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Respiratory syncytial virus prevention within reach: the vaccine and monoclonal antibody landscape - 20/12/22

Doi : 10.1016/S1473-3099(22)00291-2 
Natalie I Mazur, MD a, Jonne Terstappen, MD a, Ranju Baral, PhD b, Azucena Bardají, PhD c, d, e, Philippe Beutels, PhD f, g, Ursula J Buchholz, PhD h, Cheryl Cohen, PhD j, k, James E Crowe, MD l, Clare L Cutland, PhD m, Linda Eckert, MD n, Daniel Feikin, MD p, Tiffany Fitzpatrick, PhD q, Youyi Fong, PhD o, Barney S Graham, PhD i, Terho Heikkinen, PhD r, Deborah Higgins, BA b, Siddhivinayak Hirve, MD s, Keith P Klugman, PhD t, Leyla Kragten-Tabatabaie, PhD v, Philippe Lemey, PhD w, Romina Libster, MD x, Yvette Löwensteyn, MD a, Asuncion Mejias, PhD y, Flor M Munoz, MD z, Patrick K Munywoki, PhD aa, Lawrence Mwananyanda, MD ab, Harish Nair, PhD ac, Marta C Nunes, PhD ad, Octavio Ramilo, PhD y, Peter Richmond, MD ae, Tracy J Ruckwardt, PhD i, Charles Sande, PhD aa, af, Padmini Srikantiah, MD u, Naveen Thacker, MD ag, Kody A Waldstein, MSc ah, ai, Dan Weinberger, PhD q, Joanne Wildenbeest, PhD a, Dexter Wiseman, MD aj, Heather J Zar, PhD al, Maria Zambon, PhD ak, Louis Bont, PhD a, v,
a Department of Paediatric Infectious Diseases and Immunology, Wilhelmina Children’s Hospital, University Medical Center Utrecht, Utrecht, Netherlands 
b PATH, Center for Vaccine Innovation & Access, Seattle, WA, USA 
c ISGlobal, Hospital Clínic–Universitat de Barcelona, Barcelona, Spain 
d Centro de Investigaçao em Saúde de Manhiça, Maputo, Mozambique 
e Consorcio de Investigación Biomédica en Red de Epidemiología y Salud Pública, Madrid, Spain 
f Centre for Health Economics Research & Modelling Infectious Diseases, Vaccine & Infectious Disease Institute, University of Antwerp, Antwerp, Belgium 
g School of Public Health, The University of New South Wales, Sydney, NSW, Australia 
h RNA Viruses Section, Laboratory of Infectious Diseases, National Institutes of Health, Bethesda, MA, USA 
i Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MA, USA 
j University of the Witwatersrand, Centre for Respiratory Disease and Meningitis at the National Institute for Communicable Diseases, Johannesburg, South Africa 
k School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa 
l Vanderbilt Vaccine Center, Pediatrics & Pathology, Microbiology & Immunology, Vanderbilt University Medical Center, Nashville, TN, USA 
m African Leadership in Vaccinology Expertise, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa 
n Obstetrics & Gynecology, Global Health, University of Washington, Seattle, WA, USA 
o Vaccine & Infectious Disease Division, Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Department of Biostatistics, University of Washington, Seattle, WA, USA 
p Department of Immunisations, Vaccines & Biologicals, World Health Organization, Geneva, Switzerland 
q Yale School of Public Health Department of Epidemiology of Microbial Diseases, Yale University, New Haven, CT, USA 
r Department of Pediatrics, University of Turku and Turku University Hospital, Turku, Finland 
s Global Influenza Programme, World Health Organization, Geneva, Switzerland 
t Pneumonia Program, Bill & Melinda Gates Foundation, Seattle, WA, USA 
u Respiratory Syncytial Virus Program and Global Health, Bill & Melinda Gates Foundation, Seattle, WA, USA 
v ReSViNET Foundation, Julius Clinical, Zeist, Netherlands 
w Clinical and Epidemiological Virology, Department of Microbiology, Immunology and Transplantation, Rega Institute, KU Leuven, Leuven, Belgium 
x Fundacion INFANT, Buenos Aires, Argentina 
y Nationwide Children’s Hospital Columbus, Columbus, OH, USA 
z Department of Pediatrics, Division of Infectious Disease, and Molecular Virology and Microbiology, Baylor College of Medicine, Houston, TX, USA 
aa Kenyan Medical Research Institute-Wellcome Trust Research Program, Kilifi, Kenya 
ab Department of Global Health, Boston University, Lusaka, Zambia 
ac Centre for Global Health, Usher Institute, University of Edinburgh, Edinburgh, UK 
ad South African Medical Research Council, Wits Vaccines & Infectious Diseases Analytics Research Unit and Department of Science and Technology and National Research Foundation, South African Research Chair Initiative in Vaccine Preventable Diseases, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa 
ae School of Medicine, Division of Paediatrics, University of Western Australia, Perth, WA, Australia 
af Centre for Tropical Medicine & Global Health, University of Oxford, Oxford, UK 
ag Deep Children Hospital & Research Centre, Gandhidham, India 
ah Department of Microbiology and Immunology, University of Iowa, Iowa, IA, USA 
ai Interdisciplinary Graduate Program in Immunology, University of Iowa, Iowa, IA, USA 
aj National Heart & Lung Institute, Imperial College, London, UK 
ak Reference Microbiology, Public Health England, Faculty of Medicine, Imperial College, London, UK 
al Department of Pediatrics & Child Health, Red Cross Children’s Hospital and SA-MRC unit of Child & Adolescent Health, University of Cape Town, Cape Town, South Africa 

* Correspondence to: Prof Louis Bont, Department of Pediatric Infectious Disease & Immunology, Wilhelmina Children’s Hospital, University Medical Center Utrecht, Lundlaan 6, 3584EA Utrecht, The Netherlands Department of Pediatric Infectious Disease & Immunology Wilhelmina Children’s Hospital University Medical Center Utrecht Lundlaan 6 Utrecht 3584EA The Netherlands

Summary

Respiratory syncytial virus is the second most common cause of infant mortality and a major cause of morbidity and mortality in older adults (aged >60 years). Efforts to develop a respiratory syncytial virus vaccine or immunoprophylaxis remain highly active. 33 respiratory syncytial virus prevention candidates are in clinical development using six different approaches: recombinant vector, subunit, particle-based, live attenuated, chimeric, and nucleic acid vaccines; and monoclonal antibodies. Nine candidates are in phase 3 clinical trials. Understanding the epitopes targeted by highly neutralising antibodies has resulted in a shift from empirical to rational and structure-based vaccine and monoclonal antibody design. An extended half-life monoclonal antibody for all infants is likely to be within 1 year of regulatory approval (from August, 2022) for high-income countries. Live-attenuated vaccines are in development for older infants (aged >6 months). Subunit vaccines are in late-stage trials for pregnant women to protect infants, whereas vector, subunit, and nucleic acid approaches are being developed for older adults. Urgent next steps include ensuring access and affordability of a respiratory syncytial virus vaccine globally. This review gives an overview of respiratory syncytial virus vaccines and monoclonal antibodies in clinical development highlighting different target populations, antigens, and trial results.

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