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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05073003
Other study ID # 212149
Secondary ID 2021-000891-12
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date October 6, 2021
Est. completion date June 4, 2025

Study information

Verified date February 2024
Source GlaxoSmithKline
Contact US GSK Clinical Trials Call Center
Phone 877-379-3718
Email GSKClinicalSupportHD@gsk.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of the current clinical study is to evaluate, for the first time in humans (FTIH), the safety and immunogenicity of the altSonflex1-2-3 candidate vaccine against S. sonnei and S. flexneri serotypes 1b, 2a, and 3a. The vaccine will be first administered in adults 18 to 50 years of age in Europe. Subsequently, the vaccine will be administered to a shigellosis-endemic population in Africa, first in adults 18 to 50 years of age, then in children 24 to 59 months of age, and finally in infants 9 months of age. Infants will also receive a third vaccination. Three different doses of the vaccine [low (Dose A), medium (Dose B), and high (Dose C) amounts of antigen] will be evaluated using an age de-escalation approach (from least vulnerable adult population to most vulnerable paediatric population). The results of this study will allow the selection of the most appropriate dose for further vaccine development in infants 9 months of age, which is the main target age group for this vaccine.


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Study Design


Related Conditions & MeSH terms


Intervention

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Locations

Country Name City State
Belgium GSK Investigational Site Gent
Kenya GSK Investigational Site Kericho

