Adults 18 to 50, any sex, with Dysentery, Bacillary. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Subjects With at Least One Episode of Shigellosis According to the Protocol Primary Case DefinitionPrimary· Starting with the challenge visit (Day 57) and lasting up to the end of the inpatient stay (Day 64)
Attack rate of shigellosis expressed as percentage of subjects with at least one episode of shigellosis after challenge, and 90% confidence interval (CI) (Clopper-Pearson method). Episodes of shigellosis fulfilling primary case definition: Shedding of S. sonnei 53G accompanied by moderate or severe diarrhea OR shedding with oral temperature greater than or equal to (≥) 38.5°C. Moderate diarrhea consists of 4 to 5 loose or watery (Grade \[G\]3 to 5) stools or 400 to 800 grams of G3 to 5 stools within 24 hours. Severe diarrhea consists of 6 or more loose or watery (G3 to 5) stools or \> 800 gram
Group
Value
95% CI
S. Sonnei Group
46.9
31.5 – 62.7
Placebo Group
42.9
26.9 – 60.0
Percentage of Subjects With at Least One Episode of Shigellosis According to Controlled Human Infection Model (CHIM) Working Group Case Definition for ShigellosisSecondary· Starting with the challenge visit (Day 57) and lasting up to the end of the inpatient stay (Day 64)
Percentage of subjects with shigellosis fulfilling the CHIM expert working group case definition for shigellosis, and 90% confidence interval (CI) (Clopper-Pearson method). According to the working group, the participant must fulfil any of the three following possible endpoints to qualify as having reached the CHIM case definition for this objective: 1. Severe diarrhea defined as \[\[≥ 6 loose stools in 24 hours\] OR \[˃800 grams loose stools in 24 hours\]; 2. Moderate diarrhea defined as \[4-5 loose stools in 24 hours OR 400-800 grams loose stools in 24 hours\] AND \[oral temperature \[≥ 38.0
Group
Value
95% CI
S. Sonnei Group
46.9
31.5 – 62.7
Placebo Group
32.1
17.9 – 49.4
Percentage of Subjects With at Least One Episode of ShigellosisSecondary· Starting with the challenge visit (Day 57) and lasting up to the end of the inpatient stay (Day 64)
Percentage of subjects with shigellosis fulfilling the following definition of shigellosis (with 90% confidence interval (CI) - Clopper-Pearson method): 1) severe diarrhea OR 2) moderate diarrhea AND oral temperature ≥ 38.0 °C OR ≥ 1 moderate constitutional/enteric symptom OR 3) dysentery \[\[≥ 2 loose stools with gross blood (hemoccult positive) in 24 hours\] AND \[≥ 1 reportable constitutional/enteric symptom\]\].
Group
Value
95% CI
S. Sonnei Group
46.9
31.5 – 62.7
Placebo Group
35.7
20.8 – 53.0
Percentage of Subjects With at Least One Episode of More Severe ShigellosisSecondary· Starting with the challenge visit (Day 57) and lasting up to the end of the inpatient stay (Day 64)
Percentage of subjects with more severe shigellosis fulfilling the following definition of more severe shigellosis (with 90% confidence interval (CI) - Clopper-Pearson method): 1) moderate OR severe diarrhea AND oral temperature ≥ 38.0 °C OR ≥ 1 severe constitutional/enteric symptom OR 2) dysentery \[\[≥ 2 loose stools with gross blood (hemoccult positive) in 24 hours\] AND \[oral temperature ≥ 38.0°C OR ≥ 1 severe constitutional/enteric symptom\]\].
