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Randomized Controlled Trial
. 2024 Dec 2;42(26):126369.
doi: 10.1016/j.vaccine.2024.126369. Epub 2024 Sep 23.

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)

Rajeka Lazarus  1 , Rosie Harris  2 , Russell Thirard  2 , Sarah Baos  2 , Lucy Culliford  2 , Rachel Todd  2 , Bassam Hallis  3 , Sue Charlton  3 , Adam Finn  4 , Matthew D Snape  5 , Chris A Rogers  2 ; ComFluCOV Trial Investigators
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Free article
Randomized Controlled Trial

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)

Rajeka Lazarus et al. Vaccine. .
Free article

Abstract

Background: 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.

Methods: 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.

Results: 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.

Conclusion: 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.

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Conflict of interest statement

Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Rajeka Lazarus reports a relationship with National Institute for Health and Care Research that includes: funding grants. Rajeka Lazarus reports a relationship with University of Bristol Elizabeth Blackwell Institute for Health Research that includes: funding grants. Rajeka Lazarus reports a relationship with AstraZeneca that includes: funding grants. Rajeka Lazarus reports a relationship with Janssen that includes: funding grants. Rajeka Lazarus reports a relationship with Valneva that includes: funding grants. Chris Rogers reports a relationship with National Institute for Health and Care Research that includes: funding grants. Adam Finn reports a relationship with Pfizer that includes: funding grants. Adam Finn reports a relationship with UK Joint Committee for Vaccination and Immunisation that includes: board membership. Adam Finn reports a relationship with WHO SAGE Working Group on COVID-19 vaccines that includes: board membership. Adam Finn reports a relationship with University of Bristol Elizabeth Blackwell Institute for Health Research that includes: funding grants. Adam Finn reports a relationship with Sanofi Pasteur that includes: funding grants. Adam Finn reports a relationship with VBI Vaccines Inc. that includes: funding grants. Adam Finn reports a relationship with Janssen that includes: funding grants. Adam Finn reports a relationship with GSK that includes: funding grants. Adam Finn reports a relationship with MedImmune that includes: funding grants. Adam Finn reports a relationship with Novavax that includes: funding grants. Adam Finn reports a relationship with Valneva that includes: funding grants. Matthew Snape reports a relationship with Moderna that includes: employment. Investigator on studies funded or sponsored by vaccine manufacturers, including AstraZeneca, GSK, Pfizer, Novavax, Pfizer, Janssen, Medimmune, and MCM of behalf of the University of Oxford - MDS If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

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