ABSTRACT
Introduction: Bharat Biotech International Ltd in partnership with National Institute of Virology (NIV), has developed an indigenous whole virion inactivated Severe Acute Respiratory Syndrome Corona Virus 2 (SARS-CoV-2) viral vaccine BBV-152 (Covaxin), formulated with Toll Like Receptors 7/8 agonist Imidazoquinoline (IMDG) molecule adsorbed to alum (Algel). Variety of factors other than environmental ones can affect vaccines efficiency outside the strict setting of clinical trials, like how the vaccine is stored or transported, and even how patients are vaccinated. In addition, the intrinsic capacity of the recipient to respond to a vaccine which is determined by sex, genetic factors, age, psychological stress, nutrition and other diseases are also likely to have an impact. Aim(s): To determine the safety, reactogenicity and immunogenicity of the inactivated whole virus vaccine (Covaxin) amongst hospital-based population groups. Material(s) and Method(s): The prospective analytical study was conducted in the Department of Microbiology, Sawai Man Singh Medical College, Jaipur, Rajasthan, India, from January 2021 to March 2021.The study primarily included Healthcare Workers (HCWs) employed at SMS Medical college and attached hospitals. In-vitro quantitative IgG antibodies against SARS-CoV-2 spike Receptor Binding Domain (RBD) were measured using Chemiluminescence Immunoassay (CLIA) based Advia centaur SARS-CoV-2 IgG, manufactured by Siemens Pvt Ltd, Munich, Germany, as per manufacture's instructions. Result(s): Out of total 223 individuals, 61.88 % (138/223) showed neutralising antibody titre of >1 index value by CLIA, rest 38.12% (85/223) were non reactive i.e., titre <1 index value, after four weeks of receiving first dose of Covaxin. After 2 to 4 weeks of receiving second dose 84.30% (188/223) showed neutralising antibody titre of >1 index value by CLIA, rest 15.70% (35/223) were non reactive i.e., titre <1 index value. After receiving first dose, 100% (223/223) of the participants developed localised pain and bodyache 33.63% (75/223). None of the participants showed any anaphylactic reaction or any emergency condition just after vaccination. Conclusion(s): Covaxin is a well-tolerated vaccine, and induces good humoral response against SARS-CoV-2 with a significant rise in the neutralising antibody titres. Copyright © 2022 Journal of Clinical and Diagnostic Research. All rights reserved.
ABSTRACT
Introduction: Coronavirus Disease 2019 (COVID-19) has been haunting the world since December 2019 and has grown to pandemic proportions from March 2020. Even after a full year of research and study, the most effective way to control the spread of this infection is early diagnosis and isolation of the cases. Real-time Reverse Transcription Polymerase Chain Reaction (RT-PCR) is considered the standard test all over the world for the diagnosis of Severe Acute Respiratory Syndrome Corona Virus 2 (SARS-CoV-2) infection. All the sample collection guidelines have recommended stringent maintenance of the cold chain for the sample transport. However, it is not possible for the resource constrained developing countries with inadequate infrastructure to comply with these guidelines all the time. Aim: To determine necessity of these stringent transport criteria and the effect of temperature on the clinical sensitivity of a RT-PCR assay for diagnosis of SARS-CoV-2 infection. Materials and Methods: In this prospective experimental study conducted in November 2020, 49 positive samples were kept at ambient room temperature and were tested everyday with RT-PCR for the detection of SARS-CoV-2 Ribonucleic Acid (RNA). The samples were also kept under refrigeration at the 4°C and were also tested by RT-PCR and the results were compared with their respective counterparts kept at room temperature till nine days. Python Jupiter notebook SciPy and Anaconda software was used for statistical analysis. Results: It was observed that the positivity of the RT-PCR results were not deteriorated till five days and there was no significant deterioration even after nine days of samples being stored at room temperature suggesting that even if the viral RNA itself is not stable outside strict temperature control but small fragment or target genetic sequences are enough for detection of virus by RT-PCR. Conclusion: It is possible to keep samples at this ambient temperature for five days without any loss of positivity in RT-PCR.