SNPMiner Trials by Shray Alag

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SNPMiner SNPMiner Trials (Home Page)


Report for Mutation L460D

Developed by Shray Alag, 2020-2021.
SNP Clinical Trial Gene

There are 2 clinical trials

Clinical Trials


1 A Dose-Finding Study to Assess the Safety, Tolerability, and Immunogenicity of Inactivated Streptococcus Pneumoniae Whole Cell Vaccine Formulated With Alum (PATH-wSP) in Healthy Kenyan Young Adults and PCV-Primed Toddlers

The purpose of this study is to assess the safety and tolerability of PATH-wSP, administered intramuscularly to healthy Kenyan adults and toddlers who have been primed with a pneumococcal conjugate vaccine (PCV). Additionally, the study will explore whether a measurable immune response is elicited when PATH-wSP is administered to healthy Kenyan adults and toddlers who have been primed with PCV.

NCT02097472
Conditions
  1. Pneumonia, Pneumococcal
Interventions
  1. Biological: PATH-wSP
  2. Biological: Synflorix
  3. Biological: Pentavac
  4. Other: Saline
MeSH:Pneumonia, Pneumococcal Pneumonia
HPO:Pneumonia

Severity was defined in the protocol as grade 0-4 (none, mild, moderate, and severe).. Geometric Mean Concentrations (GMC) of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: ELISA Assay. --- L460D ---

Measured with enzyme-linked immunosorbent assay (ELISA).. Geometric Mean Concentrations (GMC) of IgG Antibodies Against L460D Pneumococcal Protein. --- L460D ---

Geometric Mean Fold Change of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: ELISA. --- L460D ---

Geometric Mean Fold Change of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: MSD. --- L460D ---

Fold Change in IgG Response to Pneumolysoid (L460D) Pneumococcal Protein Among Toddler Cohort (ELISA). --- L460D ---

Fold Change in IgG Response to L460D Pneumococcal Protein (MSD). --- L460D ---

Primary Outcomes

Description: Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination.

Measure: Number/Percent of Adult Subjects Experiencing Fatigue/Malaise Following Vaccination

Time: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)

Description: Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination.

Measure: Number/Percent of Adult Subjects Experiencing Myalgia Following Vaccination

Time: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)

Description: Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination. Grade 2 includes repeated use of non-narcotic pain reliever for more than 24 hours.

Measure: Number/Percent of Adult Subjects Experiencing Headache Following Vaccination

Time: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)

Description: Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination. Grade 2 includes use of non-narcotic pain reliever for more than 24 hours.

Measure: Number/Percent of Adult Subjects Experiencing Pain at Injection Site Following Vaccination

Time: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)

Description: Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination.

Measure: Number/Percent of Adult Subjects Experiencing Tenderness at Injection Site Following Vaccination

Time: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)

Description: Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination. Grade 1: does not interfere with activity Grade 2: interferes with activity

Measure: Number/Percent of Adult Subjects Experiencing Induration at Injection Site Following Vaccination

Time: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)

Description: Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination.

Measure: Number/Percent of Adult Subjects Experiencing Fever at Injection Site Following Vaccination

Time: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)

Description: Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination.

Measure: Number/Percent of Toddler Subjects Experiencing Fever Following Vaccination

Time: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)

Description: Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination. Grade 2: includes diffuse macular/maculopapular/morbilliform rash

Measure: Number/Percent of Toddler Subjects Experiencing Cutaneous Rash Following Vaccination

Time: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)

Description: Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination. Severity was defined in the protocol as grade 0-4 (none, mild, moderate, and severe).

Measure: Number/Percent of Toddler Subjects Experiencing Irritability Following Vaccination

Time: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)

Description: Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination. Severity was defined in the protocol as grade 0-4 (none, mild, moderate, and severe).

Measure: Number/Percent of Toddler Subjects Experiencing Drowsiness Following Vaccination

Time: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)

Description: Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination. Severity was defined in the protocol as grade 0-4 (none, mild, moderate, and severe).

Measure: Number/Percent of Toddler Subjects Experiencing Loss of Appetite Following Vaccination

Time: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)

Description: Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination.

Measure: Number/Percent of Toddler Subjects Experiencing Pain/Tenderness at Injection Site Following Vaccination

Time: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)

Description: Solicited reactions were assessed for severity during the 60 minutes post vaccination time period, daily for the first week by Field Staff and then at the clinic visit 1 week post vaccination. Severity was defined in the protocol as grade 0-4 (none, mild, moderate, and severe).

Measure: Number/Percent of Toddler Subjects Experiencing Induration/Swelling at Injection Site Following Vaccination

Time: up to 1 week following first vaccination (Day 7) or second vaccination (Day 35)

Secondary Outcomes

Description: Measured with enzyme-linked immunosorbent assay (ELISA).

