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Comparison of assays used to detect antibody response in COVID-19 vaccine trials: Results from of a UK multi-Centre randomised controlled trial to determine the immunogenicity responses of COVID-19 vaccines administered concomitantly with seasonal influenza vaccines (ComFluCOV)
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Comparison of assays used to detect antibody response in COVID-19 vaccine trials: Results from of a UK multi-Centre randomised controlled trial to determine the immunogenicity responses of COVID-19 vaccines administered concomitantly with seasonal influenza vaccines (ComFluCOV)
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Comparison of assays used to detect antibody response in COVID-19 vaccine trials: Results from of a UK multi-Centre randomised controlled trial to determine the immunogenicity responses of COVID-19 vaccines administered concomitantly with seasonal influenza vaccines (ComFluCOV)
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Journal Article
Comparison of assays used to detect antibody response in COVID-19 vaccine trials: Results from of a UK multi-Centre randomised controlled trial to determine the immunogenicity responses of COVID-19 vaccines administered concomitantly with seasonal influenza vaccines (ComFluCOV)
2024
Overview
The ComFluCOV trial tested the safety and immunogenicity of COVID-19 and influenza vaccines co-administration. Binding and functional SARS-CoV2 anti-spike responses were measured using assays developed in response to the COVID-19 pandemic. The three assays used to measure the immunogenicity outcomes are reported here and their performance compared to inform future vaccine development.
Adults aged over 18 were vaccinated with a COVID-19 and either an influenza vaccine or saline placebo. Serum sampled one month after vaccination was used to measure SARS-CoV2 anti-spike antibody concentrations using a commercial in-house enzyme-linked immunosorbent assay (ELISA), a commercial fast throughput electrochemiluminescence immunoassay (ECLIA) and a viral neutralisation assay (VNA). Geometric mean ratios were used to compare the response to COVID-19 with or without influenza vaccine with a threshold of 0.67 considered non-inferior. The relationship between the different assays was examined using Kendall rank correlations.
The geometric mean ratios exceeded 0.67 using all assays for all COVID-19 and influenza vaccine combinations tested. Moderate rank correlations were found between the three assays.
All three assays confirmed that vaccine co-administration did not significantly impact on immunogenicity of any of the vaccines tested.
Trial registration: ISRCTN14391248, registered on 17/03/2021.
Publisher
Elsevier Ltd,Elsevier Limited
Subject
/ Aged
/ Antibody Formation - immunology
/ Antigens
/ COVID-19
/ COVID-19 - prevention & control
/ COVID-19 Vaccines - administration & dosage
/ COVID-19 Vaccines - immunology
/ Enzyme-linked immunosorbent assay
/ Enzyme-Linked Immunosorbent Assay - methods
/ Enzymes
/ Female
/ Humans
/ Influenza Vaccines - administration & dosage
/ Influenza Vaccines - immunology
/ Influenza, Human - immunology
/ Influenza, Human - prevention & control
/ Male
/ Neutralization Tests - methods
/ placebos
/ Proteins
/ Severe acute respiratory syndrome
/ Severe acute respiratory syndrome coronavirus 2
/ Spike Glycoprotein, Coronavirus - immunology
/ Vaccines
