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SNPMiner SNPMiner Trials (Home Page)

Report for Mutation I1314L

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

There are 4 clinical trials

Clinical Trials

1 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
Conditions
  1. Respiratory Syncytial Virus Infections
Interventions
  1. Biological: RSV ΔNS2 Δ1313 I1314L Vaccine
  2. Biological: Placebo
MeSH:Respiratory Syncytial Virus Infections

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 ---

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
2 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

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.

NCT03227029
Conditions
  1. Respiratory Syncytial Virus Infections
Interventions
  1. Biological: RSV ΔNS2/Δ1313/I1314L
  2. Biological: RSV 276
  3. Biological: Placebo
MeSH:Respiratory Syncytial Virus Infections

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 ---

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 vaccine virus

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 12

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
3 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
Conditions
  1. Respiratory Syncytial Virus Infections
Interventions
  1. Biological: RSV ΔNS2/Δ1313/I1314L
  2. Biological: RSV 276
  3. Biological: Placebo
MeSH:Respiratory Syncytial Virus Infections

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 ---

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
4 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

The purpose of this study is 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.

NCT03916185
Conditions
  1. Respiratory Syncytial Virus (RSV)
Interventions
  1. Biological: RSV ΔNS2/Δ1313/I1314L Vaccine
  2. Biological: RSV 6120/ΔNS2/1030s Vaccine
  3. Biological: RSV 276 Vaccine
  4. Biological: Placebo
MeSH:Virus Diseases

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. --- I1314L ---

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 The purpose of this study is 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. --- I1314L ---

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 The purpose of this study is 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. --- I1314L --- --- I1314L ---

Respiratory Syncytial Virus (RSV) Virus Diseases This study will 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. --- I1314L ---

Participants will be 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. --- I1314L ---

Primary Outcomes

Description: Solicited adverse events include fever; otitis media; upper respiratory illness (URI); lower respiratory illness (LRI) and are graded following a protocol-defined grading system for solicited events.

Measure: Frequency of Grade 1 or higher solicited adverse events (AEs)

Time: Measured through Day 28

Description: Graded following a protocol-defined grading system for solicited events

Measure: Frequency of Grade 2 or higher lower respiratory illnesses (LRIs)

Time: Measured through Day 28

Description: Serious adverse events are defined according to Version 2.0 of the DAIDS EAE Manual.

Measure: Frequency of serious AEs

Time: Measured through Day 56

Description: Determined from immunologic assays

Measure: Frequency of a greater than or equal to 4-fold rise in serum RSV-neutralizing antibody titer

Time: Measured through Day 56

Secondary Outcomes

Description: Determined from immunologic assays

Measure: Frequency of a greater than or equal to 4-fold rise in serum RSV F immunoglobulin G (IgG)

Time: Measured through Day 56

Description: Determined from immunologic assays

Measure: Titer of serum RSV F IgG

Time: Measured at the Day 56 Visit

Description: Determined from immunologic assays

Measure: Titer of serum RSV-neutralizing antibodies

Time: Measured at the Day 56 Visit

Description: Graded following a protocol-defined grading system for solicited events

Measure: Frequency of RSV-associated medically attended acute respiratory illness (RSV-MAARI)

Time: Measured through the last day of the RSV season, which will occur between 5 and 12 months after study entry, depending on when the participant enrolls in the study

Description: Graded following a protocol-defined grading system for solicited events

Measure: Maximum grade (if more than one illness within a participant) of RSV-MAARI

Time: Measured through the last day of the RSV season, which will occur between 5 and 12 months after study entry, depending on when the participant enrolls in the study

Description: Graded following a protocol-defined grading system for solicited events

Measure: Frequency of RSV-associated medically attended acute lower respiratory illness (RSV-MAALRI)

Time: Measured through the last day of the RSV season, which will occur between 5 and 12 months after study entry, depending on when the participant enrolls in the study

Description: Graded following a protocol-defined grading system for solicited events

Measure: Maximum grade (if more than one illness within a participant) of RSV-MAALRI

Time: Measured through the last day of the RSV season, which will occur between 5 and 12 months after study entry, depending on when the participant enrolls in the study

HPO Nodes