Measure: Geometric Mean Concentrations (GMC) of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: ELISA Assay

Time: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Description: Measured with enzyme-linked immunosorbent assay (ELISA).

Measure: Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: ELISA Assay

Time: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Description: Measured using meso scale discovery (MSD).

Measure: Geometric Mean Concentrations (GMC) of IgG Antibodies Against L460D Pneumococcal Protein

Time: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Measure: Geometric Mean Concentrations (GMC) of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: Meso Scale Discovery (MSD) Assay

Time: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Description: Measured using Meso Scale Discovery (MSD) Assay

Measure: Geometric Mean Concentrations (GMC) of IgG Antibodies Against PhtD Pneumococcal Protein

Time: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Description: Measured using Meso Scale Discovery (MSD) Assay

Measure: Geometric Mean Concentrations (GMC) of IgG Antibodies Against BCH0785 Pneumococcal Protein

Time: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Description: Measured using Meso Scale Discovery (MSD) Assay

Measure: Geometric Mean Concentrations (GMC) of IgG Antibodies Against StkP Pneumococcal Protein

Time: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Description: Measured using Meso Scale Discovery (MSD) Assay

Measure: Geometric Mean Concentrations (GMC) of IgG Antibodies Against PcpA Pneumococcal Protein

Time: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Description: MSD Assay

Measure: Geometric Mean Concentrations (GMC) of IgG Antibodies Against SPWCA Pneumococcal Protein

Time: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Description: MSD Assay

Measure: Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiuA Pneumococcal Protein

Time: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Description: MSD Assay

Measure: Geometric Mean Concentrations (GMC) of IgG Antibodies Against PiaA Pneumococcal Protein

Time: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Description: Measured using ELISA

Measure: Geometric Mean Fold Change of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: ELISA

Time: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Description: Measured using ELISA

Measure: Geometric Mean Fold Change of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: ELISA

Time: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Description: Measured using MSD

Measure: Geometric Mean Fold Change of IgG Antibodies Against Pneumolysoid (L460D) Pneumococcal Protein: MSD

Time: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Description: Measured using ELISA

Measure: Geometric Mean Fold Change of IgG Antibodies Against PspA-Fam1 Pneumococcal Protein: MSD

Time: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Description: Measured using MSD

Measure: Geometric Mean Fold Change of IgG Antibodies Against PhtD Pneumococcal Protein

Time: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Description: Measured using MSD

Measure: Geometric Mean Fold Change of IgG Antibodies Against BCH0785 Pneumococcal Protein

Time: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Description: Measured using MSD

Measure: Geometric Mean Fold Change of IgG Antibodies Against StkP Pneumococcal Protein

Time: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Description: Measured using MSD

Measure: Geometric Mean Fold Change of IgG Antibodies Against PcpA Pneumococcal Protein

Time: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Description: Measured using MSD

Measure: Geometric Mean Fold Change of IgG Antibodies Against SPWCA Pneumococcal Protein

Time: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Description: Measured using MSD

Measure: Geometric Mean Fold Change of IgG Antibodies Against PiuA Pneumococcal Protein

Time: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Description: Measured using MSD

Measure: Geometric Mean Fold Change of IgG Antibodies Against PiaA Pneumococcal Protein

Time: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Description: Measured using ELISA

Measure: Fold Change in IgG Response to Pneumolysoid (L460D) Pneumococcal Protein Among Toddler Cohort (ELISA)

Time: 28 days (post-vaccination 1) and 56 days (post-vaccination 2)

Description: Measured using ELISA

Measure: Fold Change in IgG Response to PspA-Fam1 (ELISA)

Time: 28 days (post-vaccination 1) and 56 days (post-vaccination 2)

Description: Measured using MSD

Measure: Fold Change in IgG Response to L460D Pneumococcal Protein (MSD)

Time: 28 days (post-vaccination 1) and 56 days (post-vaccination 2)

Description: Measured using MSD

Measure: Fold Change in IgG Response to PspA-Fam1 Pneumococcal Protein (MSD)

Time: 28 days (post-vaccination 1) and 56 days (post-vaccination 2)

Description: Measured using MSD

Measure: Fold Change in IgG Response to PhtD Pneumococcal Protein

Time: 28 days (post-vaccination 1) and 56 days (post-vaccination 2)

Description: Measured using MSD

Measure: Fold Change in IgG Response to BCH0785 Pneumococcal Protein

Time: 28 days (post-vaccination 1) and 56 days (post-vaccination 2)

Description: Measured using MSD

Measure: Fold Change in IgG Response to StkP Pneumococcal Protein

Time: 28 days (post-vaccination 1) and 56 days (post-vaccination 2)

Description: Measured using MSD

Measure: Fold Change in IgG Response to PcpA Pneumococcal Protein

Time: 28 days (post-vaccination 1) and 56 days (post-vaccination 2)

