一种利福昔单抗的冻干制剂，一种重组蓖麻毒素亚单位疫苗，保留了免疫原性。
A lyophilized formulation of RiVax, a recombinant ricin subunit vaccine, retains immunogenicity.
机构信息
The Cancer Immunobiology Center and the Department of Microbiology, University of Texas Southwestern Medical Center at Dallas, 6000 Harry Hines Blvd., Dallas, TX 75390-8576, USA.
出版信息
Vaccine. 2010 Mar 11;28(12):2428-35. doi: 10.1016/j.vaccine.2009.12.081. Epub 2010 Jan 12.
Abstract
Ricin is a CDC level B biothreat. Our recombinant ricin A chain vaccine (RiVax) contains two mutations, rendering it non-toxic at high doses. Frozen or alum formulations of RiVax protected mice against ricin administered by injection, gavage or aerosol. Without alum, RiVax was safe and immunogenic in rabbits and human volunteers. For military use, the predominant target group, it would be optimal not to require a cold chain for transport and storage. We have now developed a lyophilized formulation and demonstrated stability and efficacy for at least 1 year stored refrigerated or at room temperature administered with or without alum.
摘要
蓖麻毒素是疾病预防控制中心（CDC）生物威胁级别 B 级的物质。我们的重组蓖麻毒素 A 链疫苗（RiVax）含有两种突变，使其在高剂量下也没有毒性。冷冻或明矾制剂的 RiVax 可保护小鼠免受注射、灌胃或气溶胶形式给予的蓖麻毒素的侵害。没有明矾，RiVax 在兔子和人类志愿者中是安全且具有免疫原性的。对于军队等主要目标人群，疫苗在运输和储存过程中无需冷链是最佳选择。我们现已开发出一种冻干制剂，并证明其在冷藏或室温下储存至少 1 年的稳定性和有效性，同时可与或不与明矾一起使用。
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本文引用的文献
1
Development of a freeze-stable formulation for vaccines containing aluminum salt adjuvants.
Vaccine. 2009 Jan 1;27(1):72-9. doi: 10.1016/j.vaccine.2008.10.027. Epub 2008 Oct 28.
2
Characterization of the freeze sensitivity of a hepatitis B vaccine.
Hum Vaccin. 2009 Jan-Feb;5(1):26-32. doi: 10.4161/hv.5.1.6494. Epub 2009 Jan 24.
3
Influence of particle size and antigen binding on effectiveness of aluminum salt adjuvants in a model lysozyme vaccine.
J Pharm Sci. 2008 Dec;97(12):5252-62. doi: 10.1002/jps.21390.
4
Development of stable influenza vaccine powder formulations: challenges and possibilities.
Pharm Res. 2008 Jun;25(6):1256-73. doi: 10.1007/s11095-008-9559-6.
5
RiVax, a recombinant ricin subunit vaccine, protects mice against ricin delivered by gavage or aerosol.
Vaccine. 2007 Oct 16;25(42):7459-69. doi: 10.1016/j.vaccine.2007.08.018. Epub 2007 Aug 30.
6
A rapid, three-step process for the preformulation of a recombinant ricin toxin A-chain vaccine.
J Pharm Sci. 2007 Jan;96(1):44-60. doi: 10.1002/jps.20675.
7
A pilot clinical trial of a recombinant ricin vaccine in normal humans.
Proc Natl Acad Sci U S A. 2006 Feb 14;103(7):2268-73. doi: 10.1073/pnas.0510893103. Epub 2006 Feb 3.
8
Ricin poisoning: a comprehensive review.
JAMA. 2005 Nov 9;294(18):2342-51. doi: 10.1001/jama.294.18.2342.
9
Preclinical toxicity and efficacy testing of RiVax, a recombinant protein vaccine against ricin.
Vaccine. 2005 Sep 15;23(39):4775-84. doi: 10.1016/j.vaccine.2005.04.037.
10
Effect of freezing rates and excipients on the infectivity of a live viral vaccine during lyophilization.
Biotechnol Prog. 2004 Jul-Aug;20(4):1113-20. doi: 10.1021/bp034362x.
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