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- Title
Inactivated rabies vaccines: Standardization of an in vitro assay for residual viable virus detection.
- Authors
Moreira, Beatriz Lourenço Correia; Gimenez, Ana Paula Lappas; Inagaki, Jorge Minor Fernandes; Raboni, Sonia Mara
- Abstract
Human rabies, a neglected viral zoonosis, is preventable through domestic animals vaccination and post-exposure prophylaxis using inactivated rabies vaccines. During vaccine production, several mandatory in vivo quality control trials, such as potency, live virus, and safety, are responsible for the use of large numbers of laboratory animals. Over the years, global organizations encouraged the development of alternative methods to reduce, replace and refine the use of animals in the pharmaceutical industry. In this study we standardized an in vitro assay for determination of residual live virus combining viral isolation techniques with direct immunofluorescence detection and viral quantification by a molecular method. Standardization of viral recovery steps and quantification by RT-qPCR were performed and the combined method was shown to be 3 fold more sensitive than the in vivo assay. It was possible to identify viral suspensions cultures, which still had residual viable rabies virus particles, evidencing the importance to implement this method in quality control schemes of rabies vaccine production. In addition, this developed assay is more practical, inexpensive and less time consuming, producing results in just 4 days, which may allow greater agility in the internal quality control of the vaccine. The in vitro method may reduce 2/3rd of laboratory animals numbers used for this purpose, since it can be applied in the intermediate quality control of inactivated rabies vaccine production. Author summary: Rabies is a viral disease that causes thousands of deaths worldwide every year, but can be preventable through vaccination of animals and humans. In the production of inactivated rabies vaccines, quality control assays use large amounts of laboratory animals. In order to reduce the number of animals in this practice, in vitro methods for residual live virus detection need to be developed. This study shows that combining two simple and effective techniques may be a safer and more accurate method for the detection of residual rabies virus than in vivo assays to evaluate inactivated vaccines and can be used as an intermediate quality control assay of vaccine production.
- Subjects
RABIES vaccines; ANIMAL vaccination; VIRUS diseases; QUALITY control; STANDARDIZATION
- Publication
PLoS Neglected Tropical Diseases, 2020, Vol 14, Issue 3, p1
- ISSN
1935-2727
- Publication type
Article
- DOI
10.1371/journal.pntd.0008142