Description: Measured using MSD

Measure: Fold Change in IgG Response to SPWCA Pneumococcal Protein

Time: 28 days (post-vaccination 1) and 56 days (post-vaccination 2)

Description: Measured using MSD

Measure: Fold Change in IgG Response to PiuA Pneumococcal Protein

Time: 28 days (post-vaccination 1) and 56 days (post-vaccination 2)

Description: Measured using MSD

Measure: Fold Change in IgG Response to PiaA Pneumococcal Protein

Time: 28 days (post-vaccination 1) and 56 days (post-vaccination 2)

Description: Functional antibody responses to Ply (pneumolysin) were assessed using a toxin neutralization assay based on the ability of antibodies to neutralize wild-type Ply-induced lysis of rabbit red blood cells. Briefly, serial 2-fold dilutions (starting at 1/5 dilution) of human serum samples were added together with wild-type Ply in 96-well plates. Rabbit red blood cells were then added and following incubation supernatants removed and transferred to new 96-well plates and absorbance measured at 540 nm using a spectrophotometer plate reader. The mean A450 nm blank value was subtracted by 10% to obtain the Plate Specific Cut Point for each plate. Each sample was categorized as negative (<1/20) or positive (with titer between 1/20 and 1/320).

Measure: Number/Percentage of Adult Subjects With Neutralizing Antibody Response to Pneumolysin

Time: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Description: Functional antibody responses to Ply (pneumolysin) were assessed using a toxin neutralization assay based on the ability of antibodies to neutralize wild-type Ply-induced lysis of rabbit red blood cells. Briefly, serial 2-fold dilutions (starting at 1/5 dilution) of human serum samples were added together with wild-type Ply in 96-well plates. Rabbit red blood cells were then added and following incubation supernatants removed and transferred to new 96-well plates and absorbance measured at 540 nm using a spectrophotometer plate reader. The mean A450 nm blank value was subtracted by 10% to obtain the Plate Specific Cut Point for each plate. Each sample was categorized as negative (<1/20) or positive (with titer between 1/20 and 1/320).

Measure: Number/Percentage of Toddler Subjects With Neutralizing Antibody Response to Pneumolysin

Time: 0 days, 28 days (Dose 1) and 56 days (Dose 2)

Other Outcomes

Description: GMCs of these IgG proteins were measured to assess potential interference of PATH-wSP with 10-valent pneumococcal conjugate vaccine (Synflorix). GMCs of Cohort 1 were measured at a different time point than those in Cohort 2, so results are presented separately.

Measure: Geometric Mean Concentration (GMCs) of PNC-IgG Serotypes Among Toddler Subjects

Time: 12 weeks (Cohort 1) and 4 weeks (Cohort 2) post-vaccination 1

Description: GMCs of these proteins were measured to assess potential interference of PATH-wSP with Pentavac booster dose.

Measure: Geometric Mean Concentration (GMC) Ratio of Diptheria Booster Immune Response Among Toddler Subjects

Time: 12 weeks post vaccination 1

Description: GMCs of these proteins were measured to assess potential interference of PATH-wSP with Pentavac booster dose.

Measure: Geometric Mean Concentration (GMC) Ratio of Hepatitis B Booster Immune Response Among Toddler Subjects

Time: 12 weeks post vaccination 1

Description: GMCs of these proteins were measured to assess potential interference of PATH-wSP with Pentavac booster dose.

Measure: Geometric Mean Concentration (GMC) Ratio of Haemophilus Influenzae Type b (Hib) Booster Immune Response Among Toddler Subjects

Time: 12 weeks post vaccination 1

Description: GMCs of these proteins were measured to assess potential interference of PATH-wSP with Pentavac booster dose.

Measure: Geometric Mean Concentration (GMC) Ratio of Pertussis FHA and Pertussis Toxin Immune Response Among Toddler Subjects

Time: 12 weeks post vaccination 1

Description: GMCs of these proteins were measured to assess potential interference of PATH-wSP with Pentavac booster dose.

Measure: Geometric Mean Concentration (GMC) Ratio of Pertussis Fimbriae Immune Response Among Toddler Subjects

Time: 12 weeks post vaccination 1

Description: GMCs of these proteins were measured to assess potential interference of PATH-wSP with Pentavac booster dose.

Measure: Geometric Mean Concentration (GMC) Ratio of Tetanus Booster Immune Response Among Toddler Subjects

Time: 12 weeks post vaccination 1

2 A Prospective Study to Assess the Nasopharyngeal Carriage of Streptococcus Pneumoniae (SPn), Long Term Safety and Immune Persistence in Healthy Kenyan PCV-Primed Toddlers (12-15 Months of Age) Who Received a Whole Cell Pneumococcal Vaccine (PATH-wSP) Compared to Controls

This study evaluated the change in nasopharyngeal carriage (NPC) of Streptococcus pneumoniae (SPn), hypothesizing that it would be reduced post-vaccination with Streptococcus pneumoniae whole cell vaccine with aluminum hydroxide adjuvant (PATH-wSP) and that PATH-wSP would remain safe and well-tolerated over the course of the study.

