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      Vaccine Quality Is a Key Factor to Determine Thermal Stability of Commercial Newcastle Disease (ND)Vaccines

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          Abstract

          Vaccination against Newcastle disease (ND), a devastating viral disease of chickens, is often hampered by thermal inactivation of the live vaccines, in particular in tropical and hot climate conditions. In the past, “thermostable” vaccine strains (I-2) were proposed to overcome this problem but previous comparative studies did not include formulation-specific factors of commercial vaccines. In the current study, we aimed to verify the superior thermal stability of commercially formulated I-2 strains by comparing six commercially available ND vaccines. Subjected to 37 °C as lyophilized preparations, two vaccines containing I-2 strains were more sensitive to inactivation than a third I-2 vaccine or compared to three other vaccines based on different ND strains. However, reconstitution strains proved to have a comparable tenacity. Interestingly, all vaccines still retained a sufficient virus dose for protection (10 6 EID 50) after 1 day at 37 °C. These results suggest that there are specific factors that influence thermal stability beyond the strain-specific characteristics. Exposing ND vaccines to elevated temperatures of 51 and 61 °C demonstrated that inactivation of all dissolved vaccines including I-2 vaccine strains occurred within 2 to 4 h. The results revealed important differences among the vaccines and emphasize the importance of the quality of a certain vaccine preparation rather than the strain it contains. These data highlight that regardless of the ND strain used for vaccine preparation, the appropriate cold chain is mandatory for keeping live ND vaccines efficiency in hot climates.

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          Most cited references35

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          A SIMPLE METHOD OF ESTIMATING FIFTY PER CENT ENDPOINTS12

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            Newcastle disease virus: Current status and our understanding

            Highlights • Historical perspective and global scenario about Newcastle disease. • Characteristics about Newcastle disease virus genome. • Replication and pathogenicity of Newcastle disease virus. • Use of Newcastle disease virus as a vaccine vector. • Newcastle disease virus as an oncolytic agent.
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              Vaccine instability in the cold chain: mechanisms, analysis and formulation strategies.

              Instability of vaccines often emerges as a key challenge during clinical development (lab to clinic) as well as commercial distribution (factory to patient). To yield stable, efficacious vaccine dosage forms for human use, successful formulation strategies must address a combination of interrelated topics including stabilization of antigens, selection of appropriate adjuvants, and development of stability-indicating analytical methods. This review covers key concepts in understanding the causes and mechanisms of vaccine instability including (1) the complex and delicate nature of antigen structures (e.g., viruses, proteins, carbohydrates, protein-carbohydrate conjugates, etc.), (2) use of adjuvants to further enhance immune responses, (3) development of physicochemical and biological assays to assess vaccine integrity and potency, and (4) stabilization strategies to protect vaccine antigens and adjuvants (and their interactions) during storage. Despite these challenges, vaccines can usually be sufficiently stabilized for use as medicines through a combination of formulation approaches combined with maintenance of an efficient cold chain (manufacturing, distribution, storage and administration). Several illustrative case studies are described regarding mechanisms of vaccine instability along with formulation approaches for stabilization within the vaccine cold chain. These include live, attenuated (measles, polio) and inactivated (influenza, polio) viral vaccines as well as recombinant protein (hepatitis B) vaccines.
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                Author and article information

                Contributors
                Role: Academic Editor
                Journal
                Vaccines (Basel)
                Vaccines (Basel)
                vaccines
                Vaccines
                MDPI
                2076-393X
                09 April 2021
                April 2021
                : 9
                : 4
                : 363
                Affiliations
                [1 ]Department of Poultry Diseases, Faculty of Veterinary Medicine, South Valley University, Qena 83523, Egypt; nabila.osman@ 123456vet.svu.edu.eg
                [2 ]DGVAC Consulting, 2460 Antwerp, Belgium; Danny.Goovaerts@ 123456galvmed.org
                [3 ]GALVmed, Edinburgh EH26 0PZ, UK; Jeremy.Salt@ 123456galvmed.org
                [4 ]Department of Microbiology, Virology Division, Faculty of Veterinary Medicine, South Valley University, Qena 83523, Egypt; sultanserageldeen@ 123456gmail.com
                [5 ]Institute of Diagnostic Virology, Friedrich-Loeffler-Institut, Edinburgh EH26 0PZ, UK
                Author notes
                Author information
                https://orcid.org/0000-0002-0176-0349
                https://orcid.org/0000-0003-3527-7803
                https://orcid.org/0000-0003-0404-6535
                Article
                vaccines-09-00363
                10.3390/vaccines9040363
                8069011
                33918608
                2ecd12d7-f841-4acc-b0d2-05f49d48fdd9
                © 2021 by the authors.

                Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license ( https://creativecommons.org/licenses/by/4.0/).

                History
                : 07 February 2021
                : 06 April 2021
                Categories
                Article

                heat stability,newcastle disease virus,paramyxovirus,vaccine quality,vaccine stability

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