A Study on the Safety and Immune Responses to the GVGH altSonflex1-2-3 Vaccine Against Shigellosis in Adults, Children, and Infants
A Staged Phase I/II Observer-blind, Randomised, Controlled, Multi-country Study to Evaluate the Safety, Reactogenicity, and Immune Responses to the GVGH altSonflex1-2-3 Vaccine Against S. Sonnei and S. Flexneri, Serotypes 1b, 2a, and 3a, in Adults in Europe (Stage 1) Followed by Age De-escalation From Adults to Children and Infants, and Dose-finding in Infants in Africa (Stage 2)
2 other identifiers
interventional
551
2 countries
2
Brief 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, 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2021
Typical duration for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 29, 2021
CompletedStudy Start
First participant enrolled
October 6, 2021
CompletedFirst Posted
Study publicly available on registry
October 11, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 24, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 24, 2025
CompletedDecember 4, 2025
November 1, 2025
3.7 years
September 29, 2021
November 27, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (26)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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 Outcomes (20)
Anti-serotype specific Shigella LPS/OAg serum IgG GMCs in adults 18 to 50 years of age in Europe
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)
Anti-serotype specific Shigella LPS/OAg serum IgG GMCs in adults 18 to 50 years of age in Africa
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)
Anti-serotype specific Shigella LPS/OAg serum IgG GMCs in children 24 to 59 months of age in Africa
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)
Anti-serotype specific Shigella LPS/OAg serum IgG GMCs in infants 9 months of age in Africa
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)
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)
- +15 more secondary outcomes
Study Arms (20)
ST1_Adults_Placebo_GR1 Group
PLACEBO COMPARATORAdults 18 to 50 years of age in Stage 1 (Europe) randomized to receive two doses of altSonflex Placebo, one each at Day 1 and Day 85.
ST1_Adults_Dose C_GR1 Group
EXPERIMENTALAdults 18 to 50 years of age in Stage 1 (Europe) randomized to receive two doses of altSonflex1-2-3 Dose C vaccine, one each at Day 1 and Day 85.
ST1_Adults_Placebo_GR2 Group
PLACEBO COMPARATORAdults 18 to 50 years of age in Stage 1 (Europe) randomized to receive two doses of altSonflex Placebo, one each at Day 1 and Day 169.
ST1_Adults_Dose C_GR2 Group
EXPERIMENTALAdults 18 to 50 years of age in Stage 1 (Europe) randomized to receive two doses of altSonflex1-2-3 Dose C vaccine, one each at Day 1 and Day 169.
ST2_Adults_Control C Group
ACTIVE COMPARATORAdults 18 to 50 years of age in Stage 2 (Africa) randomized to receive one dose of GSK's Meningococcal A, C, Y and W-135 conjugate vaccine at Day 1 and one dose of GSK's Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine at Day 85.
ST2_Adults_Dose C Group
EXPERIMENTALAdults 18 to 50 years of age in Stage 2 (Africa) randomized to receive two doses of altSonflex1-2-3 Dose C vaccine, one each at Day 1 and Day 85.
ST2_Children_Control B Group
ACTIVE COMPARATORChildren 24 to 59 months of age in Stage 2 (Africa) randomized to receive one dose of GSK's Meningococcal A, C, Y and W-135 conjugate vaccine at Day 1 and one dose of Sanofi Pasteur's Typhoid Vi polysaccharide vaccine at Day 85. This group is a control group for children receiving altSonflex1-2-3 Dose B vaccine.
ST2_Children_Dose B Group
EXPERIMENTALChildren 24 to 59 months of age in Stage 2 (Africa) randomized to receive two doses of altSonflex1-2-3 Dose B vaccine, one each at Day 1 and Day 85.
ST2_Children_Control C Group
ACTIVE COMPARATORChildren 24 to 59 months of age in Stage 2 (Africa) randomized to receive one dose of GSK's Meningococcal A, C, Y and W-135 conjugate vaccine at Day 1 and one dose of Sanofi Pasteur's Typhoid Vi polysaccharide vaccine at Day 85. This group is a control group for children receiving altSonflex1-2-3 Dose C vaccine.
