BACKGROUND: Despite the high disease burden of respiratory syncytial virus (RSV) in older adults, there is no approved vaccine. We evaluated the experimental RSV vaccine, Ad26.RSV.preF, a replication-incompetent adenovirus 26 vector encoding the F protein stabilized in prefusion conformation. METHODS: This phase 1 clinical trial was performed in healthy adults aged ≥60 years. Seventy-two participants received 1 or 2 intramuscular injections of low-dose (LD; 5 × 1010 vector particles) or high-dose (HD; 1 × 1011 vector particles) Ad26.RSV.preF vaccine or placebo, with approximately 12 months between doses and 2-year follow-up for safety and immunogenicity outcomes. RESULTS: Solicited adverse events were reported by 44% of vaccine recipients and were transient and mild or moderate in intensity. No serious adverse events were related to vaccination. After the first vaccination, geometric mean titers for RSV-A2 neutralization increased from baseline (432 for LD and 512 for HD vaccine) to day 29 (1031 for LD and 1617 for HD). Pre-F-specific antibody geometric mean titers and median frequencies of F-specific interferon γ-secreting T cells also increased substantially from baseline. These immune responses were still maintained above baseline levels 2 years after immunization and could be boosted with a second immunization at 1 year. CONCLUSIONS: Ad26.RSV.preF (LD and HD) had an acceptable safety profile and elicited sustained humoral and cellular immune responses after a single immunization in older adults.
BACKGROUND: Despite the high disease burden of respiratory syncytial virus (RSV) in older adults, there is no approved vaccine. We evaluated the experimental RSV vaccine, Ad26.RSV.preF, a replication-incompetent adenovirus 26 vector encoding the F protein stabilized in prefusion conformation. METHODS: This phase 1 clinical trial was performed in healthy adults aged ≥60 years. Seventy-two participants received 1 or 2 intramuscular injections of low-dose (LD; 5 × 1010 vector particles) or high-dose (HD; 1 × 1011 vector particles) Ad26.RSV.preF vaccine or placebo, with approximately 12 months between doses and 2-year follow-up for safety and immunogenicity outcomes. RESULTS: Solicited adverse events were reported by 44% of vaccine recipients and were transient and mild or moderate in intensity. No serious adverse events were related to vaccination. After the first vaccination, geometric mean titers for RSV-A2 neutralization increased from baseline (432 for LD and 512 for HD vaccine) to day 29 (1031 for LD and 1617 for HD). Pre-F-specific antibody geometric mean titers and median frequencies of F-specific interferon γ-secreting T cells also increased substantially from baseline. These immune responses were still maintained above baseline levels 2 years after immunization and could be boosted with a second immunization at 1 year. CONCLUSIONS:Ad26.RSV.preF (LD and HD) had an acceptable safety profile and elicited sustained humoral and cellular immune responses after a single immunization in older adults.
Authors: Queenie Fernandes; Varghese Philipose Inchakalody; Maysaloun Merhi; Sarra Mestiri; Nassiba Taib; Dina Moustafa Abo El-Ella; Takwa Bedhiafi; Afsheen Raza; Lobna Al-Zaidan; Mona O Mohsen; Mariam Ali Yousuf Al-Nesf; Ali Ait Hssain; Hadi Mohamad Yassine; Martin F Bachmann; Shahab Uddin; Said Dermime Journal: Ann Med Date: 2022-12 Impact factor: 4.709
Authors: Antonios O Aliprantis; Christine A Shaw; Paul Griffin; Nicholas Farinola; Radha A Railkar; Xin Cao; Wen Liu; Jeffrey R Sachs; Christine J Swenson; Heather Lee; Kara S Cox; Daniel S Spellman; Colleen J Winstead; Igor Smolenov; Eseng Lai; Tal Zaks; Amy S Espeseth; Lori Panther Journal: Hum Vaccin Immunother Date: 2020-10-29 Impact factor: 3.452
Authors: Miguel Ángel Palacios-Pedrero; Albert D M E Osterhaus; Tanja Becker; Husni Elbahesh; Guus F Rimmelzwaan; Giulietta Saletti Journal: Front Immunol Date: 2021-05-12 Impact factor: 7.561
Authors: B David Persson; Lijo John; Karim Rafie; Michael Strebl; Lars Frängsmyr; Monika Z Ballmann; Katja Mindler; Menzo Havenga; Angelique Lemckert; Thilo Stehle; Lars-Anders Carlson; Niklas Arnberg Journal: Proc Natl Acad Sci U S A Date: 2021-01-19 Impact factor: 12.779
Authors: Maheshi N Ramasamy; Angela M Minassian; Katie J Ewer; Amy L Flaxman; Pedro M Folegatti; Daniel R Owens; Merryn Voysey; Parvinder K Aley; Brian Angus; Gavin Babbage; Sandra Belij-Rammerstorfer; Lisa Berry; Sagida Bibi; Mustapha Bittaye; Katrina Cathie; Harry Chappell; Sue Charlton; Paola Cicconi; Elizabeth A Clutterbuck; Rachel Colin-Jones; Christina Dold; Katherine R W Emary; Sofiya Fedosyuk; Michelle Fuskova; Diane Gbesemete; Catherine Green; Bassam Hallis; Mimi M Hou; Daniel Jenkin; Carina C D Joe; Elizabeth J Kelly; Simon Kerridge; Alison M Lawrie; Alice Lelliott; May N Lwin; Rebecca Makinson; Natalie G Marchevsky; Yama Mujadidi; Alasdair P S Munro; Mihaela Pacurar; Emma Plested; Jade Rand; Thomas Rawlinson; Sarah Rhead; Hannah Robinson; Adam J Ritchie; Amy L Ross-Russell; Stephen Saich; Nisha Singh; Catherine C Smith; Matthew D Snape; Rinn Song; Richard Tarrant; Yrene Themistocleous; Kelly M Thomas; Tonya L Villafana; Sarah C Warren; Marion E E Watson; Alexander D Douglas; Adrian V S Hill; Teresa Lambe; Sarah C Gilbert; Saul N Faust; Andrew J Pollard Journal: Lancet Date: 2020-11-19 Impact factor: 79.321