Effectiveness of Immunization Products Against Medically Attended Respiratory Syncytial Virus Infection: Generic Protocol for a Test-Negative Case-Control Study

Abstract

Monitoring the real-life effectiveness of respiratory syncytial virus (RSV) products is of major public health importance. This generic protocol for a test-negative design study aims to address currently envisioned approaches for RSV prevention (monoclonal antibodies and vaccines) to study effectiveness of these products among target groups: children, older adults and pregnant women. The generic protocol approach was chosen to allow for flexibility in adapting the protocol to a specific setting. This protocol includes severe acute respiratory infection (SARI) and acute respiratory infection (ARI), both due to RSV, as endpoints. These endpoints can be applied to studies in hospitals, primarily targeting patients with more severe disease, but also to studies in general practitioner clinics targeting ARI.

Standardized Phylogenetic Classification of Human Respiratory Syncytial Virus Below the Subgroup Level

“…A limitation of our definition is the uncertainty of the antigenic effect of individual amino acid substitutions on lineages. Hence, whole-genome surveillance together with the study of lineage-phenotype association are essential, as observed in genetic and antigenic characterization in influenza to estimate the effectiveness of immunization ( 47 ). In 2023, recombinant F protein vaccines were approved; as their implementation progresses, we will learn how the vaccines affect viral evolution.…”

The unified proposal for classification of human respiratory syncytial virus below the subgroup level

“…We do not know a priori whether a simple amino acid substitution may have a significant epidemiological impact. Hence, whole genome surveillance and the study of the lineagephenotype association will be essential, as observed in genetic and antigenic characterization in influenza to estimate the effectiveness of immunization (50). Other knowledge gaps include, but are HRSV classification below the subgroup level not limited to, analyzing the association between lineages and the severity of HRSV disease, as well as associations of particular lineages with demographic characteristics of individuals.…”