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

NCT03854630 | Unknown Phase 4

• 1 other identifier: 201608051MIPC
• Study Type: interventional
• Target: 575
• Locations: 1 country
• Sites: 1

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.

Conditions

Viral Hepatitis B; Immunization; Infection; HIV Infections

Outcome Measures

Primary Outcomes (1)

• Vaccine efficacy

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

  week 28

Secondary Outcomes (6)

• High-titer response

  week 28

• Long-term efficacy

  48 weeks

• Long-term high-titer response

  48 weeks

• Hepatitis B incident infection rate

  48 weeks,

• Hepatitis C infection and syphilis infection rate

  at 24 week, 48 weeks

Study Arms (2)

Standard dose (20µg)

ACTIVE COMPARATOR

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

Drug: Engerix-B

Double dose (40µg)

EXPERIMENTAL

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

Drug: Engerix-B

Interventions

Engerix-B DRUG

The vaccine contains HBsAg which was produced by genetic engineering yeast. It stimulates the active immunity generated by human immune system toward the HBsAg.

Double dose (40µg); Standard dose (20µg)

Eligibility Criteria

• Age: 20 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• Taipei Veterans General Hospital, Taiwan: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Hepatitis B; Infections; HIV Infections

Interventions

Engerix-B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Chien-Ching Hung, MD, PhD

  Department of Internal Medicine, National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chien-Ching Hung, MD, PhD

CONTACT

+886-2-23123456; hcc0401@ntu.edu.tw

Hsin-Yun Sun, MD

CONTACT

+886-2-23707772; hysun@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2017
• First Posted: February 26, 2019
• Study Start: September 6, 2017
• Primary Completion: June 1, 2023
• Study Completion: December 31, 2023
• Last Updated: May 22, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)