Vandepapelière Pierre, Lau George K K, Leroux-Roels Geert, Horsmans Yves, Gane Edward, Tawandee Tawesak, Merican Mohd Ismail bin, Win Khin Maung, Trepo Christian, Cooksley Graham, Wettendorff Martine, Ferrari Carlo
GlaxoSmithKline Biologicals, 1330 Rixensart, Belgium.
Vaccine. 2007 Dec 12;25(51):8585-97. doi: 10.1016/j.vaccine.2007.09.072. Epub 2007 Oct 24.
Induction of curative immune responses by therapeutic vaccination in chronic viral infections such as chronic hepatitis B (CHB) is expected to be facilitated by reduction of viral load by antiviral treatment. In this open label, controlled, randomized study, 195 patients with HBeAg positive CHB were randomized to receive 12 doses of HBsAg with AS02B adjuvant candidate vaccine plus lamivudine daily for 52 weeks or lamivudine daily alone. The combined administration of vaccine and lamivudine was safe and well tolerated, but did not improve the HBe seroconversion rate (18.8%) when compared to treatment with lamivudine alone (16.1%) (p=0.6824). Despite induction of a vigorous HBsAg-specific lymphoproliferative response, cytokine production and anti-HBs antibodies, therapeutic vaccination with an adjuvanted HBsAg vaccine administered concomitantly with lamivudine did not demonstrate superior clinical efficacy in HBeAg positive CHB patients as compared to lamivudine therapy alone.
在慢性病毒感染如慢性乙型肝炎（CHB）中，通过抗病毒治疗降低病毒载量有望促进治疗性疫苗接种诱导治愈性免疫反应。在这项开放标签、对照、随机研究中，195例HBeAg阳性CHB患者被随机分为两组，一组接受12剂含AS02B佐剂的候选乙肝表面抗原（HBsAg）疫苗加每日拉米夫定，共治疗52周；另一组仅每日接受拉米夫定治疗。疫苗与拉米夫定联合给药安全且耐受性良好，但与单独使用拉米夫定治疗相比，HBe血清学转换率并未提高（联合治疗组为18.8%，单独拉米夫定治疗组为16.1%）（p = 0.6824）。尽管诱导了强烈的HBsAg特异性淋巴细胞增殖反应、细胞因子产生和抗HBs抗体，但与单独使用拉米夫定治疗相比，含佐剂的HBsAg疫苗与拉米夫定联合进行治疗性疫苗接种在HBeAg阳性CHB患者中并未显示出更优的临床疗效。
