Immunologic Response of Hepatitis B Vaccine

Phase 4

• Conditions: Hepatitis B
• Interventions: Biological: Hepatitis B vaccine

• Registration Number: NCT03219203
• Lead Sponsor: Chiang Mai University

Brief Summary

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.

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 Timeline

• Status Verified: 2017-07
• Study Start: 2017-07-01
• Study First Submitted: 2017-07-06
• Study First Submitted QC: 2017-07-13
• Last Update Submitted: 2017-07-13
• Study First Posted: 2017-07-17
• Last Update Posted: 2017-07-17
• Primary Completion: 2018-07-01
• Study Completion: 2018-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A: Single dose hepatitis B vaccine	Hepatitis B vaccine	Single dose of hepatitis B vaccine group will receive a 20 µg recombinant HBV vaccine intramuscular at entry
Arm B: 3-dose series of hepatitis B vaccine	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

Primary Outcome Measures

Name	Time	Method
Immunologic response to single dose versus 3-dose series of HBV vaccination in HIV-infected adults	28 weeks after the first dose of HBV vaccination	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Maharaj Nakorn Chiang Mai Hospital, Department of medicine, Chiang Mai University; 🇹🇭 Muang, Chiang Mai, Chiang Mai, Thailand