NCT02146365
Conditions
  1. Pneumococcal Disease
MeSH:Pneumococcal Infections

Immunogenicity was evaluated based on the following assays: Immunoglobulin (IgG) response to pneumolysoid [L460D] and pneumococcal surface protein A family 1 [PspA-Fam1] was measured by enzyme-linked immunosorbent assay (ELISA). --- L460D ---

IgG response to the following pneumococcal proteins was measured using the Meso Scale Discovery (MSD) platform: L460D PspA-Fam1 Pneumococcal histidine triad D (PhtD) Boston Children's Hospital protein 785 (BCH0785) Serine threonine kinase protein (StkP) Pneumococcal choline-binding protein A (PcpA) Streptococcus pneumonia whole cell antigen (SPWCA) Pneumococcal iron uptake protein A (PiuA) Pneumococcal iron acquisition protein A (PiaA). --- L460D ---

Immunogenicity was evaluated based on the following assays: Immunoglobulin (IgG) response to pneumolysoid (L460D) and pneumococcal surface protein A family 1 (PspA-Fam1) was measured by enzyme-linked immunosorbent assay (ELISA). --- L460D ---

Immunogenicity was evaluated based on the following assays: IgG response to pneumolysoid [L460D] and pneumococcal surface protein A family 1 [PspA-Fam1] was measured by enzyme-linked immunosorbent assay (ELISA). --- L460D ---

IgG response to the following pneumococcal proteins was measured using the Meso Scale Discovery (MSD) platform: L460D PspA-Fam1 Pneumococcal histidine triad D (PhtD) Boston Children's Hospital protein 785 (BCH0785) Serine threonine kinase protein (StkP) Pneumococcal choline-binding protein A (PcpA) Streptococcus pneumonia whole cell antigen (SPWCA) Pneumococcal iron uptake protein A (PiuA) Pneumococcal iron acquisition protein A (PiaA) The fold-change was calculated as the 6-month post-vaccination (Week 32) IgG response divided by the Baseline IgG response.. Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2. The percentage of participants with a seroresponse, defined as a ≥ 2, ≥ 3, and ≥ 4 fold-rise above Baseline in IgG antibody levels against Pneumococcal proteins. --- L460D ---

Primary Outcomes

Description: The prevalence of Streptococcus pneumoniae (SPn) in the nasopharynx was measured by the number (and percentage) of participants positive for SPn detected by quantitative polymerase chain reaction (qPCR) from nasopharyngeal swabs taken at each study visit. NPC endpoints were analyzed within combined study groups: PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only plus non-interventional participants enrolled during Cohort 1 PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only plus non-interventional participants enrolled during Cohort 2

Measure: Prevalence of Streptococcus Pneumoniae in Nasopharynx

Time: Week 0, Week 12, Week 16, Week 20, Week 32

Description: The density of Streptococcus pneumoniae (SPn) in the nasopharynx was measured by the number of autolysin (LytA) gene copies detected by quantitative polymerase chain reaction (qPCR) from nasopharyngeal swabs taken at each study visit. NPC endpoints were analyzed within combined study groups: PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only plus non-interventional group enrolled during Cohort 1 PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only, plus non-interventional group enrolled during Cohort 2

Measure: Density of Streptococcus Pneumoniae in the Nasopharynx

Time: Week 0, Week 12, Week 16, Week 20, Week 32

Secondary Outcomes

Description: Immunogenicity was evaluated based on the following assays: Immunoglobulin (IgG) response to pneumolysoid [L460D] and pneumococcal surface protein A family 1 [PspA-Fam1] was measured by enzyme-linked immunosorbent assay (ELISA). IgG response to the following pneumococcal proteins was measured using the Meso Scale Discovery (MSD) platform: L460D PspA-Fam1 Pneumococcal histidine triad D (PhtD) Boston Children's Hospital protein 785 (BCH0785) Serine threonine kinase protein (StkP) Pneumococcal choline-binding protein A (PcpA) Streptococcus pneumonia whole cell antigen (SPWCA) Pneumococcal iron uptake protein A (PiuA) Pneumococcal iron acquisition protein A (PiaA)

Measure: Geometric Mean Concentration (GMC) of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins

Time: Baseline (Week 0), 4 weeks post-vaccination 2 (Week 12), and 6 months post-vaccination 2 (Week 32).

