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Status unknownNCT03854630Updated May 22, 2020

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

A Phase 4 interventional study of Engerix-B in Viral Hepatitis B, Immunization; Infection and HIV Infections, sponsored by National Taiwan University Hospital. Status unknown at 1 site in Taiwan. Open to male participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-22.

Sponsored by National Taiwan University Hospital · Phase 4, Interventional, and Prevention

The sponsor has not verified this record recently (last verified May 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
575
Allocation
Randomized
Ages
20 Years and older
Sex
Male
01

Study 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.

Read the 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.
02

Conditions studied

  • Viral Hepatitis B
  • Immunization; Infection
  • HIV Infections
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's planned enrollment of 575 is above the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
575 participants (estimated)

Study arms

  • Active comparator
    Standard dose (20µg)

    Three doses of 20µg HBV vaccine given intramuscularly at week 0, 4, 24.

    Drug: Engerix-B

  • Experimental
    Double dose (40µg)

    Three doses of 40µg HBV vaccine given intramuscularly at week 0, 4, 24.

    Drug: Engerix-B

Interventions

  • DrugEngerix-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.

06

What researchers measure

Primary outcomes

  1. Vaccine efficacy

    The proportion of patients with Anti-HBs antibody higher than 10mIU/ml

    Time frame: week 28

Secondary outcomes

  1. High-titer response

    The proportion of patients with Anti-HBs antibody higher than 100mIU/ml

    Time frame: week 28

  2. Long-term efficacy

    The proportion of anti-HBs antibody titers higher than 10mIU/ml

    Time frame: 48 weeks

  3. Long-term high-titer response

    The proportion of anti-HBs antibody titers higher than 100mIU/ml

    Time frame: 48 weeks

  4. Hepatitis B incident infection rate

    new HBsAg and anti-HBc antibody seroconversion

    Time frame: 48 weeks,

  5. Hepatitis C infection and syphilis infection rate

    new hepatitis C infection and syphilis infection

    Time frame: at 24 week, 48 weeks

  6. HIV seroconversion among HIV-negative MSM

    new HIV seroconversion among HIV-negative MSM

    Time frame: at 24 weeks, 48 weeks

07

Study locations

1 of 1 sites recruiting
  • National Taiwan University Hospital
    Taipei, 100, Taiwan
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03854630
Lead sponsor
National Taiwan University Hospital
Collaborators
Taipei Veterans General Hospital, Taiwan
Responsible party
Sponsor
First posted
Feb 26, 2019
Start date
Sep 6, 2017
Primary completion
Jun 1, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
May 22, 2020

Study contacts

Chien-Ching Hung, MD, PhD
Contact
hcc0401@ntu.edu.tw
+886-2-23123456 ext. 67552
Hsin-Yun Sun, MD
Contact
hysun@ntu.edu.tw
+886-2-23707772
Chien-Ching Hung, MD, PhD
principal investigator · Department of Internal Medicine, National Taiwan University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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