Production, quality control, stability and pharmacotoxicity of cGMP-produced Plasmodium falciparum AMA1 FVO strain ectodomain expressed in Pichia pastoris

Faber, Bart W.; Remarque, Edmond J.; Kocken, Clemens H. M.; Cheront, Pascale; Cingolani, Doriano; Xhonneux, Florence; Jurado, Margarita; Haumont, Michèle; Jepsen, Søren; Leroy, Odile; Thomas, Alan W.

doi:10.1016/j.vaccine.2008.08.055

Cited by 31 publications

(65 citation statements)

References 22 publications

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“…61 A Phase I study in malaria-naïve adults in the Netherlands has been completed with this antigen formulated with three different adjuvants; Alhydrogel ® , Montanide ® ISA 720 and ASO2A. 62 The best antibody responses were induced by the ASO2A formulations, which approached the levels of anti-AMA1 antibodies seen in semi-immune adults and immunoglobulin isolated from the sera of subjects showed considerable inhibitory activity in a GIA.…”

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confidence: 99%

“…62 The best antibody responses were induced by the ASO2A formulations, which approached the levels of anti-AMA1 antibodies seen in semi-immune adults and immunoglobulin isolated from the sera of subjects showed considerable inhibitory activity in a GIA. This antigen, expressed in P. pastoris was partially cleaved by proteolysis 61 and it will be of interest to see if it provides the level of efficacy in a Phase II trial that was achieved with the E. coliexpressed 3D7 AMA1/ASO2A formulation tested in Mali. 50 Clinical development of recombinant protein MSP2 vaccines (Table 4).…”

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confidence: 99%

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Recombinant protein vaccines against the asexual blood-stages ofPlasmodium falciparum

et al. 2010

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It is now more than 25 years since asexual blood stage antigens of Plasmodium falciparum were first expressed as recombinant proteins. Although many asexual blood stage vaccine candidates have been identified, none has yet been fully evaluated in clinical trials. The results of studies in animal models, and from in vitro studies with P. falciparum, indicate that antibody responses induced by many of these recombinant proteins can inhibit parasite development, but so far the evidence that protection can be achieved in exposed human populations is limited. Recombinant forms of MSP2 and AMA1 expressed in E. coli have had significant effects in Phase II trials, although for both antigens the effect was against a subset of parasites expressing a form of these polymorphic antigens related to that in the vaccine. More knowledge of the antigenic structure of the native parasite antigens is required so that recombinant protein constructs can be optimized to induce the correct antibody fine specificity. The very different structural characteristics of MSP2 and AMA1 are discussed, as are some approaches being taken to overcoming the problem of diversity in these antigens.

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confidence: 99%

Section: Downloaded By [Illinois Institutementioning

confidence: 99%

Recombinant protein vaccines against the asexual blood-stages ofPlasmodium falciparum

et al. 2010

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“…The major difference is the greater number of repeats, which are the primary target of anti-LSA-1 antibodies (29), in the NF54 sequence than in the 3D7 sequence (30). Amino acids 25 to 545 of codon-optimized AMA-1 of the P. falciparum FVO strain were expressed in the methylotrophic yeast Pichia pastoris (31,32). A peptide covering the C-terminal amino acids 73 to 162 of the integral parasitophorous vacuolar membrane protein EXP-1 (Swiss-Prot Database primary accession number P04926) was chemically synthesized using solid-phase 9-fluorenylmethoxy carbonyl (Fmoc) chemistry and differs from the 3D7 sequence only by a single amino acid in position 160 (33).…”

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Impact of Malaria Preexposure on Antiparasite Cellular and Humoral Immune Responses after Controlled Human Malaria Infection

