FMP 2.1 malaria vaccine(Walter Reed Army Institute of Research)(FMP 2.1 malaria vaccine(Walter Reed Army Institute of Research))

概要

基本信息

药物类型

预防性疫苗、重组亚单位疫苗

别名

FMP 2.1-AS02A-malaria-vaccine、FMP-2.1 vaccine、FMP2.1 vaccine

+ [3]

靶点

AMA-1

作用机制

AMA-1 inhibitors(Apical membrane antigen 1 inhibitors)、免疫刺激剂

治疗领域

感染

在研适应症-

非在研适应症

疟疾恶性疟

原研机构

Walter Reed Army Institute of Research

在研机构-

非在研机构

Walter Reed Army Institute of ResearchNational Institute of Allergy & Infectious Diseases

United States Army Medical Research and Materiel Command

+ [2]

最高研发阶段终止临床2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

4

项与 FMP 2.1 malaria vaccine(Walter Reed Army Institute of Research) 相关的临床试验

NCT00460525

/ Completed临床2期IIT

Randomized, Controlled Phase II Clinical Trial to Evaluate the Safety, Immunogenicity and Efficacy of the AMA-1 Malaria Vaccine FMP2.1/AS02A Versus Rabies Vaccine in 1-6 Year Old Children in Bandiagara, Mali

Malaria is a disease that affects many people in Africa. Malaria is caused by germs spread by mosquito bites. The purpose of this study is to compare the number of children who get malaria after receiving an experimental malaria vaccine (FMP2.1/AS02A) to the number of children who get malaria after receiving a vaccine for rabies (an approved vaccine that does not prevent malaria). The children will be assigned to one of the vaccine groups by chance. Participants and doctors will not know which vaccine was given. Study participants will include 400 children, ages 1-6 years, living in Bandiagara, Mali. Children will receive 3 vaccine doses, by injection, to their upper arm. Study procedures will include physical exams and several blood samples. Participants will be involved in the study for 26 months.

开始日期2007-05-01

申办/合作机构

U S Army Medical Research & Development Command

[+4]

NCT00358332

/ Completed临床1期IIT

Randomized, Controlled, Dose Escalation Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of WRAIR's AMA-1 Malaria Vaccine (FMP2.1) Adjuvanted in GSKBio's AS02A Vs. Rabies Vaccine in 1-6 Year Old Children in Bandiagara, Mali

The purpose of this study is to test the safety and dosages of a malaria vaccine in 100 children, 1-6 years old, in Bandiagara, Mali. The study is testing the safety of the vaccine when it is given to people who are regularly exposed to malaria and it will provide information regarding optimal vaccine dosage. This study will compare 3 injections of different vaccine doses to a rabies vaccine that is already approved. During the study, the child's health will be checked in the clinic and during home visits. Children may participate for about 14 months, and blood will be taken from each child throughout the study. If the child becomes sick from malaria, he/she will be treated. Information from this study may be used to develop a malaria vaccine that will help control the disease.

开始日期2006-11-01

申办/合作机构

U S Army Medical Research & Development Command

[+4]

NCT00385047

/ Completed临床1/2期IIT

Phase I/IIa Study of the Safety, Immunogenicity and Preliminary Efficacy After Sporozoite Challenge of FMP2.1/AS01B and FMP2.1/AS02A Candidate Malaria Vaccines Administered Intramuscularly at Months 0, 1, and 2 in Malaria-naive Adults Living in the United States

The purpose of this study is to determine whether 2 investigational malaria vaccines are safe as well as protective against malaria in adults living in the United States

开始日期2006-09-01

申办/合作机构

U S Army Medical Research & Development Command

[+2]

100 项与 FMP 2.1 malaria vaccine(Walter Reed Army Institute of Research) 相关的临床结果

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100 项与 FMP 2.1 malaria vaccine(Walter Reed Army Institute of Research) 相关的转化医学

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100 项与 FMP 2.1 malaria vaccine(Walter Reed Army Institute of Research) 相关的专利（医药）

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16

项与 FMP 2.1 malaria vaccine(Walter Reed Army Institute of Research) 相关的文献（医药）

2022-02-01·Carbohydrate Polymers1区 · 化学

Characterization and immunomodulatory effect of an alkali-extracted galactomannan from Morchella esculenta

