Live-Attenuated Respiratory Syncytial Virus Vaccine With Deletion of RNA Synthesis Regulatory Protein M2-2 and Cold Passage Mutations Is Overattenuated. (6th May 2019)

• Record Type: Journal Article
• Authors: Cunningham, Coleen K; Karron, Ruth; Muresan, Petronella; McFarland, Elizabeth J; Perlowski, Charlotte; Libous, Jennifer; Thumar, Bhagvanji; Gnanashanmugam, Devasena; Moye, Jack; Schappell, Elizabeth; Barr, Emily; Rexroad, Vivian; Aziz, Mariam; Deville, Jaime; Rutstein, Richard; Yang, Lijuan; Luongo, Cindy; Collins, Peter; Buchholz, Ursula
• Is Part Of: Open forum infectious diseases. Volume 6:Number 6(2019)
• Publication Date: 2019-05-06
• Subjects: immunogenicity -- live-attenuated viral vaccine -- neutralizing antibodies -- pediatric RSV vaccine -- respiratory syncytial virus -- RNA regulatory protein M2-2; Communicable diseases -- Periodicals; Medical microbiology -- Periodicals; Infection -- Periodicals; 616.9
• DOI: 10.1093/ofid/ofz212
• Languages: English
• ISSNs: 2328-8957

Abstract

Abstract: Background: The live respiratory syncytial virus (RSV) candidate vaccine LIDcpΔM2-2 is attenuated through deletion of M2-2 and 5 cold-passage mutations. Methods: RSV-seronegative children aged 6–24 months received a single intranasal dose of 10 5 plaque-forming units (PFU) of LIDcpΔM2-2 or placebo. RSV serum antibodies, vaccine infectivity, and reactogenicity were assessed. Results: Four of 11 (36%) vaccinees shed vaccine virus with median peak titers of 1.6 log10 PFU/mL by quantitative culture and 4.5 log10 copies/mL by polymerase chain reaction; 45% had ≥4-fold rise in serum-neutralizing antibodies. Respiratory symptoms or fever were common in vaccinees (64%) and placebo recipients (6/6, 100%). Conclusions: RSV LIDcpΔM2-2 is overattenuated. Clinical Trial Numbers. NCT02890381, NCT02948127.