Description: Data reported are the geometric mean concentration at 6 months post-vaccination 2 (Week 32) for each PATH-wSP group divided by the Booster (Synflorix and Pentavax)-only group (N=38). Immunogenicity was evaluated based on the following assays: Immunoglobulin (IgG) response to pneumolysoid (L460D) and pneumococcal surface protein A family 1 (PspA-Fam1) was measured by enzyme-linked immunosorbent assay (ELISA). IgG response to the following pneumococcal proteins was measured using the Meso Scale Discovery (MSD) platform: L460D PspA-Fam1 Pneumococcal histidine triad D (PhtD) Boston Children's Hospital protein 785 (BCH0785) Serine threonine kinase protein (StkP) Pneumococcal choline-binding protein A (PcpA) Streptococcus pneumonia whole cell antigen (SPWCA) Pneumococcal iron uptake protein A (PiuA) Pneumococcal iron acquisition protein A (PiaA)

Measure: Geometric Mean Concentration Ratios of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins for PATH-wSP Groups Versus the Booster Only Group

Time: Week 32

Description: Immunogenicity was evaluated based on the following assays: IgG response to pneumolysoid [L460D] and pneumococcal surface protein A family 1 [PspA-Fam1] was measured by enzyme-linked immunosorbent assay (ELISA). IgG response to the following pneumococcal proteins was measured using the Meso Scale Discovery (MSD) platform: L460D PspA-Fam1 Pneumococcal histidine triad D (PhtD) Boston Children's Hospital protein 785 (BCH0785) Serine threonine kinase protein (StkP) Pneumococcal choline-binding protein A (PcpA) Streptococcus pneumonia whole cell antigen (SPWCA) Pneumococcal iron uptake protein A (PiuA) Pneumococcal iron acquisition protein A (PiaA) The fold-change was calculated as the 6-month post-vaccination (Week 32) IgG response divided by the Baseline IgG response.

Measure: Geometric Mean Fold Change of Immunoglobulin G (IgG) Antibodies Against Pneumococcal Proteins

Time: Baseline and Week 32

Description: The percentage of participants with a seroresponse, defined as a ≥ 2, ≥ 3, and ≥ 4 fold-rise above Baseline in IgG antibody levels against Pneumococcal proteins. Fold-rise was calculated as the 6-month post-vaccination (Week 32) IgG response divided by the Baseline IgG level. Immunogenicity was evaluated based on the following assays: IgG response to pneumolysoid [L460D] and pneumococcal surface protein A family 1 [PspA-Fam1] was measured by enzyme-linked immunosorbent assay (ELISA). IgG response to the following pneumococcal proteins was measured using the Meso Scale Discovery (MSD) platform: L460D PspA-Fam1 Pneumococcal histidine triad D (PhtD) Boston Children's Hospital protein 785 (BCH0785) Serine threonine kinase protein (StkP) Pneumococcal choline-binding protein A (PcpA) Streptococcus pneumonia whole cell antigen (SPWCA) Pneumococcal iron uptake protein A (PiuA) Pneumococcal iron acquisition protein A (PiaA)

Measure: Percentage of Participants Meeting Seroresponse Fold-Rise Categories at 6 Months Post Vaccination 2

Time: Baseline and Week 32

Description: Neutralizing antibody responses to pneumolysin were assessed at Baseline and 6 months post vaccination 2 using an in vitro toxin neutralization assay that measures the ability of antibodies to neutralize wild-type pneumolysin-induced lysis of rabbit red blood cells. Each sample was categorized as negative (< 1/20 dilution) or positive (with titer between 1/20 and 1/320 dilution). Responses at higher dilutions indicate higher levels of neutralizing antibodies to pneumolysin.

Measure: Number of Participants With Neutralizing Antibody Response to Pneumolysin

Time: Baseline (Week 0) and 6 months post-vaccination 2 (Week 32)

Description: An AE was defined as any untoward, undesired, or unplanned event in the form of signs, symptoms, disease, or laboratory or psychological/physiologic observations occurring in a person in a clinical study. The AEs collected in this non-interventional study were those that remained open after the last visit in the VAC-010 Study, those attributed to study vaccine in VAC-010 with onset after the participant exited VAC-010, those that were related to a VAC-011 procedure (i.e. blood draw, nasal swab sample), and all serious adverse events.

Measure: Number of Adverse Events (AE)

Time: 32 weeks; for participants enrolled concurrently in Study VAC-010 adverse events were collected after the last VAC-010 visit through to Week 32.

