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Article ; Online: Disagreement FDA and EMA on RSV Maternal Vaccination: Possible Consequence for Global Mortality.

Willemsen, Joukje E / Borghans, José A M / Bont, Louis J / Drylewicz, Julia

The Pediatric infectious disease journal

2023 Volume 43, Issue 1, Page(s) e1–e2

Abstract: The European Medicines Agency and the US Food and Drug Administration have recently approved a maternal vaccine for respiratory syncytial virus. The US Food and Drug Administration limits vaccination to later in pregnancy. Mathematical modeling ... ...

Abstract	The European Medicines Agency and the US Food and Drug Administration have recently approved a maternal vaccine for respiratory syncytial virus. The US Food and Drug Administration limits vaccination to later in pregnancy. Mathematical modeling demonstrates that this vaccination window may reduce the global mortality impact of the vaccine by 12%. Policymakers should carefully consider vaccine risks and benefits to safeguard vulnerable infants effectively.
MeSH term(s)	Infant ; Pregnancy ; Female ; Humans ; Respiratory Syncytial Virus Infections ; Respiratory Syncytial Virus, Human ; Vaccination ; Family ; Respiratory Syncytial Virus Vaccines
Chemical Substances	Respiratory Syncytial Virus Vaccines
Language	English
Publishing date	2023-10-11
Publishing country	United States
Document type	Journal Article
ZDB-ID	392481-6
ISSN	1532-0987 ; 0891-3668
ISSN (online)	1532-0987
ISSN	0891-3668
DOI	10.1097/INF.0000000000004173
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Article ; Online: Maternal vaccination against RSV can substantially reduce childhood mortality in low-income and middle-income countries: A mathematical modeling study.

Willemsen, Joukje E / Borghans, José A M / Bont, Louis J / Drylewicz, Julia

Vaccine: X

2023 Volume 15, Page(s) 100379

Abstract: Background: Respiratory syncytial virus (RSV) is a leading cause of childhood mortality in infants below 6 months of age. In low-income and middle-income countries (LMICs), the public health burden is substantial and resources are limited. It is ... ...

Abstract	Background: Respiratory syncytial virus (RSV) is a leading cause of childhood mortality in infants below 6 months of age. In low-income and middle-income countries (LMICs), the public health burden is substantial and resources are limited. It is critical to inform decision makers about effectiveness of new interventions. Methods: We developed a mathematical model where individual RSV subtype A (RSV-A) and B (RSV-B) maternally derived neutralizing titers were predicted at time of birth after maternal vaccination with the RSV prefusion F protein-based vaccine. We estimated the subsequent duration of vaccine-induced immunity and compared this to the age at time of death distribution in the RSV GOLD Mortality Database to predict the potential impact of maternal vaccination on RSV-related childhood mortality. We used country-specific timing of antenatal care visits distributions and mortality estimates to make country-specific predictions for number of cases averted. Findings: The model predicts that on average a neonate born at 40 weeks gestational age will be protected between 6 and 7 months from RSV-A and approximately 5 months from RSV-B related mortality. We estimated the potential impact of RSV-related mortality for in-hospital and out-of-hospital cases in LMICs and predicted that in 51 GAVI-eligible countries maternal vaccination could avert between 55% and 63% of the RSV-related in-hospital mortality cases below 6 months of age. Interpretation: We show that maternal vaccination could substantially decrease RSV-A and RSV-B related in-hospital and out-of-hospital mortality in LMICs in the first 6 months of life.
Language	English
Publishing date	2023-09-01
Publishing country	England
Document type	Journal Article
ISSN	2590-1362
ISSN (online)	2590-1362
DOI	10.1016/j.jvacx.2023.100379
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Article: Incorporating data from multiple endpoints in the analysis of clinical trials: example from RSV vaccines.

Prunas, Ottavia / Willemsen, Joukje E / Bont, Louis / Pitzer, Virginia E / Warren, Joshua L / Weinberger, Daniel M

medRxiv : the preprint server for health sciences

2023

Abstract: Background: To achieve licensure, interventions typically must demonstrate efficacy against a primary outcome in a randomized clinical trial. However, selecting a single primary outcome : Method: We simulated data from three different populations in ... ...

