Delving into the Latest Updates on FMP 2.1 malaria vaccine(Walter Reed Army Institute of Research) with Synapse

Overview

Basic Info

Drug Type

Prophylactic vaccine, Genetically engineered subunit vaccine

Synonyms

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

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Target

AMA-1

Mechanism

AMA-1 inhibitors(Apical membrane antigen 1 inhibitors), Immunostimulants

Therapeutic Areas

Infectious Diseases

Active Indication-

Inactive Indication

MalariaMalaria, Falciparum

Originator Organization

Walter Reed Army Institute of Research

Active Organization-

Inactive Organization

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

United States Army Medical Research and Materiel Command

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Drug Highest PhaseDiscontinuedPhase 2

First Approval Date-

Regulation-

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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.

Start Date01 May 2007

Sponsor / Collaborator

U S Army Medical Research & Development Command

[+4]

NCT00358332

/ CompletedPhase 1IIT

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.

Start Date01 Nov 2006

Sponsor / Collaborator

U S Army Medical Research & Development Command

[+4]

NCT00385047

/ CompletedPhase 1/2IIT

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

Start Date01 Sep 2006

Sponsor / Collaborator

U S Army Medical Research & Development Command

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100 Clinical Results associated with FMP 2.1 malaria vaccine(Walter Reed Army Institute of Research)

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100 Translational Medicine associated with FMP 2.1 malaria vaccine(Walter Reed Army Institute of Research)

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100 Patents (Medical) associated with FMP 2.1 malaria vaccine(Walter Reed Army Institute of Research)

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16

Literatures (Medical) associated with FMP 2.1 malaria vaccine(Walter Reed Army Institute of Research)

01 Feb 2022·Carbohydrate PolymersQ1 · CHEMISTRY

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

Q1 · CHEMISTRY

Article

Author: 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.

01 Dec 2020·International Journal of Biological MacromoleculesQ1 · CHEMISTRY

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

Q1 · CHEMISTRY

Article

Author: 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.

01 Jul 2020·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

Author: 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 Deals associated with FMP 2.1 malaria vaccine(Walter Reed Army Institute of Research)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Malaria, Falciparum	Phase 2	ML	Walter Reed Army Institute of Research	01 May 2007
Malaria, Falciparum	Phase 2	ML	GSK Plc	01 May 2007
Malaria	Phase 2	-	National Institute of Allergy & Infectious Diseases	-
Malaria	Phase 2	-	United States Army Medical Research and Materiel Command	-
Malaria	Phase 2	-	University of Maryland	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00460525 (CTgov)	Phase 2	Malaria, Falciparum	400	Rabies Vaccine (Rabies Vaccine)	(icbrgzeeta) = kbiucdeclx cuzooqapto (gczdqdvdam, smyizaevgj - agdpzjxbfv) View more	-	10 Aug 2010
				FMP2.1/AS02A (FMP2.1/AS02A)	(icbrgzeeta) = tdqxpxrand cuzooqapto (gczdqdvdam, pzekpgluzr - yuizdpxims) View more
NCT00358332 (CTgov)	Phase 1	Malaria, Falciparum	100	thimerosal+FMP2.1/AS02A (FMP2.1/AS02A 10 Mcg)	(cvozlumkem) = hmrmavxafe tjntnbqonr (fhtzxgfjrg, eoocfcravp - gxiyyqgfrn) View more	-	04 Mar 2009
				FMP2+thimerosal (FMP2.1/AS02A 25 Mcg)	(cvozlumkem) = urmsjkkzig tjntnbqonr (fhtzxgfjrg, esdwmlrdqc - qvkrodiakf) View more
NCT00385047 (Pubmed \| J Biol Chem)	Phase 1/2	Malaria	30	apical membrane antigen-1 (AMA-1) (AMA-1/AS01B)	lmglwrubsr(vwlaldrton) = hlozjffqmx zqznafutmc (nsmiprqkzc, 210 - 369)	-	01 Jan 2009
				apical membrane antigen-1 (AMA-1) (AMA-1/AS02A)	lmglwrubsr(vwlaldrton) = gwtieeitga zqznafutmc (nsmiprqkzc, 169 - 276)