NCT03962803

Brief Summary

At present, HIV-Infected Patients of Hepatitis B Vaccination in are vaccinated with hepatitis B vaccine according to the standard three-dose schedule immunization program, and the effect of preventing HBV infection is not ideal. This is a randomized, controlled trial. The study will evaluate the immunogenicity and persistence of 20 µg and 60 µg recombinant hepatitis B vaccine with three or four injections at months 0, 1, and 6 or 0, 1,2, and 6 in HIV-Infected Patients

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2019

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 24, 2019

Completed
12 days until next milestone

Study Start

First participant enrolled

June 5, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

May 24, 2019

Status Verified

May 1, 2019

Enrollment Period

8 months

First QC Date

May 23, 2019

Last Update Submit

May 23, 2019

Conditions

Hepatitis B Vaccine

Keywords

Hepatitis B VaccineRandomized Controlled TrialHIV-Infected PatientsImmunogenicityLong-term Immune Response

Outcome Measures

Primary Outcomes (1)

  • Anti-HBs Seroconversion Rate at Month 7

    Anti-HBs Seroconversion Rate at month 7 as measured by CMIA

    Month 7

Secondary Outcomes (10)

  • Anti-HBs concentration at month 7

    Month 7

  • Occurrence of Adverse Events After Vaccination

    Within 7 days after the vaccination

  • Anti-HBs Seroconversion Rate at month 12

    Month 12

  • Anti-HBs concentration at month 12

    Month 12

  • Anti-HBs Seroconversion Rate at month 18

    Month 18

  • +5 more secondary outcomes

Study Arms (3)

20 µg at months 0, 1, and 6

EXPERIMENTAL

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

Biological: 20 µg recombinant hepatitis B vaccine at months 0, 1, and 6

20 µg at months 0, 1, 2,and 6

EXPERIMENTAL

20 µg recombinant hepatitis B vaccine with four injections at months 0, 1, 2, and 6

Biological: 20 µg recombinant hepatitis B vaccine at months 0, 1, 2, and 6

60 µg at months 0, 1, 2,and 6

EXPERIMENTAL

60 µg recombinant hepatitis B vaccine with four injections at months 0, 1, 2, and 6

Biological: 60 µg recombinant hepatitis B vaccine at months 0, 1, 2, and 6

Interventions

20 µg recombinant hepatitis B vaccine at months 0, 1, and 6BIOLOGICAL

three-dose, 20 µg per dose

20 µg at months 0, 1, and 6
20 µg recombinant hepatitis B vaccine at months 0, 1, 2, and 6BIOLOGICAL

four-dose, 20 µg per dose

20 µg at months 0, 1, 2,and 6
60 µg recombinant hepatitis B vaccine at months 0, 1, 2, and 6BIOLOGICAL

four-dose, 60 µg per dose

60 µg at months 0, 1, 2,and 6

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Serologically negative for hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (anti-HBs) and hepatitis B core antibody (anti-HBc) 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
  • Any vaccination during the month preceding enrollment
  • CD4 cell count ≤ 200 cells/µL
  • Patients with severe acute or chronic diseases (such as liver disease, blood disease, cancer), acute onset of chronic diseases and fever
  • The use of immunosuppressive agents in patients with nearly three months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanxi Center for Disease Control and Prevention

Taiyuan, China

Location

Related Publications (1)

  • Feng Y, Chen Z, Xie R, Yao T, Wu Y, Yang F, Yuan C, Nie X, Wang F, Liang X, Wang S. Immunogenicity and safety of 4 intramuscular standard-dose and high-dose hepatitis B vaccine in people living with HIV: a randomized, parallel-controlled trial. Expert Rev Vaccines. 2022 Jun;21(6):861-868. doi: 10.1080/14760584.2022.2056024. Epub 2022 Apr 1.

    PMID: 35312441DERIVED

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

#86-351-4135103spwang88@163.com

Yongliang Feng, PhD

CONTACT

#86-351-4135362fengyongliang048@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 23, 2019

First Posted

May 24, 2019

Study Start

June 5, 2019

Primary Completion

February 1, 2020

Study Completion

December 1, 2023

Last Updated

May 24, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)