Abstract	Background: To achieve licensure, interventions typically must demonstrate efficacy against a primary outcome in a randomized clinical trial. However, selecting a single primary outcome Method: We simulated data from three different populations in which the efficacy of the intervention and the correlation among outcomes varied. We developed a novel permutation-based approach that represents a weighted average of individual outcome test statistics ( Results: When the vaccine efficacy against different outcomes was similar, Conclusions: Analyzing multiple endpoints using a weighted permutation method can increase power while controlling the type I error rate in settings where outcomes share similar characteristics, like RSV outcomes. We developed an R package,
Language	English
Publishing date	2023-02-09
Publishing country	United States
Document type	Preprint
DOI	10.1101/2023.02.07.23285596
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Article ; Online: Incorporating Data from Multiple Endpoints in the Analysis of Clinical Trials: Example from RSV Vaccines.

Prunas, Ottavia / Willemsen, Joukje E / Bont, Louis / Pitzer, Virginia E / Warren, Joshua L / Weinberger, Daniel M

Epidemiology (Cambridge, Mass.)

2023 Volume 35, Issue 1, Page(s) 103–112

Abstract: Background: To meet regulatory approval, interventions must demonstrate efficacy against a primary outcome in randomized clinical trials. However, when there are multiple clinically relevant outcomes, selecting a single primary outcome is challenging. ... ...

Abstract	Background: To meet regulatory approval, interventions must demonstrate efficacy against a primary outcome in randomized clinical trials. However, when there are multiple clinically relevant outcomes, selecting a single primary outcome is challenging. Incorporating data from multiple outcomes may increase statistical power in clinical trials. We examined methods for analyzing data on multiple endpoints, inspired by real-world trials of interventions against respiratory syncytial virus (RSV). Method: We developed a novel permutation test representing a weighted average of individual outcome test statistics ( wavP ) to evaluate intervention efficacy in a multiple endpoint analysis. We compared the power and type I error rate of this approach to the Bonferroni correction ( bonfT ) and the minP permutation test. We evaluated the different approaches using simulated data from three hypothetical trials varying the intervention efficacy, correlation, and incidence of the outcomes, and data from a real-world RSV clinical trial. Results: When the vaccine efficacy against different outcomes was similar, wavP yielded higher power than bonfT and minP in some scenarios the improvement in power was substantial. In settings where vaccine efficacy was notably larger against one endpoint compared with the others, all three methods had similar power. We developed an R package, PERmutation basEd ANalysis of mulTiple Endpoints (PERMEATE), to guide the selection of the most appropriate method for analyzing multiple endpoints in clinical trials. Conclusions: Analyzing multiple endpoints using a weighted permutation method can increase power, whereas controlling the type I error rate compared with established methods under conditions mirroring real-world RSV clinical trials.
MeSH term(s)	Humans ; Respiratory Syncytial Virus Infections/prevention & control ; Respiratory Syncytial Virus Infections/epidemiology ; Respiratory Syncytial Virus Vaccines/therapeutic use
Chemical Substances	Respiratory Syncytial Virus Vaccines
Language	English
Publishing date	2023-11-27
Publishing country	United States
Document type	Journal Article
ZDB-ID	1053263-8
ISSN	1531-5487 ; 1044-3983
ISSN (online)	1531-5487
ISSN	1044-3983
DOI	10.1097/EDE.0000000000001680
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Article ; Online: Correction to: Describing global pediatric RSV disease at intensive care units in GAVI-eligible countries using molecular point-of-care diagnostics: the RSV GOLD-III study protocol.

Löwensteyn, Yvette N / Mazur, Natalie I / Nair, Harish / Willemsen, Joukje E / van Thiel, Ghislaine / Bont, Louis

BMC infectious diseases

2021 Volume 21, Issue 1, Page(s) 962

Language	English
Publishing date	2021-09-16
Publishing country	England
Document type	Published Erratum
ISSN	1471-2334
ISSN (online)	1471-2334
DOI	10.1186/s12879-021-06671-x
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Article ; Online: Describing global pediatric RSV disease at intensive care units in GAVI-eligible countries using molecular point-of-care diagnostics: the RSV GOLD-III study protocol.

