Methods: From February 4, 2011 to May 4, 2012, 132 HIV-infected adults who had CD4+ cell counts >200 cells/mm3, undetectable plasma HIV-1 RNA, and were negative for all hepatitis B virus markers were 1:1:1 randomly assigned to receive one of three recombinant vaccine (Hepavax-Gene® Berna, Korea) regimens: 20 μg IM at months 0, 1, and 6 (Standard doses group, n=44), 20 μg IM at months 0, 1, 2, 6 (Four doses group, n=44), or 40 μg IM at months 0, 1, 2, and 6 (Four double doses group, n=44). Between January 2015 and January 2016, 126 participants were evaluated; 42 in the “Standard doses group”, 43 in the “Four doses group”, and 41 in the “Four double doses group”.
Results: At a median duration of 49.6 months (range 40.6, 53.7) after vaccine regimen completion, the percentages of responders with anti-HBs ≥10 mIU/mL were 57.1% (95% CI, 41.5%-72.8%) in the Standard doses group; 76.7% (95% CI 63.6%-89.9%) in the Four doses group (P=0.067); and 80.5% (95% CI 67.8%-93.2%) in the Four double doses group (P=0.033 vs. the Standard group). Factor associated with a responder was vaccination schedule (either four standard doses or four double doses) and younger age.
Conclusion: Despite highly effective of standard HBV vaccination schedule at 6 months after completion of vaccine regimen, long term immunogenicity was lower than the four double doses regimen among HIV-infected adults with CD4+ cell counts >200 cells/mm3 and undetectable plasma HIV-1 RNA.
J. Wipasa, None
K. Chaiklang, None
K. Supparatpinyo, None