ST2_Children_Dose C Group
EXPERIMENTALChildren 24 to 59 months of age in Stage 2 (Africa) randomized to receive two doses of altSonflex1-2-3 Dose C vaccine, one each at Day 1 and Day 85.
ST2_Infants_Control A_Safety Group
ACTIVE COMPARATORInfants 9 months of age in Stage 2 (Africa), part of the safety cohort, randomized to receive two doses of GSK's Meningococcal A, C, Y and W-135 conjugate vaccine, one each at Day 1 and Day 85, and one dose of GSK's Diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis (inactivated), and Haemophilus influenzae type b vaccine at Day 253. These infants also receive two doses of Serum Institute of India's Measles and rubella vaccine, one each at Day 29 and Day 281, as concomitant vaccination. This group is a control group for infants receiving altSonflex1-2-3 Dose A vaccine.
ST2_Infants_Dose A_Safety Group
EXPERIMENTALInfants 9 months of age in Stage 2 (Africa), part of the safety cohort, randomized to receive three doses of altSonflex1-2-3 Dose A, one each at Day 1, Day 85 and Day 253. These infants also receive two doses of Serum Institute of India's Measles and rubella vaccine, one each at Day 29 and Day 281, as concomitant vaccination.
ST2_Infants_Control B_Safety Group
ACTIVE COMPARATORInfants 9 months of age in Stage 2 (Africa), part of the safety cohort, randomized to receive two doses of GSK's Meningococcal A, C, Y and W-135 conjugate vaccine, one each at Day 1 and Day 85, and one dose of GSK's Diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis (inactivated), and Haemophilus influenzae type b vaccine at Day 253. These infants also receive two doses of Serum Institute of India's Measles and rubella vaccine, one each at Day 29 and Day 281, as concomitant vaccination. This group is a control group for infants receiving altSonflex1-2-3 Dose B vaccine.
ST2_Infants_Dose B_Safety Group
EXPERIMENTALInfants 9 months of age in Stage 2 (Africa), part of the safety cohort, randomized to receive three doses of altSonflex1-2-3 Dose B vaccine, one each at Day 1, Day 85 and Day 253. These infants also receive two doses of Serum Institute of India's Measles and rubella vaccine, one each at Day 29 and Day 281, as concomitant vaccination.
ST2_Infants_Control C_Safety Group
ACTIVE COMPARATORInfants 9 months of age in Stage 2 (Africa), part of the safety cohort, randomized to receive two doses of GSK's Meningococcal A, C, Y and W-135 conjugate vaccine, one each at Day 1 and Day 85, and one dose of GSK's Diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis (inactivated), and Haemophilus influenzae type b vaccine at Day 253. These infants also receive two doses of Serum Institute of India's Measles and rubella vaccine, one each at Day 29 and Day 281, as concomitant vaccination. This group is a control group for infants receiving altSonflex1-2-3 Dose C vaccine.
ST2_Infants_Dose C_Safety Group
EXPERIMENTALInfants 9 months of age in Stage 2 (Africa), part of the safety cohort, randomized to receive three doses of altSonflex1-2-3 Dose C vaccine, one each at Day 1, Day 85 and Day 253. These infants also receive two doses of Serum Institute of India's Measles and rubella vaccine, one each at Day 29 and Day 281, as concomitant vaccination.
ST2_Infants_Control_Dose find Group
ACTIVE COMPARATORInfants 9 months of age in Stage 2 (Africa), part of the dose-finding cohort, randomized to receive two doses of GSK's Meningococcal A, C, Y and W-135 conjugate vaccine, one each at Day 1 and Day 85, and one dose of GSK's Diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis (inactivated), and Haemophilus influenzae type b vaccine at Day 253. These infants also receive two doses of Serum Institute of India's Measles and rubella vaccine, one each at Day 1 and Day 253, as concomitant vaccination. This group is a control group for infants in dose-finding groups receiving either altSonflex1-2-3 Dose A, Dose B or Dose C vaccine.
ST2_Infants_Dose A_Dose find Group
EXPERIMENTALInfants 9 months of age in Stage 2 (Africa), part of the dose-finding cohort, randomized to receive three doses of altSonflex1-2-3 Dose A vaccine, one each at Day 1, Day 85 and Day 253. These infants also receive two doses of Serum Institute of India's Measles and rubella vaccine, one each at Day 1 and Day 253, as concomitant vaccination.
