Volume 14, Issue 1 (Jan-Feb 2020)                   mljgoums 2020, 14(1): 36-43 | Back to browse issues page


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Soleimani S. Determination of Factors Affecting Bivalent (Type 1 and 3) Stability of Oral Poliomyelitis Vaccine. mljgoums. 2020; 14 (1) :36-43
URL: http://mlj.goums.ac.ir/article-1-1197-en.html
Department of Biobank, Razi Vaccine & Serum Research Institute, Agricultural Research Education and Extension Organization (AREEO), P.O. Box 31975-148, Karaj, Iran , s.soleimani@rvsri.ac.ir
Abstract:   (226 Views)
Background and objectives: After using of trivalent oral poliovirus vaccine (OPV) for a long time in Iran, in recent years, due to the eradication of type 2 of poliovirus, a bivalent vaccine containing types 1 and 3 is used. Since it is a highly thermo labile vaccine strain of poliovirus, it should be stored under the recommended temperature. Because in vaccine storage and transportation, the cold chain may not be achieved in Iran tropical weather conditions, the potency of this vaccine may be subject to change.
Methods: The purpose of this study was the stability evaluation of bivalent oral poliovirus vaccine produced by Razi Institute in Iran for stability study of vaccines to ensure constancy of virus at different temperatures and intervals freezing/defrosting cycles (stress tests). Three consecutive batches produced during full-scale production were sampled randomly. All quality control tests in the form of stability studies were done on vaccines stored at -20, 2-8, 22-25 and 35-37ºC in specific time intervals and 10, 20, 30, 40 and 50 freezing/defrosting cycles.
Results: The findings indicate the stability of this vaccine in different situations. The results also showed the effects of the environment affecting factors on the potency of the vaccines and determined the correlation between the VVM grade and the vaccine potency.
Conclusion: Important observations of the vaccine distribution network at different transit levels and the correlation of VVM grade and vaccine potency and freezing/defrosting are discussed in this study which will be of help to the vaccine program team.
Full-Text [PDF 948 kb]   (70 Downloads)    
Type of Study: Original Paper | Subject: Virology
Received: 2019/03/4 | Accepted: 2019/06/19 | Published: 2019/12/30 | ePublished: 2019/12/30