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Belgium,  Kenya, 

Outcome

Type Measure Description Time frame Safety issue
Primary Anti-serotype specific Shigella lipopolysaccharide (LPS)/O-Antigen (OAg) serum immunoglobulin G (IgG) geometric mean concentrations (GMCs) in infants 9 months of age in Africa Anti-serotype specific Shigella LPS/OAg serum IgG GMCs are measured by GSK Vaccines Institute for Global Health (GVGH) enzyme-linked immunosorbent assay (ELISA) and expressed in ELISA units per milliliter (EU/mL) of serum. At Day 281 (28 days after the third study intervention administration)
Primary Number of adults 18 to 50 years of age in Europe with solicited administration site events The solicited administration site events are pain, redness, and swelling. During 7 days after each study intervention administration (study interventions administered at Day 1 and Day 85/Day 169)
Primary Number of adults 18 to 50 years of age in Europe with solicited systemic events The solicited systemic event is fever. Fever is defined as temperature equal to or above (=) 38.0°C. The preferred location for measuring temperature is the axilla for all participants. During 7 days after each study intervention administration (study interventions administered at Day 1 and Day 85/Day 169)
Primary Number of adults 18 to 50 years of age in Europe with unsolicited adverse events (AEs) An unsolicited AE is an AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event. During 28 days after each study intervention administration (study interventions administered at Day 1 and Day 85/Day 169)
Primary Number of adults 18 to 50 years of age in Europe with serious adverse events (SAEs) An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement. During the entire study participation period [Day 1 to Day 113 (for ST1_Adults_Placebo_GR1 and ST1_Adults_Dose C_GR1 groups)/Day 197 (for ST1_Adults_Placebo_GR2 and ST1_Adults_Dose C_GR2 groups)
Primary Number of adults 18 to 50 years of age in Europe with deviations from normal values of haematological, renal, and hepatic panel test results at Day 8 (7 days after the first study intervention administration) Panel tests include measures of leukocytes, erythrocytes, haemoglobin, haematocrit, platelets, eosinophils, basophils, neutrophils, monocytes, lymphocytes, creatinine, blood urea, sodium, potassium, aspartate aminotransferase (AST) and alanine aminotransferase (ALT). At Day 8 (7 days after the first study intervention administration)
Primary Number of adults 18 to 50 years of age in Europe with deviations from normal values of haematological, renal, and hepatic panel test results at Day 92/Day 176 (7 days after the second study intervention administration) Panel tests include measures of leukocytes, erythrocytes, haemoglobin, haematocrit, platelets, eosinophils, basophils, neutrophils, monocytes, lymphocytes, creatinine, blood urea, sodium, potassium, aspartate aminotransferase (AST) and alanine aminotransferase (ALT). At Day 92 (for ST1_Adults_Placebo_GR1 and ST1_Adults_Dose C_GR1 groups)/Day 176 (for ST1_Adults_Placebo_GR2 and ST1_Adults_Dose C_GR2 groups) (7 days after the second study intervention administration)
Primary Number of adults 18 to 50 years of age in Africa with solicited administration site events The solicited administration site events are pain, redness, and swelling. During 7 days after each study intervention administration (study interventions administered at Day 1 and Day 85)
Primary Number of adults 18 to 50 years of age in Africa with solicited systemic events The solicited systemic event is fever. Fever is defined as temperature = 38.0°C. The preferred location for measuring temperature is the axilla for all participants. During 7 days after each study intervention administration (study interventions administered at Day 1 and Day 85)
Primary Number of adults 18 to 50 years of age in Africa with unsolicited AEs An unsolicited AE is an AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event. During 28 days after each study intervention administration (study interventions administered at Day 1 and Day 85)
Primary Number of adults 18 to 50 years of age in Africa with SAEs An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, results in abnormal pregnancy outcomes or any other situation based on appropriate medical or scientific judgement. During the entire study participation (Day 1 to Day 113)
Primary Number of adults 18 to 50 years of age in Africa with deviations from normal values of haematological, renal, and hepatic panel test results at Day 8 (7 days after the first study intervention administration) Panel tests include measures of leukocytes, erythrocytes, haemoglobin, haematocrit, platelets, eosinophils, basophils, neutrophils, monocytes, lymphocytes, creatinine, blood urea, sodium, potassium, AST, and ALT. At Day 8 (7 days after the first study intervention administration)
Primary Number of adults 18 to 50 years of age in Africa with deviations from normal values of haematological, renal, and hepatic panel test results at Day 92 (7 days after the second study intervention administration) Panel tests include measures of leukocytes, erythrocytes, haemoglobin, haematocrit, platelets, eosinophils, basophils, neutrophils, monocytes, lymphocytes, creatinine, blood urea, sodium, potassium, AST, and ALT. At Day 92 (7 days after the second study intervention administration)
