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Bridging the Gap Between Validation and Implementation of Non-Animal Veterinary Vaccine Potency Testing Methods.

ABSTRACT: In recent years, technologically advanced high-throughput techniques have been developed that replace, reduce or refine animal use in vaccine quality control tests. Following validation, these tests are slowly being accepted for use by international regulatory authorities. Because regulatory acceptance itself has not guaranteed that approved humane methods are adopted by manufacturers, various organizations have sought to foster the preferential use of validated non-animal methods by interfacing with industry and regulatory authorities. After noticing this gap between regulation and uptake by industry, we began developing a paradigm that seeks to narrow the gap and quicken implementation of new replacement, refinement or reduction guidance. A systematic analysis of our experience in promoting the transparent implementation of validated non-animal vaccine potency assays has led to the refinement of our paradigmatic process, presented here, by which interested parties can assess the local regulatory acceptance of methods that reduce animal use and integrate them into quality control testing protocols, or ensure the elimination of peripheral barriers to their use, particularly for potency and other tests carried out on production batches.

SUBMITTER: Dozier S

PROVIDER: S-EPMC4513470 | biostudies-literature | 2011 Nov

REPOSITORIES: biostudies-literature

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Bridging the Gap Between Validation and Implementation of Non-Animal Veterinary Vaccine Potency Testing Methods.

Dozier Samantha S Brown Jeffrey J Currie Alistair A

Animals : an open access journal from MDPI 20111129 4

In recent years, technologically advanced high-throughput techniques have been developed that replace, reduce or refine animal use in vaccine quality control tests. Following validation, these tests are slowly being accepted for use by international regulatory authorities. Because regulatory acceptance itself has not guaranteed that approved humane methods are adopted by manufacturers, various organizations have sought to foster the preferential use of validated non-animal methods by interfacing ...[more]

PMID: 26486625

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Project description:Infectious Bovine Rhinothracheitis (IBR) caused by bovine herpesvirus 1 (BoHV-1) infection is distributed worldwide. BoHV-1 either alone or in association with other respiratory cattle pathogens causes significant economic losses to the livestock industry. The aim of this work was to validate a guinea pig model as an alternative method to the current BoHV-1 vaccine potency testing in calves. Guinea pigs were immunized with two doses of vaccine, 21 days apart and sampled at 30 days post vaccination (dpv). BoHV-1 antibody (Ab) response to vaccination in guinea pigs, measured by ELISA and virus neutralization (VN), was statistically compared to the Ab response in cattle. The guinea pig model showed a dose-response relationship to the BoVH-1 antigen concentration in the vaccine and it was able to discriminate among vaccines containing 1log(10) difference in its BoHV-1 concentration with very good repeatability and reproducibility (CV < or = 20%). A regression analysis of the Ab titers obtained in guinea pigs and bovines at 30 and 60dpv, respectively, allowed us to classify vaccines in three potency categories: "very satisfactory", "satisfactory" and "unsatisfactory". Bovines immunized with vaccines corresponding to each of these three categories were experimentally challenged with BoVH-1 virus, the level of protection, as measured by reduction of virus shedding and disease severity, correlated well with the vaccine category used. Data generated by 85 experiments, which included vaccination of calves and guinea pigs with 18 reference vaccines of known potency, 8 placebos and 18 commercial vaccines, was subjected to statistical analysis. Concordance analysis indicated almost perfect agreement between the model and the target species for Ab titers measured by ELISA and almost perfect to substantial agreement when Ab titers were measured by VN. Taken together these results indicate that the developed guinea pig model represents a novel and reliable tool to estimate batch-to-batch vaccine potency and to predict efficacy of killed BoHV-1 veterinary vaccines.

Project description:Introduction:The use of a surgical safety checklist is recommended by the World Health Organization and is associated with advantages: improved communication and reduced complications and mortality. Adapting checklists to the environment in which they are used improves their efficiency, but their implementation can be challenging. The aim of this study was to develop and implement a perianesthetic safety checklist for a small animal hospital. Materials and methods:A panel of eight anesthesia diplomates and seven residents and doctoral students were gathered. The Delphi method was used to generate a checklist. The checklist was presented individually to each user by the primary investigator and introduced into the clinical routine over a 5-week period. An interdisciplinary meeting was then held, and the checklist was modified further. Six months after introduction, the use of the checklist was directly observed during 69 anesthetic cases and a survey was sent to the users. A second implementation was organized after formally presenting the checklist to the staff, designating the anesthesia clinical lead as the person responsible for printing and controlling use of the checklist. A second evaluation was performed 3?months later (64 anesthetic cases). Results:Using the Delphi process led to the creation of a checklist consisting of three parts: "sign in" (before induction of anesthesia), "time out" (before the beginning of the procedure), "sign out" (at the end of the procedure). At the first assessment, the checklist was printed and used in 32% of cases and not printed in 41% of cases. Response rate of the survey was fair (19/32 surveys): 14/19 users thought the checklist contributed to improving communication; 15/19 reported improved safety and better management of the animals; 9/19 users avoided mistakes (77% would have omitted the administration of antimicrobial prophylaxis); 10/19 thought it was time consuming. At the second assessment, the checklist was used in 45% of cases (printed but not used in 55%). The use of the sign-out section of the checklist was significantly improved. Conclusion and clinical relevance:This study illustrates an innovative use of the Delphi method to create a safety checklist. Challenges associated with implementation are reported.

Dataset Information

Bridging the Gap Between Validation and Implementation of Non-Animal Veterinary Vaccine Potency Testing Methods.

Publications

Bridging the Gap Between Validation and Implementation of Non-Animal Veterinary Vaccine Potency Testing Methods.

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