Evaluating the Infectivity, Safety, and Immunogenicity of Recombinant Live-Attenuated RSV Vaccines RSV ΔNS2/Δ1313/I1314L or RSV 276 in RSV-Seronegative Infants 6 to 24 Months of Age

Summary

The purpose of this study was to evaluate the infectivity, safety, and immunogenicity of the recombinant live-attenuated respiratory syncytial virus (RSV) vaccines RSV ΔNS2/Δ1313/I1314L or RSV 276 when delivered as nose drops to RSV-seronegative infants 6 to 24 months of age. This study was a companion study to Center for Immunization Research (CIR) 321.

Timeline

Start

2017-09-22

Primary completion

2019-12-19

Completion

2020-10-01

Publications

• Cunningham CK, Karron RA, Muresan P, Kelly MS, McFarland EJ, Perlowski C, Libous J, Oliva J, Jean-Philippe P, Moye J, Schappell E, Barr E, Rexroad V, Johnston B, Chadwick EG, Cielo M, Paul M, Deville JG, Aziz M, Yang L, Luongo C, Collins PL, Buchholz UJ; International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) 2018 Study Team. Evaluation of Recombinant Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccines RSV/DeltaNS2/Delta1313/I1314L and RSV/276 in RSV-Seronegative Children. J Infect Dis. 2022 Dec 13;226(12):2069-2078. doi: 10.1093/infdis/jiac253.

Drugs

Indications