• Jerald Sadoff, Els De Paepe, John DeVincenzo, Efi Gymnopoulou, Joris Menten, Bryan Murray, Arangassery Rosemary Bastian, An Vandebosch, Wouter Haazen, Nicolas Noulin, Christy Comeaux, Esther Heijnen, Kingsley Eze, Anthony Gilbert, Rob Lambkin-Williams, Hanneke Schuitemaker, and Benoit Callendret.
• Janssen Vaccines & Prevention BV, Leiden, The Netherlands.
• J. Infect. Dis. 2021 Jan 5.

BackgroundRespiratory syncytial virus (RSV) is a significant cause of severe lower respiratory tract disease in children and older adults, but has no approved vaccine. This study assessed the potential of Ad26.RSV.preF to protect against RSV infection and disease in an RSV human challenge model.MethodsIn this double-blind, placebo-controlled study, healthy adults aged 18-50 years were randomized 1:1 to receive 1x1011 vp Ad26.RSV.preF or placebo intramuscularly. Twenty-eight days post-immunization, volunteers were challenged intranasally with RSV-A (Memphis 37b). Assesments included viral load (VL), RSV infections, clinical symptom score (CSS), safety and immunogenicity.ResultsPost-challenge, VL, RSV infections and disease severity were lower in Ad26.RSV.preF (n=27) versus placebo (n=26) recipients: median VL-AUC (area under the curve) qRT-PCR: 0.0 versus 236.0 (P=.012; predefined primary endpoint); median VL-AUC quantitative culture: 0.0 versus 109; RSV infections 11 (40.7%) versus 17 (65.4%); median RSV AUC-CSS 35 versus 167, respectively. From baseline to 28 days post-immunization, geometric mean fold-increases in RSV A2 neutralizing antibody titers of 5.8 and 0.9 were observed in Ad26.RSV.preF and placebo, respectively. Ad26.RSV.preF was well tolerated.ConclusionsAd26.RSV.preF demonstrated protection from RSV infection through immunization in a human challenge model, and therefore could potentially protect against natural RSV infection and disease.Clinical Trials RegistrationNCT03334695.© The Author(s) 2021. Published by Oxford University Press for the Infectious Diseases Society of America.

7 keywords...

hide…