TY - JOUR
T1 - Evaluating the Quality of Studies Assessing COVID-19 Vaccine Neutralizing Antibody Immunogenicity
AU - Katzmarzyk, Maeva
AU - Naughton, Robert
AU - Sitaras, Ioannis
AU - Jacobsen, Henning
AU - Higdon, Melissa M.
AU - Deloria Knoll, Maria
N1 - Publisher Copyright:
© 2024 by the authors.
PY - 2024/11
Y1 - 2024/11
N2 - Objective: COVID-19 vaccine-neutralizing antibodies provide early data on potential vaccine effectiveness, but their usefulness depends on study reliability and reporting quality. Methods: 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. Results: None of the studies attained an overall high or very high score, 8% (n = 4) attained moderate, 42% (n = 21) low, and 50% (n = 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. Conclusions: We found that reporting in neutralization studies is widely incomplete, limiting their usefulness for downstream analyses.
AB - Objective: COVID-19 vaccine-neutralizing antibodies provide early data on potential vaccine effectiveness, but their usefulness depends on study reliability and reporting quality. Methods: 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. Results: None of the studies attained an overall high or very high score, 8% (n = 4) attained moderate, 42% (n = 21) low, and 50% (n = 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. Conclusions: We found that reporting in neutralization studies is widely incomplete, limiting their usefulness for downstream analyses.
KW - COVD-19
KW - SARS-CoV-2
KW - neutralizing antibodies
KW - reliability
KW - reporting quality
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U2 - 10.3390/vaccines12111238
DO - 10.3390/vaccines12111238
M3 - Review article
C2 - 39591141
AN - SCOPUS:85210320707
SN - 2076-393X
VL - 12
JO - Vaccines
JF - Vaccines
IS - 11
M1 - 1238
ER -