First-in-human randomised trial and follow-up study of Plasmodium falciparum blood-stage malaria vaccine BK-SE36 with CpG-ODN(K3)

Ezoe Sachiko; Palacpac Nirianne Marie Q.; Tetsutani Kohhei; Yamamoto Kouji; Okada Kiyoshi; Taira Masaki; Nishida Sumiyuki; Hirata Haruhiko; Ogata Atsushi; Yamada Tomomi; Yagi Masanori; Edula Jyotheeswara R.; Oishi Yuko; Tougan Takahiro; Ishii Ken J.; Myoui Akira; Horii Toshihiro

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First-in-human randomised trial and follow-up study of Plasmodium falciparum blood-stage malaria vaccine BK-SE36 with CpG-ODN(K3)

机译：具有CpG-ODN（K3）的疟原虫血浆血浆疟疾疫苗疫苗BK-SE36的先进的随机试验和后续研究

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Background: BK-SE36 is blood-stage malaria vaccine candidate that is undergoing clinical trials. Here, the safety and immunogenicity of BK-SE36 with a novel adjuvant, CpG-ODN(K3) (thus, BK-SE36/CpG) was assessed in a phase 1a trial in Japan.

机译：背景：BK-SE36是正在进行临床试验的血阶疟疾疫苗候选者。这里，在日本的第1A期试验中评估BK-SE36与新佐剂，CPG-ODN（K3）（因此，BK-SE36 / CPG）的安全性和免疫原性。

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来源
《Vaccine》 |2020年第46期|共12页
作者
Ezoe Sachiko; Palacpac Nirianne Marie Q.; Tetsutani Kohhei; Yamamoto Kouji; Okada Kiyoshi; Taira Masaki; Nishida Sumiyuki; Hirata Haruhiko; Ogata Atsushi; Yamada Tomomi; Yagi Masanori; Edula Jyotheeswara R.; Oishi Yuko; Tougan Takahiro; Ishii Ken J.; Myoui Akira; Horii Toshihiro;
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作者单位

Osaka Univ Hosp Med Ctr Translat Res Dept Med Innovat 2-2 Yamadaoka Suita Osaka 5650871 Japan;

Osaka Univ Res Inst Microbial Dis Dept Mol Protozool 3-1 Yamadaoka Suita Osaka 5650871 Japan;

Natl Inst Biomed Innovat Hlth &

Nutr Ctr Vaccine Adjuvant Res Lab Adjuvant Innovat Mockup Vaccine 7-6-8 Saito Asagi Ibaraki Osaka 5670085 Japan;

Osaka Univ Hosp Data Coordinating Ctr Dept Med Innovat 2-2 Yamadaoka Suita Osaka 5650871 Japan;

Osaka Univ Dept Orthopaed Grad Sch Med 2-2 Yamadaoka Suita Osaka 5650871 Japan;

Osaka Univ Hosp Med Ctr Translat Res Dept Med Innovat 2-2 Yamadaoka Suita Osaka 5650871 Japan;

Osaka Univ Dept Resp Med &

Clin Immunol Grad Sch Med Suita Osaka 5650871 Japan;

Osaka Univ Dept Resp Med &

Clin Immunol Grad Sch Med Suita Osaka 5650871 Japan;

Osaka Univ Dept Resp Med &

Clin Immunol Grad Sch Med Suita Osaka 5650871 Japan;

Osaka Univ Hosp Data Coordinating Ctr Dept Med Innovat 2-2 Yamadaoka Suita Osaka 5650871 Japan;

Osaka Univ Res Inst Microbial Dis Dept Mol Protozool 3-1 Yamadaoka Suita Osaka 5650871 Japan;

Osaka Univ Res Inst Microbial Dis Dept Mol Protozool 3-1 Yamadaoka Suita Osaka 5650871 Japan;

Osaka Univ Res Inst Microbial Dis Dept Mol Protozool 3-1 Yamadaoka Suita Osaka 5650871 Japan;

Osaka Univ Res Inst Microbial Dis Dept Mol Protozool 3-1 Yamadaoka Suita Osaka 5650871 Japan;

