Clinical and immunologic responses to multiple doses of IMVAMUNE® (Modified Vaccinia Ankara) followed by Dryvax® challenge

Clinical and immunologic responses to multiple doses of IMVAMUNE® (Modified Vaccinia Ankara) followed by Dryvax® challenge
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DOI:
10.1016/j.vaccine.2007.10.017
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发表时间:
2007-12-12
期刊:
影响因子:
5.5
通讯作者:
Belshe, Robert B.
Belshe, Robert B.
中科院分区:
医学3区
文献类型:
--
作者:
Frey, Sharon E.;Newman, Frances K.;Belshe, Robert B.

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与目前可用的天花疫苗相比,用复制缺陷型牛痘菌株如改良的安卡拉牛痘(MVA)接种天花疫苗可诱导具有改善的安全性和耐受性特征的保护性免疫。在一项部分设盲、随机、对照临床试验中,将90名受试者平均随机分为6组。在研究第0天和第28天通过皮下或肌内注射施用IMVAUNE(MVA-BN(R),Bavarian Nordic A/S,Kvistgard,丹麦)疫苗或安慰剂,并在研究第112天用Dryvax(R)攻击五组。与Dryvax(R)相比,接种两剂IMVAMUNE(R)是安全的,耐受性良好。INIVAMUNE(R)产生了与一剂Dryvax(R)相当的细胞和不道德免疫应答,并且通过Dryvax(R)后减弱的原发性皮肤反应应答的证据,诱导的免疫在接种后90天似乎是稳健的。在Dryvax(R)之前接种IMVAMUNE(R)疫苗减少了Dryvax(R)部位的病毒复制,缩小了原发性皮肤病变的大小,并缩短了愈合时间,但并没有完全改善免疫反应。(c)2007年爱思唯尔有限公司保留所有战斗。
Smallpox vaccination with replication deficient vaccinia strains such as Modified Vaccinia Ankara (MVA) may induce protective immunity with improved safety and tolerability profiles compared with currently available smallpox vaccines. Ninety subjects were randomized equally to six groups in a partially blinded, randomized, controlled clinical trial. lMVAMUNE (R) (MVA-BN (R), Bavarian Nordic A/S, Kvistgard, Denmark) vaccine or placebo was administered at Study Days 0 and 28 by subcutaneous or intramuscular injection and five groups were challenged with Dryvax (R) at study Day 112. Vaccination with two doses of IMVAMUNE (R) was safe and well tolerated compared to Dryvax (R). INIVAMUNE (R) produced comparable cellular and Immoral immune responses to one dose of Dryvax (R) and the immunity induced appears robust 90 days post-vaccination by evidence of attenuated primary cutaneous reaction responses following Dryvax (R). IMVAMUNE (R) vaccination prior to Dryvax (R) reduced virus replication at the Dryvax (R) site, decreased the size of the primary cutaneous lesion, and decreased the time to healing but did not completely ameliorate the immune response. (c) 2007 Elsevier Ltd. All fights reserved.