AASLD2018[440]HBV疫苗接种可以加速HBsAg 慢性乙型肝炎患者的血清

StephenW

440
HBV Vaccination Can Accelerate HBsAg
Seroconversion in Chronic Hepatitis B Patients
Who Loss HBsAg: A Randomized Controlled
Trial - Preliminary Analysis
Tawesak Tanwandee and Suppawat Jiraphairot, Internal
Medicine, Mahidol University
Background: Most of chronic hepatitis B (CHB) patients
carry HBsAg life-long even with current treatment. Moreover,
those who clear HBsAg, many still do not have Anti-HBs
presence, some patients even have HBsAg reappearance
during follow up. It would be helpful if we can induce sustained
HBsAg seroconversion. HBV vaccine contain both HBsAg
and immunoadjuvant which can help induction of antibody
response. This study was aimed to determine whether
HBV vaccination can induce HBsAg seroconversion and to
determine whether Anti-HBs is sustained. Methods: This
is a prospective randomized control trial involved 79 CHB
patients who loss HBsAg at least twice, 3 months (M) apart
without Anti-HBs at Hepatitis clinic, Siriraj Hospital. Patients
who previously exposed to interferon was excluded and we
also included 16 healthy volunteers who did not exposed to
hepatitis B to determine the efficacy of HBV vaccine. The
subjects were randomly assigned 1:1 ratio to receive either
3 standard doses of HBV vaccine or no intervention. HBV
DNA, HBsAg, Anti-HBs as well as liver function tests was
measured at baseline, M7 (1M after vaccine completion)
and M12. HBV vaccine used in the study was recombinant
hepatitis B vaccine 20 microgram at M0, 1, 6. The primary
end-point was presence of Anti-HBs (≥10 IU/mL) at M7 of
the study with secondary endpoint to measure Anti-HBs at
M12 and identify factors that may associate with vaccine
response and side effect of vaccination. Results: Of the 79
CHB patients, baseline characteristic as shown in Table1.
There were 45 patients who had completed M7 (on May,
22th2018), of which, 20 patients in vaccination group and
there was no significant different of baseline characteristic as
compared with the whole groups. At M7, vaccine response in
healthy volunteers was 15/16(93%), whereas, in CHB, Anti-
HBs was present 12/20(60%) and 2/25(8%) in vaccine and
no intervention group, respectively, (p< 0.001). There was
no HBsAg reappearance in both groups and there was no
serious side effect. Conclusion: In CHB patient who have
lost HBsAg, standard dose HBV vaccination can accelerate
HBsAg seroconversion as compared with no intervention.
This can secure safe discontinuation of nucleoside analogues
in CHB patients. To our knowledge, this is the first randomized
controlled trial to demonstrate usefulness of HBV vaccination.
However, we need the data of all patients which will be
completed M7 by November, 2018 and M12 by early 2019.
HBV vaccination was safe.

StephenW

440
HBV疫苗接种可以加速HBsAg
慢性乙型肝炎患者的血清学转换
谁丢失HBsAg：随机对照
试验 - 初步分析
Tawesak Tanwandee和Suppawat Jiraphairot，内部
医学，玛希隆大学
背景：大多数慢性乙型肝炎（CHB）患者
即使使用目前的治疗，也可以终身携带HBsAg。此外，
那些清除HBsAg的人，许多人仍然没有抗HBs
存在，一些患者甚至有HBsAg再现
在跟进期间。如果我们能够持续发展，那将会很有帮助
HBsAg血清学转换。 HBV疫苗含有HBsAg
和免疫佐剂，可以帮助诱导抗体
响应。本研究旨在确定是否
HBV疫苗接种可以诱导HBsAg血清学转换
确定抗-HBs是否持续存在。方法：这个
是一项前瞻性随机对照试验，涉及79例CHB
HBsAg至少损失两次，间隔3个月（M）的患者
在Siriraj医院的肝炎诊所没有抗-HBs。耐心
先前接触干扰素的人被排除在外，我们
还包括16名没有接触过的健康志愿者
乙型肝炎确定HBV疫苗的疗效。该
受试者以1：1的比例随机分配接受任一项
3标准剂量的HBV疫苗或无干预。 HBV
DNA，HBsAg，抗-HBs以及肝功能检查
在基线时测量，M7（疫苗完成后为1M）
和M12。该研究中使用的HBV疫苗是重组的
乙型肝炎疫苗20微克，M0,1,6。初级
终点是在M7处存在抗-HBs（≥10IU/ mL）
用二级终点研究抗-HBs的研究
M12并确定可能与疫苗相关的因素
疫苗接种的反应和副作用。结果：79
CHB患者的基线特征如表1所示。
有45名患者完成了M7（5月，
其中，20名患者接种疫苗组和
基线特征没有显着差异
与整个群体相比。在M7，疫苗反应在
健康志愿者是15/16（93％），而在CHB，反 -
在疫苗和疫苗中，HBs存在12/20（60％）和2/25（8％）
没有干预组（p <0.001）。有
没有HBsAg再次出现在两组中，没有
严重的副作用。结论：CHB患者有
HBsAg丢失，标准剂量HBV疫苗接种可加速
与无干预相比，HBsAg血清学转换。
这可以确保核苷类似物的安全中断
在CHB患者中。据我们所知，这是第一个随机化的
对照试验证明HBV疫苗接种有用。
但是，我们需要所有患者的数据
到2018年11月完成M7，到2019年初完成M12。
HBV疫苗接种是安全的。