FMP1 adjuvanted with AS02A vaccine(Walter Reed Army Institute of Research)(FMP1 adjuvanted with AS02A vaccine(Walter Reed Army Institute of Research))

概要

基本信息

药物类型

灭活疫苗、预防性疫苗

别名

+ [2]

靶点-

作用机制-

治疗领域

感染

在研适应症-

非在研适应症

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 Research

GSK Plc

最高研发阶段无进展临床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 FMP1 adjuvanted with AS02A vaccine(Walter Reed Army Institute of Research) 相关的临床试验

NCT00223990 / Completed临床2期IIT

A Dbl-blind,Randomized,Controlled,Phase IIb Field Trial in 12-47 Month-old Children in Western Kenya to Eval the Efficacy,Safety and Immunogenicity of the FMP1/AS02A Malaria Vaccine vs Rabies Vaccine

This trial is currently evaluating one candidate malaria vaccine, FMP1/AS02A. This candidate malaria vaccine is being developed for the routine immunization of infants and children living in malaria-endemic areas. This vaccine would offer protection against malaria disease due to the parasite Plasmodium falciparum.
Prior to the start of this study, FMP1/AS02A had been given to approximately 60 malaria-naïve adults and 40 adults and 90 children living in malaria-endemic regions.
This study will investigate whether the candidate vaccine prevents malaria disease for 6 months post-vaccination.
One half of the enrolled subjects will receive FMP1/AS02A and the other half rabies vaccine (RabAvert).

开始日期2005-04-08

申办/合作机构

U S Army Medical Research & Development Command

[+4]

NCT00308061 / Completed临床1期IIT

Double Blind Randomized Controlled Phase I Trial to Evaluate the Safety and Immunogenicity of WRAIR's MSP1 Candidate Malaria Vaccine (FMP1) Adjuvant in GSK Bio's AS02A vs. Rabies Vaccine in Semi-immune Adults in Bandiagara, Mali.

This study tested the safety of a new malaria vaccine in adults in Mali, West Africa, and measured the ability of the vaccine to stimulate antibodies directed against the malaria protein that the vaccine is based on. Forty adults were randomly assigned to get either the experimental malaria vaccine or a rabies vaccine, for comparison.

开始日期2003-07-01

申办/合作机构

U S Army Medical Research & Development Command

[+3]

NCT00317473 / Completed临床1期IIT

Double-blind,Randomized,Controlled,Dose Escalation Phase 1 Trial in 12-47 Month Old Children in Western Kenya to Evaluate the Safety and Immunogenicity of WRAIR's MSP-1(FMP1) Malaria Vaccine Adjuvanted in GSK's AS02A Versus Rabies Vaccine.

To assess the safety and reactogenicity of the FMP-1/AS02A malaria vaccine in malaria-exposed children living in western Kenya and aged 12-47 months

开始日期2003-06-01

申办/合作机构

U S Army Medical Research & Development Command

[+4]

100 项与 FMP1 adjuvanted with AS02A vaccine(Walter Reed Army Institute of Research) 相关的临床结果

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100 项与 FMP1 adjuvanted with AS02A vaccine(Walter Reed Army Institute of Research) 相关的转化医学

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100 项与 FMP1 adjuvanted with AS02A vaccine(Walter Reed Army Institute of Research) 相关的专利（医药）

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4

项与 FMP1 adjuvanted with AS02A vaccine(Walter Reed Army Institute of Research) 相关的文献（医药）

2007-01-01·Vaccine3区 · 医学

Phase 1 randomized double-blind safety and immunogenicity trial of Plasmodium falciparum malaria merozoite surface protein FMP1 vaccine, adjuvanted with AS02A, in adults in western Kenya

3区 · 医学

Article

作者: Lorraine Soisson ; Joash Gombe ; Mark R. Withers ; James F. Cummings ; Kathryn Tucker ; Amanda Leach ; Jessica Milman ; D. Gray Heppner ; Janet Wittes ; V. Ann Stewart ; José A. Stoute ; Joe Cohen ; Melanie Onyango ; Kent E. Kester ; Denise McKinney ; Evelina Angov ; Carter L. Diggs ; Joram Siangla ; Carolyn A. Holland ; Jeffrey A. Lyon ; Christian F. Ockenhouse

We report the first trial of candidate malaria vaccine antigen FMP1, a 42kDa fragment from the C-terminus of merozoite surface protein-1 (MSP-1) from the 3D7 strain of Plasmodium falciparum, in an endemic area. Forty adult male and female residents of western Kenya were enrolled to receive 3 doses of either FMP1/AS02A or Imovax rabies vaccine by intra-deltoid injection on a 0, 1, 2 month schedule. Thirty-seven volunteers received all three immunizations and 38 completed the 12-month evaluation period. Slightly more recipients of the FMP1/AS02A vaccine experienced any instance of pain at 24 h post-immunization than in the Imovax group (95% versus 65%), but otherwise the two vaccines were equally safe and well-tolerated. Baseline antibody levels were high in both groups and were boosted in the FMP1/AS02A group. Longitudinal models revealed a highly significant difference between groups for both the average post-baseline antibody responses to MSP-1(42) (F1,335=13.16; P<0.001) and the Day 90 responses to MSP-1(42) (F1,335=16.69; P<0.001). The FMP1/AS02A vaccine is safe and immunogenic in adults and should progress to safety testing in children at greatest risk of malaria.

