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Trial record 70 of 309 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

HBV Vaccination in HIV-infected Adults

This study is currently recruiting participants.
Verified July 2017 by Romanee Chaiwarith, Chiang Mai University
Sponsor:
ClinicalTrials.gov Identifier:
NCT03212911
First Posted: July 11, 2017
Last Update Posted: July 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Romanee Chaiwarith, Chiang Mai University
  Purpose
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.

Condition Intervention Phase
Hepatitis B Vaccination, HIV Biological: Hepatitis B vaccine Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Open-label, randomized controlled trial (RCT) with 1:1 allocation in parallel arms
Masking: None (Open Label)
Masking Description:
No masking
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of 4- vs. 3-standard Doses HBV Vaccination in HIV-infected Adults With Isolated Anti-HBc Antibody

Resource links provided by NLM:


Further study details as provided by Romanee Chaiwarith, Chiang Mai University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Anamnestic response at week 4 [ Time Frame: 4 weeks after the first dose of HBV vaccination ]
    Anamnestic response at week 4

  • 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

  • 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

  • Intensity and frequency of vaccine adverse event (AE) [ Time Frame: 1 year ]
    Intensity and frequency of vaccine adverse event (AE)

  • 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

  • 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)


Estimated Enrollment: 96
Actual Study Start Date: July 1, 2017
Estimated Study Completion Date: July 1, 2018
Estimated Primary Completion Date: February 1, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03212911


Contacts
Contact: Romanee Chaiwarith, MD +66-5393-6457 rchaiwar@gmail.com
Contact: Quanhathai Kaewpoowat, MD +66-5393-6457 quanhathai@rihes.org

Locations
Thailand
Maharaj Nakorn Chiang Mai Hospital, Department of medicine, Chiang Mai University Recruiting
Muang, Chiang Mai, Chiang Mai, Thailand, 50200
Contact: Romanee Chaiwarith, MD    +66-5393-6457    rchaiwar@gmail.com   
Contact: Quanhathai Kaewpoowat, MD    +66-5393-6457    quanhathai@rihes.org   
Sponsors and Collaborators
Chiang Mai University
Investigators
Principal Investigator: Romanee Chaiwarith, MD Chiang Mai University
  More Information

Responsible Party: Romanee Chaiwarith, Associate Professor, Chiang Mai University
ClinicalTrials.gov Identifier: NCT03212911     History of Changes
Other Study ID Numbers: 04565
First Submitted: July 6, 2017
First Posted: July 11, 2017
Last Update Posted: July 11, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Romanee Chaiwarith, Chiang Mai University:
HBV vaccination, HIV, isolated anti-HBc

Additional relevant MeSH terms:
Hepatitis B
Hepatitis, Viral, Human
Hepatitis
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Liver Diseases
Digestive System Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs