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Updated: Jun 13, 2026
An In vitro Model to Study Immune Responses of Human Peripheral Blood Mononuclear Cells to Human Respiratory Syncytial Virus Infection
Published on: December 10, 2013
Study protocol: Effectiveness of the maternal RSVpreF vaccine by virus type
Anna Mensah1, Rebecca Symes1, Chengetai Mpamhanga2
1United Kingdom Health Security Agency, 61 Colindale Ave, London, NW9 5EQ, UK.
Insights
This study assesses if respiratory syncytial virus (RSV) genomic variability affects the effectiveness of the new RSVpreF maternal vaccine. Findings will guide global vaccine rollout and surveillance strategies for RSV prevention in infants.
Area of Science:
- Virology
- Immunology
- Public Health
Background:
- Respiratory syncytial virus (RSV) causes significant infant illness and death globally.
- A new maternal vaccine (RSVpreF) targeting the prefusion F protein shows promise for reducing disease burden.
- The impact of RSV genetic diversity on this vaccine's effectiveness is currently unknown.
Purpose of the Study:
- To determine if RSV type or lineage influences the effectiveness of maternal RSVpreF vaccination in preventing infant hospitalizations.
- To analyze the relationship between RSV genomic variability and vaccine effectiveness.
Main Methods:
- Whole genome sequencing of RSV samples from hospitalized infants in England and Scotland during the 2024-2025 winter season.
- Calculation of relative vaccine effectiveness (rVE) for RSV-A and RSV-B using case-control logistic regression and a test-negative design.
- Comparison of viral lineages between vaccinated and unvaccinated infants.
Main Results:
- The study aims to identify if current RSV genomic variability impacts relative vaccine effectiveness (rVE).
- Results will indicate if RSV type or lineage affects RSVpreF vaccine performance.
Conclusions:
- Confirmation of no impact from viral genomic variability will support global RSVpreF vaccine implementation.
- Evidence of decreased effectiveness linked to RSV type or lineage will necessitate enhanced global molecular surveillance for RSV.
Background:
Respiratory syncytial virus (RSV) is a virus with two antigenic types, A and B, that cause significant morbidity and mortality in infants globally. A recently developed maternal vaccination based on the prefusion F protein ("RSVpreF") could have a significant impact on disease burden, if introduced globally. Whether or not the effectiveness of this vaccine is affected by circulating viral genomic variability is currently unknown.
Objectives:
To examine whether the vaccine effectiveness of maternal RSVpreF administration in preventing hospitalisation in infants is affected by RSV type or lineage.
Methods:
We will conduct whole genome sequencing of RSV positive samples from infants hospitalised with acute lower respiratory tract infection (ALRI) in the 2024-2025 winter season, at multiple hospitals in England and Scotland, to calculate the relative vaccine effectiveness (rVE) of maternal RSVpreF vaccination by virus type (RSV-A and RSV-B). rVE will be calculated using a case control logistic regression with adjustment by infant age and admission date; sex, socioeconomic status and hospital location will be included as potential confounders if they are associated with a >3% change in rVE. We will also perform a test negative design to examine the VE for RSV-A and RSV-B separately, using RSV-negative controls from hospitals where cases were admitted. Finally, we will compare viral lineages in vaccinated versus unvaccinated infants.
Results And Conclusions:
Our study will identify whether currently circulating RSV genomic variability impacts on rVE. Confirmation of the null hypothesis - that there is no impact of viral genomic variability on rVE - will provide reassurance to policymakers and public health bodies as RSVpreF is rolled out globally. Conversely, an association between RSV type or lineage and decreased vaccine effectiveness will highlight the need for the enhanced comprehensive national and global molecular surveillance of RSV.
