Stability of lyophilized measles vaccine: Stabilizers and Temperature parameters
Heat-Stability of lyophilized measles vaccine
Keywords:
Measles virus, Potency, Stabilizers, Quality Control, Heat-stable, StorageAbstract
The effectiveness of live measles vaccine is based on numerous factors like complete attenuation of the vaccine virus, appropriate stabilizer, pH, exposure to light, and also on the maintenance of cold chain (temperature) till the time vaccine is injected to the end-users which are normally infants in case of Measles. The purpose of the present study was the estimation of the thermal stability of the vaccine using three different types of stabilizers for lyophilization. All batches were prepared using different types (ST, SH & SG) of stabilizer and tested in triplicate against reference according to WHO’s method of Spearman-Karber for calculation of vaccine titer. Potency and accelerated stability were carried out by incubating each of the three vaccines at 2-4oC and 37oC for seven days. For calculation of potency drop at increasing temperatures, titer was calculated for consecutive fourteen days at 24 hours interval, three vials from each vaccine type were incubated at 4oC, 25oC, 37oC, and 41oC. The potency observed was between log 103.64 to 104.89. Thus, making them fall within the WHO laid down criteria. These potency results also demonstrated that ST based stabilizer was comparatively more stable among the three. It also verified that vaccine remains stable for 14 days at 37oC but rapidly loses potency at 41oC even after 4 days. This study verifies that regardless of external hard weather conditions (e.g., Pakistan), maintenance of manufacturer recommended storage temperature and effective use of proper stabilizer is the only way to ensure the stability of the measles vaccine.
References
World Health Organization. Department of Immunization, Biologicals. Immunization in practice: A practical guide for health staff. World Health Organization (2015).
D. Thorrington., M. Ramsey, A.J.V. Hoek, J.W. Edmunds, R. Vivancos, A. Bukasa, and K. Eames. The Effect of Measles on Health-Related Quality of Life: A Patient-Based Survey. 9: e105153 (2014).
M.K. Patel. Increase in the Measles Cases-United States. Morbidity and Mortality Weekly Report 68:402-404 (2019).
M.K. Patel, and W.A. Orenstein. Classification of global measles cases in 2013–17 as due to policy or vaccination failure: a retrospective review of global surveillance data. The Lancet Global Health 7: e313-e320 (2019).
WHO Expert Committee on Biological Standardization. Meeting and World Health Organization, Sixtieth Report. World Health Organization 977 (2013).
WHO Expert Committee on Biological Standardization. Meeting and World Health Organization, Sixty-sixth Report. World Health Organization 999 (2016).
World Health Organization. Manual for the laboratory diagnosis of measles and rubella virus infection. World Health Organization (2007).
A.B. Hill., C. Kilgore, M. McGlynn, and C.H. Jones. Improving global vaccine accessibility. Current opinion in biotechnology 42: 67-73 (2016).
R. Kamali-Jamil., M. Shayestehpour, Z.A. Sadigh, M. Taqavian, M.K. Shahkarami, F. Esna-Ashari, R. Shahbazi, A. Mohammadi, A. Foroughi, and B. Romani. The effect of various stabilizers on reserving immunogenicity of lyophilized mumps vaccines. Journal of Research in Health Sciences 17: e00393 (2017).
J. Shin., D. Lei, C. Conrad, I. Knezevic and D. Wood. International regulatory requirements for vaccine safety and potency testing. WHO perspective&. Procedia in Vaccinology 5: 164-170 (2011).
M. Shahkarami., M. Taqavian, A. Shafyi, B. Alirezaie, F. Esna-ashari, S. Soleimani, and R. Shahbazi. Investigation of the relationship between the residual moisture and thermal stability of lyophilized MMR vaccine. Iranian Journal of Virology 3: 25-28 (2009).
A. Arsalan., S.B.S. Naqvi, A. Iqbal, and O. Shakeel. Temperature monitoring of vaccines’ storage compartments in different health centres and pharmacies at Karachi, Pakistan. International Journal of Pharmacy Teaching & Practices 5: 1-5 (2014).
R. Kamali-Jamil., M. Taqavian, Z.A. Sadigh, M.K. Shahkarami, F. Esna-Ashari, R. Hamkar, S.M. Hosseini, and A. Hatami. Evaluation of the thermal stability of a novel strain of live-attenuated mumps vaccine (RS-12 strain) lyophilized in different stabilizers. Journal of Virological Methods, 199: 35-38 (2014).
G.S. Marshall. The vaccine handbook: a practical guide for clinicians. Lippincott Williams & Wilkins (2004).
S.P. Naik., J.K. Zade, R.N. Sabale, S.S. Pisal, R. Menon, S.G. Bankar, S. Gairola, and R.M. Dhere. Stability of heat-stable, live attenuated Rotavirus vaccine (ROTASIIL®). Vaccine 35: 2962-2969 (2017).
A. Dabbagh., M.K. Patel, L. Dumolard, M.G. Dobbo, M.N. Mulders. J.M. OkwaBele, K. Kretsinger, M.J. Papania, P.A. Rota, and J.L. Goodson. Progress toward regional measles elimination—worldwide, 2000–2016. MMWR. Morbidity and mortality weekly report 66: 1148 (2017).
B.C. Pastorino., C. Baronti, E.A. Gould, R.N. Charrel, and X. De Lamballerie. Effect of chemical stabilizers on the thermostability and infectivity of a representative panel of freeze-dried viruses. PloS One 10: e0118963 (2015).
G. Colinet, G., J. Rossignol, and J. Peetermans. A study of the stability of a bivalent measles-mumps vaccine. Journal of Biological Standardization, 10:341-346 (1982).
J.C. Mariner., J. Gachanja, S.H. Tindih, and P. Toye. A thermostable presentation of the live, attenuated peste des petits ruminants vaccine in use in Africa and Asia. Vaccine 35: 3773-3779 (2017).
S. Shokr., M.K. Shahkarami, A. Shafyi, A. Mohammadi, F. Esna-ashari, and A. Hamta. Evaluation of the thermal stability of live-attenuated Rubella vaccine (Takahashi strain) formulated and lyophilized in different stabilizers. Journal of Virological Methods, 264: 18-22 (2019).
M. Clarke. Stability of Measles Vaccine. British Medical Journal 2: 455 (1977).
Y. Qiongying., F. Chuanxi, W. Naizhen,D. Zhiqiang, H. Wensui, and W. Ming. The effects of weather conditions on measles incidenc in Ghuangzhou, South China. Human Vaccines & Immunotherapeutics 10: 1104-1110 (2014).
H.Q. McLean., A.P. Fiebelkorn, J.L. G.S. Temte, and G.S. Wallace. Prevention of measles, rubella, congenital rubella syndrome, and mumps, 2013: summary recommendations of the Advisory Committee on Immunization Practices (ACIP). Morbidity and Mortality Weekly Report: Recommendations and Reports 62: 1-34 (2013).
S. Ohtake., R.A. Martin, L. Yee, D. Chen, D.D. Kristensen, D. LecChuga, Ballerteros, and V. Truong-Le. Heat – Stable measles vaccine produced by spray drying. Vaccines, 28: 1275-1284 (2010).
A. Wesolowski., A. Winter, J.T. Andrew, T. Qureshi, E.M. Kenth, O.B. Caroline, A.T. Deak, and E.M. Jessica. Measles outbreak in Pakistan: exploring the potential of combining vaccination coverage and incidence data with novel data-streams to strengthen control. Epidemiology and Infection 146: 1575-1583 (2018).
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