ST2_Infants_Dose B_Dose find Group
EXPERIMENTALInfants 9 months of age in Stage 2 (Africa), part of the dose-finding cohort, randomized to receive three doses of altSonflex1-2-3 Dose B vaccine, one each at Day 1, Day 85 and Day 253. These infants also receive two doses of Serum Institute of India's Measles and rubella vaccine, one each at Day 1 and Day 253, as concomitant vaccination.
ST2_Infants_Dose C_Dose find Group
EXPERIMENTALInfants 9 months of age in Stage 2 (Africa), part of the dose-finding cohort, randomized to receive three doses of altSonflex1-2-3 Dose C vaccine, one each at Day 1, Day 85 and Day 253. These infants also receive two doses of Serum Institute of India's Measles and rubella vaccine, one each at Day 1 and Day 253, as concomitant vaccination.
Interventions
2 doses of altSonflex1-2-3 Dose C administered intramuscularly, in the non-dominant arm, at Day 1 and Day 85 to adults in the ST1\_Adults\_Dose C\_GR1 and ST2\_Adults\_Dose C groups in Stage 1 and 2 (Europe and Africa) and children in the ST2\_Children\_Dose C group in Stage 2 (Africa), and at Day 1 and Day 169 to adults in the ST1\_Adults\_Dose C\_GR2 group in Stage 1 (Europe); 3 doses of altSonflex1-2-3 Dose C administered intramuscularly, in the non-dominant arm, at Day 1, Day 85 and Day 253 to infants in the ST2\_Infants\_Dose C\_Safety and ST2\_Infants\_Dose C\_Dose find groups in Stage 2 (Africa).
2 doses of altSonflex1-2-3 Dose B administered intramuscularly, in the non-dominant arm, at Day 1 and Day 85 to children in the ST2\_Children\_Dose B group in Stage 2 (Africa); 3 doses of altSonflex1-2-3 Dose B administered intramuscularly, in the non-dominant arm, at Day 1, Day 85 and Day 253 to infants in the ST2\_Infants\_Dose B\_Safety and ST2\_Infants\_Dose B\_Dose find groups in Stage 2 (Africa).
1 dose of GSK's Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine administered intramuscularly, in the non-dominant arm, at Day 85 to adults in the ST2\_Adults\_Control C group in Stage 2 (Africa).
1 dose of Sanofi Pasteur's Typhoid Vi polysaccharide vaccine administered intramuscularly, in the non-dominant arm, at Day 85 to children in the ST2\_Children\_Control B and ST2\_Children\_Control C groups in Stage 2 (Africa).
3 doses of altSonflex1-2-3 Dose A administered intramuscularly, in the non-dominant arm, at Day 1, Day 85 and Day 253 to infants in the ST2\_Infants\_Dose A\_Safety and ST2\_Infants\_Dose A\_Dose find groups in Stage 2 (Africa).
1 dose of GSK's Meningococcal A, C, Y and W-135 conjugate vaccine administered intramuscularly, in the non-dominant arm, at Day 1 to adults in the ST2\_Adults\_Control C group and children in the ST2\_Children\_Control B and ST2\_Children\_Control C groups in Stage 2 (Africa); 2 doses of GSK's Meningococcal A, C, Y and W-135 conjugate vaccine administered intramuscularly, in the non-dominant arm, at Day 1 and Day 85 to infants in the ST2\_Infants\_Control A\_Safety, ST2\_Infants\_Control B\_Safety, ST2\_Infants\_Control C\_Safety and ST2\_Infants\_Control\_Dose find groups in Stage 2 (Africa).
1 dose of GSK's Diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis (inactivated), and Haemophilus influenzae type b vaccine administered intramuscularly, in the non-dominant arm, at Day 253 to infants in the ST2\_Infants\_Control A\_Safety, ST2\_Infants\_Control B\_Safety, ST2\_Infants\_Control C\_Safety and ST2\_Infants\_Control\_Dose find groups in Stage 2 (Africa).
