Division of Infectious Diseases, Department of Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, 50200, Thailand.
Research Institute for Health Science, Chiang Mai University, Chiang Mai, Thailand.
AIDS Res Ther. 2019 May 3;16(1):10. doi: 10.1186/s12981-019-0225-3.
Presence of isolated anti-HBc antibody is common in HIV-infected patients in endemic areas and could be caused by prior HBV infection with loss of anti-HBs antibody. The role of vaccination in these patients remains controversial and is based largely on limited and low quality data. We, therefore, conducted this study to determine immunogenicity and safety of 4 vs. 3 standard doses of HBV vaccination in HIV-infected adults with isolated anti-HBc antibody.
An open-label, randomized controlled trial was conducted among HIV-infected patients visiting HIV clinic of the Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand between July and September 2017. Inclusion criteria included ≥ 18 years of age, currently on a stable antiretroviral regimen, CD4+ cell count ≥ 200 cells/mm, plasma HIV-1 RNA < 20 copies/mL, and isolated anti-HBc antibody. The participants were randomized to receive either 3 standard doses (20 µg at month 0, 1, 6) or 4 standard-doses (20 µg at month 0, 1, 2, 6) of IM HBV vaccination, and were evaluated for anamnestic response at week 4 and vaccine response at week 28.
Of the 97 patients screened, 54 (32 male, mean age of 46 years) were enrolled and 27 were allocated to each of the vaccination groups. Anamnestic response occurred in 25.9% vs. 33.3% in 3-dose group vs. 4-dose group, respectively (p = 0.551). The vaccine response rates at week 28 were 85.2% in 3-dose group vs. 88.9% in 4-dose group (p = 1.000); geometric mean titer of anti-HBs antibody at week 28 was 63.8 and 209.8 mIU/mL in 3-dose group and 4-dose group, respectively (p = 0.030). No adverse events were reported.
An anamnestic response occurred in one-third of Thai HIV-infected patients with isolated anti-HBc antibody who received one dose of HBV vaccination; however, the majority were still unprotected. The use of either 3 or 4 standard-doses of vaccination was highly effective and should be recommended in all HIV-infected individuals with isolated anti-HBc antibody. Trial registration ClinicalTrials.gov; NCT03212911. Registered 11 July 2019, https://clinicaltrials.gov/ct2/show/NCT03212911.
在流行地区感染 HIV 的患者中，常出现单独抗-HBc 抗体，这可能是由 HBV 感染引起的，同时抗-HBs 抗体丢失。这些患者的疫苗接种作用仍存在争议，主要是基于有限且低质量的数据。因此，我们进行了这项研究，以确定在感染 HIV 的单独抗-HBc 抗体的成年患者中，接种 4 剂与 3 剂标准剂量乙型肝炎疫苗的免疫原性和安全性。
这是一项在泰国清迈大学医学院 HIV 诊所就诊的 HIV 感染患者中进行的开放标签、随机对照试验。纳入标准包括年龄≥ 18 岁、目前正在接受稳定的抗逆转录病毒治疗、CD4+细胞计数≥ 200 个/立方毫米、血浆 HIV-1 RNA < 20 拷贝/mL 以及单独的抗-HBc 抗体。参与者被随机分配接受 3 剂标准剂量（0 个月、1 个月、6 个月时各 20μg）或 4 剂标准剂量（0 个月、1 个月、2 个月、6 个月时各 20μg）的 IM 乙型肝炎疫苗接种，并在第 4 周和第 28 周评估回忆应答情况。
在筛选的 97 例患者中，有 54 例（32 例男性，平均年龄 46 岁）入组，其中 27 例被分配到 3 剂组和 4 剂组。3 剂组和 4 剂组的回忆应答发生率分别为 25.9%和 33.3%（p=0.551）。第 28 周的疫苗应答率分别为 3 剂组 85.2%和 4 剂组 88.9%（p=1.000）；第 28 周时，3 剂组和 4 剂组的抗-HBs 抗体几何平均滴度分别为 63.8 和 209.8 mIU/mL（p=0.030）。未报告不良事件。
在接受一剂乙型肝炎疫苗接种的泰国 HIV 感染患者中，单独抗-HBc 抗体患者中有三分之一出现回忆应答，但大多数仍未得到保护。使用 3 剂或 4 剂标准剂量的疫苗接种非常有效，应推荐用于所有单独抗-HBc 抗体的 HIV 感染患者。
ClinicalTrials.gov；NCT03212911。于 2019 年 7 月 11 日注册，https://clinicaltrials.gov/ct2/show/NCT03212911。
