Safety and immunogenicity of SII-NVX-CoV2373 (COVID-19 vaccine) in adults in a phase 2/3, observer-blind, randomised, controlled studyResearch in context

Autor: Prasad S. Kulkarni, Abhijit Kadam, Sheela Godbole, Varsha Bhatt, Abhishek Raut, Sunil Kohli, Santanu Tripathi, Praveen Kulkarni, Rakhi Ludam, Madhav Prabhu, Ashish Bavdekar, Nithya J. Gogtay, Sushant Meshram, Tamilarasu Kadhiravan, Sonali Kar, D.H. Ashwath Narayana, Clarence Samuel, Govind Kulkarni, Abhay Gaidhane, Dipu Sathyapalan, Sidram Raut, Vijay Hadda, Hira Lal Bhalla, Chetanraj Bhamare, Abhijeet Dharmadhikari, Joyce S. Plested, Shane Cloney-Clarke, Mingzhu Zhu, Melinda Pryor, Stephanie Hamilton, Madhuri Thakar, Ashwini Shete, Manish Gautam, Nivedita Gupta, Samiran Panda, Umesh Shaligram, Cyrus S. Poonawalla, Balram Bhargava, Bhagwat Gunale, Dhananjay Kapse, Shubhangi A. Kanitkar, Arjun L. Kakrani, Srikanth P. Tripathy, Abhijit V. Tilak, Akshay A. Dhamne, Shahzad Beg Mirza, Prachi V. Athavale, Mandakini Bhowmik, Parag J. Ratnakar, Subodh Gupta, Vijayshri Deotale, Jyoti Jain, Ashwini Kalantri, Vineet Jain, Nidhi Goyal, Alok Arya, Temsunaro Rongsen-Chandola, Shreyasi Dasgupta, Pratibha Periera, Vanmathi A, Anand Kawade, Arunkumar Gondhali, Palvi Kudyar, Abhishek Singh, Ravi Yadav, Alina Alexander, Venugopalan Gunasekaran, Sekar Dineshbabu, P.C. Samantaray, H.S. Ravish, Deepshikha Kamra, Shilpa Gaidhane, Quazi Syed Zahiruddin, Merlin Moni, Anil Kumar, Ameet Dravid, Anant Mohan, Tejas Suri, Tejas K. Patel, Surekha Kishore, Rahul Choche, Deepak Ghatage, Sugam Salvi

Publikováno v: The Lancet Regional Health - Southeast Asia, Vol 10, Iss , Pp 100139- (2023)

Summary: Background: NVX-CoV2373, a Covid-19 vaccine was developed in the USA with ∼90% efficacy. The same vaccine is manufactured in India after technology transfer (called as SII-NVX-CoV2373), was evaluated in this phase 2/3 immuno-bridging study

Externí odkaz: https://doaj.org/article/82d9dafd89e042aabbf3940c237b71b1

A prospective study to assess the association between genotype, phenotype and Prakriti in individuals on phenytoin monotherapy

Autor: Saket J. Thaker, Prajakta P. Gandhe, Charuta J. Godbole, Shital R. Bendkhale, Nitin B. Mali, Urmila M. Thatte, Nithya J. Gogtay

Publikováno v: Journal of Ayurveda and Integrative Medicine, Vol 8, Iss 1, Pp 37-41 (2017)

Background: Genetic polymorphisms in drug metabolizing enzymes (DMEs) impart distinct drug metabolizing capacity and a unique phenotype to an individual. Phenytoin has large inter-individual variability in metabolism due to polymorphisms in CYP2C9 an

Externí odkaz: https://doaj.org/article/031a6e1331a14920b1291f112aea32d5

Evaluation of satisfaction and reasons for participation in a Covid-19 vaccine clinical trial: A single-centre, observational study

Autor: PALVI KUDYAR, DHRUVE SONI, NITHYA J. GOGTAY

Publikováno v: The National Medical Journal of India. 35:214-218

Background In May 2020, WHO recognized the role of extensive immunization for interrupting the transmission of the SARS-CoV-2 virus. The development of such vaccines in clinical trials relies upon participants who are expected to be vested in the res

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::15a4361e938e9dc9521db2879b802a94
https://doi.org/10.25259/nmji_496_22

A Systematic Review and Meta-Analysis of the Safety of Hydroxychloroquine in a Randomized Controlled Trial and Observational Studies

Autor: Nithya J Gogtay, Miteshkumar Rajaram Maurya, Mahanjit Konwar, Debdipta Bose, U M Thatte

Publikováno v: Current Reviews in Clinical and Experimental Pharmacology. 17:216-235

Introduction: Hydroxychloroquine (HCQ) has recently become the focus of attention in the current COVID-19 pandemic. With an increase in the off-label use of HCQ, concern for the safety of HCQ has been raised. We, therefore, performed this systematic

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::f6174bde7b764ec25d4d59fc9871c3b5
https://doi.org/10.2174/1574884716666210726104424

An audit of US FDA warning letters issued to sponsors, institutional review boards and investigators over a six-year period

Autor: Unnati Saxena, Debdipta Bose, Shruti Saha, Nithya J Gogtay, Urmila M Thatte

Publikováno v: Indian journal of medical ethics. (2)

The present audit was carried out with the objective of evaluating warning letters (WLs) issued to trial sponsors, clinical investigators and institutional review boards (IRBs) by the United States Food and Drug Administration during a six-year perio

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3ecb7e2dc36b0253a90c385948aa040c
https://pubmed.ncbi.nlm.nih.gov/35765256