The purpose of this study is to evaluate the infectivity, safety, and immunogenicity of the recombinant live-attenuated respiratory syncytial virus (RSV) vaccines RSV ΔNS2/Δ1313/I1314L or RSV 276 or placebo when delivered as nose drops to RSV-seronegative infants 6 to 24 months of age. This study is a companion study to CIR 321.
Name: RSV ΔNS2/Δ1313/I1314L
Description: 10^6 plaque-forming units (PFU); administered as nose dropsType: BiologicalRSV ΔNS2/Δ1313/I1314L vaccine
Name: RSV 276
Description: 10^5 PFU; administered as nose dropsType: BiologicalRSV 276 vaccine
Name: Placebo
Description: Administered as nose dropsType: BiologicalPlacebo
Description: May include fever, acute otitis media, upper respiratory tract illness (URI), or lower respiratory tract illness (LRI)
Measure: Grades of study product-related solicited adverse events (AEs) Time: Measured through Day 28Description: Defined as all other AEs that are not solicited AEs
Measure: Grades of study product-related unsolicited AEs Time: Measured through Day 28Description: SAEs as defined in the protocol
Measure: Grades of study product-related serious adverse events (SAEs) Time: Measured through Day 56Description: Defined as 1) vaccine virus identified in a nasal wash from Study Day 0-28 (a binary outcome based on nasal washes done throughout this time period; Day 0 nasal wash will be counted as baseline) and/or 2) greater than or equal to 4-fold rise in RSV serum neutralizing antibody titer and/or serum enzyme-linked immunosorbent assay (ELISA) titer to the RSV F protein from study entry to Study Day 56
Measure: Number of participants infected with vaccine virus Time: Measured through Day 56Description: Determined from virologic assays
Measure: Peak titer of vaccine virus shed Time: Measured through Day 28Description: As determined by a) culture and b) reverse transcription polymerase chain reaction (RT-PCR)
Measure: Duration of virus shedding in nasal washes Time: Measured through Day 28Description: Determined from virologic and immunologic assays
Measure: Frequency of a greater than or equal to 4-fold rise in RSV serum neutralizing antibody titer Time: Measured through Day 56Description: Assessed by 60% RSV plaque reduction neutralization assay at study entry and Study Day 56
Measure: Frequency of RSV neutralizing antibody responses Time: Measured through Day 56Description: Assessed by ELISA
Measure: Frequency of a greater than or equal to 4-fold rise in serum antibody titers to RSV F glycoprotein Time: Measured through Day 56Description: Assessed by ELISA
Measure: Frequency of antibody responses to RSV F glycoprotein Time: Measured through Day 56Description: Illness graded by severity based on clinical assessments
Measure: Frequency of symptomatic, medically attended respiratory and febrile illness AEs in the vaccine and placebo recipients who experience natural infection with wt RSV during the subsequent RSV season Time: Measured through Month 12Description: Determined from virologic and immunologic assays
Measure: Frequency of antibody responses in the vaccine and placebo recipients who experience natural infection with wt RSV during the subsequent RSV season Time: Measured through Month 13Allocation: Randomized
Parallel Assignment
There is one SNP
Randomized Phase I Study of the Infectivity, Safety, and Immunogenicity of a Single Dose of the Recombinant Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccines RSV ΔNS2/Δ1313/I1314L or RSV 276 or Placebo, Delivered as Nose Drops to RSV-Seronegative Infants 6 to 24 Months of Age. --- I1314L ---
Evaluating the Infectivity, Safety, and Immunogenicity of the Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccines RSV ΔNS2/Δ1313/I1314L or RSV 276 in RSV-Seronegative Infants 6 to 24 Months of Age The purpose of this study is to evaluate the infectivity, safety, and immunogenicity of the recombinant live-attenuated respiratory syncytial virus (RSV) vaccines RSV ΔNS2/Δ1313/I1314L or RSV 276 or placebo when delivered as nose drops to RSV-seronegative infants 6 to 24 months of age. --- I1314L ---
Evaluating the Infectivity, Safety, and Immunogenicity of the Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccines RSV ΔNS2/Δ1313/I1314L or RSV 276 in RSV-Seronegative Infants 6 to 24 Months of Age The purpose of this study is to evaluate the infectivity, safety, and immunogenicity of the recombinant live-attenuated respiratory syncytial virus (RSV) vaccines RSV ΔNS2/Δ1313/I1314L or RSV 276 or placebo when delivered as nose drops to RSV-seronegative infants 6 to 24 months of age. --- I1314L --- --- I1314L ---
This study will evaluate the infectivity, safety, and immunogenicity of two recombinant live-attenuated RSV vaccines: RSV ΔNS2/Δ1313/I1314L and RSV 276. --- I1314L ---
Participants will be randomly assigned to receive a single dose of the RSV ΔNS2/Δ1313/I1314L vaccine, the RSV 276 vaccine, or placebo at study entry (Day 0). --- I1314L ---