ArticleInfectious diseases and therapy2026
A Statistical Immune Correlates of Protection Model for Predicting Efficacy from Neutralizing Antibody Titers to Establish Immunobridging of Monoclonal Antibodies for Prevention of COVID-19.
Article in Infectious diseases and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06039449 (A Study to Evaluate the Efficacy and Safety of VYD222 for Prevention of COVID-19), which is not on this map. Not yet cited in PubMed.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Study to Evaluate the Efficacy and Safety of VYD222 for Prevention of COVID-19 (CANOPY)
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionNeutralizing antibody titers are recognized as an acceptable surrogate efficacy endpoint for immunobridging next-generation monoclonal antibodies (mAbs) to those with demonstrated clinical efficacy for the prevention of COVID-19. However, titers measured at early time points after dosing overestimate levels required for clinical protection. Long-term efficacy data are limited due to continued evolution of SARS-CoV-2 and loss of activity of previously effective mAbs against emerging variants. We aimed to develop a predictive tool for efficacy using neutralizing titers to provide a framework for dose selection, target efficacy, and immunobridging of mAbs for the prevention of COVID-19.
methodsDrug concentration and clinical efficacy data collected over 12 months following pemivibart administration in the phase 3 CANOPY trial were used to develop a Cox proportional hazards model with time-varying covariate as a statistical immune correlates of protection model. The time-varying covariate was estimated serum virus neutralizing antibody activity, estimated at 2-week intervals by integrating drug concentration with weighted average IC
resultsEfficacy increased with antibody titer in a non-linear manner, with smaller incremental gains at higher concentrations. Predicted efficacy was lower at all titer levels in the immunocompromised cohort. Model-derived estimates aligned well with observed infection outcomes and external analyses, supporting model validity. A titer of 1:500 predicted an estimated efficacy of 50% (immunocompromised) and 70% (non-immunocompromised).
conclusionThe Cox model enables evaluation of suitable neutralizing titer targets to guide dosing, predict estimated clinical benefit for related mAbs derived from the same platform, and support immunobridging in both immunocompromised and non-immunocompromised populations.
trial registrationClinicalTrials.gov identifier, NCT06039449.
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