Evaluation of Rev.1 vaccine stability aftere solubilization lyophilized vaccine produced in Razi Institute

Document Type : Full Research Paper

Authors

1 Department of Microbiology and Immunology, Faculty of Veterinary Medicine, University of Tehran, Tehran, Iran

2 Department of Bacterial vaccines Quality Control. Razi Vaccine and Serum Research Institute, Agricultural Research, Education and Extension Organisation (AREEO), Karaj, Iran.

3 Department of Brucella Vaccine Production. Razi Vaccine and Serum Research Institute, Agricultural Research, Education and Extension Organisation (AREEO), Karaj, Iran.

Abstract

Brucellosis is one of the important zoonotic diseases, that causes fever in human and abortion in animals. Prevention of Brucellosis in humans is based on the vaccination of animals. Vaccination is the best way to prevent brucellosis in livestock. Rev.1 vaccine is one of the most effective vaccines to prevent and control brucellosis in sheep and goat. Since one of the most important topics in biological products  make ensure the quality of the product at all stages, including during storage and consumption.Also,according to the field conditions and the vaccine injection process,evaluation of Rev.1 vaccine stability after solubilization lyophilized vaccine is necessary. the present study was conducted to evaluation stability of Rev.1 vaccine after solublizathion. To do this, samples were collected randomly from three consecutive batches of Rev.1 vaccine. Serial dilution were prepared with physiological saline, and the live mass of the Rev.1 vaccine was obtained. After that dissolved vaccine was kept in different temperature conditions  at 4°C, 25°C and 37°C, Afterword four, eight, 12, 18 and 24 hours after solublizing the vaccine, the live mass of the  Rev.1 vaccine was analyzed. The results showed that Rev.1 vaccine after being solublized was congurous with OIE 2019 criteria when maintained 24 hours at 4°C, 18 hours at 25° C and 12 hours at 37° C. Therefore It is recommended to use the vaccine after solublizing procsee as soon as possible to prevent the reduction in the titer of Rev.1 vaccine and loose of time.

Keywords

References

1- Ali Ahmadi, M., D. Saadati, M. Najimi, H. Ganjali and F. Shah Karami. 2021. Comparison of PCR and Conventional Serological Methods for Detection of Brucella spp. in Ovine and Caprine Blood Serum. Archives of Razi Institute. 76: 445-452
2- Behroozikhah, A.M. Alamian, S. Pourahmadi, A. Moghadampour, M. (2009). Evaluation on stability process of Brucella melitensis Rev. 1 vaccine in Iran. Archives of Razi Institute 64(2):87-92. 
3- Blasco JM (1997) A review of the use of B. melitensis Rev 1 vaccine in adult sheep and goats. Prev Vet Mee 283-31: 275.
4- Bosseray N (1991) Brucella melitensis Rev. 1 living attenuated vaccine: stability of markers, residual virulence and immunogenicity in mice. Biologicals 19:355–363 
5- Dostdari, S. Mahmoodi, P. Mohammadzadeh, A. Khafri, A. (2019). Evaluation of Humoral Immune Responses of Sheep Vaccinated With Razi Institute Rev.1 Brucellosis Vaccine in Comparison to a Spanish (CZV) Rev.1 Vaccine. Avicenna Journal of Clinical Microbiology and Infection. August;6(3):95-99.  
6- Dostari, S. Hasannya,E. Khafari, A. Emadi, A. Bagheri Nejad,R. Alamyan S., Bagheri Sh (2017). Stability Study of Rev.1 Reduced dose Brucellosis Vaccine Produced by Razi Institute in Iran. Veterinary Researches & Biological Products. No 116 pp: 26-33.
7- Dostari, S. Hasannya,E. Khafari, A. Emadi, A. Bagheri Nejad,R.(2017). Stability study of the thermal stability of Brucellosis IRIBA strain vaccine after reconstitute. Veterinary Researches & Biological Products. No 117 pp: 85-91.
8- Elberg SS (1981) Rev. 1 Brucella melitensis vaccine. Part II, 1968–1980. Vet Bull 51:67–73.
9- Fatemi, Maryam. (1390). Stability Study of Rev.1 Brucellosis Vaccine With evaluation viable germ count. Thesis submitted for Doctor of Veterinary Medicine. University of Tehran. Tehra. 
10- Garrity, G. (2001). Bergey’s Manual of Systematic Bacteriology, second edition. .Springer. pp.721 
11- Godfroid, J., Nielsen, K. & Saegerman, C. (2010). Diagnosis of Brucellosis in Livestock and Wildlife. Croatian Medical Journal 51: 296-305.
12- Hasannia1, E., Soleimani*2, S., Alamian3, S., Behrozikhah3, A., Emadi1, A., Dostdari1, S. Stability Study of Iriba Brucellosis Full-dose and Reduceddose Vaccine Produced by Razi Institute in Iran Archives of Razi Institute, Vol. 70, No. 1 (2015) 37-44.
13- Instructions of Razi Vaccine and Serum Research Institute.(2015) Acquisition to technology for the production of vaccines and animals biological products. First Edition, Publications: Agricultural Research, Education and Extension Organisation. Pp 44-51.
14- Moriyon, I. Osterman, B. (2006). International committee on systematics of prokaryotes. Subcommittee on the taxonomy of brucella. Journal of Systematic and Evolutionary Microbiology. 56(5): 1173-1175.
15- Munoz PM, de Miguel MJ, Grillo MJ, Marin CM, Barberan M, Blasco JM (2008) Immunopathological responses and kinetics of Brucella melitensis Rev 1 infection after subcutaneous or conjunctival vaccination in rams. Vaccine 26:2562–2569.
16- Nabila, A. Wafaa, R. Ibrahim, H.M.  Shell, W.S. Hosein, H.I. (2018). The use of different stabilizers for improving integrity of the locally prepared lyophilized Brucella melitensis Rev 1 vaccine. JOURNAL OF VETERINARY MEDICAL RESEARCH 2018, 25 ( 1 ): 59- 67.
17- Jones, L.M., Entessar, F., and Ardalan, A. (1965). Comparison of living vaccine in producing immunity against natural Brucella melitensis infection in sheeps and goats in Iran.  ARI_Volume 17, Issue 1, Pages 39-42.
18- Osterman, B., Moriyon, I. (2006). International Committee on Systematics of Prokaryotes Subcommittee on the taxonomy of Brucella. International Journal of Systematic and Evolutionary Microbiology 56, 1173–1175.
19- World Organization for Animal Health (2019). Chapter, 3.1.4- Brucellosis.
20- Shayestehpour, M., Shafyi, A., Taqavian, M., Esna-ashari, F.,Mohammadi, A. and Shahbazi, R., 2012. A study of the thermalstability of measles vaccine produced by AIK-C strain. Arak Medical University Journal, 15(4), pp.26-33.
21- United States Pharmacopoeia (2012). USB 35, NF30, Wates determination 921. 
22- Verger JM (1985) B. melitensis infection in cattle. In: Verger JM, Plommet M (eds) Brucella melitensis. Martinus Nijhoff Publishers D, Leiden, pp 197–203.
23- World Health Organization, Technical report series. (1986). Joint FAO WHO expert committee on brucellosis, sixth report, WHO Technical Report Series. No, 740, Geneva.
24-World Health Organization, Technical Report Series. (1970). Joint FAO WHO expert committee on brucellosis. Fifth report. WHO Technical Report Series.  No. 464. Geneva.
25- World Health Organization. (1997). The development of new/ improved brucellosis vaccines: report of WHO Meeting with the participation of the Food and Agriculture Organization of the United Nations (FAO) and the Office International des Epizooties (OIE) Geneva, Switzerland 11-12 December 1997.  WHO/ EMC/ ZD/ 98. 14.
26- WHO, 1977. Requirements for Brucella melitensis strain Rev.1 vaccine (Live-for Veterinary use). WHO expert committee on Biological standardization, 28th Report, Annex 4, Technical Report Series No. 610. World Heath Organization, Geneva.
27- Zowghi, E., Ebadi, A., Yarahmadi, M. (2008). Isolation and identification of Brucella organisms in Iran.  Iranian Journal of Clinical Infectious Diseases 3(4):185-188.

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History

  • Receive Date: 25 November 2020
  • Revise Date: 03 January 2021
  • Accept Date: 05 January 2021

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