Evaluating the Infectivity, Safety and Immunogenicity of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine (RSV LID cp ΔM2-2) in RSV-Seronegative Infants 6 to 24 Months of Age

Summary

The purpose of this study was to evaluate the safety, infectivity, and immunogenicity of a single intranasal dose of a recombinant live-attenuated respiratory syncytial virus (RSV) vaccine in RSV-seronegative infants 6 to 24 months of age. This study was a companion study to CIR 312.

Timeline

Start

2016-10-05

Primary completion

2017-04-24

Completion

2017-04-24

Outcome

Missed primary endpoint

Stopped: “Interim data indicated this vaccine will not meet the protocol criteria for a good vaccine candidate.”

registry analysis (superiority test); RSV LID cp ΔM2-2 Vaccine vs Placebo; p = 0.64; Fisher Exact NCT02890381 ↗

registry analysis (superiority test); RSV LID cp ΔM2-2 Vaccine vs Placebo; p = 0.73; Log Rank NCT02890381 ↗

Publications

• Cunningham CK, Karron R, Muresan P, McFarland EJ, Perlowski C, Libous J, Thumar B, Gnanashanmugam D, Moye J Jr, 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. Live-Attenuated Respiratory Syncytial Virus Vaccine With Deletion of RNA Synthesis Regulatory Protein M2-2 and Cold Passage Mutations Is Overattenuated. Open Forum Infect Dis. 2019 May 6;6(6):ofz212. doi: 10.1093/ofid/ofz212. eCollection 2019 Jun.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	RSV LID cp ΔM2-2	Vaccine	100000 unknown	Intranasal

Indications