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.
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
80
Hepatitis B vaccine (20 µg/ml) 1 ml intramuscular injection in single (at 0 month) or 3-dose series (at 0, 1, 6 months)
Maharaj Nakorn Chiang Mai Hospital, Department of medicine, Chiang Mai University
Muang, Chiang Mai, Chiang Mai, Thailand
RECRUITINGImmunologic 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
Time frame: 28 weeks after the first dose of HBV vaccination
Anamnestic response at week 4
Anamnestic response at week 4, demonstrated by percentage of responders (with anti-HBs Ab ≥ 10 mIU/mL )
Time frame: 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
Time frame: 12 months after the first dose of HBV vaccination]
Intensity and frequency of vaccine adverse event (AE)
Intensity and frequency of vaccine adverse event (AE)
Time frame: 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.