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

NCT03854630 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 575

Last updated 2020-05-22

No results posted yet for this 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.

Conditions

  • Viral Hepatitis B
  • Immunization; Infection
  • HIV Infections

Interventions

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.

Sponsors & Collaborators

  • Taipei Veterans General Hospital, Taiwan

    collaborator OTHER_GOV

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • Chien-Ching Hung, MD, PhD · Department of Internal Medicine, National Taiwan University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-06
Primary Completion
2023-06-01
Completion
2023-12-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03854630 on ClinicalTrials.gov