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Report for Clinical Trial NCT03422237

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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 and Children 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 and children 6 to 24 months of age. This study is a companion study to IMPAACT 2018.

NCT03422237 Respiratory Syncytial Virus Infections
MeSH:Respiratory Syncytial Virus Infections

3 Interventions

Name: RSV ΔNS2/Δ1313/I1314L

Description: 10^6 plaque-forming units (PFU); administered as nose drops
Type: Biological
Group Labels: 1

RSV ΔNS2/Δ1313/I1314L vaccine

Name: RSV 276

Description: 10^5 PFU; administered as nose drops
Type: Biological
Group Labels: 1

RSV 276 vaccine

Name: Placebo

Description: Administered as nose drops
Type: Biological
Group Labels: 1

Placebo


Primary Outcomes

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 28

Description: Defined as all other AEs that are not solicited AEs

Measure: Grades of study product-related unsolicited AEs

Time: Measured through Day 28

Description: SAEs as defined in the protocol

Measure: Grades of study product-related serious adverse events (SAEs)

Time: Measured through Day 56

Description: 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 RSV

Time: Measured through Day 56

Description: Determined from virologic assays

Measure: Peak titer of vaccine virus shed

Time: Measured through Day 28

Description: 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 28

Description: 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 56

Description: 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 56

Description: 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 56

Description: Assessed by ELISA

Measure: Frequency of antibody responses to RSV F glycoprotein

Time: Measured through Day 56

Secondary Outcomes

Description: 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 13

Description: 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 13

Description: Determined from virologic and immunologic assays

Measure: Frequency of B cell response to vaccine

Time: Measured through Month 13

Description: Determined from nasal wash or nasosorption samples

Measure: Frequency of mucosal antibody responses to vaccine

Time: Measured through Month 13

Purpose: Prevention

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 I1314L

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 and Children 6 to 24 Months of Age. --- I1314L ---

Evaluating the Infectivity, Safety, and Immunogenicity of the Recombinant Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccines RSV ΔNS2/Δ1313/I1314L or RSV 276 in RSV-Seronegative Infants and Children 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 and children 6 to 24 months of age. --- I1314L ---

Evaluating the Infectivity, Safety, and Immunogenicity of the Recombinant Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccines RSV ΔNS2/Δ1313/I1314L or RSV 276 in RSV-Seronegative Infants and Children 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 and children 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 ---



HPO Nodes