Description: Nasopharyngeal samples were further analyzed for the prevalence of specific Streptococcus pneumoniae serotypes by microarray. The number of participants with a positive result for SPn serotype 11A/D/E [11A] is reported. NPC endpoints were analyzed within combined study groups: PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only, plus non-interventional group enrolled during Cohort 1 PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only, plus non-interventional group enrolled during Cohort 2

Measure: Prevalence of Streptococcus Pneumoniae Serotype 11A/D/E [11A] in the Nasopharynx

Time: Week 0, Week 12, Week 16, Week 20, Week 32

Description: Nasopharyngeal samples were further analyzed for the prevalence of specific Streptococcus pneumoniae serotypes by microarray. The number of participants with a positive result for SPn serotype 13 is reported. NPC endpoints were analyzed within combined study groups: PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only, plus non-interventional group enrolled during Cohort 1 PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only, plus non-interventional group enrolled during Cohort 2

Measure: Prevalence of Streptococcus Pneumoniae Serotype 13 in the Nasopharynx

Time: Week 0, Week 12, Week 16, Week 20, Week 32

Description: Nasopharyngeal samples were further analyzed for the prevalence of specific Streptococcus pneumoniae serotypes by microarray. The number of participants with a positive result for SPn serotype 15A is reported. NPC endpoints were analyzed within combined study groups: PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only, plus non-interventional group enrolled during Cohort 1 PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only, plus non-interventional group enrolled during Cohort 2

Measure: Prevalence of Streptococcus Pneumoniae Serotype 15A in the Nasopharynx

Time: Week 0, Week 12, Week 16, Week 20, Week 32

Description: Nasopharyngeal samples were further analyzed for the prevalence of specific Streptococcus pneumoniae serotypes by microarray. The number of participants with a positive result for SPn serotype 15B/C [15B] is reported. NPC endpoints were analyzed within combined study groups: PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only, plus non-interventional group enrolled during Cohort 1 PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only, plus non-interventional group enrolled during Cohort 2

Measure: Prevalence of Streptococcus Pneumoniae Serotype 15B/C [15B] in the Nasopharynx

Time: Week 0, Week 12, Week 16, Week 20, Week 32

Description: Nasopharyngeal samples were further analyzed for the prevalence of specific Streptococcus pneumoniae serotypes by microarray. The number of participants with a positive result for SPn serotype 19A is reported. NPC endpoints were analyzed within combined study groups: PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only, plus non-interventional group enrolled during Cohort 1 PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only, plus non-interventional group enrolled during Cohort 2

Measure: Prevalence of Streptococcus Pneumoniae Serotype 19A in the Nasopharynx

Time: Week 0, Week 12, Week 16, Week 20, Week 32

Description: Nasopharyngeal samples were further analyzed for the prevalence of specific Streptococcus pneumoniae serotypes by microarray. The number of participants with a positive result for SPn serotype 19F is reported. NPC endpoints were analyzed within combined study groups: PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only, plus non-interventional group enrolled during Cohort 1 PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only, plus non-interventional group enrolled during Cohort 2

Measure: Prevalence of Streptococcus Pneumoniae Serotype 19F in the Nasopharynx

Time: Week 0, Week 12, Week 16, Week 20, Week 32

Description: Nasopharyngeal samples were further analyzed for the prevalence of specific Streptococcus pneumoniae serotypes by microarray. The number of participants with a positive result for SPn serotype 3 is reported. NPC endpoints were analyzed within combined study groups: PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only, plus non-interventional group enrolled during Cohort 1 PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only, plus non-interventional group enrolled during Cohort 2

Measure: Prevalence of Streptococcus Pneumoniae Serotype 3 in the Nasopharynx

Time: Week 0, Week 12, Week 16, Week 20, Week 32

Description: Nasopharyngeal samples were further analyzed for the prevalence of specific Streptococcus pneumoniae serotypes by microarray. The number of participants with a positive result for SPn serotype 35B is reported. NPC endpoints were analyzed within combined study groups: PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only, plus non-interventional group enrolled during Cohort 1 PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only, plus non-interventional group enrolled during Cohort 2

Measure: Prevalence of Streptococcus Pneumoniae Serotype 35B in the Nasopharynx

Time: Week 0, Week 12, Week 16, Week 20, Week 32

Description: Nasopharyngeal samples were further analyzed for the prevalence of specific Streptococcus pneumoniae serotypes by microarray. The number of participants with a positive result for SPn serotype 6A/B [6A] is reported. NPC endpoints were analyzed within combined study groups: PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only, plus non-interventional group enrolled during Cohort 1 PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only, plus non-interventional group enrolled during Cohort 2

Measure: Prevalence of Streptococcus Pneumoniae Serotype 6A/B [6A] in the Nasopharynx

Time: Week 0, Week 12, Week 16, Week 20, Week 32

Description: Nasopharyngeal samples were further analyzed for the prevalence of specific Streptococcus pneumoniae serotypes by microarray. The number of participants with a positive result for SPn serotype NT4b is reported. NPC endpoints were analyzed within combined study groups: PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only, plus non-interventional group enrolled during Cohort 1 PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only, plus non-interventional group enrolled during Cohort 2

