Potency of Veterinary Rabies Vaccines Marketed in Sri Lanka
Abstract
:1. Introduction
2. Materials and Methods
2.1. Materials
2.1.1. Test Vaccines
2.1.2. Reference Vaccine
2.1.3. Animals
- 4 groups to test the 4 doses of the CVS challenge virus (back titration of the virus).
- 4 groups to test the 4 doses of the reference vaccine BRP N°5.
- 4 groups to test the 4 doses of each test vaccine.
2.1.4. Challenge Virus
2.2. Method
2.2.1. NIH Test
2.2.2. Statistical Analysis
2.2.3. Validation of Potency Tests
3. Results
4. Discussion
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
- Fooks, A.R.; Cliquet, F.; Finke, S.; Freuling, C.; Hemachudha, T.; Mani, R.S.; Müller, T.; Nadin-Davis, S.; Picard-Meyer, E.; Wilde, H.; et al. Rabies. Nat. Rev. Dis. Prim. 2017, 3, 17091. [Google Scholar] [CrossRef] [PubMed]
- Taylor, E.; Banyard, A.C.; Bourhy, H.; Cliquet, F.; Ertl, H.; Fehlner-Gardiner, C.; Horton, D.L.; Mani, R.S.; Müller, T.; Rupprecht, C.E.; et al. Avoiding preventable deaths: The scourge of counterfeit rabies vaccines. Vaccine 2019, 37, 2285–2287. [Google Scholar] [CrossRef] [PubMed]
- Hu, R.L.; Fooks, A.R.; Zhang, S.F.; Liu, Y.; Zhang, F. Inferior rabies vaccine quality and low immunization coverage in dogs (Canis familiaris) in China. Epidemiol. Infect. 2008, 136, 1556–1563. [Google Scholar] [CrossRef] [PubMed]
- Sri Lanka Death Statistics. Public Health Veterinary Services; Ministry of Healthcare and Indigenous Medical Services: Colombo, Sri Lanka, 2023. Available online: http://www.rabies.gov.lk/english/static.php (accessed on 27 February 2023).
- Weekly Epidemiological Report. Human Rabies; Epidemiology Unit Ministry of Health, Nutrition, and Indigenous Medicine: Colombo, Sri Lanka, 2017. Available online: https://www.epid.gov.lk/web/images/pdf/wer/2017/vol_44_no_09-english.pdf (accessed on 13 July 2021).
- Finnegan, C.J.; Brookes, S.M.; Johnson, N.; Smith, J.; Mansfield, K.L.; Keene, V.L.; McElhinney, L.M.; Fooks, A.R. Rabies in North America and Europe. J. R. Soc. Med. 2002, 95, 9–13. [Google Scholar] [CrossRef]
- Cleaveland, S.; Kaare, M.; Knobel, D.; Laurenson, M.K. Canine vaccination--providing broader benefits for disease control. Vet. Microbiol. 2006, 117, 43–50. [Google Scholar] [CrossRef]
- Banerjee, Y. Mission Indradhanush and the counterfeit drug trade in India. Lancet Infect. Dis. 2015, 15, 1379–1380. [Google Scholar] [CrossRef]
- Servat, A.; Kempff, S.; Brogat, V.; Litaize, E.; Schereffer, J.L.; Cliquet, F. A step forward in the quality control testing of inactivated rabies vaccines—Extensive evaluation of European vaccines by using alternative methods to the in vivo potency tests. Altern. Lab. Anim. 2015, 43, 19–27. [Google Scholar] [CrossRef]
- Daas, A.; Bruckner, L.; Milne, C. EDQM biological reference preparation for rabies vaccine (inactivated) for veterinary use. Pharmeuropa Bio Sci. Notes 2015, 2015, 57–72. [Google Scholar]
- Anon. Monograph 04/2013:0451. Rabies vaccine (inactivated) for veterinary use. In European Pharmacopoeia, 8th ed.; Council of Europe: Strasbourg, France, 2013; pp. 1055–1057. [Google Scholar]
- Servat, A.; Cliquet, F. The NIH test for potency testing of rabies vaccines. In Current Laboratory Techniques in Rabies Diagnosis, Research and Prevention; Rupprecht, C., Nagarajan, T., Eds.; Elsevier Inc.: Amsterdam, The Netherlands, 2018; Volume 2, pp. 180–188. [Google Scholar]
- Servat, A.; Kempff, S.; Labadie, A.; Schereffer, J.L.; Boué, F.; Cliquet, F. In vivo potency tests of rabies inactivated vaccines for veterinary use. A 2-year retrospective analysis of data according to the criteria of the European Pharmacopoeia. Pharmeuropa Bio Sci. Notes 2008, 20, 655–664. [Google Scholar]
- World Health Organization (WHO), Food and Agriculture Organization of the United Nations (FAO), and World Organization for Animal Health (WOAH) (2019) United Against Rabie Collaboration. Available online: https://apps.who.int/iris/bitstream/handle/10665/328053/WHO-CDS-NTD-NZD-2019.04-eng.pdf?sequence=1&isAllowed=y (accessed on 29 August 2022).