1区 · 化学

Article

作者: Pan, Wen-Juan ; Zhang, Nan-Nan ; Lu, Yong-Ming ; Wu, Qing-Xi ; Chen, Yan ; Chen, Lei ; Zhang, Wen-Na ; Zhang, Zhong-Fei ; Ma, He

In our continuous exploration for bioactive polysaccharides, a novel polysaccharide FMP-2 was isolated and purified from the fruiting bodies of Morchella esculenta by alkali-assisted extraction. FMP-2 had an average molecular weight of 1.09 × 10⁶ Da and contained mannose, glucuronic acid, glucose, galactose, and arabinose in a molar ratio of 4.10:0.22:1.00:5.75:0.44. The backbone of FMP-2 mainly consisted of 1,2-α-D-Galp, 1,6-α-D-Galp, and 1,4-α-D-Manp, with branches of 1,4,6-α-D-Manp and 1,2,6-α-D-Galp. FMP-2 can stimulate phagocytosis and promote the secretion of NO, ROS, and cytokines like IL-6, IL-1β, and TNF-α in RAW264.7 cells ranging from 25 to 400 μg/mL. FMP-2 had great repairing effect on the immune injury of zebrafish induced by chloramphenicol. The phagocytosis ability of zebrafish macrophages and the proliferation of neutrophils can be greatly enhanced by polysaccharide FMP-2 with concentrations from 50 to 200 μg/mL. These findings suggest that FMP-2 might be used as a potential immunomodulator in the food and pharmaceutical industries.

2020-12-01·International Journal of Biological Macromolecules1区 · 化学

Extraction optimization, physicochemical properties and antioxidant and hypoglycemic activities of polysaccharides from roxburgh rose (Rosa roxburghii Tratt.) leaves

1区 · 化学

Article

作者: Yang, Xiuru ; Li, Mingming ; Zhao, Jiangchao ; Wei, Qing ; Shang, Hongmei ; Sun, Lingziyin ; Wu, Hongyan

The optimum extraction conditions of polysaccharides from roxburgh rose (Rosa roxburghii Tratt.) leaves (RLP) were obtained by response surface methodology (RSM), which were a liquid to solid ratio of 21.16 mL/g, an extraction temperature of 81.32 °C, and an extraction time of 90.49 min. An RLP yield of 11.04% was obtained under these conditions. DEAE-52 cellulose and Sepharose CL-6B columns were used to purify the RLP, and the purified polysaccharide components RLP-1.2 and RLP-2.1 were obtained. Both RLP-1.2 and RLP-2.1 were composed of galacturonic acid (GalA), glucose (Glc), galactose (Gal), and arabinose (Ara). However, the molar ratios of GalA, Glc, Gal, and Ara in RLP-1.2 and RLP-2.1 were different. At a concentration of 10 mg/mL, the α-amylase inhibitory activities of RLP-1.2 and RLP-2.1 reached 80.74% and 89.85% that of acarbose, respectively, and the α-glucosidase inhibitory activity of RLP-1.2 reached 87.91% that of acarbose. In addition, both RLP-1.2 and RLP-2.1 showed good antioxidant activity. These results suggested that RLP-1.2 and RLP-2.1 possess potential as natural hypoglycemic agents or natural antioxidants.

2020-07-01·Vaccine

Epitope-based sieve analysis of Plasmodium falciparum sequences from a FMP2.1/AS02A vaccine trial is consistent with differential vaccine efficacy against immunologically relevant AMA1 variants

Article

作者: Laurens, Matthew B ; Niangaly, Amadou ; Kone, Abdoulaye K ; Thera, Mahamadou A ; Takala-Harrison, Shannon ; Djimdé, Abdoulaye ; Tolo, Youssouf ; Coulibaly, Drissa ; Doumbo, Ogobara K ; Adams, Matthew ; Diallo, Dapa A ; Plowe, Christopher V ; Laufer, Miriam K ; Kouriba, Bourema ; Silva, Joana C ; Ouattara, Amed ; Traore, Karim

