SNPMiner Trials by Shray Alag


SNPMiner SNPMiner Trials (Home Page)


Report for Clinical Trial NCT02097472

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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 Pneumonia, Pneumococcal
MeSH:Pneumonia, Pneumococcal Pneumonia
HPO:Pneumonia

4 Interventions

Name: PATH-wSP

Description: Streptococcus pneumoniae Whole Cell Vaccine adsorbed to Alum
Type: Biological
Group Labels: 6

Adult Cohort 1, PATH-wSP, 600 mcg Adult Cohort 2, PATH-wSP, 1000 mcg Toddler Cohort 1 PATH-wSP 300 mcg+Active control Toddler Cohort 1 PATH-wSP 300 mcg+Saline Toddler Cohort 2 PATH-wSP 600 mcg+Active control Toddler Cohort 2 PATH-wSP 600 mcg+saline

Name: Synflorix

Description: 1 dose (0.5 mL) contains: 1 μg of each of the following pneumococcal polysaccharide serotypes: 1, 5, 6B, 7F, 9V, 14, and 23 F And 3 μg of the following pneumococcal polysaccharide serotypes: 4, 18C and 19F. The serotypes are conjugated to either: protein D (derived from Non-Typeable Haemophilus influenzae) carrier protein, tetanus toxoid carrier protein or diphtheria toxoid carrier protein
Type: Biological
Group Labels: 4

Toddler Cohort 1 PATH-wSP 300 mcg+Active control Toddler Cohort 1: Active Control Only Toddler Cohort 2 PATH-wSP 600 mcg+Active control Toddler Cohort 2: Active Control Only

Name: Pentavac

Description: Each PFS contains 0.5 ml (single dose): Diphtheria Toxoid 20 Lf to 30 Lf Tetanus Toxoid 2.5 Lf to 10 Lf B. Pertussis 4 IU HBsAg (rDNA) 10 mcg Purified capsular HIB Polysaccharide (PRP) Conjugated to Tetanus Toxoid (carrier protein) 10 mcg Adsorbed on Aluminium Phosphate, AL+++ 1.25 mg Preservative: Thiomersal 0.005 % Dose: O.5ml by intramuscular injection.
Type: Biological
Group Labels: 4

Toddler Cohort 1 PATH-wSP 300 mcg+Active control Toddler Cohort 1: Active Control Only Toddler Cohort 2 PATH-wSP 600 mcg+Active control Toddler Cohort 2: Active Control Only

Name: Saline

Description: 0.9% Sodium Chloride Injection, USP
Type: Other
Group Labels: 6

Adult Cohort 1, Saline Adult Cohort 2, Saline Toddler Cohort 1 PATH-wSP 300 mcg+Saline Toddler Cohort 1: Active Control Only Toddler Cohort 2 PATH-wSP 600 mcg+saline Toddler Cohort 2: Active Control Only


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

Purpose: Prevention

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 L460D

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 ---



HPO Nodes


HPO: