There is one clinical trial.
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.
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 ---
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)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)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)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 1Description: 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 1Description: 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 1Description: 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 1Description: 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 1Description: 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 1Description: 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