References
1. Martin Ndinakie Yakum JA, Fida Ramsina Pélagie, Ebile Akoh Walter and Pierre Watcho. Factors associated with the exposure of vaccines to adverse temperature conditions: the case of North West region, Cameroon. BMC Res Notes 2015;8(1):277. [DOI:10.1186/s13104-015-1257-y]
2. Samant Y LH, Parker D, Block L, Tomar GS, Stein B. Evaluation of the cold-chain for oral polio vaccine in a rural district of India. Public Health Reports 2007;122:112e21. [DOI:10.1177/003335490712200116]
3. JohnLloyd a. The origins of the vaccine cold chain and a glimpse of the future. 2017;35(17):2115-20. [DOI:10.1016/j.vaccine.2016.11.097]
4. Deshpande DP, Nadkarni S.S. . Field performance of VVM is evaluated in India. World Health Organization, Polio Lab Network Quarterly Update. 2004:2-3.
5. Heleen Kraan PvH, Gideon Kersten, and Jean-Pierre Amorij. Development of Thermostable Lyophilized Inactivated Polio Vaccine. Pharm Res. 2014;31(10):2618-29. [DOI:10.1007/s11095-014-1359-6]
6. Thapa SBAHAOEDJNA. The Switch From Trivalent to Bivalent Oral Poliovirus Vaccine in the South-East Asia Region. The Journal of Infectious Diseases. 2017;216(1):S94-S100. [DOI:10.1093/infdis/jiw602]
7. Ashutosh Shrivastava NG, Pramod Upadhyay, and Jacob Puliyel. Caution needed in using oral polio vaccine beyond the cold chain: Vaccine vial monitors may be unreliable at high temperatures. Indian J Med Res. 2012;135(4):520-2.
8. Soleimani S, Bordbar, N. . Stability Study of Razi Trivalent and Monovalent Oral Poliomyelitis Vaccine. Archives of Razi Institute 2012;67(1):27-34.
9. D C. Accurate prediction of vaccine stability under real storage conditions and during temperature excursions. Eur J Pharm Biopharm. 2018;125:76-84. [DOI:10.1016/j.ejpb.2018.01.005]
10. Soleimani S. Stability Study of Measles AIK-C Strain, Mumps RS-12 Strain and Rubella Takahashi Strain in MMR Vaccine. Archives of Razi Institute. 2016;71(1):21-8.
11. WHO. Manual of laboratory methods for testing the potency of final vaccines used in the WHO expanded program on immunization. Potency. Geneva: World Health Organization. Vaccine Supply and Quality Unit; 1995. p. 67-74.
12. Freshny RI. Culture of Animal cells, A manual of basic technique and specialized applications. sixth, editor. Hoboken, New Jersey: Wiley- Black well; 2010. 732 p.
13. Muhammad T, Baba, S.S., Zaria, L.T., Yuguda, AD., Thilza, IB., . Determination Of thermal stability of oral polio vaccine (Opv) at different temperature under laboratory conditions. Stem cell 2010;1(1):69-73.
14. WHO. WHO expert committee on biological standardization, Recommendation for the production and control of poliomyelitis vaccine (oral). WHO expert commitee on biological standardization. ; 2002. p. 56-8.
15. ICH. Validation of analytical procedures: Text and methodology. Q2(R1) International conference on harmonization of technical requiremnets for registration of pharmaceuticals for human use. ; 2005.
16. Ashvin Ashok MB, Yann LeTallec. Improving cold chain systems: Challenges and solutions. vaccine. 2017;35:2217-23. [DOI:10.1016/j.vaccine.2016.08.045]
17. Middaugh DTBSJMWR. Thermal Stability of Vaccines. Journal of Pharmaceutical Sciences. 2003;92(2):218-31. [DOI:10.1002/jps.10296]
18. Ozan S. Kumru SBJ, Dawn E. Smith , C. Russell Middaugh , Ted Prusik , David B. Volkin. . Vaccine instability in the cold chain: Mechanisms, analysis and formulation strategies. Biologicals 2014;42:237e59. [DOI:10.1016/j.biologicals.2014.05.007]
19. Jain R, Sahu, A.K., Tewari, S., Malik, N., Singh, S., Khare, S., Bhatia, R. . Cold chain monitoring of OPV at transit levels in India: correlation of VVM and potency status. Biologicals 2003;31:237-44. [DOI:10.1016/S1045-1056(03)00061-7]
20. Gradon JD, Lutwick, L.I. . Maintaining and enhancing vaccine immunogene city Infectious Disease Clinics of North America 1999;13(1):39-60. [DOI:10.1016/S0891-5520(05)70042-8]
21. Ananda S Bandyopadhyay JG, Katherine Seib & Walter A Orenstein. Polio vaccination: past, present and future. Future Microbiol. 2015;10(5):791-808. [DOI:10.2217/fmb.15.19]
22. Weldon EBBCBSWFW-ARICSLJAWMEAMAMSOWC. Intestinal Immune Responses to Type 2 Oral Polio Vaccine (OPV) Challenge in Infants Previously Immunized With Bivalent OPV and Either High-Dose or Standard Inactivated Polio Vaccine. The Journal of Infectious Diseases. 2018;217(3):371-80. [DOI:10.1093/infdis/jix556]
23. Acu FD AA, Esan JS, Odusanya OG. Live viral vaccine potency: an index for assessing the cold chain system. Public Health Rep. 1996;110:325e30. [DOI:10.1016/S0033-3506(96)80003-5]
24. Samant Y, Lanjewar, H., Parker, D., Block, L., Tomar, G.S., Stein, B. . Evaluation of the cold-chain for oral polio vaccine in a rural district of India. Public Health Rep 2007;122(1):112-21. [DOI:10.1177/003335490712200116]
25. Halm A YeI, Kamissoko M, Keïta T, Modjirom N, Zipursky S, et al. Using oral polio vaccine beyond the cold chain: a feasibility study conducted during the national immunization campaign in Mali. Vaccine 2010;28:3467e72. [DOI:10.1016/j.vaccine.2010.02.066]
26. Zipursky S BL, Cheikh DO, Fournier-Caruana J, Hamid D, Janssen M, et al. Assessing the potency of oral polio vaccine kept outside of the cold chain during a national immunization campaign in Chad. Vaccine 2011;29(5652e6). [DOI:10.1016/j.vaccine.2011.06.011]
27. Yuan Wang D, Ing Yang, R., Chen Yang, Y., Yen Yeh, Sh., Ling Chen, T., Fang Cheng, H., Tian Hsieh, J., Polin, C. . The Relationship between the Cold Chain System and Vaccine Potency in Taiwan: (II) Oral Polio Vaccine. Journal of Food and Drug Analysis 2000;8(8):17-23.
28. Chand T, Sahu, A. K., Saha, K., Meena, j., Singh, S. . Stability of oral polio vaccine at different temperatures and its correlation with vaccine vial monitors. Current science 2008;94(2):172-5.
29. Sokhey J, Gupta, C.K., Sharma, B., Singh, H. . Stability of oral polio vaccine at different temperature. Vaccine 1988;6(6):12-3. [DOI:10.1016/0264-410X(88)90006-0]
30. Petersen I, Von Magnus, H.P., Pipkin, P.A. . Characterisation of L Cells Expressing the Human Poliovirus Receptor for the Specific Detection of Polioviruses in Vitro. Journal of Virological Methods. 1993;41:333-40. [DOI:10.1016/0166-0934(93)90022-J]

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