Human respiratory syncytial virus (RSV) is a common cause of respiratory illness in infants and children around the world. This study will evaluate the safety and immune response to a RSV vaccine in three groups of participants: healthy children who have already had an RSV infection (RSV seropositive), healthy infants and children who have not already had an RSV infection (RSV seronegative), and healthy younger infants who have not been screened for prior RSV infection.
Name: RSV ΔNS2 Δ1313 I1314L VaccineDescription: For participants in Groups 1, 3, and 4: 10^6 plaque forming units (PFU) of RSV ΔNS2 Δ1313 I1314L vaccine will be administered as nose drops (0.25 mL per nostril for a total of 0.5 mL). For participants in Group 2: 10^5 PFU of RSV ΔNS2 Δ1313 I1314L vaccine will be administered as nose drops (0.25 mL per nostril for a total of 0.5 mL).Type: Biological
Group 1: RSV vaccine Group 2: RSV vaccine Group 3: RSV vaccine Group 4: RSV vaccine
Name: PlaceboDescription: Placebo will be administered as nose drops (0.25 mL per nostril for a total of 0.5 mL).Type: Biological
Group 1: Placebo Group 2: Placebo Group 3: Placebo Group 4: Placebo
Description: Antibody responses to the RSV F glycoprotein will also be assessed by enzyme-linked immunosorbent assay (ELISA).Measure: Proportion of participants that develop 4-fold or greater rises in RSV neutralizing antibody titer following vaccination Time: Measured through follow-up period, up to 1 year after study entry
There is one SNP
A Phase I Study of the Safety and Immunogenicity of a Single Dose of the Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine RSV ΔNS2 Δ1313 I1314L, Lot RSV#006A, Delivered as Nose Drops to RSV-Seropositive Children 12 to 59 Months of Age, RSV-Seronegative Infants and Children 6 to 24 Months of Age, and Infants 4 to 6 Months of Age. --- I1314L ---