et al. 2015

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e To understand the effect of previous malaria exposure on antiparasite immune responses is important for developing successful immunization strategies. Controlled human malaria infections (CHMIs) using cryopreserved Plasmodium falciparum sporozoites provide a unique opportunity to study differences in acquisition or recall of antimalaria immune responses in individuals from different transmission settings and genetic backgrounds. In this study, we compared antiparasite humoral and cellular immune responses in two cohorts of malaria-naive Dutch volunteers and Tanzanians from an area of low malarial endemicity, who were subjected to the identical CHMI protocol by intradermal injection of P. falciparum sporozoites. Samples from both trials were analyzed in parallel in a single center to ensure direct comparability of immunological outcomes. Within the Tanzanian cohort, we distinguished one group with moderate levels of preexisting antibodies to asexual P. falciparum lysate and another that, based on P. falciparum serology, resembled the malaria-naive Dutch cohort. Positive P. falciparum serology at baseline was associated with a lower parasite density at first detection by quantitative PCR (qPCR) after CHMI than that for Tanzanian volunteers with negative serology. Post-CHMI, both Tanzanian groups showed a stronger increase in anti-P. falciparum antibody titers than Dutch volunteers, indicating similar levels of B-cell memory independent of serology. In contrast to the Dutch, Tanzanians failed to increase P. falciparum-specific in vitro recall gamma interferon (IFN-␥) production after CHMI, and innate IFN-␥ responses were lower in P. falciparum lysate-seropositive individuals than in seronegative individuals. In conclusion, positive P. falciparum lysate serology can be used to identify individuals with better parasite control but weaker IFN-␥ responses in circulating lymphocytes, which may help to stratify volunteers in future CHMI trials in areas where malaria is endemic. In 2012, Plasmodium falciparum malaria caused an estimated 207 million cases and 627,000 deaths, of which 90% occurred in children under 5 years of age and in pregnant women in subSaharan Africa (1). Major control efforts have been implemented with some success (2, 3), but malaria eradication will likely require a safe and highly protective vaccine. Subunit vaccines have thus far shown moderate efficacy at best. RTS,S is the only vaccine candidate in phase 3 trials but, despite averting substantial numbers of malaria cases (4), shows only 30 to 50% reduction in clinical disease after 12 months depending on both age and malaria endemicity and even less after 18 months (5-7). These results stress the need for more effective second-generation vaccines. Key requirements are not only the identification of novel immunogens but also a better understanding of protection-related immune responses. This includes the effect of previous malaria exposure on immune responses upon reexposure or vaccination (8,9).During the past 3 decades, controlled human malar...

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“…In fact, the product complexity and purity for quality control of biologics are quite difficult to evaluate by current physicochemical methodologies, such as SDS-PAGE, CE, MS, and HPLC. [2][3][4][5][6][7][8][9][10] As a new approach for assessing the quality of biopharmaceuticals, we examined a method to distinguish time-dependent changes of OXT 1 H-NMR spectra by introducing PCA of NMR signals. We initially found that simple visual inspection was insufficient to distinguish whether the three 1 H-NMR spectra of OXT, gathered every 7 d for 14 d, showed time-dependent changes.…”

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confidence: 99%

“…To date, many analysis methods, such as sodium dodecyl sulfate polyacrylamide gel electrophoresis (SDS-PAGE), 4,5) capillary electrophoresis (CE), 6) mass spectrometry (MS), tandem MS (MS/MS), 7) liquid chromatography-mass spectrometry (LC-MS), high-performance liquid chromatography (HPLC) 8 and nuclear magnetic resonance (NMR), are employed to evaluate physicochemical characteristics and purity, and thus determine the quality of biopharmaceuticals.…”

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Time-Dependent Changes of Oxytocin Using 1H-NMR Coupled with Multivariate Analysis: a New Approach for Quality Evaluation of Protein/Peptide Biologic Drugs

Ohno¹,

Kawasaki²,

Fukuhara³

et al. 2009

CHEMICAL & PHARMACEUTICAL BULLETIN

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Production, quality control, stability and pharmacotoxicity of cGMP-produced Plasmodium falciparum AMA1 FVO strain ectodomain expressed in Pichia pastoris

Cited by 31 publications

References 22 publications

Recombinant protein vaccines against the asexual blood-stages ofPlasmodium falciparum

Recombinant protein vaccines against the asexual blood-stages ofPlasmodium falciparum

Impact of Malaria Preexposure on Antiparasite Cellular and Humoral Immune Responses after Controlled Human Malaria Infection

Time-Dependent Changes of Oxytocin Using 1H-NMR Coupled with Multivariate Analysis: a New Approach for Quality Evaluation of Protein/Peptide Biologic Drugs

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