HBV Vaccination in HIV-infected Adults

July 6, 2017 updated by: Romanee Chaiwarith, Chiang Mai University

Immunogenicity and Safety of 4- vs. 3-standard Doses HBV Vaccination in HIV-infected Adults With Isolated Anti-HBc Antibody

The finding of isolated hepatitis B core antibody (isolated HBc) in absent of recent active hepatitis could cause by several scenarios, including false positive, remote infection without viremia, and occult infection with low viremia. Hepatitis B virus (HBV) vaccine booster could be a great prevention strategy for those who do not have HBV viremia. There is no standard consensus for management of this issue especially among HIV infected population. In addition, prior studies revealed that HIV-infected individuals had lower immunologic response to HBV vaccine than general population. This study intends to compare the immune response and safety of 4- versus 3-standard dose of hepatitis B virus vaccination in HIV-infected adults who has isolated HBc. The immunologic response will be evaluated after the participants receive vaccination.

Study Overview

Status

Status

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

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

  • A randomized controlled trial to evaluate differences in immunogenicity and safety of the two hepatitis B vaccination regimens, including the percentage of responders, high-level responders, anamnestic response, geometric mean titers of anti-HBs antibody, adverse events and predictive factors associated with vaccine responsiveness
  • After participant enrollment, data on baseline characteristics, time since HIV diagnosis, CD4 counts, HIV viral load, antiretroviral treatment regimen and duration will be collected, then the participants will be randomized into 2 groups to receive either 3- or 4-standard doses (20 mcg per dose) of HBV vaccination, and follow-up blood test for anti-HBs titers at multiple pre-specified time points to evaluate outcomes

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.
96

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.

Study Contact Backup

Study Locations

  • Thailand
    • Chiang Mai
      • Muang, Chiang Mai, Chiang Mai, Thailand, 50200
        • Recruiting
        • Maharaj Nakorn Chiang Mai Hospital, Department of Medicine, Chiang Mai University
        • Contact:
        • 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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged ≥ 18 years
  • On combination antiretroviral therapy (cART)
  • CD4 ≥ 200 cell/mm3 for ≥ 1 year
  • HIV viral load < 20 copies/ml for ≥ 1 year
  • Isolated anti-HBc Ab (negative HBsAg, anti-HBs Ab) and negative anti-HCV at screening

Exclusion Criteria:

  • Pregnancy
  • Previous HBV vaccination
  • Intolerance to any component of HBV vaccine
  • Transaminitis in the past 3 months (≥ 5 UNL)
  • Ongoing opportunistic infection (OI)
  • Active malignancy, with current chemotherapy or radiotherapy
  • Systemic steroid therapy (≥ 0.5 mg/kg/day) or any immunomodulating therapy in the last 6 months
  • Other immunocompromised disorders (e.g. solid organ transplant)
  • Asplenism
  • Renal insufficiency (CrCl ≤ 30 mL/min)
  • Decompensated cirrhosis (Child-Pugh C)

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: 3-standard dose HBV vaccination group
participants will receive 3 standard doses of HBV vaccination at 0, 1, 6 months
Biological: Hepatitis B vaccine
Hepatitis B vaccine (20 mcg/ml) 1 ml intramuscular injection in 3 (at 0, 1, 6 months) or 4 doses (0, 1, 2, 6 months)
ACTIVE_COMPARATOR: 4-standard dose HBV vaccination group
participants will receive 4 standard doses of HBV vaccination at 0, 1, 2, 6 months
Biological: Hepatitis B vaccine
Hepatitis B vaccine (20 mcg/ml) 1 ml intramuscular injection in 3 (at 0, 1, 6 months) or 4 doses (0, 1, 2, 6 months)

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
Immunologic response to 4 versus 3 doses of HBV vaccination in HIV-infected adults with isolated anti-HBc antibody, demonstrated by percentage of responders (with anti-HBs Ab ≥ 10 mIU/mL ) at week 28
Time Frame: 28 weeks after the first dose of HBV vaccination
Immunologic response to 4 versus 3 doses of HBV vaccination in HIV-infected adults with isolated anti-HBc antibody, demonstrated by percentage of responders (with anti-HBs Ab ≥ 10 mIU/mL ) at week 28
28 weeks after the first dose of HBV vaccination

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
Anamnestic response at week 4
Time Frame: 4 weeks after the first dose of HBV vaccination
Anamnestic response at week 4
4 weeks after the first dose of HBV vaccination
Percentage of responders (with anti-HBs Ab ≥ 10 mIU/mL) at month 12
Time Frame: 12 months after the first dose of HBV vaccination
Percentage of responders (with anti-HBs Ab ≥ 10 mIU/mL) at month 12
12 months after the first dose of HBV vaccination
Percentage of high-level responders (with anti-HBs Ab ≥ 100 mIU/mL) at week 28 and month 12
Time Frame: 28 weeks and 12 months after the first dose of HBV vaccination
Percentage of high-level responders (with anti-HBs Ab ≥ 100 mIU/mL) at week 28 and month 12
28 weeks and 12 months after the first dose of HBV vaccination
Intensity and frequency of vaccine adverse event (AE)
Time Frame: 1 year
Intensity and frequency of vaccine adverse event (AE)
1 year
Geometric mean titers of anti-HBs Ab at week 28 and month 12
Time Frame: 28 weeks and 12 months after the first dose of HBV vaccination
Geometric mean titers of anti-HBs Ab at week 28 and month 12
28 weeks and 12 months after the first dose of HBV vaccination
Predictive factors associated with response to vaccine (age, sex, CD4 count)
Time Frame: 1 year
Predictive factors associated with response to vaccine (age, sex, CD4 count)
1 year

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.
Chiang Mai University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
July 1, 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.
February 1, 2018

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.
July 1, 2018

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).
July 6, 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.
July 6, 2017

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.
July 11, 2017

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.
July 11, 2017

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.
July 6, 2017

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.
July 1, 2017

More Information

Terms related to this study

Keywords

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.
  • 04565

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

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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