Inhibition assay for anti-IFN-γ antibody by competition with different concentrations of IFN-γ among 20 cases.

<p>Sera at 1∶2,000 dilution were incubated with different concentrations of recombinant human IFN-γ, ranging from 80 to 0.02 ng/ml for 1 hour at 37°C. Unbound anti-IFN-γ antibody was then detected by ELISA. The results show the average ± standard error of the means (SEM) O.D. values.</p

Patients with adult-onset immunodeficiency in northern Thailand (1991 to 2011).

<p>Patients with adult-onset immunodeficiency in northern Thailand (1991 to 2011).</p

Laboratory data in cases with and without active opportunistic infection.

<p>Data presented in means±SD or median (IQR).</p

Levels of autoantibody to IFN-γ as determined by ELISA among 20 cases, 20 HIV-controls, and 20 healthy controls.

<p>Each symbol represents the data of one individual. Solid lines show the mean ± 95% confidence interval of each group.</p

Opportunistic infections among 20 cases and 20 HIV-infected controls.

*<p>One participant might have more than 1 infectious episode.</p

Geometric mean titers of anti-HBs antibody by vaccination regimen.

<p>Geometric mean titers of anti-HBs antibody by vaccination regimen.</p

Comparison of Immunogenicity and Safety of Four Doses and Four Double Doses vs. Standard Doses of Hepatitis B Vaccination in HIV-Infected Adults: A Randomized, Controlled Trial

<div><p>Background</p><p>HBV vaccination is recommended in HIV-infected adults with CD4+ cell count >200/mm³ although the efficacy is only 33.3% -65%. We conducted a randomized, controlled trial to evaluate the efficacy and safety of three regimens of HBV vaccination at Chiang Mai University Hospital, Thailand.</p> <p>Methods</p><p>From February 4, 2011 to May 4, 2012, 132 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 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). The primary outcomes were to compare the immunogenicity and safety between the four-doses groups with the Standard doses group.</p> <p>Results</p><p>At months 7 and 12, the percentages of responders (anti-HBs ≥10 mIU/mL) were 88.6% and 70.4% in the Standard doses group, 93.2% and 86.4% in the four doses group, (<i>P</i>=0.713 and 0.119), and 95.4% and 88.6% in the four double doses group, (<i>P</i>=0.434 and 0.062), respectively. Factors associated with a high titer level (anti-HBs ≥100 mIU/mL) were vaccination schedule and younger age. The most common adverse event was pain at the injection site (42.4%); this was significantly more frequent in the four double doses group compared to the Standard doses group. No serious adverse events were observed.</p> <p>Conclusions</p><p>In Northern Thailand, the standard three-doses HBV vaccination in HIV-infected adults with CD4+ cell counts >200 cells/mm³ and undetectable plasma HIV-1 RNA is highly effective. Although regimens of four injections of either standard or double doses could not significantly increase the response rate, these regimens may induce higher levels of antibody to the virus.</p> <p>Trial registration information: ClinicalTrials.gov; NCT1289106; <a href="http://clinicaltrials.gov/ct2/show/NCT01289106" target="_blank">http://clinicaltrials.gov/ct2/show/NCT01289106</a></p> </div

Consort diagram of participants.

<p>Consort diagram of participants.</p

Percentages of responders (anti-HBs ≥ 10 mIU/ml) to hepatitis B vaccine by vaccination regimen.

<p>Percentages of responders (anti-HBs ≥ 10 mIU/ml) to hepatitis B vaccine by vaccination regimen.</p

Percentages of responders (anti-HBs ≥ 100 mIU/ml) to hepatitis B vaccine by vaccination regimen.

<p>Percentages of responders (anti-HBs ≥ 100 mIU/ml) to hepatitis B vaccine by vaccination regimen.</p