Measure: Prevalence of Streptococcus Pneumoniae Serotype NT4b in the Nasopharynx

Time: Week 0, Week 12, Week 16, Week 20, Week 32

Description: The density of Streptococcus pneumoniae serotype 11A/D/E [11A] in the nasopharynx was measured by the number of LytA gene copies detected by microarray from nasopharyngeal swabs taken at each study visit. NPC endpoints were analyzed within combined study groups: PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only, plus non-interventional group enrolled during Cohort 1 PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only, plus non-interventional group enrolled during Cohort 2

Measure: Density of Streptococcus Pneumoniae Serotype 11A/D/E [11A] in the Nasopharynx

Time: Week 0, Week 12, Week 16, Week 20, Week 32

Description: The density of Streptococcus pneumoniae serotype 13 in the nasopharynx was measured by the number of LytA gene copies detected by microarray from nasopharyngeal swabs taken at each study visit. NPC endpoints were analyzed within combined study groups: PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only, plus non-interventional group enrolled during Cohort 1 PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only, plus non-interventional group enrolled during Cohort 2

Measure: Density of Streptococcus Pneumoniae Serotype 13 in the Nasopharynx

Time: Week 0, Week 12, Week 16, Week 20, Week 32

Description: The density of Streptococcus pneumoniae serotype 15A in the nasopharynx was measured by the number of LytA gene copies detected by microarray from nasopharyngeal swabs taken at each study visit. NPC endpoints were analyzed within combined study groups: PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only, plus non-interventional group enrolled during Cohort 1 PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only, plus non-interventional group enrolled during Cohort 2

Measure: Density of Streptococcus Pneumoniae Serotype 15A in the Nasopharynx

Time: Week 0, Week 12, Week 16, Week 20, Week 32

Description: The density of Streptococcus pneumoniae serotype 15B/C [15B] in the nasopharynx was measured by the number of LytA gene copies detected by microarray from nasopharyngeal swabs taken at each study visit. NPC endpoints were analyzed within combined study groups: PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only, plus non-interventional group enrolled during Cohort 1 PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only, plus non-interventional group enrolled during Cohort 2

Measure: Density of Streptococcus Pneumoniae Serotype 15B/C [15B] in the Nasopharynx

Time: Week 0, Week 12, Week 16, Week 20, Week 32

Description: The density of Streptococcus pneumoniae serotype 19A in the nasopharynx was measured by the number of LytA gene copies detected by microarray from nasopharyngeal swabs taken at each study visit. NPC endpoints were analyzed within combined study groups: PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only, plus non-interventional group enrolled during Cohort 1 PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only, plus non-interventional group enrolled during Cohort 2

Measure: Density of Streptococcus Pneumoniae Serotype 19A in the Nasopharynx

Time: Week 0, Week 12, Week 16, Week 20, Week 32

Description: The density of Streptococcus pneumoniae serotype 19F in the nasopharynx was measured by the number of LytA gene copies detected by microarray from nasopharyngeal swabs taken at each study visit. NPC endpoints were analyzed within combined study groups: PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only, plus non-interventional group enrolled during Cohort 1 PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only, plus non-interventional group enrolled during Cohort 2

Measure: Density of Streptococcus Pneumoniae Serotype 19F in the Nasopharynx

Time: Week 0, Week 12, Week 16, Week 20, Week 32

Description: The density of Streptococcus pneumoniae serotype 3 in the nasopharynx was measured by the number of LytA gene copies detected by microarray from nasopharyngeal swabs taken at each study visit. NPC endpoints were analyzed within combined study groups: PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only, plus non-interventional group enrolled during Cohort 1 PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only, plus non-interventional group enrolled during Cohort 2

Measure: Density of Streptococcus Pneumoniae Serotype 3 in the Nasopharynx

Time: Week 0, Week 12, Week 16, Week 20, Week 32

Description: The density of Streptococcus pneumoniae serotype 35B in the nasopharynx was measured by the number of LytA gene copies detected by microarray from nasopharyngeal swabs taken at each study visit. NPC endpoints were analyzed within combined study groups: PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only, plus non-interventional group enrolled during Cohort 1 PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only, plus non-interventional group enrolled during Cohort 2

Measure: Density of Streptococcus Pneumoniae Serotype 35B in the Nasopharynx

Time: Week 0, Week 12, Week 16, Week 20, Week 32

Description: The density of Streptococcus pneumoniae serotype 6A/B [6A] in the nasopharynx was measured by the number of LytA gene copies detected by microarray from nasopharyngeal swabs taken at each study visit. NPC endpoints were analyzed within combined study groups: PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only, plus non-interventional group enrolled during Cohort 1 PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only, plus non-interventional group enrolled during Cohort 2

