PHASE-1 TRIAL OF A 24-VALENT KLEBSIELLA CAPSULAR POLYSACCHARIDE VACCINE AND AN 8-VALENT PSEUDOMONAS O-POLYSACCHARIDE CONJUGATE VACCINE ADMINISTERED SIMULTANEOUSLY
PHASE-1 TRIAL OF A 24-VALENT KLEBSIELLA CAPSULAR POLYSACCHARIDE VACCINE AND AN 8-VALENT PSEUDOMONAS O-POLYSACCHARIDE CONJUGATE VACCINE ADMINISTERED SIMULTANEOUSLY
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DOI：
10.1016/s0264-410x(94)80054-4
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发表时间：
1994-11-01
期刊：
影响因子：
5.5
通讯作者：
CRYZ, SJ
中科院分区：
文献类型：
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作者：
EDELMAN, R;TAYLOR, DN;CRYZ, SJ
由24种荚膜多糖抗原组成的克雷伯氏菌(K)疫苗和由8种o -多糖抗原结合P毒素A组成的铜绿假单胞菌(P)疫苗已被开发出来，可通过主动或被动免疫预防来预防败血症。为了寻找一个实际的免疫计划，两种疫苗同时在相反的手臂注射（20名志愿者）或相隔14天（21名志愿者）。两组志愿者对疫苗的耐受性同样良好。两组在2个月时对33种疫苗抗原（包括毒素A）的几何平均抗体、浓度和平均折叠抗体上升相似，在18个月时测定的抗体下降也相似。由于这两种疫苗在两组疫苗中都是安全的，并且具有相似的免疫原性，因此它们可以在实际的疫苗接种计划中同时施用于患者或血浆捐献者。
A Klebsiella (K) vaccine consisting of 24 capsular polysaccharide antigens and a Pseudomonas aeruginosa (P) vaccine consisting of eight O-polysaccharide antigens conjugated to P toxin A have been developed to prevent sepsis by means of active or passive immunoprophylaxis. In search for a practical immunization schedule, the two vaccines were injected in opposite arms simultaneously (20 volunteers) or 14 days apart (21 volunteers). The vaccines were similarly well tolerated by both volunteer groups. Geometric mean antibody, concentrations and mean fold antibody rises to the 33 vaccine antigens (including toxin A) were similar in the two groups at 2 months, and the decline in antibody measured at 18 months,was also similar. Because the two vaccines were safe and similarly immunogenic in the two vaccine groups, they can be administered simultaneously to patients or plasma donors in a practical vaccination schedule.