- Servat, A.; Cliquet, F.; Wasniewski, M. Assessing the Potency of Inactivated Veterinary Vaccines and Oral Live Vaccines against Rabies. In Rabies and Rabies Vaccines; Ertl, H.C.J., Ed.; Springer: Cham, Switzerland, 2020; pp. 181–193. [Google Scholar]
- World Health Organization. Laboratory Techniques in Rabies, 5th ed.; Rupprecht, C.E., Fooks, A.R., Abela-Ridder, B., Eds.; World Health Organization: Geneva, Switzerland, 2018; Volume 1. Available online: https://apps.who.int/iris/handle/10665/310836 (accessed on 29 August 2022).
- Seligmann, E.B., Jr. Laboratory techniques in rabies: The NIH test for potency. Monogr. Ser. World Health Organ. 1973, 23, 279–286. [Google Scholar]
- Krämer, B.; Bruckner, L.; Daas, A.; Milne, C. Collaborative study for validation of a serological potency assay for rabies vaccine (inactivated) for veterinary use. Pharmeuropa Bio Sci. Notes 2010, 2, 37–55. [Google Scholar]
- Russell, W.M.S.; Burch, R.L. The Principles of Humane Experimental Technique; Methuen: London, UK, 1959; p. 238. [Google Scholar]
- Blackstone, E.A.; Fuhr, J.P., Jr.; Pociask, S. The health and economic effects of counterfeit drugs. Am. Health Drug Benefits 2014, 7, 216–224. [Google Scholar] [PubMed]
- Development of Sri Lanka’s National Strategic Plan for the Elimination of Dog-Mediated Human Rabies (2022–2026), World Health Organization, South-East Asia News. Available online: https://www.who.int/southeastasia/news/feature-stories/detail/development-of-sri-lanka-s-national-strategic-plan-for-the-elimination-of-dog-mediated-human-rabies-(2022-2026) (accessed on 28 February 2023).
Vaccines | Manufacturer | Batch Number | Valence | Rabies Virus Strain and (Adjuvants) | Target Species |
---|---|---|---|---|---|
Canvac R (Single dose 1 mL) | Dyntec spol. S r.o., Czech Republic | 010119 | Rabies | Inactivated rabies virus strain (Aluminum hydroxide gel) | Dog, cat, fur-bearing animals, cattle, sheep, goat, horse, pig |
Defensor 3 (Single dose 1 mL) | Zoetis, South Africa | 343374B 364249 | Rabies | Strain Pasteur original | Dog, cat, ferret, cattle, sheep |
Nobivac Rabies (Single dose 1 mL) | Intervet International B.V., The Netherlands | A508A02 | Rabies | Strain Pasteur derivative (Aluminum phosphate) | Dog, cat |
Nobivac RL (Single dose 1 mL) | Intervet International B.V., The Netherlands | A138A01 | Rabies + Leptospirosis | Strain Pasteur derivative (Aluminum phosphate) | Dog |
Rabies killed vaccine (Single dose 1 mL) | Komipharm International, South Korea | 58RVKV12 | Rabies | Strain Pasteur derivative (Aluminum hydroxide) | Dog, cat, horse, cattle, sheep, goat |
Rabisin (Single dose 1 mL) | Boehringer–Ingelheim (Merial), Germany | L465131 | Rabies | G52 fixed virus of the Pasteur strain (Aluminum hydroxide) | Dog, cat, horse, sheep, cattle, ferret |
Raksharab (Single dose 1 mL) | Indian Immunologicals Ltd., India | 01RAB01319 | Rabies | CVS * strain (Aluminum hydroxide gel) | Dog, cattle, sheep, camel |
Raksharab (Multidose 10 mL) | Indian Immunologicals Ltd., India | 03RAB00319 | Rabies | CVS strain (Aluminum hydroxide gel) | Dog, cattle, sheep, camel |
Vaccine | Potency (IU/Dose) |
---|---|
Canvac R | <1 |
Defensor 3 | 0.7 |
Nobivac Rabies | 3.4 |
Nobivac RL | 4.4 |
Rabies killed vaccine | 0.1 |
Rabisin | 12 |
Raksharab | 7.2 |
Raksharab multidose | 1.3 |
Disclaimer/Publisher’s Note: The statements, opinions and data contained in all publications are solely those of the individual author(s) and contributor(s) and not of MDPI and/or the editor(s). MDPI and/or the editor(s) disclaim responsibility for any injury to people or property resulting from any ideas, methods, instructions or products referred to in the content. |
© 2023 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/).
Share and Cite
Rathnadiwakara, H.; Gunatilake, M.; Servat, A.; Wasniewski, M.; Thibault, J.-C.; Cliquet, F. Potency of Veterinary Rabies Vaccines Marketed in Sri Lanka. Vaccines 2023, 11, 961. https://doi.org/10.3390/vaccines11050961
Rathnadiwakara H, Gunatilake M, Servat A, Wasniewski M, Thibault J-C, Cliquet F. Potency of Veterinary Rabies Vaccines Marketed in Sri Lanka. Vaccines. 2023; 11(5):961. https://doi.org/10.3390/vaccines11050961
Chicago/Turabian StyleRathnadiwakara, Hasanthi, Mangala Gunatilake, Alexandre Servat, Marine Wasniewski, Jean-Christophe Thibault, and Florence Cliquet. 2023. "Potency of Veterinary Rabies Vaccines Marketed in Sri Lanka" Vaccines 11, no. 5: 961. https://doi.org/10.3390/vaccines11050961