Phase I Safety and Immunogenicity Trial of Plasmodium vivax CS Derived Long Synthetic Peptides Adjuvanted with Montanide ISA 720 or Montanide ISA 51

Phase I Safety and Immunogenicity Trial of Plasmodium vivax CS Derived Long Synthetic Peptides Adjuvanted with Montanide ISA 720 or Montanide ISA 51
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DOI:
10.4269/ajtmh.2011.09-0516
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发表时间:
2011-02-01
影响因子:
3.3
通讯作者:
Arevalo-Herrera, Myriam
Arevalo-Herrera, Myriam
中科院分区:
医学4区
文献类型:
--
作者:
Herrera, Socrates;Lucia Fernandez, Olga;Arevalo-Herrera, Myriam

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我们评估了在Montanide伊萨720或Montanide伊萨51中配制的源自间日疟原虫环子孢子蛋白的三种合成肽的混合物的安全性、耐受性和免疫原性。将40名健康的未患疟疾的志愿者分配到5个实验组(A-E):在0、2和4个月时,用50和100 μ g/剂量注射配制在两种不同佐剂中的N、R和C肽的混合物对4个组(A-D)进行肌内免疫,并且一个组施用安慰剂。疫苗具有免疫原性、安全性、耐受性好,未发生与疫苗相关的严重不良事件。90%以上的疫苗发生血清阳转,免疫荧光抗体试验显示抗体识别子孢子蛋白。Montanide伊萨51中的疫苗显示出较高的子孢子蛋白识别和干扰素产生。结果鼓励进一步测试疫苗的保护效力。
We assessed the safety, tolerability, and immunogenicity of a mixture of three synthetic peptides derived from the Plasmodium vivax circumsporozoite protein formulated in Montanide ISA 720 or Montanide ISA 51. Forty healthy malaria-naive volunteers were allocated to five experimental groups (A-E): four groups (A-D) were immunized intramuscularly with 50 and 100 mu g/dose injections of a mixture of N, R, and C peptides formulated in the two different adjuvants at 0, 2, and 4 months and one group was administered placebo. Vaccines were immunogenic, safe, well tolerated, and no serious adverse events related to the vaccine occurred. Seroconversion occurred in >90% of the vaccines and antibodies recognized the sporozoite protein on immunofluorescent antibody test. Vaccines in Montanide ISA 51 showed a higher sporozoite protein recognition and interferon production. Results encourage further testing of the vaccine protective efficacy.