This study aimed to evaluate the efficacy of different hepatitis B vaccination regimens in HIV-infected adults with low CD4 cell count in northern Thailand.
HIV-infected adults with CD4+ cell counts \< 200 cells/mm3, undetectable plasma HIV-1 RNA, and negative for all HBV markers were randomly assigned to receive one of these 2 regimens of recombinant hepatitis B vaccine (Centro De Ingenieria Genetica Y Biotecnologia, La Habana, Cuba); 1) 20 μg IM at months 0, 1, and 6 (3-standard doses group), and 2) 20 μg IM at months 0, 1, 2, 6 (4-standard doses group). This study aimed to evaluate the efficacy and safety of these 2 hepatitis B vaccination regimens at month 7 after vaccination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
16
Different HBV vaccine regimen in each group
Maharaj Nakorn Chiang Mai Hospital, Department of Medicine, Chiang Mai University
Muang, Chiang Mai, Thailand
Proportion of participants with protective immunity against HBV
comparison of proportion of participants who had protective immunity (anti-HBS titer \>=10 mIU/ml) against HBV between HIV group 2 v.s. HIV group 1
Time frame: 1 month after vaccination
The geometric means of anti-HBs titers
Comparison of the geometric means of anti-HBS titers between HIV group 2 v.s. HIV group 1
Time frame: 1 month after vaccination
Proportion of participants with high level of immune response against HBV
Comparison of proportion of participants who had anti-HBS titers \>= 100 mIU/ml between HIV group 2 v.s. HIV group 1
Time frame: 1 month after vaccination
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.