Abstract
Correlates of protection for COVID-19 vaccines are urgently needed to license additional vaccines. We measured immune responses to four COVID-19 vaccines of proven efficacy using a single serological platform. IgG anti-Spike antibodies were highly correlated with ID50 neutralization in a validated pseudoviral assay and correlated significantly with efficacies for protection against infection with wild-type, alpha and delta variant SARS-CoV-2 virus. The protective threshold for each vaccine was calculated for IgG anti-Spike antibody. The mean protective threshold for all vaccine studies for WT virus was 154 BAU/ml (95 %CI 42-559), and for studies with antibody distributions that enabled precise estimation of thresholds (i.e. leaving out 2-dose mRNA regimens) was 60 BAU/ml (95 %CI 35-102). We propose that the proportion of individuals with responses above the appropriate protective threshold together with the geometric mean concentration can be used in comparative non-inferiority studies with licensed vaccines to ensure that new vaccines will be efficacious.
Keywords: COVID vaccines; COVID-19; Correlates of protection; SARS-CoV-2.
【저자키워드】 COVID-19, SARS-CoV-2, correlates of protection, COVID vaccines, 【초록키워드】 SARS-CoV-2, IgG, Efficacy, Vaccine, COVID-19 vaccine, immune response, Vaccines, antibody, neutralization, variant, Infection, SARS-CoV-2 virus, COVID, COVID-19 vaccines, mRNA, immune responses, response, Alpha, threshold, distribution, serological, platform, Protective, geometric mean, individual, regimens, geometric mean concentration, wild-type, thresholds, WT virus, IgG anti-Spike antibodies, significantly, proportion, can be used, calculated, correlated, non-inferiority study, 【제목키워드】 COVID-19 vaccine, threshold,