Journal Article Review Epublish
PubMed: 39591141 DOI: 10.3390/vaccines12111238
Evaluating the Quality of Studies Assessing COVID-19 Vaccine Neutralizing Antibody Immunogenicity.
Vaccines (Basel) 12(11)
Authors: Maeva Katzmarzyk, Robert Naughton, Ioannis Sitaras, Henning Jacobsen, Melissa M Higdon, Maria Deloria Knoll
Affiliations
- Department of Viral Immunology, Helmholtz Center for Infection Research, 38124 Braunschweig, Germany.
- Independent Researcher, London SW16 2TS, UK.
- W. Harry Feinstone Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21205, USA.
- International Vaccine Access Center, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21205, USA.
Abstract
COVID-19 vaccine-neutralizing antibodies provide early data on potential vaccine effectiveness, but their usefulness depends on study reliability and reporting quality. 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. None of the studies attained an overall high or very high score, 8% ( = 4) attained moderate, 42% ( = 21) low, and 50% ( = 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. We found that reporting in neutralization studies is widely incomplete, limiting their usefulness for downstream analyses.
MeSH
Sample Size, Vaccines, Covid-19 Vaccines, Antibodies, Neutralizing, Vaccination, Covid-19, Viruses, Infections