The effect of immune correlates on the precision of vaccine efficacy evaluation: demographic subgroups

Authors: J. Dudášová, Zdeněk Valenta, J. R. Sachs
Publication year: 2023
Publication type: Abstrakt
Periodical: ISCB44: 44th Annual Conference of the International Society for Clinical Biostatistics: Final Programme & Abstract Book
Bibliographic citation: DUDÁŠOVÁ, J., VALENTA, Zdeněk, SACHS, J. R. The effect of immune correlates on the precision of vaccine efficacy evaluation: demographic subgroups. In: ISCB44: 44th Annual Conference of the International Society for Clinical Biostatistics: Final Programme & Abstract Book. Milano: ISCB, 2023, S. 310-310. Dostupné z: https://iscb.international/wp-content/uploads/2023/08/Book-of-Abstract-ISCB44_25-AGO-2.pdf
ID: 576946
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Abstract

ZÁKLADNÍ ÚDAJE: ISCB44: 44th Annual Conference of the International Society for Clinical Biostatistics: Final Programme & Abstract Book. Milano: ISCB, 2023. s. 310-310. [ISCB 2023: Annual Conference of the International Society for Clinical Biostatistics /44./. 27.08.2023-31.08.2023, Milano]. ABSTRAKT: Clinical trials assessing vaccine efficacy typically provide data on binary and time-to-event clinical endpoints along with subjectspecific characteristics such as immune response to vaccination (immunogenicity) and demographics. Immunogenicity measurements often represent an established or a putative correlate of protection. Simulations have previously revealed that the understanding of efficacy in demographic subgroups can be substantially improved by quantifying the relationship betweenimmunogenicity and probability of disease (or of another binary clinical endpoint) and integrating that relationship with observed immunogenicity data to obtain relatively precise estimates of efficacy in subgroups of interest.