2 doses of Serum Institute of India's Measles and rubella vaccine administered subcutaneously, in the non-dominant arm, at Day 29 and Day 281 to infants in the safety groups, and at Day 1 and Day 253 to infants in the dose-finding groups, in Stage 2 (Africa).
2 doses of altSonflex Placebo, administered intramuscularly, in the non-dominant arm, either at Day 1 and Day 85 or at Day 1 and Day 169 (depending on the vaccination schedule) to adults in the ST1\_Adults\_Placebo\_GR1 and ST1\_Adults\_Placebo\_GR2 groups in Stage 1 (Europe).
Eligibility Criteria
You may qualify if:
- All participants:
- Participants and/or participants' parent(s)/legally acceptable representative(s) LAR(s), who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits).
- Written or witnessed/thumb printed informed consent obtained from the participant/parent(s)/LAR(s) of the participant prior to performance of any study specific procedure.
- Healthy participants as established by medical history, clinical examination, and laboratory assessment.
- Participants satisfying all screening requirements.
- Participants seronegative for hepatitis B, and hepatitis C.
- Participants negative for human leukocyte antigen B27 (HLA-B27).
- Adults 18 to 50 years of age:
- A male or female between, and including, 18 and 50 years of age at the time of the first study intervention administration.
- Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause.
- Female participants of childbearing potential may be enrolled in the study, if the participant:
- \- has practiced adequate contraception for 1 month prior to study intervention administration, and
- \- has a negative pregnancy test on the day of study intervention administration, and
- has agreed to continue adequate contraception during the entire treatment period and for 1 month after completion of the study intervention administration series.
- Participants seronegative for human immunodeficiency virus (HIV).
- +12 more criteria
You may not qualify if:
- All participants:
- Known exposure to Shigella during lifetime of the participant as confirmed during interview with the participant or documented by patient records (e.g., history of microbiologically-confirmed Shigella infection), recent travel\* (within 2 years) to a country where Shigella or other enteric infections are endemic, or recent occupation\* (within 3 years) involving Shigella species.
- Progressive, unstable or uncontrolled clinical conditions.
- History (known or suspected) of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccine.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- Hypersensitivity, including allergy, to medicinal products or medical equipment whose use is foreseen in this study.
- Clinical conditions representing a contraindication to IM vaccination and blood draws.
- Any behavioural or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the participant's ability to participate in the study.
- Acute disease and/or fever (defined as temperature ≥38.0°C) at the time of enrolment\*.
- The participant can still be enrolled into the study at a time when the acute disease and/or fever has resolved.
- Any clinically significant haematological and/or biochemical laboratory abnormality.
- Confirmed positive COVID-19 test during the period starting 30 days before the first administration of study vaccines (Day -30 to Day 1).
- Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
- Administration of long-acting immune-modifying drugs at any time during the study period (e.g. infliximab).
- Prior receipt of an experimental Shigella vaccine or live Shigella challenge.
- +20 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (2)
GSK Investigational Site
Ghent, 9000, Belgium
GSK Investigational Site
Kericho, 20200, Kenya
Related Publications (1)
Leroux-Roels I, Maes C, Mancini F, Jacobs B, Sarakinou E, Alhatemi A, Joye J, Grappi S, Cilio GL, Serry-Bangura A, Vitali CG, Ferruzzi P, Marchetti E, Necchi F, Rappuoli R, De Ryck I, Auerbach J, Colucci AM, Rossi O, Conti V, Scorza FB, Arora AK, Micoli F, Podda A, Nakakana UN; Shigella Project Team. Safety and Immunogenicity of a 4-Component Generalized Modules for Membrane Antigens Shigella Vaccine in Healthy European Adults: Randomized, Phase 1/2 Study. J Infect Dis. 2024 Oct 16;230(4):e971-e984. doi: 10.1093/infdis/jiae273.
PMID: 38853614DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Observer blind
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 29, 2021
First Posted
October 11, 2021
Study Start
October 6, 2021
Primary Completion
June 24, 2025
Study Completion
June 24, 2025
Last Updated
December 4, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
- Access Criteria
- Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
IPD for this study will be made available via the Clinical Study Data Request site.