NCT05099757

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 29, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

February 20, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2022

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
Last Updated

December 6, 2021

Status Verified

December 1, 2021

Enrollment Period

9 months

First QC Date

October 13, 2021

Last Update Submit

December 2, 2021

Conditions

Hepatitis B Vaccine

Keywords

Hepatitis B VaccineImmunogenicityBooster DoseLong-term Immune ResponseCollege Students

Outcome Measures

Primary Outcomes (7)

  • 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 Outcomes (7)

  • Anti-HBs Concentration at Months 1

    Months 1

  • Anti-HBs Concentration at Months 3

    Months 3

  • Anti-HBs Concentration at Months 7

    Months 7

  • Anti-HBs Concentration at Months 12

    Months 12

  • Anti-HBs Concentration at Months 18

    Months 18

  • +2 more secondary outcomes

Other Outcomes (2)

  • Occurrence of Adverse Events After Vaccination

    Within 7 days after the vaccination

  • Occurrence of Adverse Events After Vaccination

    Within 28 days after vaccination

Study Arms (1)

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

EXPERIMENTAL

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

20 µg dose hepatitis B vaccineBIOLOGICAL

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

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Suping Wang, PhD

    Shanxi Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Suping Wang, PhD

CONTACT

+86-351-4135103supingwang@sxmu.edu.cn

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 13, 2021

First Posted

October 29, 2021

Study Start

February 20, 2022

Primary Completion

November 25, 2022

Study Completion

December 15, 2023

Last Updated

December 6, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share