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Report for Clinical Trial NCT02146365

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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 Pneumococcal Disease
MeSH:Pneumococcal Infections


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

Time Perspective: Prospective

Cohort


There is one SNP

SNPs


1 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 ---

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 ---



HPO Nodes