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

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ClinicalTrials.gov Identifier: NCT03854630
Recruitment Status : Recruiting
First Posted : February 26, 2019
Last Update Posted : May 22, 2020
Sponsor:
Collaborator:
Taipei Veterans General Hospital, Taiwan
Information provided by (Responsible Party):
National Taiwan University Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Viral Hepatitis B Immunization; Infection HIV Infections Drug: Engerix-B Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 575 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Hepatitis B Virus Vaccination in HIV-positive Patients and Individuals at High Risk for HIV Infection: an Open-label Randomized Clinical Trial
Actual Study Start Date : September 6, 2017
Estimated Primary Completion Date : June 1, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Vaccine efficacy [ Time Frame: week 28 ]
    The proportion of patients with Anti-HBs antibody higher than 10mIU/ml


Secondary Outcome Measures :
  1. High-titer response [ Time Frame: week 28 ]
    The proportion of patients with Anti-HBs antibody higher than 100mIU/ml

  2. Long-term efficacy [ Time Frame: 48 weeks ]
    The proportion of anti-HBs antibody titers higher than 10mIU/ml

  3. Long-term high-titer response [ Time Frame: 48 weeks ]
    The proportion of anti-HBs antibody titers higher than 100mIU/ml

  4. Hepatitis B incident infection rate [ Time Frame: 48 weeks, ]
    new HBsAg and anti-HBc antibody seroconversion

  5. Hepatitis C infection and syphilis infection rate [ Time Frame: at 24 week, 48 weeks ]
    new hepatitis C infection and syphilis infection

  6. HIV seroconversion among HIV-negative MSM [ Time Frame: at 24 weeks, 48 weeks ]
    new HIV seroconversion among HIV-negative MSM


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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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): NCT03854630


Contacts
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Contact: Chien-Ching Hung, MD, PhD +886-2-23123456 ext 67552 hcc0401@ntu.edu.tw
Contact: Hsin-Yun Sun, MD +886-2-23707772 hysun@ntu.edu.tw

Locations
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Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Chien-Ching Hung, MD, PhD    +886-2-23123456 ext 67552    hcc0401@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Taipei Veterans General Hospital, Taiwan
Investigators
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Principal Investigator: Chien-Ching Hung, MD, PhD Department of Internal Medicine, National Taiwan University Hospital
More Information
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03854630    
Other Study ID Numbers: 201608051MIPC
First Posted: February 26, 2019    Key Record Dates
Last Update Posted: May 22, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Hepatitis A
HIV Infections
Acquired Immunodeficiency Syndrome
Hepatitis B
Hepatitis
Disease Attributes
Pathologic Processes
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
 Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Hepadnaviridae Infections
DNA Virus Infections