RSV 6120/ΔNS2/1030s / National Institute of Allergy and Infectious Diseases - LARVOL DELTA

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

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

Evaluation of the live-attenuated intranasal respiratory syncytial virus (RSV) vaccine RSV/6120/ΔNS2/1030s in RSV-seronegative young children. (PubMed, J Infect Dis) - "RSV/6120/ΔNS2/1030s is immunogenic and genetically stable in RSV-seronegative children, but the frequency of rhinorrhea in vaccinees exceeded that in placebo recipients.A live-attenuated intranasal respiratory syncytial virus vaccine candidate containing a deletion of the interferon antagonist NS2 gene and a genetically stabilized temperature-sensitivity mutation in the polymerase gene was infectious and induced primary neutralizing serum antibody responses and potent memory antibody responses in 6-to-24 month-old RSV-seronegative children, but may be associated with rhinorrhea."

Journal • Infectious Disease • Pediatrics • 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