{Reference Type}: Journal Article
{Title}: Immunogenicity of SARS-CoV-2 vaccines BBV152 (COVAXIN®) and ChAdOx1 nCoV-19 (COVISHIELD™) in seronegative and seropositive individuals in India: a multicentre, nonrandomised observational study.
{Author}: Asokan MS;Joan RF;Babji S;Dayma G;Nadukkandy P;Subrahmanyam V;Pandey A;Malagi G;Arya P;Mahajan V;Bhavikatti J;Pawar K;Thorat A;Shah P;Goud RB;Roy B;Rajukutty S;Immanuel S;Agarwal D;Saha S;Shivaraj A;Panikulam P;Shome R;Gulzar SE;Sharma AU;Naik A;Talashi S;Belekar M;Yadav R;Khude P;V M;Shivalingaiah S;Deshmukh U;Bhise C;Joshi M;Inbaraj LR;Chandrasingh S;Ghose A;Jamora C;Karumbati AS;Sundaramurthy V;Johnson A;Ramesh N;Chetan N;Parthiban C;Ahmed A;Rakshit S;Adiga V;D'souza G;Rale V;George CE;John J;Kawade A;Chaturvedi A;Raghunathan A;Dias M;Bhosale A;Raghu P;Shashidhara LS;Vyakarnam A;Bal V;Kang G;Mayor S;
{Journal}: Lancet Reg Health Southeast Asia
{Volume}: 22
{Issue}: 0
{Year}: 2024 Mar
暂无{DOI}: 10.1016/j.lansea.2024.100361
{Abstract}: <B>UNASSIGNED: </B>There are limited global data on head-to-head comparisons of vaccine platforms assessing both humoral and cellular immune responses, stratified by pre-vaccination serostatus. The COVID-19 vaccination drive for the Indian population in the age group 18-45 years began in April 2021 when seropositivity rates in the general population were rising due to the delta wave of COVID-19 pandemic during April-May 2021.<BR><B>UNASSIGNED: </B>Between June 30, 2021, and Jan 28, 2022, we enrolled 691 participants in the age group 18-45 years across four clinical sites in India. In this non-randomised and laboratory blinded study, participants received either two doses of Covaxin® (4 weeks apart) or two doses of Covishield™ (12 weeks apart) as per the national vaccination policy. The primary outcome was the seroconversion rate and the geometric mean titre (GMT) of antibodies against the SARS-CoV-2 spike and nucleocapsid proteins post two doses. The secondary outcome was the frequency of cellular immune responses pre- and post-vaccination.<BR><B>UNASSIGNED: </B>When compared to pre-vaccination baseline, both vaccines elicited statistically significant seroconversion and binding antibody levels in both seronegative and seropositive individuals. In the per-protocol cohort, Covishield™ elicited higher antibody responses than Covaxin® as measured by seroconversion rate (98.3% vs 74.4%, p < 0.0001 in seronegative individuals; 91.7% vs 66.9%, p < 0.0001 in seropositive individuals) as well as by anti-spike antibody levels against the ancestral strain (GMT 1272.1 vs 75.4 binding antibody units/ml [BAU/ml], p < 0.0001 in seronegative individuals; 2089.07 vs 585.7 BAU/ml, p < 0.0001 in seropositive individuals). As participants at all clinical sites were not recruited at the same time, site-specific immunogenicity was impacted by the timing of vaccination relative to the delta and omicron waves. Surrogate neutralising antibody responses against variants-of-concern including delta and omicron was higher in Covishield™ recipients than in Covaxin® recipients; and in seropositive than in seronegative individuals after both vaccination and asymptomatic infection (omicron variant). T cell responses are reported from only one of the four site cohorts where the vaccination schedule preceded the omicron wave. In seronegative individuals, Covishield™ elicited both CD4+ and CD8+ spike-specific cytokine-producing T cells whereas Covaxin® elicited mainly CD4+ spike-specific T cells. Neither vaccine showed significant post-vaccination expansion of spike-specific T cells in seropositive individuals.<BR><B>UNASSIGNED: </B>Covishield™ elicited immune responses of higher magnitude and breadth than Covaxin® in both seronegative individuals and seropositive individuals, across cohorts representing the pre-vaccination immune history of most of the vaccinated Indian population.<BR><B>UNASSIGNED: </B>Corporate social responsibility (CSR) funding from Hindustan Unilever Limited (HUL) and Unilever India Pvt. Ltd. (UIPL).