NCT03916185

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

Randomized Phase I/II Study of the 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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 6 Months – 25 Months
• Healthy volunteers: Accepted

Summary

The purpose of this study was to evaluate the 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, and RSV 276, in RSV-seronegative children 6 to 24 months of age.

Detailed description

This study evaluated the 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, and RSV 276, in RSV-seronegative children 6 to 24 months of age. Participants were randomly assigned to receive a single dose of RSV ΔNS2/Δ1313/I1314L vaccine, RSV 6120/ΔNS2/1030s vaccine, RSV 276 vaccine, or placebo intranasally at study entry. Participants were enrolled in the study outside of RSV season. All participants were to remain on study until they completed the post-RSV season visit in the calendar year following enrollment. Participants' total study duration was expected to be between 5 and 15 months, depending on when they enrolled in the study and accommodations given for the COVID pandemic. Participants attended several study visits throughout the study, which included physical examinations, blood collection, and nasal washes or swabs, if applicable. Participants' parents or guardians were contacted by study staff at various times during the study to monitor participants' health. The study closed to enrollment prior to fully accruing due to difficulties with slower than expected accrual.

Conditions

• Respiratory Syncytial Virus (RSV)

Interventions

Type	Name	Description
BIOLOGICAL	RSV ΔNS2/Δ1313/I1314L Vaccine	10\^6 plaque-forming units (PFU); administered as nose drops
BIOLOGICAL	RSV 6120/ΔNS2/1030s Vaccine	10\^5 plaque-forming units (PFU); administered as nose drops
BIOLOGICAL	RSV 276 Vaccine	10\^5 plaque-forming units (PFU); administered as nose drops
BIOLOGICAL	Placebo	Administered as nose drops

Timeline

• Start date: 2019-06-20
• Primary completion: 2024-01-22
• Completion: 2024-04-25
• First posted: 2019-04-16
• Last updated: 2025-02-21
• Results posted: 2025-02-21

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study