Löwensteyn, Yvette N / Mazur, Natalie I / Nair, Harish / Willemsen, Joukje E / van Thiel, Ghislaine / Bont, Louis

BMC infectious diseases

2021 Volume 21, Issue 1, Page(s) 857

Abstract: Background: Respiratory syncytial virus (RSV) infection is an important cause of hospitalization and death in young children. The majority of deaths (99%) occur in low- and lower-middle-income countries (LMICs). Vaccines against RSV infection are ... ...

Abstract	Background: Respiratory syncytial virus (RSV) infection is an important cause of hospitalization and death in young children. The majority of deaths (99%) occur in low- and lower-middle-income countries (LMICs). Vaccines against RSV infection are underway. To obtain access to RSV interventions, LMICs depend on support from Gavi, the Vaccine Alliance. To identify future vaccine target populations, information on children with severe RSV infection is required. However, there is a lack of individual patient-level clinical data on instances of life-threatening RSV infection in LMICs. The RSV GOLD III-ICU Network study aims to describe clinical, demographic and socioeconomic characteristics of children with life-threatening RSV infection in Gavi-eligible countries. Methods: The RSV GOLD-III-ICU Network study is an international, prospective, observational multicenter study and will be conducted in 10 Gavi-eligible countries at pediatric intensive care units and high-dependency units (PICUs/HDUs) during local viral respiratory seasons for 2 years. Children younger than 2 years of age with respiratory symptoms fulfilling the World Health Organization (WHO) "extended severe acute respiratory infection (SARI)" case definition will be tested for RSV using a molecular point-of-care (POC) diagnostic device. Patient characteristics will be collected through a questionnaire. Mortality rates of children admitted to the PICU and/or HDU will be calculated. Discussion: This multicenter descriptive study will provide a better understanding of the characteristics and mortality rates of children younger than 2 years with RSV infection admitted to the PICU/HDU in LMICs. These results will contribute to knowledge on global disease burden and awareness of RSV and will directly guide decision makers in their efforts to implement future RSV prevention strategies. Trial registration number: NL9519, May 27, 2021.
MeSH term(s)	Child, Preschool ; Hospitalization ; Humans ; Infant ; Intensive Care Units, Pediatric ; Multicenter Studies as Topic ; Observational Studies as Topic ; Point-of-Care Systems ; Prospective Studies ; Respiratory Syncytial Virus Infections/diagnosis ; Respiratory Syncytial Virus Infections/epidemiology ; Respiratory Syncytial Viruses
Language	English
Publishing date	2021-08-23
Publishing country	England
Document type	Clinical Trial Protocol ; Journal Article
ZDB-ID	2041550-3
ISSN	1471-2334 ; 1471-2334
ISSN (online)	1471-2334
ISSN	1471-2334
DOI	10.1186/s12879-021-06544-3
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Article ; Online: Nosocomial RSV-related In-hospital Mortality in Children <5 Years: A Global Case Series.

Löwensteyn, Yvette N / Willemsen, Joukje E / Mazur, Natalie I / Scheltema, Nienke M / van Haastregt, Nynke C J / Buuren, Amber A A Ten / van Roessel, Ichelle / Scheepmaker, Dunja / Nair, Harish / van de Ven, Peter M / Bont, Louis J

The Pediatric infectious disease journal

2022 Volume 42, Issue 1, Page(s) 1–7

Abstract: Background: According to the World Health Organization, the global burden of nosocomial infections is poorly characterized as surveillance systems are lacking. Nosocomial infections occur at higher rates in low- and lower-middle-income countries (LMICs) ...