Natl Inst Biomed Innovat Hlth &

Nutr Ctr Vaccine Adjuvant Res Lab Adjuvant Innovat Mockup Vaccine 7-6-8 Saito Asagi Ibaraki Osaka 5670085 Japan;

Osaka Univ Hosp Med Ctr Translat Res Dept Med Innovat 2-2 Yamadaoka Suita Osaka 5650871 Japan;

Osaka Univ Res Inst Microbial Dis Dept Mol Protozool 3-1 Yamadaoka Suita Osaka 5650871 Japan;

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原文格式 PDF
正文语种 eng
中图分类医学免疫学;
关键词
Malaria blood-stage vaccine; BK-SE36; CpG-ODN(K3); BK-SE36/CpG; Plasmodium falciparum; SERA5;

机译：疟疾血液疫苗;BK-SE36;CPG-ODN（K3）;BK-SE36 / CPG;疟原虫;血清;

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专利

1. First-in-human randomised trial and follow-up study of Plasmodium falciparum blood-stage malaria vaccine BK-SE36 with CpG-ODN(K3) [J] . Ezoe Sachiko, Palacpac Nirianne Marie Q., Tetsutani Kohhei, Vaccine . 2020,第46期

机译：具有CpG-ODN（K3）的疟原虫血浆血浆疟疾疫苗疫苗BK-SE36的先进的随机试验和后续研究
2. Development of cultured Plasmodium falciparum blood-stage malaria cell banks for early phase in vivo clinical trial assessment of anti-malaria drugs and vaccines [J] . Danielle I Stanisic, Xue Q Liu, Sai Lata De, Malaria Journal . 2015,第S1期

机译：开发培养的恶性疟原虫血期疟疾细胞库，用于抗疟疾药物和疫苗的体内早期临床试验评估
3. Duration of protection with RTS,S/AS02A malaria vaccine in prevention of Plasmodium falciparum disease in Mozambican children: single-blind extended follow-up of a randomised controlled trial. [J] . Alonso PL, Sacarlal J, Aponte JJ, The Lancet . 2005,第9502期

机译：在莫桑比克儿童中使用RTS，S / AS02A疟疾疫苗预防恶性疟原虫疾病的保护时间：随机对照试验的单盲扩展随访。
4. Immunogenicity of Malaria Vaccine Candidate-Plasmodium falciparum Merozoite Surface Protein 5 (PfMSP5) Expressed in Bacillus subtilis [C] . Chittibabu Gottimukkala, Charles Ma, Hans J. Netter International Conference on Chemical, Biological and Environmental Engineering . 2014

机译：疟疾疫苗候选疟原虫的免疫原性是恶魔植物在枯草芽孢杆菌中表达的疟原虫候选疟原虫疟原虫表面蛋白5（PFMSP5）
5. Analysis of vaccine- and infection-induced immune responses contributing to suppression of blood-stage malaria in the Plasmodium yoelii rodent model. [D] . Petritus, Patricia M. 2009

机译：在约氏疟原虫啮齿动物模型中分析疫苗和感染诱导的免疫反应，有助于抑制血液阶段的疟疾。
6. Phase 1b Randomized Trial and Follow-Up Study in Uganda of the Blood-Stage Malaria Vaccine Candidate BK-SE36 [O] . Nirianne Marie Q. Palacpac, Edward Ntege, Adoke Yeka, -1

机译：乌干达血期疟疾疫苗候选人BK-SE36的1b期随机试验和随访研究
7. Development of cultured Plasmodium falciparum blood-stage malaria cell banks for early phase in vivo clinical trial assessment of anti-malaria drugs and vaccines [O] . Stanisic Danielle, Liu Xueqin, De Sai Lata, 2015

机译：开发培养的恶性疟原虫血液阶段疟疾细胞库，用于抗疟疾药物和疫苗的体内早期临床试验评估

First-in-human randomised trial and follow-up study of Plasmodium falciparum blood-stage malaria vaccine BK-SE36 with CpG-ODN(K3)

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