Prasad S Kulkarni, Chandrasekaran Padmapriyadarsini, Johan Vekemans, Ashish Bavdekar, Madhu Gupta, Praveen Kulkarni, B S Garg, Nithya J Gogtay, Muralidhar Tambe, Sanjay Lalwani, Kiranjit Singh, Renuka Munshi, Sushant Meshram, T S Selvavinayagam, Krishna Pandey, Devi Madhavi Bhimarasetty, S R Ramakrishnan, Chetanraj Bhamare, Abhijeet Dharmadhikari, Chandrashekhar Budhawant, Cyrille J Bonhomme, Madhuri Thakar, Swarali N Kurle, Elizabeth J Kelly, Manish Gautam, Nivedita Gupta, Samiran Panda, Balram Bhargava, Cyrus S Poonawalla, Umesh Shaligram, Dhananjay Kapse, Bhagwat Gunale
AZD1222 (ChAdOx1 nCoV-19) is a replication-deficient adenoviral vectored coronavirus disease-19 (COVID-19) vaccine that is manufactured as SII-ChAdOx1 nCoV-19 by the Serum Institute of India Pvt Ltd following technology transfer from Oxford University/AstraZeneca. The non-inferiority of SII-ChAdOx1 nCoV-19 with AZD1222 was previously demonstrated in an observer-blind, phase 2/3 immuno-bridging study (trial registration: CTRI/2020/08/027170). In this analysis of immunogenicity and safety data 6 months post first vaccination (Day 180), 1,601 participants were randomized 3:1 to SII-ChAdOx1 nCoV-19 or AZD1222 (immunogenicity/reactogenicity cohort n = 401) and 3:1 to SII-ChAdOx1 nCoV-19 or placebo (safety cohort n = 1,200)...
December 31, 2024: Human Vaccines & Immunotherapeutics