The primary aim of this open-label, randomized control trial is to compare the immunogenicity at week 28 after 20g HBV vaccine (at week 0, 4, 24) versus 40g HBV vaccine (40-g at week 0, 4, 24 week) among HIV-positive patients or HIV-negative MSM who were born in Taiwan after July 1986 and tested negative for all HBV serological markers. The secondary aims are to assess the safety of double-dose HBV vaccination, the proportions of high-level responders (anti-HBs antibody >100 mIU/ml) at weeks 28 and 48, the serological responses at week 48, and incident HBV infection (indicated by appearance of anti-HBc and/or HBsAg) at week 48.
I. Study procedures:
Condition | HIV infection, HIV Infections, Immunodeficiency, Primary Immunodeficiency Disorders, Hepatitis B, Hepatitis B, Primary Immunodeficiency Disorders, HIV Infections, Immunization; Infection, Immunization; Infection, human immunodeficiency virus, hiv disease, Immunization; Infection |
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Treatment | Engerix-B |
Clinical Study Identifier | NCT03854630 |
Sponsor | National Taiwan University Hospital |
Last Modified on | 24 January 2021 |
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