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Effect of Aluminum Adjuvant and Preservatives on Structural Integrity and Physicochemical Stability Profiles of Three Recombinant Subunit Rotavirus Vaccine Antigens.

ABSTRACT: A nonreplicating rotavirus vaccine (NRRV) containing 3 recombinant fusion proteins adsorbed to aluminum adjuvant (Alhydrogel [AH]) is currently in clinical trials. The compatibility and stability of monovalent NRRV antigen with key components of a multidose vaccine formulation were examined using physicochemical and immunochemical methods. The extent and strength of antigen-adjuvant binding were diminished by increasing phosphate concentration, and acceptable levels were identified along with alternate buffering agents. Addition of the preservative thimerosal destabilized AH-adsorbed P2-VP8-P[8] as measured by differential scanning calorimetry. Over 3 months at 4°C, AH-adsorbed P2-VP8-P[8] was stable, whereas at 25°C and 37°C, instability was observed which was greatly accelerated by thimerosal addition. Loss of antibody binding (enzyme-linked immunosorbent assay) correlated with loss of structural integrity (differential scanning calorimetry, fluorescence spectroscopy) with concomitant nonnative disulfide bond formation (sodium dodecyl sulfate-polyacrylamide gel electrophoresis) and Asn deamidation (liquid chromatography -mass spectrometry peptide mapping). An alternative preservative (2-phenoxyethanol) showed similar antigen destabilization. Due to limited availability, only key assays were performed with monovalent P2-VP8-P[4] and P2-VP8-P[6] AH-adsorbed antigens, and varying levels of preservative incompatibility were observed. In summary, monovalent AH-adsorbed NRRV antigens stored at 4°C showed good stability without preservatives; however, future formulation development efforts are required to prepare a stable, preservative-containing, multidose NRRV formulation.

SUBMITTER: Agarwal S

PROVIDER: S-EPMC6941222 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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Effect of Aluminum Adjuvant and Preservatives on Structural Integrity and Physicochemical Stability Profiles of Three Recombinant Subunit Rotavirus Vaccine Antigens.

Agarwal Sanjeev S Hickey John M JM McAdams David D White Jessica A JA Sitrin Robert R Khandke Lakshmi L Cryz Stanley S Joshi Sangeeta B SB Volkin David B DB

Journal of pharmaceutical sciences 20191004 1

A nonreplicating rotavirus vaccine (NRRV) containing 3 recombinant fusion proteins adsorbed to aluminum adjuvant (Alhydrogel [AH]) is currently in clinical trials. The compatibility and stability of monovalent NRRV antigen with key components of a multidose vaccine formulation were examined using physicochemical and immunochemical methods. The extent and strength of antigen-adjuvant binding were diminished by increasing phosphate concentration, and acceptable levels were identified along with al ...[more]

PMID: 31589875

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Project description:The use of natural preservatives in the storage of fresh fruits is a promising approach to healthier and more sustainable food processing. The current study was conducted to evaluate the effect of pomegranate peel extract (PPE) and lactic acid (LA) as natural preservatives on the shelf life of Khalal Barhi date fruits. Physicochemical properties, antioxidant activity, color parameters, texture profile, sensory characteristics, and microbiological quality of date fruits were evaluated during six weeks of cold storage (4 ± 1 °C). The bioactive compounds in PPE were determined by HPLC analysis, which showed that PPE is a rich source of bioactive compounds, particularly phenolics and flavonoids. The results exhibited decreased moisture content (from 68.36–68.43 to 62.13–63.11%) and an increased soluble solids content (from 27.16–27.24 to 31.45–33.91%) in all samples with prolonged storage. Likewise, a slight decrease in the pH (from 6.00–6.28 to 4.89–5.29) with an increase in acidity (from 0.12–0.14 to 0.23–0.27%) during storage was observed. Generally, treated samples showed lower changes in moisture content, soluble solids content, pH, and acidity than the control. A decrease in total phenolic content (TPC) (from 8.22–12.36 to 3.19–5.17 mg GAE/g) and antioxidant activity (from 44.11–68.26 to 23.84–38.52%) of all samples was observed with progressed storage, meanwhile, the treatment with PPE significantly (p < 0.05) increased TPC with a concomitant increase in antioxidant activity and maintained higher values of both throughout storage. The results exhibited a decrease in L* (from 54.87–55.92 to 41.68–45.68) and b* (from 36.25–37.09 to 23.59–25.42) values of all samples, while the a* value of all samples increased (from 1.29–1.40 to 2.22–2.43) with storage. Dipping treatment in PPE solution improved the color, exhibited the lowest change in color parameters, and maintained better texture properties during storage. Similarly, sensory properties decreased (from 8.21–8.66 to 6.71–7.21) during storage with insignificant (p > 0.05) differences among samples. Dipping treatments inhibited the growth of yeasts and molds over time, with the lowest microbial count recorded in the PPE-treated samples. It can be concluded that PPE was found to have protective effects on Khalal Barhi date fruit quality by controlling post-harvest changes and lowering the microbial load.

Dataset Information

Effect of Aluminum Adjuvant and Preservatives on Structural Integrity and Physicochemical Stability Profiles of Three Recombinant Subunit Rotavirus Vaccine Antigens.

Publications

Effect of Aluminum Adjuvant and Preservatives on Structural Integrity and Physicochemical Stability Profiles of Three Recombinant Subunit Rotavirus Vaccine Antigens.

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