To prevent premature dismissal of promising vaccine programs, it is critical to determine if lack of efficacy in the field is due to allele specific-efficacy, rather than to the lack of immunogenicity of the candidate antigen. Here we use samples collected during a field trial of the AMA1-based FMP2.1/AS02_A malaria vaccine, which incorporates the AMA1 variant encoded by the reference Plasmodium falciparum 3D7 strain, to assess the usefulness of epitope-based sieve analysis for the detection of vaccine-induced allele-specific immune responses. The samples used are from volunteers who received the malaria vaccine FMP2.1/AS02_A or a control (rabies vaccine), during a vaccine efficacy field trial, and who later developed malaria. In a previous study, P. falciparum DNA was extracted from all samples, and the ama1 locus amplified and sequenced. Here, a sieve analysis was used to measure T and B-cell escape, and difference in 3D7-like epitopes in the two treatment arms. Overall, no difference was observed in mean amino acid distance to the 3D7 AMA1 variant between sequences from vaccinees and controls in B-cell epitopes. However, we found a significantly greater proportion of 3D7-like T-cell epitopes that map to the AMA1 cluster one loop (c1L) region in the control vs. the vaccinee group (p = 0.02), consistent with allele-specific vaccine efficacy. Interestingly, AMA1 epitopes in infections from vaccinees had higher mean IC50, and consequently lower binding affinity, than epitopes generated from the control group (p = 0.01), suggesting that vaccine-induced selection impacted the immunological profile of the strains that pass through the sieve imposed by the vaccine-induced protection. These findings are consistent with a vaccine-derived sieve effect on the c1L region of AMA1 and suggest that sieve analyses of malaria vaccine trial samples targeted to epitopes identified in silico can help identify protective malaria antigens that may be efficacious if combined in a multivalent vaccine.

100 项与 FMP 2.1 malaria vaccine(Walter Reed Army Institute of Research) 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
恶性疟	临床2期	马里	Walter Reed Army Institute of Research	2007-05-01
恶性疟	临床2期	马里	GSK Plc	2007-05-01
疟疾	临床2期	-	National Institute of Allergy & Infectious Diseases	-
疟疾	临床2期	-	United States Army Medical Research and Materiel Command	-
疟疾	临床2期	-	University of Maryland	-

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT00460525 (CTgov)	临床2期	恶性疟	400	Rabies Vaccine (Rabies Vaccine)	(壓齋艱窪衊廠醖範鏇醖) = 選鹽襯獵淵簾衊鬱壓鹽夢糧衊願積獵鏇壓齋鬱 (鹽膚選遞鏇簾構範築淵, 遞顧築選顧廠鏇範憲築 ~ 願構襯膚膚糧繭襯鬱襯) 更多	-	2010-08-10
				FMP2.1/AS02A (FMP2.1/AS02A)	(壓齋艱窪衊廠醖範鏇醖) = 廠範醖憲獵襯齋顧網淵夢糧衊願積獵鏇壓齋鬱 (鹽膚選遞鏇簾構範築淵, 遞淵範淵遞鏇獵顧糧築 ~ 範衊製衊顧艱繭窪窪選) 更多
NCT00358332 (CTgov)	临床1期	恶性疟	100	thimerosal+FMP2.1/AS02A (FMP2.1/AS02A 10 Mcg)	(鑰衊蓋築製夢積壓艱選) = 願顧網餘積願範顧觸構鹹蓋夢鏇艱蓋繭醖齋繭 (鹽憲襯遞醖鏇醖壓夢積, 觸糧獵衊選憲獵襯積簾 ~ 鹽鏇顧鹽衊獵醖觸餘觸) 更多	-	2009-03-04
				FMP2+thimerosal (FMP2.1/AS02A 25 Mcg)	(鑰衊蓋築製夢積壓艱選) = 蓋膚齋衊襯壓淵憲夢構鹹蓋夢鏇艱蓋繭醖齋繭 (鹽憲襯遞醖鏇醖壓夢積, 齋壓鏇顧構遞餘網願蓋 ~ 憲壓顧鑰衊憲廠鏇網築) 更多
NCT00385047 (Pubmed \| J Biol Chem)	临床1/2期	疟疾	30	apical membrane antigen-1 (AMA-1) (AMA-1/AS01B)	選淵憲網窪構鬱網繭積(糧膚醖顧顧範繭選餘遞) = 窪糧網築積衊獵顧襯願餘積膚築網醖艱願淵憲 (鹽網襯齋齋繭顧鑰觸遞, 210 ~ 369)	-	2009-01-01
				apical membrane antigen-1 (AMA-1) (AMA-1/AS02A)	選淵憲網窪構鬱網繭積(糧膚醖顧顧範繭選餘遞) = 範選願獵鹹選壓遞餘醖餘積膚築網醖艱願淵憲 (鹽網襯齋齋繭顧鑰觸遞, 169 ~ 276)