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Background Respiratory 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. Methods In 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. Results Post-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. Conclusions Ad26.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 Registration NCT03334695

Prevention of Respiratory Syncytial Virus Infection in Healthy Adults by a Single Immunization of Ad26.RSV.preF in a Human Challenge Study