HEPATITIS-B VACCINE IN PATIENTS RECEIVING HEMODIALYSIS - IMMUNOGENICITY AND EFFICACY
HEPATITIS-B VACCINE IN PATIENTS RECEIVING HEMODIALYSIS - IMMUNOGENICITY AND EFFICACY
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DOI：
10.1056/nejm198408233110803
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发表时间：
1984-01-01
影响因子：
158.5
通讯作者：
SZMUNESS, W
中科院分区：
文献类型：
--
作者：
STEVENS, CE;ALTER, HJ;SZMUNESS, W
乙型肝炎疫苗 (Heptavax-B) 的免疫原性和功效在一项随机、双盲、安慰剂对照试验中进行了评估，该试验涉及 1311 名在美国接受血液透析的患者。接种 3 剂疫苗（每剂 40 μg）后，63% 的患者抗体呈阳性。在对可能通过输血被动转移抗体进行校正后，只有 50% 的疫苗接种者被认为是疫苗反应者。 25个月内乙型肝炎病毒感染的发生率。该试验的比例远低于预期，并且疫苗和安慰剂接受者的比例几乎相同（分别为 6.4% 和 5.4%）。 4 例乙型肝炎发生在对疫苗有明显抗体反应的患者中，但在每例患者中，在检测到乙型肝炎表面抗原或患者接受免疫抑制治疗之前，抗体已达到低水平或无法检测到的水平。这项研究没有证明该疫苗对接受透析的患者群体的有效性，这些患者对乙型肝炎疫苗的抗体反应率和病毒攻击率均较低。必须继续采取其他措施控制透析室中乙型肝炎病毒的传播，包括监测乙型肝炎表面抗原和隔离抗原阳性的患者。
The immunogenicity and efficacy of hepatitis B vaccine (Heptavax-B) in a randomized, double-blind, placebo-controlled trial involving 1311 patients receiving heomodialysis in the USA were evaluated. After 3 doses of vaccine (40 .mu.g each) had been administered, 63% of the patients were antibody-positive. After correction for possible passive transfer of antibodies by blood transfusion, only 50% of vaccine recipients were considered vaccine responders. The incidence of hepatitis B viral infection during the 25 mo. of the trial was much lower than had been anticipated and was virtually the same in the vaccine and placebo recipients (6.4 and 5.4%, respectively). Four cases of hepatitis B occurred in patients who had an apparent antibody response to the vaccine, but in each case either antibody had reached low or undetectable levels before hepatitis B surface antigen was detected or the patient had been receiving immunosuppressive therapy. This study did not demonstrate the efficacy of the vaccine in a population of patients receiving dialysis in whom both the rate of antibody response to hepatitis B vaccine and the viral attack rate were low. Other measures to control transmission of hepatitis B virus in dialysis units, including surveillance for hepatitis B surface antigen and isolation of patients who are positive for the antigen, must be continued.