RSV ΔNS2/Δ1313/I1314L / National Institute of Allergy and Infectious Diseases - LARVOL DELTA

Live-attenuated vaccines of human respiratory syncytial virus for infants and young children: Progress and prospects of an old yet promising platform. (PubMed, Biosaf Health) - "Due to the sustained efforts over the past five decades on RSV LAVs, significant advances have been made both in the technology to generate RSV LAVs-most notably reverse genetics-and in our understanding of pivotal benchmarks, including attenuation design, evaluation criteria for attenuation and immune efficacy, as well as the stepwise strategy for clinical research in RSV-seronegative children. Concurrently, this review provides a comprehensive synthesis of these historical and ongoing efforts, while highlighting future directions to prevent RSV disease in RSV-seronegative pediatric populations."

Journal • Review • Infectious Disease • Pediatrics • Respiratory Diseases • Respiratory Syncytial Virus Infections • CD8

Evaluating the Safety and Immune Response to a Single Dose of a Respiratory Syncytial Virus (RSV) Vaccine in Infants and Children (clinicaltrials.gov) - P1 | N=88 | Completed | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Live-Attenuated Intranasal RSV Vaccine in Infants and Toddlers. (PubMed, NEJM Evid) - P1/2 | "The RSVt vaccine demonstrated promising immunogenicity profiles at both LD and HD strengths among infants and toddlers, without identified safety concerns. (Funded by Sanofi; ClinicalTrials.gov number, NCT04491877)."

Clinical • Journal • Respiratory Diseases • Respiratory Syncytial Virus Infections

Safety and Immunogenicity of a Single Dose of the Recombinant Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccines RSV ΔNS2/Δ1313/I1314L, RSV 6120/ΔNS2/1030s, RSV 276 or Placebo, Delivered as Nose Drops to RSV-Seronegative Children 6 to 24 Months of Age (clinicaltrials.gov) - P1/2 | N=67 | Terminated | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Completed ➔ Terminated; The study closed to enrollment prior to fully accruing due to difficulties with slower than expected accrual.

Trial termination • Respiratory Diseases • Respiratory Syncytial Virus Infections

Safety and Immunogenicity of a Single Dose of the Recombinant Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccines RSV ΔNS2/Δ1313/I1314L, RSV 6120/ΔNS2/1030s, RSV 276 or Placebo, Delivered as Nose Drops to RSV-Seronegative Children 6 to 24 Months of Age (clinicaltrials.gov) - P1/2 | N=67 | Completed | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Active, not recruiting ➔ Completed

Trial completion • Respiratory Diseases • Respiratory Syncytial Virus Infections

Mutations in the F protein of the live-attenuated respiratory syncytial virus vaccine candidate ΔNS2/Δ1313/I1314L increase the stability of infectivity and content of prefusion F protein. (PubMed, PLoS One) - "In African green monkeys, ΔNS2-L19F-4M and ΔNS2 had similar growth kinetics, peak titer, and immunogenicity. These results suggest that ΔNS2-L19F-4M is an improved live attenuated vaccine candidate whose enhanced stability may simplify its manufacture, storage and distribution, which merits further evaluation in a clinical trial in humans."

Journal • Infectious Disease • Pediatrics • Pneumonia • Pulmonary Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Safety and Immunogenicity of a Single Dose of the Recombinant Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccines RSV ΔNS2/Δ1313/I1314L, RSV 6120/ΔNS2/1030s, RSV 276 or Placebo, Delivered as Nose Drops to RSV-Seronegative Children 6 to 24 Months of Age (clinicaltrials.gov) - P1/2 | N=67 | Active, not recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Recruiting ➔ Active, not recruiting | N=130 ➔ 67

Enrollment change • Enrollment closed • Respiratory Diseases • Respiratory Syncytial Virus Infections

Safety and Immunogenicity of a Single Dose of the Recombinant Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccines RSV ΔNS2/Δ1313/I1314L, RSV 6120/ΔNS2/1030s, RSV 276 or Placebo, Delivered as Nose Drops to RSV-Seronegative Children 6 to 24 Months of Age (clinicaltrials.gov) - P1/2 | N=160 | Recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Trial completion date: Apr 2023 ➔ Apr 2024 | Trial primary completion date: Dec 2022 ➔ Dec 2023

Trial completion date • Trial primary completion date • Respiratory Diseases • Respiratory Syncytial Virus Infections