A Phase 4 interventional study of Recombinant Hepatitis B vaccine [(CIGB) La Habana, Cuba] in Hepatitis B, sponsored by Chiang Mai University. Completed at 1 site in Thailand. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2017-04-19.
Sponsored by Chiang Mai University · Phase 4, Interventional, and Prevention
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.
1,662 studies on the registry are indexed under Hepatitis B; 192 are open to participants now.
This study's enrollment of 16 is below the median of 120 across 1,191 interventional studies indexed under Hepatitis B.
Browse Hepatitis B studies →Chiang Mai University is the lead sponsor of 119 studies on the registry; 12 are open to participants now.
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Exclusion criteria
Receiving three intramuscular injections of 20 µg of recombinant hepatitis B vaccine \[(CIGB) La Habana, Cuba\] at months 0, 1, and 6
Biological: Recombinant Hepatitis B vaccine [(CIGB) La Habana, Cuba]
Receiving four intramuscular injections of 20 µg of recombinant hepatitis B vaccine \[(CIGB) La Habana, Cuba\] at months 0, 1, 2, and 6
Biological: Recombinant Hepatitis B vaccine [(CIGB) La Habana, Cuba]
Different HBV vaccine regimen in each group
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
Plan to share: No
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This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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