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      • Record: found
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      Early estimates of nirsevimab immunoprophylaxis effectiveness against hospital admission for respiratory syncytial virus lower respiratory tract infections in infants, Spain, October 2023 to January 2024

      research-article
      Author(s): 1 , 2 , * , 1 , 2 , * , 1 , 2 , 2 , 3 , 4 , 2 , 3 , 1 , 5 , 6 , 7 , 8 , 9 , 10 , 11 , 11 , 11 , 12 , 12 , 13 , 13 , 13 , 14 , 15 , 15 , 16 , 16 , 17 , 17 , 1 , 2 , 18 , 1 , 2 , 18
      Publication date (Print):
      Journal: Eurosurveillance
      Publisher: European Centre for Disease Prevention and Control (ECDC)
      Keywords: Respiratory Syncytial Virus, RSV, immunoprophylaxis, effectiveness, long-acting monoclonal antibodies, nirsevimab

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          Abstract

          The monoclonal antibody nirsevimab was at least 70% effective in preventing hospitalisations in infants with lower respiratory tract infections (LRTI) positive for respiratory syncytial virus (RSV) in Spain (Oct 2023–Jan 2024), where a universal immunisation programme began late September (coverage range: 79–99%). High protection was confirmed by two methodological designs (screening and test-negative) in a multicentre active surveillance in nine hospitals in three regions. No protection against RSV-negative LRTI-hospitalisations was shown. These interim results could guide public-health decision-making.

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          Single-Dose Nirsevimab for Prevention of RSV in Preterm Infants

          M Griffin, Yuan Yuan, Therese Takas … (2020)
          Respiratory syncytial virus (RSV) is the most common cause of lower respiratory tract infection in infants, and a need exists for prevention of RSV in healthy infants. Nirsevimab is a monoclonal antibody with an extended half-life that is being developed to protect infants for an entire RSV season with a single intramuscular dose.
          Article 0 comments Cited 215 times – based on 0 reviews     Review now
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            Nirsevimab for Prevention of RSV in Healthy Late-Preterm and Term Infants

            Laura Hammitt, Ron Dagan, Yuan Yuan … (2022)
            Respiratory syncytial virus (RSV) is a major cause of lower respiratory tract infection and hospitalization in infants. Nirsevimab is a monoclonal antibody to the RSV fusion protein that has an extended half-life. The efficacy and safety of nirsevimab in healthy late-preterm and term infants are uncertain.
            Article 0 comments Cited 210 times – based on 0 reviews     Review now
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              The test-negative design for estimating influenza vaccine effectiveness.

              Michael L Jackson, Jennifer C Nelson (2013)
              The test-negative design has emerged in recent years as the preferred method for estimating influenza vaccine effectiveness (VE) in observational studies. However, the methodologic basis of this design has not been formally developed. In this paper we develop the rationale and underlying assumptions of the test-negative study. Under the test-negative design for influenza VE, study subjects are all persons who seek care for an acute respiratory illness (ARI). All subjects are tested for influenza infection. Influenza VE is estimated from the ratio of the odds of vaccination among subjects testing positive for influenza to the odds of vaccination among subjects testing negative. With the assumptions that (a) the distribution of non-influenza causes of ARI does not vary by influenza vaccination status, and (b) VE does not vary by health care-seeking behavior, the VE estimate from the sample can generalized to the full source population that gave rise to the study sample. Based on our derivation of this design, we show that test-negative studies of influenza VE can produce biased VE estimates if they include persons seeking care for ARI when influenza is not circulating or do not adjust for calendar time. The test-negative design is less susceptible to bias due to misclassification of infection and to confounding by health care-seeking behavior, relative to traditional case-control or cohort studies. The cost of the test-negative design is the additional, difficult-to-test assumptions that incidence of non-influenza respiratory infections is similar between vaccinated and unvaccinated groups within any stratum of care-seeking behavior, and that influenza VE does not vary across care-seeking strata. Copyright © 2013 Elsevier Ltd. All rights reserved.
              Article 0 comments Cited 203 times – based on 0 reviews     Review now
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                Author and article information

                Journal
                Journal ID (nlm-ta): Euro Surveill
                Journal ID (iso-abbrev): Euro Surveill
                Journal ID (publisher-id): eurosurveillance
                Title: Eurosurveillance
                Publisher: European Centre for Disease Prevention and Control (ECDC)
                ISSN (Print): 1025-496X
                ISSN (Electronic): 1560-7917
                Publication date (Print): 08 February 2024
                Volume: 29
                Issue: 6
                Electronic Location Identifier: 2400046
                Affiliations
                [1 ]Vaccine Research Department, Fisabio-Public Health, Valencia, Spain
                [2 ]CIBERESP, Instituto de Salud Carlos III, Madrid, Spain
                [3 ]Virology Laboratory, Fisabio-Public Health, Valencia, Spain
                [4 ]Department of Microbiology and Ecology, Medical School, University of Valencia, Valencia, Spain
                [5 ]Hospital General Universitario de Castellón, Castellón, Spain
                [6 ]Medicine Department, Universidad CEU Cardenal Herrera, Castellón de la Plana, Spain
                [7 ]Hospital Universitario Dr. Peset, Valencia, Spain
                [8 ]Hospital Universitario La Fe, Valencia, Spain
                [9 ]Hospital Marina Baixa, Alicante, Spain
                [10 ]Hospital General Universitario, Valencia, Spain
                [11 ]Murcia Health Council, Murcia, Spain
                [12 ]Hospital Clínico Universitario Virgen de la Arrixaca, Murcia, Spain
                [13 ]Hospital General Universitario Santa Lucía, Murcia, Spain
                [14 ]Hospital Rafael Méndez, Murcia, Spain
                [15 ]National Influenza Centre, Valladolid, Spain
                [16 ]Hospital Clínico, Valladolid, Spain
                [17 ]Dirección General de Salud Pública, Valencia, Spain
                [18 ]Catholic University of Valencia, Valencia, Spain
                [* ]These authors contributed equally to this article and share first authorship.
                Author notes

                Correspondence: Mónica López-Lacort ( monica.lopez@ 123456fisabio.es )

                Author information
                https://orcid.org/0000-0003-2397-4011
                Article
                Publisher ID: 2400046 Publisher ID: 2400046
                DOI: 10.2807/1560-7917.ES.2024.29.6.2400046
                PMC ID: 10853977
                PubMed ID: 38333937
                SO-VID: 8ebd8579-e37c-4103-a20b-9572a22c5e06
                Copyright © This article is copyright of the authors or their affiliated institutions, 2024.
                License:

                This is an open-access article distributed under the terms of the Creative Commons Attribution (CC BY 4.0) Licence. You may share and adapt the material, but must give appropriate credit to the source, provide a link to the licence, and indicate if changes were made.

                History
                Date received : 19 January 2024
                Date accepted : 06 February 2024
                Categories
                Subject: Rapid Communication
                Custom metadata
                sequence 61

                Keywords: respiratory syncytial virus,rsv,immunoprophylaxis,effectiveness,long-acting monoclonal antibodies,nirsevimab
                Data availability:
                Keywords: respiratory syncytial virus, rsv, immunoprophylaxis, effectiveness, long-acting monoclonal antibodies, nirsevimab

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