Quality Evaluation of Rubella Vaccine used in India

Autor:	Manjula Kiran, Gul Raj Soni, Subhash Chand, Farha Hasan, Ajay Kumar Ade, Neeraj Malik, Shalini Tewari, Gurminder Bindra, Surinder Singh, Jaipal Meena
Rok vydání:	2016
Předmět:	Veterinary medicine 030505 public health Viral Vaccine Biology medicine.disease Virology Rubella Virus 03 medical and health sciences Titer Rubella vaccine 0302 clinical medicine medicine Potency Who criteria 030212 general & internal medicine 0305 other medical science Hot and humid medicine.drug
Zdroj:	International Journal of Biomedical and Advance Research. 7:27
ISSN:	2229-3809 2455-0558
DOI:	10.7439/ijbar.v7i1.2900
Popis:	Objectives: Cold chain maintenance is essential to ensure vaccine quality till it reaches the end user. In tropical countries like India with hot and humid environment, the transport of vaccines with required cold chain is comparatively difficult. Also, the efficacy of live viral vaccines is dependent on proper attenuation of vaccine virus. The present study was carried out to analyse the quality of 41 batches of rubella vaccine stored at 2-8C and their thermostability after exposure at 37C for 7 days, as such no study is published from India. Accordingly, the trends for the potency and stability titres of these batches of rubella vaccine were analysed during the present study.Method: All the Rubella vaccines batches were tested in triplicates against reference vaccine as per the WHO formula. The number of wells showing cytopathic effect was counted and titres were calculated using Spearman-Karber formula. The geometric mean titre was calculated for the triplicate readings. The assay is considered valid only if confidence limits (P=0.95) of the logarithm of the virus concentration is greater than 0.3. WHO criteria state that minimum virus concentration should be 103.0CCID50 per human dose for both exposed and non-exposed rubella vaccine. Also, after incubation the loss in titre should not be more than 101.0.Result: The potency and thermostability titres of all the batches tested were found to be between 103.467 to 104.03 and 103.276 to 103.72 respectively and were well within prescribed specifications of WHO. Conclusion: Potency and thermostability of the rubella vaccine tested were found in the acceptable range indicating rubella vaccine used in India is quite potent and thermostable.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_________::5f7cdd16ea55ad77126fb3e24810d30b https://doi.org/10.7439/ijbar.v7i1.2900 Zobrazit plný text záznamu