Primary Number of children 24 to 59 months of age in Africa with solicited administration site events The solicited administration site events are pain, redness, and swelling. During 7 days after each study intervention administration (study interventions administered at Day 1 and Day 85)
Primary Number of children 24 to 59 months of age in Africa with solicited systemic events The solicited systemic event is fever. Fever is defined as temperature = 38.0°C. The preferred location for measuring temperature is the axilla for all participants. During 7 days after each study intervention administration (study interventions administered at Day 1 and Day 85)
Primary Number of children 24 to 59 months of age in Africa with unsolicited AEs An unsolicited AE is an AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event. During 28 days after each study intervention administration (study interventions administered on Day 1 and Day 85)
Primary Number of children 24 to 59 months of age in Africa with SAEs An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity or any other situation based on appropriate medical or scientific judgement. During the entire study participation period (Day 1 to Day 113)
Primary Number of children 24 to 59 months of age in Africa with deviations from normal values of haematological, renal, and hepatic panel test results at Day 8 (7 days after the first study intervention administration) Panel tests include measures of leukocytes, erythrocytes, haemoglobin, haematocrit, platelets, eosinophils, basophils, neutrophils, monocytes, lymphocytes, creatinine, blood urea, sodium, potassium, AST, and ALT. At Day 8 (7 days after the first study intervention administration)
Primary Number of children 24 to 59 months of age in Africa with deviations from normal values of haematological, renal, and hepatic panel test results at Day 92 (7 days after the second study intervention administration) Panel tests include measures of leukocytes, erythrocytes, haemoglobin, haematocrit, platelets, eosinophils, basophils, neutrophils, monocytes, lymphocytes, creatinine, blood urea, sodium, potassium, AST, and ALT. At Day 92 (7 days after the second study intervention administration)
Primary Number of infants 9 months of age in Africa with solicited administration site events The solicited administration site events are pain, redness and swelling. During 7 days after each study intervention administration (study interventions administered at Day 1, Day 85 and Day 253)
Primary Number of infants 9 months of age in Africa with solicited systemic events The solicited systemic event is fever. Fever is defined as temperature = 38.0°C. The preferred location for measuring temperature is the axilla for all participants. During 7 days after each study intervention administration (study interventions administered at Day 1, Day 85 and Day 253)
Primary Number of infants 9 months of age in Africa with unsolicited AEs An unsolicited AE is an AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event. During 28 days after each study intervention administration (study intervention administered at Day 1, Day 85 and Day 253)
Primary Number of infants 9 months of age in Africa with SAEs An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity or any other situation based on appropriate medical or scientific judgement. During the entire study participation period (Day 1 to Day 281)
Primary Number of infants 9 months of age in Africa with deviations from normal values of haematological, renal, and hepatic panel test results at Day 8 (7 days after the first study intervention administration) Panel tests include measures of leukocytes, erythrocytes, haemoglobin, haematocrit, platelets, eosinophils, basophils, neutrophils, monocytes, lymphocytes, creatinine, blood urea, sodium, potassium, AST, and ALT. At Day 8 (7 days after the first study intervention administration)
Primary Number of infants 9 months of age in Africa with deviations from normal values of haematological, renal, and hepatic panel test results at Day 92 (7 days after the second study intervention administration) Panel tests include measures of leukocytes, erythrocytes, haemoglobin, haematocrit, platelets, eosinophils, basophils, neutrophils, monocytes, lymphocytes, creatinine, blood urea, sodium, potassium, AST, and ALT. At Day 92 (7 days after the second study intervention administration)
Primary Number of infants 9 months of age in Africa with deviations from normal values of haematological, renal, and hepatic panel test results at Day 260 (7 days after the third study intervention administration) Panel tests include measures of leukocytes, erythrocytes, haemoglobin, haematocrit, platelets, eosinophils, basophils, neutrophils, monocytes, lymphocytes, creatinine, blood urea, sodium, potassium, AST, and ALT. At Day 260 (7 days after the third study intervention administration)
Secondary Anti-serotype specific Shigella LPS/OAg serum IgG GMCs in adults 18 to 50 years of age in Europe Anti-serotype specific Shigella LPS/OAg serum IgG GMCs are measured by GVGH ELISA and expressed in EU/mL of serum. At Day 1 and Day 85/Day 169 (before each study intervention administration), at Day 15 (14 days after the first study intervention administration) and at Day 29 and Day 113/Day197 (28 days after each study intervention administration)
Secondary Anti-serotype specific Shigella LPS/OAg serum IgG GMCs in adults 18 to 50 years of age in Africa Anti-serotype specific Shigella LPS/OAg serum IgG GMCs are measured by GVGH ELISA and expressed in EU/mL of serum. At Day 1 and Day 85 (before each study intervention administration) and at Day 29 and Day 113 (28 days after each study intervention administration)
