HBs Seroconversion Rate at Months 1

    Anti-HBs Seroconversion Rate at Months 1

    Time frame: Months 1

  2. Anti-HBs Seroconversion Rate at Months 3

    Anti-HBs Seroconversion Rate at Months 3

    Time frame: Months 3

  3. Anti-HBs Seroconversion Rate at Months 7

    Anti-HBs Seroconversion Rate at Months 7

    Time frame: Months 7

  4. Anti-HBs Seroconversion Rate at Months 12

    Anti-HBs Seroconversion Rate at Months 12

    Time frame: Months 12

  5. Anti-HBs Seroconversion Rate at Months 18

    Anti-HBs Seroconversion Rate at Months 18

    Time frame: Months 18

  6. Anti-HBs Seroconversion Rate at Months 24

    Anti-HBs Seroconversion Rate at Months 24

    Time frame: Months 24

  7. Anti-HBs Seroconversion Rate at Months 30

    Anti-HBs Seroconversion Rate at Months 30

    Time frame: Months 30

Secondary outcomes

  1. Anti-HBs Concentration at Months 1

    Anti-HBs Concentration at Months 1

    Time frame: Months 1

  2. Anti-HBs Concentration at Months 3

    Anti-HBs Concentration at Months 3

    Time frame: Months 3

  3. Anti-HBs Concentration at Months 7

    Anti-HBs Concentration at Months 7

    Time frame: Months 7

  4. Anti-HBs Concentration at Months 12

    Anti-HBs Concentration at Months 12

    Time frame: Months 12

  5. Anti-HBs Concentration at Months 18

    Anti-HBs Concentration at Months 18

    Time frame: Months 18

  6. Anti-HBs Concentration at Months 24

    Anti-HBs Concentration at Months 24

    Time frame: Months 24

  7. Anti-HBs Concentration at Months 30

    Anti-HBs Concentration at Months 30

    Time frame: Months 30

Other outcomes

  1. Occurrence of Adverse Events After Vaccination

    Occurrence of Adverse Events After Vaccination

    Time frame: Within 7 days after the vaccination

  2. Occurrence of Adverse Events After Vaccination

    Occurrence of Adverse Events After Vaccination

    Time frame: Within 28 days after vaccination

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 6, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05099757
Lead sponsor
Shanxi Medical University
Responsible party
Suping Wang (Professor, Shanxi Medical University) — Principal investigator
First posted
Oct 29, 2021
Start date
Feb 20, 2022 (estimated)
Primary completion
Nov 25, 2022 (estimated)
Completion
Dec 15, 2023 (estimated)
Last update
Dec 6, 2021

Study contacts

Suping Wang, PhD
Contact
supingwang@sxmu.edu.cn
+86-351-4135103
Suping Wang, PhD
principal investigator · Shanxi Medical University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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