Evaluating the Infectivity, Safety, and Immunogenicity of a Single Dose of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine (D46/NS2/N/ΔM2-2-HindIII) in RSV-Seronegative Infants 6 to 24 Months of Age

NCT03102034 ↗

Phase 1 Completed 32 enrolled National Institute of Allergy and Infectious Diseases (NIAID)

RandomizedParallel-groupQuadruple-blindPrevention

Summary

The purpose of this study was to evaluate the safety, infectivity, and immunogenicity of a single dose of a recombinant live-attenuated respiratory syncytial virus (RSV) vaccine in RSV-seronegative infants and children 6 to 24 months of age. This study was a companion study to CIR 313.

Timeline

Start: 2017-04-06
Primary completion: 2018-05-25
Completion: 2018-05-25

Outcome

Met primary endpoint

registry analysis (superiority test); RSV D46/NS2/N/ΔM2-2-HindIII Vaccine vs Placebo; p <0.001; Fisher Exact NCT03102034 ↗

registry analysis (superiority test); RSV D46/NS2/N/ΔM2-2-HindIII Vaccine vs Placebo; p <0.001; Log Rank NCT03102034 ↗

Publications

McFarland EJ, Karron RA, Muresan P, Cunningham CK, Perlowski C, Libous J, Oliva J, Jean-Philippe P, Moye J, Schappell E, Barr E, Rexroad V, Fearn L, Cielo M, Wiznia A, Deville JG, Yang L, Luongo C, Collins PL, Buchholz UJ. Live-Attenuated Respiratory Syncytial Virus Vaccine With M2-2 Deletion and With Small Hydrophobic Noncoding Region Is Highly Immunogenic in Children. J Infect Dis. 2020 Jun 11;221(12):2050-2059. doi: 10.1093/infdis/jiaa049.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	D46/NS2/N/ΔM2-2-HindIII	Vaccine	100000 unknown	Intranasal