2006-04-05·Vaccine3区 · 医学

Phase I safety and immunogenicity trial of FMP1/AS02A, a Plasmodium falciparum MSP-1 asexual blood stage vaccine☆

3区 · 医学

Article

作者: Urszula Krzych ; M Vanhandenhove ; Lorraine Soisson ; Nadia Tornieporth ; Babita Mahajan ; D Gray Heppner ; Christian F Ockenhouse ; James F Cummings ; Joe Cohen ; Kent E Kester ; Ann V Stewart ; Evelina Angov ; Jeffrey A Lyon ; Carter Diggs ; Opokua Ofori-Anyinam ; Dupeh R Palmer ; M Delchambre

We report the first safety and immunogenicity trial of the Plasmodium falciparum malaria blood stage vaccine candidate, FMP1/AS02A consisting of the FMP1 antigen, an Escherichia coli-expressed His-tagged fusion protein from the 42 kDa C-terminal fragment from the 3D7 clone of the merozoite surface protein 1 formulated in the AS02A adjuvant. An open label, prospective, single-center Phase I dose escalation trial of FMP1/AS02A was conducted in 15 adult malaria-naïve human volunteers to assess safety, reactogenicity, and immunogenicity. The vaccine was safe and well-tolerated and no serious adverse events were observed. The vaccine induced high-titer ELISA and IFA responses in all volunteers. Proliferative and ELISPOT responses were induced to vaccine antigen. Biologically active antibodies were induced as measured by GIA. This study establishes the foundation to further evaluate and measure the vaccine's ability to reduce morbidity and mortality in target populations directly affected by P. falciparum malaria.

PLoS Clinical Trials

Safety and Allele-Specific Immunogenicity of a Malaria Vaccine in Malian Adults: Results of a Phase I Randomized Trial

Article

作者: Mahamadou A Thera ; Dapa A Diallo ; V. Ann Stewart ; Lorraine Soisson ; Christopher V Plowe ; Alassane Dicko ; Evelina Angov ; Ogobara K Doumbo ; Drissa Coulibaly ; Issaka Sagara ; D. Gray Heppner ; David J Diemert ; Amanda Leach ; Kathryn Tucker ; Kirsten E Lyke

OBJECTIVESThe objectives were to evaluate the safety, reactogenicity, and allele-specific immunogenicity of the blood-stage malaria vaccine FMP1/AS02A in adults exposed to seasonal malaria and the impact of natural infection on vaccine-induced antibody levels.DESIGNWe conducted a randomized, double-blind, controlled phase I clinical trial.SETTINGBandiagara, Mali, West Africa, is a rural town with intense seasonal transmission of Plasmodium falciparum malaria.PARTICIPANTSForty healthy, malaria-experienced Malian adults aged 18-55 y were enrolled.INTERVENTIONSThe FMP1/AS02A malaria vaccine is a 42-kDa recombinant protein based on the carboxy-terminal end of merozoite surface protein-1 (MSP-1(42)) from the 3D7 clone of P. falciparum, adjuvanted with AS02A. The control vaccine was a killed rabies virus vaccine (Imovax). Participants were randomized to receive either FMP1/AS02A or rabies vaccine at 0, 1, and 2 mo and were followed for 1 y.OUTCOME MEASURESSolicited and unsolicited adverse events and allele-specific antibody responses to recombinant MSP-1(42) and its subunits derived from P. falciparum strains homologous and heterologous to the 3D7 vaccine strain were measured.RESULTSTransient local pain and swelling were more common in the malaria vaccine group than in the control group (11/20 versus 3/20 and 10/20 versus 6/20, respectively). MSP-1(42) antibody levels rose during the malaria transmission season in the control group, but were significantly higher in malaria vaccine recipients after the second immunization and remained higher after the third immunization relative both to baseline and to the control group. Immunization with the malaria vaccine was followed by significant increases in antibodies recognizing three diverse MSP-1(42) alleles and their subunits.CONCLUSIONSFMP1/AS02A was well tolerated and highly immunogenic in adults exposed to intense seasonal malaria transmission and elicited immune responses to genetically diverse parasite clones. Anti-MSP-1(42) antibody levels followed a seasonal pattern that was significantly augmented and prolonged by the malaria vaccine.

100 项与 FMP1 adjuvanted with AS02A vaccine(Walter Reed Army Institute of Research) 相关的药物交易

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研发状态

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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	肯尼亚	GSK Plc	2005-04-08
恶性疟	临床2期	肯尼亚	Walter Reed Army Institute of Research	2005-04-08

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临床结果

适应症

分期

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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


NCT00223990 (CTgov)	临床2期	恶性疟	400	FMP1/AS02A (FMP1/AS02A)	簾築顧選願壓願繭廠範(鬱範築蓋艱顧鹹蓋鑰選) = 衊築淵齋壓餘範構餘糧鬱鏇獵繭網選選鏇蓋鏇 (廠襯齋網糧築蓋窪築鑰, 膚範獵範醖壓淵築廠鑰 ~ 鬱廠壓餘鏇遞憲艱範蓋) 更多	-	2020-05-21
				RabAvert (RabAvert (Rabies Vaccine))	簾築顧選願壓願繭廠範(鬱範築蓋艱顧鹹蓋鑰選) = 願糧鹽夢鏇衊觸顧膚築鬱鏇獵繭網選選鏇蓋鏇 (廠襯齋網糧築蓋窪築鑰, 鬱簾繭構廠獵繭簾築衊 ~ 遞鑰網製艱鬱鹹膚衊鬱) 更多