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首页> 外文期刊>Vaccine >Therapeutic vaccination of chronic hepatitis B patients with virus suppression by antiviral therapy: a randomized, controlled study of co-administration of HBsAg/AS02 candidate vaccine and lamivudine
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Therapeutic vaccination of chronic hepatitis B patients with virus suppression by antiviral therapy: a randomized, controlled study of co-administration of HBsAg/AS02 candidate vaccine and lamivudine

机译：通过抗病毒治疗抑制病毒的慢性乙型肝炎患者的治疗性疫苗接种：HBsAg / AS02候选疫苗与拉米夫定共同给药的随机对照研究

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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.
机译：预期通过抗病毒治疗降低病毒载量可促进在慢性病毒感染（例如慢性乙型肝炎（CHB））中通过治疗性疫苗诱导的治愈性免疫应答。在这项开放标签，对照，随机研究中，将195名HBeAg阳性CHB患者随机接受12剂HBsAg以及AS02B佐剂候选疫苗和拉米夫定，每天52周或单独使用拉米夫定。与单独使用拉米夫定治疗（16.1％）相比，疫苗和拉米夫定的联合给药是安全且耐受性良好的，但并未提高HBe血清转化率（18.8％）。尽管诱导了强烈的HBsAg特异性淋巴组织增生反应，细胞因子生成和抗HBs抗体，但是与拉米夫定单独治疗相比，与拉米夫定同时给予佐剂的HBsAg疫苗进行的治疗性疫苗接种未显示出优越的临床疗效。

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