Quality Evaluation of Rubella Vaccine used in India
Journal Title: International Journal of Biomedical and Advance Research - Year 2016, Vol 7, Issue 1
Abstract
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.
Authors and Affiliations
Manjula Kiran, Shalini Tewari, Jaipal Meena, Farha Hasan, Ajay Kumar Ade, Gurminder Bindra, Subhash Chand, Neeraj Malik, Gul Raj Soni, Surinder Singh
Keywords
Related Articles
- EP ID EP356342
- DOI 10.7439/ijbar.v7i1.2900
- Views 96
- Downloads 0
Study of subcutaneous fat, BMI in diabetic and non-diabetic adolescents
Introduction: Diabetes is a Metabolic Disorder which has got prime focus in the present days. An increase in body fat is generally associated with an increase in risk of metabolic diseases such as type 2 diabetes mellitu...
Perception of different teaching aids by the final year MBBS students in a Medical College
Introduction: Time to time evaluation of medical curriculum by experts is the routine practice in medical education. However the students perception and opinion about the teaching - learning methodology is equally import...
A study of serum magnesium level in critically ill patients
Prasad G Ugaragol
Variation in 1(3S) and 2(2S) rejections incidence in internal quality control program on using 20 reading mean and SD of different periods
Objectives: Objective of the study is to measure dispersion of 1(3S) and 2(2S) rejection incidence in six month period using mean and SD derived from 20 readings of different periods of internal quality control program....
Rudimentary horn of Uterus : A diagnostic challenge in pregnancy
When the development of the mullerian duct is normal on one side, but imperfect on the other side , a lateral fusion defect often with obstruction ,described as rudimentary horn,is produced. Most rudimentary horn are non...