| Title | Live-Attenuated Respiratory Syncytial Virus Vaccine With Deletion of RNA Synthesis Regulatory Protein M2-2 and Cold Passage Mutations Is Overattenuated. | ||
| Author | Cunningham, Coleen K; Karron, Ruth; Muresan, Petronella; McFarland, Elizabeth J; Perlowski, Charlotte; Libous, Jennifer; Thumar, Bhagvanji; Gnanashanmugam, Devasena; Moye, Jack Jr; Schappell, Elizabeth; Barr, Emily; Rexroad, Vivian; Aziz, Mariam; Deville, Jaime; Rutstein, Richard; Yang, Lijuan; Luongo, Cindy; Collins, Peter; Buchholz, Ursula | ||
| Journal | Open Forum Infect Dis | Publication Year/Month | 2019-Jun |
| PMID | 31211158 | PMCID | PMC6559275 |
| Affiliation + expend | 1.Department of Pediatrics, Duke University Medical Center, Durham, North Carolina. | ||
BACKGROUND: The live respiratory syncytial virus (RSV) candidate vaccine LIDcpDeltaM2-2 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 LIDcpDeltaM2-2 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 log(10) PFU/mL by quantitative culture and 4.5 log(10) 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 LIDcpDeltaM2-2 is overattenuated. Clinical Trial Numbers. NCT02890381, NCT02948127.