Immunologic Response of Hepatitis B Vaccine

Immunologic Response of Hepatitis B Single Dose Versus 3-dose Series in Previously Vaccinated HIV-infected Adults at Maharaj Nakorn Chiang Mai Hospital: A Randomized Controlled Trial

This study aims to evaluate the immunologic response to the two hepatitis B virus (HBV) vaccination booster strategies in previously vaccinated HIV-infected adults at Maharaj Nakorn Chiang Mai Hospital.

Study Overview

• Status: Unknown
• Conditions: Hepatitis B
• Intervention / Treatment: Biological: Hepatitis B vaccine

Detailed Description

This study intended to evaluate the immunologic response to the two hepatitis B virus (HBV) vaccination strategies in previously vaccinated HIV-infected adults at Maharaj Nakorn Chiang Mai Hospital.

As a part of HBV prevention program, HBV vaccine has been included in Thailand expanded program on immunization (EPI) since 1992. HBV vaccine has been shown to be safe, effective, and has a prolonged protective immunity to HBV infection. Despite the immunity from HBV vaccination could wane overtime, the previous data in general population revealed that HBV vaccine booster could raise the immune in very well. However, the data about booster effects for HBV vaccine among HIV-infected population who previously received a vaccination during their childhood is lagging. Based on previous data of vaccination response in HIV-infected population, the investigators estimate that the protective antibody will rise up to 60% with HBV vaccine one dose booster versus 90% with 3-dose series. Eighty participants, HIV-infected person who were born after HBV vaccine were born after HBV has been included in Thai EPI without evidence of HBV infection nor protective immunity, will be enrolled to this study (with estimation of 5% loss follow up rate). The participants will be randomized in 1:1. The immune response and vaccine safety will be evaluated at 1,7 and 12 months after the first dose HBV vaccine.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Romanee Chaiwarith, MD; Phone Number: +66-5393-6457; Email: rchaiwar@gmail.com
• Study Contact Backup: Name: Quanhathai Kaewpoowat, MD; Phone Number: +66-5393-6457; Email: quanhathai@rihes.org

Study Locations

• Thailand
  • Chiang Mai
    • Muang, Chiang Mai, Chiang Mai, Thailand, 50200
      • Recruiting
      • Maharaj Nakorn Chiang Mai Hospital, Department of Medicine, Chiang Mai University
      • Contact: Romanee Chaiwarith, MD; Phone Number: +66-5393-6457; Email: rchaiwar@gmail.com
      • Contact: Quanhathai Kaewpoowat, MD; Phone Number: +66-5393-6457; Email: quanhathai@rihes.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Document of HIV infection
• Thai nationality
• Age ≥18 years old
• Born after 1 January 1992
• Has been taking antiretroviral drugs for HIV treatment
• CD4 ≥200 cell/mm3 and VL <50 copies/mL for at least 6 months before enrollment
• Negative for any HBV and HCV serological markers
• Willing to sign informed consent
• Able to follow up

Exclusion Criteria:

• Active opportunistic infection
• Pregnancy or breast feeding
• History of previous hepatitis B vaccine booster
• History of hypersensitivity to any component of vaccine
• Malignancy which received chemotherapy or radiation
• Immunocompromised condition such as solid-organ transplantation, chemotherapy in the last 6 months
• On Immunosuppressive treatment, immunomodulating treatment or general corticotherapy (equal or above 0.5 mg per kg per day )
• Renal failure (creatinine clearance <30 mL/min)
• Transaminitis in the past 3 months (≥ 5 UNL)
• Decompensated cirrhosis (child-Pugh class C)
• Unable or not willing to return for follow up

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Arm A: Single dose hepatitis B vaccine; Single dose of hepatitis B vaccine group will receive a 20 µg recombinant HBV vaccine intramuscular at entry	Biological: Hepatitis B vaccine; Hepatitis B vaccine (20 µg/ml) 1 ml intramuscular injection in single (at 0 month) or 3-dose series (at 0, 1, 6 months)
ACTIVE_COMPARATOR: Arm B: 3-dose series of hepatitis B vaccine; 3-dose series of hepatitis B vaccine group will receive a 20 µg recombinant HBV vaccine intramuscular at month 0, 1, and 6	Biological: Hepatitis B vaccine; Hepatitis B vaccine (20 µg/ml) 1 ml intramuscular injection in single (at 0 month) or 3-dose series (at 0, 1, 6 months)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunologic response to single dose versus 3-dose series of HBV vaccination in HIV-infected adults	Immunologic response to single versus 3-dose series of HBV vaccination in HIV-infected adults, demonstrated by percentage of responders (with anti-HBs Ab ≥ 10 mIU/mL ) at week 28	28 weeks after the first dose of HBV vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intensity and frequency of vaccine adverse event (AE)	Intensity and frequency of vaccine adverse event (AE)	1 year
Anamnestic response at week 4	Anamnestic response at week 4, demonstrated by percentage of responders (with anti-HBs Ab ≥ 10 mIU/mL )	4 weeks after the first dose of HBV vaccination
Percentage of responders (with anti-HBs Ab ≥ 10 mIU/mL) at month 12	Percentage of responders (with anti-HBs Ab ≥ 10 mIU/mL) at month 12	12 months after the first dose of HBV vaccination]

Collaborators and Investigators

• Sponsor: Chiang Mai University

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2017
• Primary Completion (ANTICIPATED): July 1, 2018
• Study Completion (ANTICIPATED): October 1, 2018

Study Registration Dates

• First Submitted: July 6, 2017
• First Submitted That Met QC Criteria: July 13, 2017
• First Posted (ACTUAL): July 17, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 17, 2017
• Last Update Submitted That Met QC Criteria: July 13, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: immunity; HBV vaccination
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Hepatitis B; Hepatitis; Hepatitis A
• Other Study ID Numbers: 4564

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No