Secondary Anti-serotype specific Shigella LPS/OAg serum IgG GMCs in children 24 to 59 months of age in Africa Anti-serotype specific Shigella LPS/OAg serum IgG GMCs are measured by GVGH ELISA and expressed in EU/mL of serum. At Day 1 and Day 85 (before each study intervention administration) and at Day 29 and Day 113 (28 days after each study intervention administration)
Secondary Anti-serotype specific Shigella LPS/OAg serum IgG GMCs in infants 9 months of age in Africa Anti-serotype specific Shigella LPS/OAg serum IgG GMCs are measured by GVGH ELISA and expressed in EU/mL of serum. At Day 1, Day 85 and Day 253 (before each study intervention administration) and at Day 29, Day 113 and Day 281 (28 days after each study intervention administration)
Secondary Number of adults 18 to 50 years of age in Europe achieving a GVGH ELISA level equivalent to =1:800 titer against S. sonnei LPS/OAg At Day 1 and Day 85/Day 169 (before each study intervention administration), at Day 15 (14 days after the first study intervention administration) and at Day 29 and Day 113/Day 197 (28 days after each study intervention administration)
Secondary Number of adults 18 to 50 years of age in Africa achieving a GVGH ELISA level equivalent to =1:800 titer against S. sonnei LPS/OAg At Day 1 and Day 85 (before each study intervention administration) and at Day 29 and Day 113 (28 days after each study intervention administration)
Secondary Number of children 24 to 59 months of age in Africa achieving a GVGH ELISA level equivalent to =1:800 titer against S. sonnei LPS/OAg At Day 1 and Day 85 (before each study intervention administration) and at Day 29 and Day 113 (28 days after each study intervention administration)
Secondary Number of infants 9 months of age in Africa achieving a GVGH ELISA level equivalent to =1:800 titer against S. sonnei LPS/OAg At Day 1, Day 85 and Day 253 (before each study intervention administration) and at Day 29, Day 113 and Day 281 (28 days after each study intervention administration)
Secondary Number of adults 18 to 50 years of age in Europe achieving a GVGH ELISA level equivalent to =1:1600 titer against S. sonnei LPS/OAg At Day 1 and Day 85/Day 169 (before each study intervention administration), at Day 15 (14 days after the first study intervention administration) and at Day 29 and Day 113/Day 197 (28 days after each study intervention administration)
Secondary Number of adults 18 to 50 years of age in Africa achieving a GVGH ELISA level equivalent to =1:1600 titer against S. sonnei LPS/OAg At Day 1 and Day 85 (before each study intervention administration) and at Day 29 and Day 113 (28 days after each study intervention administration)
Secondary Number of children 24 to 59 months of age in Africa achieving a GVGH ELISA level equivalent to =1:1600 titer against S. sonnei LPS/OAg At Day 1 and Day 85 (before each study intervention administration) and at Day 29 and Day 113 (28 days after each study intervention administration)
Secondary Number of infants 9 months of age in Africa achieving a GVGH ELISA level equivalent to =1:1600 titer against S. sonnei LPS/OAg At Day 1, Day 85 and Day 253 (before each study intervention administration) and at Day 29, Day 113 and Day 281 (28 days after each study intervention administration)
Secondary Number of adults 18 to 50 years of age in Europe showing at least a 4-fold increase in anti-serotype specific Shigella LPS/OAg serum IgG concentrations, as measured by GVGH ELISA At Day 15 (14 days after first study intervention administration) and at Day 29 and Day 113/197 (28 days after each study intervention administration) compared to Day 1 and Day 85/Day 169 (baseline)
Secondary Number of adults 18 to 50 years of age in Africa showing at least a 4-fold increase in anti-serotype specific Shigella LPS/OAg serum IgG concentrations, as measured by GVGH ELISA At Day 29 and Day 113 (28 days after each study intervention administration) compared to Day 1 and Day 85 (baseline)
Secondary Number of children 24 to 59 months of age in Africa showing at least a 4-fold increase in anti-serotype specific Shigella LPS/OAg serum IgG concentrations, as measured by GVGH ELISA At Day 29 and Day 113 (28 days after each study intervention administration) compared to Day 1 and Day 85 (baseline)
Secondary Number of infants 9 months of age in Africa showing at least a 4-fold increase in anti-serotype specific Shigella LPS/OAg serum IgG concentrations, as measured by GVGH ELISA At Day 29, Day 113 and Day 281 (28 days after each study intervention administration) compared to Day 1, Day 85 and Day 253 (baseline)
Secondary Anti-measles IgG concentrations in infants 9 months of age in the dose-finding groups in Africa At Day 1 (before the first MR-VAC dose administration) and Day 281 (28 days after the second MR-VAC dose administration)
Secondary Anti-rubella IgG concentrations in infants 9 months of age in the dose-finding groups in Africa At Day 1 (before the first MR-VAC dose administration) and Day 281 (28 days after the second MR-VAC dose administration)
Secondary Number of infants 9 months of age in the dose-finding groups in Africa achieving anti-measles IgG concentrations of =150 mIU/mL and =200 mIU/mL At Day 281 (28 days after the second MR-VAC dose administration)
Secondary Number of infants 9 months of age in the dose-finding groups in Africa achieving anti-rubella IgG concentrations of =4 IU/mL and =10 IU/mL At Day 281 (28 days after the second MR-VAC dose administration)
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