Live-Attenuated Respiratory Syncytial Virus Vaccine With Deletion of RNA Synthesis Regulatory Protein M2-2 and Cold Passage Mutations Is Overattenuated.

Published online

Journal Article

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 105 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.

Full Text

Duke Authors

Cited Authors

  • Cunningham, CK; Karron, R; Muresan, P; McFarland, EJ; Perlowski, C; Libous, J; Thumar, B; Gnanashanmugam, D; Moye, J; Schappell, E; Barr, E; Rexroad, V; Aziz, M; Deville, J; Rutstein, R; Yang, L; Luongo, C; Collins, P; Buchholz, U; International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) 2012 Study Team,

Published Date

  • June 2019

Published In

Volume / Issue

  • 6 / 6

Start / End Page

  • ofz212 -

PubMed ID

  • 31211158

Pubmed Central ID

  • 31211158

International Standard Serial Number (ISSN)

  • 2328-8957

Digital Object Identifier (DOI)

  • 10.1093/ofid/ofz212


  • eng

Conference Location

  • United States