School of Public Health, Shanxi Medical University, Taiyuan, Shanxi PR, China.
Center of Clinical Epidemiology and Evidence Based Medicine, Shanxi Medical University, Taiyuan, Shanxi PR, China.
Expert Rev Vaccines. 2022 Jun;21(6):861-868. doi: 10.1080/14760584.2022.2056024. Epub 2022 Apr 1.
The immunogenicity of hepatitis B vaccine is unsatisfactory in the people living with HIV (PLHIV). Studies evaluating optimal regimens to enhance immunogenicity have heretofore been inconclusive. The study was to compare the immunogenicity and safety of the four standard-dose and high-dose regimens of hepatitis B vaccine among PLHIV.
A randomized, parallel-controlled trial was conducted between May, 2020, and January, 2021. Patients were randomly assigned to receive 3 or 4 doses of 20 or 60 µg of hepatitis B vaccine. Seroconversion rate, high-level response rate, and geometric mean concentration (GMC) of antibody to hepatitis B surface antigen (anti-HBs) at weeks 12 and 28 were the main outcome measures.
At week 28, the seroconversion rate and GMC of anti-HBs in both IM20 × 4 and IM60 × 4 groups were significantly higher than those in the IM20 × 3 group ( < 0.05), and the GMC of anti-HBs was numerically higher in the IM60 × 4 group than that in the IM20 × 4 group.
In PLHIV, both the four standard-dose and high-dose regimens significantly improved immunogenicity. The GMC of anti-HBs was numerically higher in the IM60 × 4 group than that in the IM20 × 4 group.
ClinicalTrials.gov (NCT03962803).
乙型肝炎疫苗在 HIV 感染者（PLHIV）中的免疫原性并不令人满意。评估增强免疫原性的最佳方案的研究迄今尚无定论。本研究旨在比较 PLHIV 中四种标准剂量和高剂量乙型肝炎疫苗方案的免疫原性和安全性。
这是一项于 2020 年 5 月至 2021 年 1 月进行的随机、平行对照试验。患者被随机分配接受 3 或 4 剂 20 或 60µg 乙型肝炎疫苗。主要结局指标为血清转换率、高水平应答率以及乙型肝炎表面抗原（抗-HBs）抗体的几何平均浓度（GMC）在第 12 周和第 28 周时的变化。
在第 28 周时，IM20×4 和 IM60×4 组的血清转换率和抗-HBs 的 GMC 均明显高于 IM20×3 组（<0.05），且 IM60×4 组的抗-HBs GMC 高于 IM20×4 组。
在 PLHIV 中，四种标准剂量和高剂量方案均显著提高了免疫原性。IM60×4 组的抗-HBs GMC 高于 IM20×4 组。
ClinicalTrials.gov（NCT03962803）。
