Hepatitis B Virus Vaccination in HIV-positive Patients and Individuals at High Risk for HIV Infection

May 22, 2020 updated by: National Taiwan University Hospital

Hepatitis B Virus Vaccination in HIV-positive Patients and Individuals at High Risk for HIV Infection: an Open-label Randomized Clinical Trial

The primary aim of this open-label, randomized control trial is to compare the immunogenicity at week 28 after 20µg HBV vaccine (at week 0, 4, 24) versus 40µg HBV vaccine (40-µg at week 0, 4, 24 week) among HIV-positive patients or HIV-negative MSM who were born in Taiwan after July 1986 and tested negative for all HBV serological markers. The secondary aims are to assess the safety of double-dose HBV vaccination, the proportions of high-level responders (anti-HBs antibody >100 mIU/ml) at weeks 28 and 48, the serological responses at week 48, and incident HBV infection (indicated by appearance of anti-HBc and/or HBsAg) at week 48.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

I. Study procedures:

  1. Well explain, complete inform and consent documents
  2. A blood test for hepatitis B surface antigen (HBsAg), anti-hepatitis B surface antibody (anti-HBs antibody), anti-hepatitis B core antibody (anti-HBc antibody), anti-HCV and RPR will be performed first.
  3. The patients with all negative seromarkers (within 1 month) will be allocated to two groups (random blank=4), a standard-dose booster of 20µg and a double-dose booster of 40µg. For patients receiving 40µg, two 20µg of vaccines are injected at both sides of deltoid muscles. The schedules of booster vaccination are the same in two groups, which is at 0, 1, 6 months.
  4. To detect and manage possible immediate and severe allergic reaction, patients who received vaccination will be observed for 30 minutes after injection.
  5. The solicited adverse effect will be recorded on the diary card if occurred in 7 days after each dose of vaccination.
  6. The titer of hepatitis B surface antibody will be examined before booster vaccination, at the 4th week, the 24th week, 28th week, 48th week. By comparing the responses in the two groups, the effect of different doses of booster vaccination can be evaluated. For those HIV-negative individuals at baseline, HIV screening test will be evaluated every 6 months during the study, at the 24th week, the 48th.
  7. To screen the acquisition of hepatitis B, the anti-HBc antibody and HBsAg will be examined at the 48th week
  8. To screen the acquisition of hepatitis C and syphilis, anti-HCV and RPR will be examined at the 24th week, the 48th week
  9. The results of the study will be informed by phone or the physician during the follow-up care.
  10. The serum/blood samples will be preserved in the research lab of the department of internal medicine and kept for 20 years. During this period, the sample will be applied or used in other studies after the patients and the Research Ethics Committee both agreed.
  11. During the follow-up care, the treatment or record of hospitalization will be recorded or reviewed.
  12. The participants will drop out of clinical trial when protocol violation occurred or the participant is not willing to continue.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
575

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Chien-Ching Hung, MD, PhD
  • Phone Number: 67552 +886-2-23123456
  • Email: hcc0401@ntu.edu.tw

Study Contact Backup

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • Recruiting
        • National Taiwan University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Men who have sex with men (MSM)
  • Birth date after 1986/7/1 and aged 20 years or older
  • Seronegative for HBsAg, anti-HBs (<10 mIU/ml), and anti-HBc at screening (within 1 month of the first dose)
  • Regularly receiving HIV care for HIV-positive patients over the past 6 months
  • Seeking VCT for at least once for HIV-negative patients over the past 12 months

Exclusion Criteria:

  • Active infection or malignancy within 12 months of screening
  • Receiving chemotherapy, immunosuppressant, or IVIG within 12 months of screening
  • Received higher than 5 mg of prednisolone, including IV, oral, or topical form, per day for more than 1 weeks within 6 months of screening
  • Receiving HBV vaccination within 1 months of screening, or being allergic to HBV vaccine
  • Receiving other vaccination within 1 months of screening, such as influenza, pneumococcus, HPV, HAV, varicella vaccine.
  • Stage 4 and 5 of chronic kidney disease (GFR<30 mL/min/1.73m), or receiving dialysis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: Standard dose (20µg)
Three doses of 20µg HBV vaccine given intramuscularly at week 0, 4, 24.
Drug: Engerix-B
The vaccine contains HBsAg which was produced by genetic engineering yeast. It stimulates the active immunity generated by human immune system toward the HBsAg.
EXPERIMENTAL: Double dose (40µg)
Three doses of 40µg HBV vaccine given intramuscularly at week 0, 4, 24.
Drug: Engerix-B
The vaccine contains HBsAg which was produced by genetic engineering yeast. It stimulates the active immunity generated by human immune system toward the HBsAg.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Vaccine efficacy
Time Frame: week 28
The proportion of patients with Anti-HBs antibody higher than 10mIU/ml
week 28

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
High-titer response
Time Frame: week 28
The proportion of patients with Anti-HBs antibody higher than 100mIU/ml
week 28
Long-term efficacy
Time Frame: 48 weeks
The proportion of anti-HBs antibody titers higher than 10mIU/ml
48 weeks
Long-term high-titer response
Time Frame: 48 weeks
The proportion of anti-HBs antibody titers higher than 100mIU/ml
48 weeks
Hepatitis B incident infection rate
Time Frame: 48 weeks,
new HBsAg and anti-HBc antibody seroconversion
48 weeks,
Hepatitis C infection and syphilis infection rate
Time Frame: at 24 week, 48 weeks
new hepatitis C infection and syphilis infection
at 24 week, 48 weeks
HIV seroconversion among HIV-negative MSM
Time Frame: at 24 weeks, 48 weeks
new HIV seroconversion among HIV-negative MSM
at 24 weeks, 48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Taiwan University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Taipei Veterans General Hospital, Taiwan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Chien-Ching Hung, MD, PhD, Department of Internal Medicine, National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 6, 2017

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2023

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 7, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 26, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 201608051MIPC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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