Abstract	Background: According to the World Health Organization, the global burden of nosocomial infections is poorly characterized as surveillance systems are lacking. Nosocomial infections occur at higher rates in low- and lower-middle-income countries (LMICs) than in high-income countries (HICs). Current global RSV burden estimates are largely based on community-acquired infection. We aimed to characterize children with nosocomial RSV-related mortality and to understand the potential impact of RSV immunization strategies. Materials: RSV GOLD is a global registry of children younger than 5 years who died with laboratory-confirmed RSV infection. We compared clinical and demographic characteristics of children with nosocomial and community-acquired RSV in-hospital mortality. Results: We included 231 nosocomial and 931 community-acquired RSV-related in-hospital from deaths from 65 countries. Age at death was similar for both groups (5.4 vs. 6 months). A higher proportion of nosocomial deaths had comorbidities (87% vs. 57%; P < 0.001) or was born preterm (46% vs. 24%; P < 0.001) than community-acquired deaths. The proportion of nosocomial deaths among all RSV deaths was lower in LMICs than in upper-middle-income countries (UMICs) and HICs (12% vs. 18% and 26%, respectively). Conclusions: This is the first global case series of children dying with nosocomial RSV infection. Future infant-targeted immunization strategies could prevent the majority of nosocomial RSV-related deaths. Although nosocomial RSV deaths are expected to occur at highest rates in LMICs, the number of reported nosocomial RSV deaths was low in these countries. Hospital-based surveillance is needed to capture the full burden of nosocomial RSV mortality in LMICs.
MeSH term(s)	Child ; Humans ; Infant, Newborn ; Cross Infection/epidemiology ; Hospital Mortality ; Hospitals ; Research
Language	English
Publishing date	2022-11-08
Publishing country	United States
Document type	Journal Article
ZDB-ID	392481-6
ISSN	1532-0987 ; 0891-3668
ISSN (online)	1532-0987
ISSN	0891-3668
DOI	10.1097/INF.0000000000003747
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Article ; Online: Global Respiratory Syncytial Virus-Related Infant Community Deaths.

Mazur, Natalie I / Löwensteyn, Yvette N / Willemsen, Joukje E / Gill, Christopher J / Forman, Leah / Mwananyanda, Lawrence M / Blau, Dianna M / Breiman, Robert F / Madhi, Shabir A / Mahtab, Sana / Gurley, Emily S / El Arifeen, Shams / Assefa, Nega / Scott, J Anthony G / Onyango, Dickens / Tippet Barr, Beth A / Kotloff, Karen L / Sow, Samba O / Mandomando, Inacio /

Ogbuanu, Ikechukwu / Jambai, Amara / Bassat, Quique / Caballero, Mauricio T / Polack, Fernando P / Omer, Saad / Kazi, Abdul Momin / Simões, Eric A F / Satav, Ashish / Bont, Louis J

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

2021 Volume 73, Issue Suppl_3, Page(s) S229–S237

Abstract: Background: Respiratory syncytial virus (RSV) is a leading cause of pediatric death, with >99% of mortality occurring in low- and lower middle-income countries. At least half of RSV-related deaths are estimated to occur in the community, but clinical ... ...

Abstract	Background: Respiratory syncytial virus (RSV) is a leading cause of pediatric death, with >99% of mortality occurring in low- and lower middle-income countries. At least half of RSV-related deaths are estimated to occur in the community, but clinical characteristics of this group of children remain poorly characterized. Methods: The RSV Global Online Mortality Database (RSV GOLD), a global registry of under-5 children who have died with RSV-related illness, describes clinical characteristics of children dying of RSV through global data sharing. RSV GOLD acts as a collaborative platform for global deaths, including community mortality studies described in this supplement. We aimed to compare the age distribution of infant deaths <6 months occurring in the community with in-hospital. Results: We studied 829 RSV-related deaths <1 year of age from 38 developing countries, including 166 community deaths from 12 countries. There were 629 deaths that occurred <6 months, of which 156 (25%) occurred in the community. Among infants who died before 6 months of age, median age at death in the community (1.5 months; IQR: 0.8-3.3) was lower than in-hospital (2.4 months; IQR: 1.5-4.0; P < .0001). The proportion of neonatal deaths was higher in the community (29%, 46/156) than in-hospital (12%, 57/473, P < 0.0001). Conclusions: We observed that children in the community die at a younger age. We expect that maternal vaccination or immunoprophylaxis against RSV will have a larger impact on RSV-related mortality in the community than in-hospital. This case series of RSV-related community deaths, made possible through global data sharing, allowed us to assess the potential impact of future RSV vaccines.
MeSH term(s)	Age Distribution ; Child ; Hospitalization ; Humans ; Infant ; Infant Death ; Infant, Newborn ; Respiratory Syncytial Virus Infections/epidemiology ; Respiratory Syncytial Virus Vaccines ; Respiratory Syncytial Virus, Human
Chemical Substances	Respiratory Syncytial Virus Vaccines
Language	English
Publishing date	2021-09-02
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1099781-7
ISSN	1537-6591 ; 1058-4838
ISSN (online)	1537-6591
ISSN	1058-4838
DOI	10.1093/cid/ciab528
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