Title Live-Attenuated Respiratory Syncytial Virus Vaccine Candidate With Deletion of RNA Synthesis Regulatory Protein M2-2 is Highly Immunogenic in Children.
Author McFarland, Elizabeth J; Karron, Ruth A; Muresan, Petronella; Cunningham, Coleen K; Valentine, Megan E; Perlowski, Charlotte; Thumar, Bhagvanji; Gnanashanmugam, Devasena; Siberry, George K; Schappell, Elizabeth; Barr, Emily; Rexroad, Vivian; Yogev, Ram; Spector, Stephen A; Aziz, Mariam; Patel, Nehali; Cielo, Mikhaela; Luongo, Cindy; Collins, Peter L; Buchholz, Ursula J
Journal J Infect Dis Publication Year/Month 2018-Apr
PMID 29509911 PMCID PMC5894092
Affiliation + expend 1.Department of Pediatrics, University of Colorado Anschutz Medical Campus and Children's Hospital Colorado, Aurora.

Background: Live respiratory syncytial virus (RSV) candidate vaccine LIDDeltaM2-2 is attenuated by deletion of the RSV RNA regulatory protein M2-2, resulting in upregulated viral gene transcription and antigen expression but reduced RNA replication. Methods: RSV-seronegative children ages 6-24 months received a single intranasal dose of 105 plaque forming units (PFU) of LIDDeltaM2-2 (n = 20) or placebo (n = 9) (NCT02237209, NCT02040831). RSV serum antibodies, vaccine infectivity, and reactogenicity were assessed. During the following RSV season, participants were monitored for respiratory illness and pre- and post-RSV season serum antibodies. Results: Vaccine virus was shed by 95% of vaccinees (median peak titers of 3.8 log10 PFU/mL by quantitative culture and 6.3 log10 copies/mL by PCR); 90% had >/=4-fold rise in serum neutralizing antibodies. Respiratory symptoms and fever were common in vaccine (95%) and placebo (78%). One vaccinee had grade 2 rhonchi concurrent with vaccine shedding, rhinovirus, and enterovirus. Eight of 19 vaccinees versus 2 of 9 placebo recipients had substantially increased RSV antibody titers after the RSV season without medically attended RSV disease, indicating anamnestic vaccine responses to wild-type RSV without significant illness. Conclusion: LIDDeltaM2-2 had excellent infectivity and immunogenicity, encouraging further study of vaccine candidates attenuated by M2-2 deletion. Clinical Trials Registration: NCT02237209, NCT02040831.

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