SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT01893554

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

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

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.

NCT01893554 Respiratory Syncytial Virus Infections
MeSH: Virus Diseases Respiratory Syncytial Virus Infections

2 Interventions

Name: RSV ΔNS2 Δ1313 I1314L Vaccine

Description: 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: Placebo

Description: 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


Primary Outcomes

Measure: Frequency and severity of vaccine-related solicited adverse events (AEs) that occur during the intensive monitoring phase of the study

Time: Measured at Days 0-10 for seropositive children and Days 0-28 for seronegative infants and children

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

Purpose: Prevention

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 I1314L

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 ---



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