Evaluating the Quality of Studies Assessing COVID-19 Vaccine Neutralizing Antibody Immunogenicity

<b>Objective:</b> COVID-19 vaccine-neutralizing antibodies provide early data on potential vaccine effectiveness, but their usefulness depends on study reliability and reporting quality. <b>Methods:</b> We systematically evaluated 50 published post-vaccination neutralizing an...

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Main Authors: Maeva Katzmarzyk, Robert Naughton, Ioannis Sitaras, Henning Jacobsen, Melissa M. Higdon, Maria Deloria Knoll
Format: Article
Language:English
Published: MDPI AG 2024-10-01
Series:Vaccines
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Online Access:https://www.mdpi.com/2076-393X/12/11/1238
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author Maeva Katzmarzyk
Robert Naughton
Ioannis Sitaras
Henning Jacobsen
Melissa M. Higdon
Maria Deloria Knoll
author_facet Maeva Katzmarzyk
Robert Naughton
Ioannis Sitaras
Henning Jacobsen
Melissa M. Higdon
Maria Deloria Knoll
author_sort Maeva Katzmarzyk
collection DOAJ
description <b>Objective:</b> COVID-19 vaccine-neutralizing antibodies provide early data on potential vaccine effectiveness, but their usefulness depends on study reliability and reporting quality. <b>Methods:</b> We systematically evaluated 50 published post-vaccination neutralizing antibody studies for key parameters that determine study and data quality regarding sample size, SARS-CoV-2 infection, vaccination regimen, sample collection period, demographic characterization, clinical characterization, experimental protocol, live virus and pseudo-virus details, assay standardization, and data reporting. Each category was scored from very high to low or unclear quality, with the lowest score determining the overall study quality score. <b>Results:</b> None of the studies attained an overall high or very high score, 8% (<i>n</i> = 4) attained moderate, 42% (<i>n</i> = 21) low, and 50% (<i>n</i> = 25) unclear. The categories with the fewest studies assessed as ≥ high quality were SARS-CoV-2 infection (42%), sample size (30%), and assay standardization (14%). Overall quality was similar over time. No association between journal impact factor and quality score was found. <b>Conclusions:</b> We found that reporting in neutralization studies is widely incomplete, limiting their usefulness for downstream analyses.
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spelling doaj-art-a59a65992ff343359d64fc88c312a5d02025-08-20T02:04:41ZengMDPI AGVaccines2076-393X2024-10-011211123810.3390/vaccines12111238Evaluating the Quality of Studies Assessing COVID-19 Vaccine Neutralizing Antibody ImmunogenicityMaeva Katzmarzyk0Robert Naughton1Ioannis Sitaras2Henning Jacobsen3Melissa M. Higdon4Maria Deloria Knoll5Department of Viral Immunology, Helmholtz Center for Infection Research, 38124 Braunschweig, GermanyIndependent Researcher, London SW16 2TS, UKW. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21205, USADepartment of Viral Immunology, Helmholtz Center for Infection Research, 38124 Braunschweig, GermanyInternational Vaccine Access Center, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21205, USAInternational Vaccine Access Center, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21205, USA<b>Objective:</b> COVID-19 vaccine-neutralizing antibodies provide early data on potential vaccine effectiveness, but their usefulness depends on study reliability and reporting quality. <b>Methods:</b> We systematically evaluated 50 published post-vaccination neutralizing antibody studies for key parameters that determine study and data quality regarding sample size, SARS-CoV-2 infection, vaccination regimen, sample collection period, demographic characterization, clinical characterization, experimental protocol, live virus and pseudo-virus details, assay standardization, and data reporting. Each category was scored from very high to low or unclear quality, with the lowest score determining the overall study quality score. <b>Results:</b> None of the studies attained an overall high or very high score, 8% (<i>n</i> = 4) attained moderate, 42% (<i>n</i> = 21) low, and 50% (<i>n</i> = 25) unclear. The categories with the fewest studies assessed as ≥ high quality were SARS-CoV-2 infection (42%), sample size (30%), and assay standardization (14%). Overall quality was similar over time. No association between journal impact factor and quality score was found. <b>Conclusions:</b> We found that reporting in neutralization studies is widely incomplete, limiting their usefulness for downstream analyses.https://www.mdpi.com/2076-393X/12/11/1238SARS-CoV-2neutralizing antibodiesCOVD-19reliabilityreporting quality
spellingShingle Maeva Katzmarzyk
Robert Naughton
Ioannis Sitaras
Henning Jacobsen
Melissa M. Higdon
Maria Deloria Knoll
Evaluating the Quality of Studies Assessing COVID-19 Vaccine Neutralizing Antibody Immunogenicity
Vaccines
SARS-CoV-2
neutralizing antibodies
COVD-19
reliability
reporting quality
title Evaluating the Quality of Studies Assessing COVID-19 Vaccine Neutralizing Antibody Immunogenicity
title_full Evaluating the Quality of Studies Assessing COVID-19 Vaccine Neutralizing Antibody Immunogenicity
title_fullStr Evaluating the Quality of Studies Assessing COVID-19 Vaccine Neutralizing Antibody Immunogenicity
title_full_unstemmed Evaluating the Quality of Studies Assessing COVID-19 Vaccine Neutralizing Antibody Immunogenicity
title_short Evaluating the Quality of Studies Assessing COVID-19 Vaccine Neutralizing Antibody Immunogenicity
title_sort evaluating the quality of studies assessing covid 19 vaccine neutralizing antibody immunogenicity
topic SARS-CoV-2
neutralizing antibodies
COVD-19
reliability
reporting quality
url https://www.mdpi.com/2076-393X/12/11/1238
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AT ioannissitaras evaluatingthequalityofstudiesassessingcovid19vaccineneutralizingantibodyimmunogenicity
AT henningjacobsen evaluatingthequalityofstudiesassessingcovid19vaccineneutralizingantibodyimmunogenicity
AT melissamhigdon evaluatingthequalityofstudiesassessingcovid19vaccineneutralizingantibodyimmunogenicity
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