Immunologic Response of Hepatitis B Vaccine

Hepatitis B Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03219203
• Other study ID #: 4564
• Status: Recruiting
• Phase: Phase 4
• First received: July 6, 2017
• Last updated: July 13, 2017
• Start date: July 1, 2017
• Est. completion date: October 1, 2018

Study information

• Verified date: July 2017
• Source: Chiang Mai University
• Contact: Romanee Chaiwarith, MD
• Phone: +66-5393-6457
• Email: rchaiwar[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 1, 2018
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B

Intervention

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)

Locations

Country	Name	City	State
Thailand	Maharaj Nakorn Chiang Mai Hospital, Department of medicine, Chiang Mai University	Muang, Chiang Mai	Chiang Mai

Sponsors (1)

Lead Sponsor	Collaborator
Chiang Mai University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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]
Secondary	Intensity and frequency of vaccine adverse event (AE)	Intensity and frequency of vaccine adverse event (AE)	1 year