Delving into the Latest Updates on FMP 2.1 malaria vaccine 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-

Mechanism

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

GSK Plc

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Drug Highest PhaseDiscontinuedPhase 2

First Approval Date-

Regulation-

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

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NCT00358332 / CompletedPhase 1

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

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NCT00385047 / CompletedPhase 1/2

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

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100 Translational Medicine associated with FMP 2.1 malaria vaccine

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100 Patents (Medical) associated with FMP 2.1 malaria vaccine

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15

Literatures (Medical) associated with FMP 2.1 malaria vaccine

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 Dec 2019·Malaria JournalQ3 · MEDICINE

Immunoglobulin G subclass and antibody avidity responses in Malian children immunized with Plasmodium falciparum apical membrane antigen 1 vaccine candidate FMP2.1/AS02A

Q3 · MEDICINE

ArticleOA

Author: Dutta, Sheetij ; Plowe, Christopher V ; Diggs, Carter L ; Ouattara, Amed ; Niangaly, Amadou ; Berry, Andrea A ; Laurens, Matthew B ; Coulibaly, Drissa ; Thera, Mahamadou A ; Gottlieb, Eric R ; Tolo, Youssouf ; Traore, Karim ; Sztein, Marcelo B ; Doumbo, Ogobara K ; Kone, Abdoulaye K ; Lyke, Kirsten E ; Kouriba, Bourema ; Mishcherkin, Vladimir ; Soisson, Lorraine ; Blackwelder, William C ; Diarra, Issa

BACKGROUNDA malaria vaccine based on Plasmodium falciparum apical membrane antigen 1 (AMA1) elicited strain specific efficacy in Malian children that waned in the second season after vaccination despite sustained AMA1 antibody titers. With the goal of identifying a humoral correlate of vaccine-induced protection, pre- and post-vaccination sera from children vaccinated with the AMA1 vaccine and from a control group that received a rabies vaccine were tested for AMA1-specific immunoglobulin G (IgG) subclasses (IgG1, IgG2, IgG3, and IgG4) and for antibody avidity.METHODSSamples from a previously completed Phase 2 AMA1 vaccine trial in children residing in Mali, West Africa were used to determine AMA1-specific IgG subclass antibody titers and avidity by ELISA. Cox proportional hazards models were used to assess correlation between IgG subclass antibody titers and risk of time to first or only clinical malaria episode and risk of multiple episodes. Asexual P. falciparum parasite density measured for each child as area under the curve were used to assess correlation between IgG subclass antibody titers and parasite burden.RESULTSAMA1 vaccination did not elicit a change in antibody avidity; however, AMA1 vaccinees had a robust IgG subclass response that persisted over the malaria transmission season. AMA1-specific IgG subclass responses were not associated with decreased risk of subsequent clinical malaria. For the AMA1 vaccine group, IgG3 levels at study day 90 correlated with high parasite burden during days 90-240. In the control group, AMA1-specific IgG subclass rise and persistence over the malaria season was modest and correlated with age. In the control group, titers of several IgG subclasses at days 90 and 240 correlated with parasite burden over the first 90 study days, and IgG3 at day 240 correlated with parasite burden during days 90-240.CONCLUSIONSNeither IgG subclass nor avidity was associated with the modest, strain-specific efficacy elicited by this blood stage malaria vaccine. Although a correlate of protection was not identified, correlations between subclass titers and age, and correlations between IgG subclass titers and parasite burden, defined by area under the curve parasitaemia levels, were observed, which expand knowledge about IgG subclass responses. IgG3, known to have the shortest half-life of the IgG subclasses, might be the most temporally relevant indicator of ongoing malaria exposure when examining antibody responses to AMA1.

100 Deals associated with FMP 2.1 malaria vaccine

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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	GSK Plc	01 May 2007
Malaria	Phase 2	-	United States Army Medical Research and Materiel Command	-
Malaria	Phase 2	-	Walter Reed Army Institute of Research	-
Malaria	Phase 2	-	National Institute of Allergy & Infectious Diseases	-
Malaria	Phase 2	-	GSK Plc	-
Malaria	Phase 2	US	-	-
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)	(utwcctgsdd) = wdpjjosbky tllqpctxll (gzpujjoxzf, xefrdfwift - tnfmaoirnq) View more	-	10 Aug 2010
				FMP2.1/AS02A (FMP2.1/AS02A)	(utwcctgsdd) = vfwuhnqags tllqpctxll (gzpujjoxzf, jksuuxvlzr - ijevixfpqt) View more
NCT00385047 (Pubmed \| J Biol Chem)	Phase 1/2	Malaria	30	apical membrane antigen-1 (AMA-1) (AMA-1/AS01B)	gmccwywckf(fbwdsjgkwe) = dqlwffjwwc zntbhavlzz (cuubemxluv, 210 - 369)	-	01 Jan 2009
				apical membrane antigen-1 (AMA-1) (AMA-1/AS02A)	gmccwywckf(fbwdsjgkwe) = dxiimdrjpk zntbhavlzz (cuubemxluv, 169 - 276)
NCT00358332 (CTgov)	Phase 1	Malaria, Falciparum	100	thimerosal+FMP2.1/AS02A (FMP2.1/AS02A 10 Mcg)	(xzrciscfmh) = yyvnrfpjud qvpdavtrex (umjfhqwctb, zluwrxcvkm - oredjfvigr) View more	-	04 Mar 2009
				FMP2+thimerosal (FMP2.1/AS02A 25 Mcg)	(xzrciscfmh) = vfjonvjpfq qvpdavtrex (umjfhqwctb, rsuzobmuzn - zoplrbydle) View more