Measure: Density of Streptococcus Pneumoniae Serotype 6A/B [6A] in the Nasopharynx

Time: Week 0, Week 12, Week 16, Week 20, Week 32

Description: The density of Streptococcus pneumoniae serotype NT4b in the nasopharynx was measured by the number of LytA gene copies detected by microarray from nasopharyngeal swabs taken at each study visit. NPC endpoints were analyzed within combined study groups: PATH-wSP 300 µg: Combines groups who received 300 µg PATH-wSP with or without booster Control (300 µg): Participants in VAC-010 Cohort 1 who received booster-only, plus non-interventional group enrolled during Cohort 1 PATH-wSP 600 µg: Combines groups who received 600 µg PATH-wSP with or without booster Control (600 µg): Participants in VAC-010 Cohort 2 who received booster-only, plus non-interventional group enrolled during Cohort 2

Measure: Density of Streptococcus Pneumoniae Serotype NT4b in the Nasopharynx

Time: Week 0, Week 12, Week 16, Week 20, Week 32


HPO Nodes


HP:0002090: Pneumonia
Genes 280
TLL1 CHD7 TGIF1 KMT2D ACP5 PIGN JAK3 NOS1 SFTPB SRP54 MS4A1 NODAL USB1 CD79B SGCG ACTC1 CASP8 TGFB1 OFD1 CD19 CD247 NHLRC1 SHH NTRK1 EGFR LAMA3 PLOD1 FANCF JAK3 RAG2 PGM3 CACNA1C BTK IL2RG PIK3CD CREBBP KCNJ6 FMO3 ACTA1 TNFSF12 GATA6 ZAP70 PLOD1 UNC119 FGF8 GAS1 DNAI1 WAS GNPTAB FOXH1 CYBC1 LAMC2 RAG1 PEPD PDHA1 PMM2 PAFAH1B1 CD19 CD3D SIX3 CD81 DLL1 LTBP3 EP300 TNFRSF13B SIX3 GLI2 SMARCD2 TIMM8A MYH6 DCLRE1C ABCA3 IL7R TBC1D24 STAT3 CFB FOXH1 FOXP3 FCGR2A P4HTM AP3B1 POLA1 TK2 CDON PKHD1 TAF1 CDON NIPBL GRHL3 GAS1 EFEMP2 CRLF1 SLC35A1 SLC25A24 DOCK8 ZIC2 LEP AFF4 DDR2 CD3E PTPRC BLM RNU4ATAC TNFRSF13C KNSTRN CDON SELENON FOXH1 ORC6 RAG1 RNF168 SHH DISP1 CYBA IL7R CARD11 LONP1 COL11A2 CR2 FGF8 ZIC2 CARD11 CYBB NBN ICOS DNAJC21 DNMT3B DISP1 TGIF1 HLA-DQB1 ADA SETBP1 MED25 FOXH1 SLC35C1 ACADVL TDGF1 PNP SP110 SMC1A ICOS SREBF1 TDGF1 NBN DCLRE1C ALMS1 GLI2 MCIDAS FGF8 NCF1 RAG1 PTCH1 NADK2 IL2RG ZBTB24 ZAP70 GLI2 FGFR1 GAS1 TNFRSF13B GAS1 IFNGR1 CFTR COL11A2 CR2 SAMD9 CD247 TGIF1 TREX1 CARMIL2 TCIRG1 BLNK UBB SRP54 LAMB3 DISP1 RMRP TNFRSF13C NFKB1 STAG2 IRF8 PTCH1 SIX3 KPTN TBX20 TDGF1 CSPP1 IGHM BTK NFIX RNU4ATAC CXCR4 NFKB2 RAC1 CD27 TGIF1 ADA TBX20 ZIC2 MTHFD1 RAG2 GATA4 TNFRSF11A DZIP1L FGF8 KIAA0586 SHH TDGF1 RYR1 ODAD1 WDR1 CREBBP CITED2 DLL1 NCF2 TBCD SHH NODAL RAC2 SIX3 GBA PTCH1 DNAI2 ZIC2 TNFRSF13C ALMS1 PURA STAG2 DLL1 SBDS ICOS EFL1 ACP5 SFTPC CFAP410 MASP2 IL2RG IGLL1 AFF4 BTK LIG4 NFKB2 WDR19 CD55 CDON GAS8 EPM2A NKX2-1 RNF125 DCLRE1C NODAL LRBA ELANE MAN2B1 DLL1 PTCH1 HLA-DQA1 EXTL3 SLC35C1 MAN2B1 FOXN1 PRKCD GLI2 RANBP2 MID1 IL2RG FBLN5 NKX2-5 NODAL GFI1 TNFSF12 RAG2 ADA IL21R KDM6A OSTM1 ASAH1 DISP1 PANK2 FGFR1
SNP 0