Group
Value
95% CI
S. Sonnei Group
15.6
6.4 – 30.1
Placebo Group
14.3
5.0 – 29.8
Percentage of Subjects With Specific Disease SymptomsSecondary· Starting with the challenge visit (Day 57) and lasting up to the end of the inpatient stay (Day 64)
Percentage of subjects with 90% CI-Clopper-Pearson method was also measured for: shedding of S.sonnei strain 53G (defined as positivity of ≥1 stool sample by culture/quantitative Polymerase Chain Reaction/both); severe diarrhea; more severe diarrhea; dysentery; confirmed S.sonnei 53G shedding AND moderate or severe diarrhea OR dysentery OR presence of oral temperature ≥ 38.5°C OR presence of 1 or more severe intestinal symptoms (abdominal pain, cramping, nausea, vomiting, gas, and anorexia) abbreviated as "shedding of S.sonnei 53G and \[…"; disease not fulfilling the protocol primary case defi
Shedding of S. sonnei strain 53G
Group
Value
95% CI
S. Sonnei Group
96.9
86.0 – 99.8
Placebo Group
100
89.9 – 100.0
Severe diarrhea
Group
Value
95% CI
S. Sonnei Group
40.6
26.0 – 56.7
Placebo Group
25
12.4 – 41.9
More severe diarrhea
Group
Value
95% CI
S. Sonnei Group
34.4
20.6 – 50.4
Placebo Group
17.9
7.3 – 33.9
Dysentery
Group
Value
95% CI
S. Sonnei Group
34.4
20.6 – 50.4
Placebo Group
28.6
15.1 – 45.7
Shedding of S. sonnei 53G and […
Group
Value
95% CI
S. Sonnei Group
46.9
31.5 – 62.7
Placebo Group
42.9
26.9 – 60.0
≥1 stool and no moderate/severe diarrhea evidence
Group
Value
95% CI
S. Sonnei Group
50.0
34.4 – 65.6
Placebo Group
60.7
43.5 – 76.2
Any Abdominal pain
Group
Value
95% CI
S. Sonnei Group
50.0
34.4 – 65.6
Placebo Group
46.4
30.1 – 63.4
Any Abdominal cramps
Group
Value
95% CI
S. Sonnei Group
53.1
37.3 – 68.5
Placebo Group
50.0
33.3 – 66.7
Mean Number of Grade 3-5 Stools Per SubjectSecondary· Starting with the challenge visit (Day 57) and lasting up to the end of the inpatient stay (Day 64)
The mean number of grade 3-5 stools (and standard deviation) were calculated per subject from challenge to discharge.
Group
Value
95% CI
S. Sonnei Group
28
± 13.0
Placebo Group
13.9
± 6.6
Weight of Grade 3-5 StoolsSecondary· Starting with the challenge visit (Day 57) and lasting up to the end of the inpatient stay (Day 64)
Mean and standard deviation (SD) of weights were expressed in grams. The following measures were calculated: mean and SD of the weight of grade 3-5 stools calculated on all subjects (Weight/all subjects), mean and SD of the weight of grade 3-5 stools calculated on subjects with at least one grade 3-5 stool (Weight/subj.with at least 1 grade 3-5 stool), Cumulative mean and SD weight of grade 3-5 stools per subjects, accumulated from challenge to discharge (Cumulative weight/all subjects).
Weight/all subjects
Group
Value
95% CI
S. Sonnei Group
87.4
± 68.3
Placebo Group
91.3
± 54.7
Weight/subj. with at least 1 grade 3-5 stool
Group
Value
95% CI
S. Sonnei Group
127.2
± 39.8
Placebo Group
116.3
± 28.5
Cumulative weight/all subjects
Group
Value
95% CI
S. Sonnei Group
1161.1
± 1416.9
Placebo Group
766.9
± 884.9
Number of Subjects With Any Solicited Local Adverse Events (AEs)Secondary· During the 7-day period after each vaccination (vaccine/placebo administered at Day 1 and Day 29)
Solicited local AEs include: pain, erythema and induration at injection site. Any = occurrence of local adverse event regardless of intensity grade. Any erythema or induration at injection site is any symptom with a surface diameter greater than 25 millimeters.
Dose 1, Pain
Group
Value
95% CI
S. Sonnei Group
29
Placebo Group
12
Dose 2, Pain
Group
Value
95% CI
S. Sonnei Group
24
Placebo Group
5
Dose 1, Erythema
Group
Value
95% CI
S. Sonnei Group
0
Placebo Group
0
Dose 2, Erythema
Group
Value
95% CI
S. Sonnei Group
0
Placebo Group
0
Dose 1, Induration
Group
Value
95% CI
S. Sonnei Group
0
Placebo Group
1
Dose 2, Induration
Group
Value
95% CI
S. Sonnei Group
0
Placebo Group
0
Number of Subjects With Any Solicited Systemic AEsSecondary· During the 7-day period after each vaccination (vaccine/placebo administered at Day 1 and Day 29)
Solicited systemic AEs include: arthralgia, chills, fatigue, headache, malaise, myalgia, fever (oral temperature ≥ 38.0°C). Any = occurrence of systemic adverse event regardless of intensity and relation to study vaccination.
Dose 1, Arthralgia
Group
Value
95% CI
S. Sonnei Group
6
Placebo Group
3
Dose 2, Arthralgia
Group
Value
95% CI
S. Sonnei Group
7
Placebo Group
2
Dose 1, Chills
Group
Value
95% CI
S. Sonnei Group
5
Placebo Group
2
Dose 2, Chills
Group
Value
95% CI
S. Sonnei Group
3
Placebo Group
1
Dose 1, Fatigue
Group
Value
95% CI
S. Sonnei Group
6
Placebo Group
8
Dose 2, Fatigue
Group
Value
95% CI
S. Sonnei Group
7
Placebo Group
3
Dose 1, Headache
Group
Value
95% CI
S. Sonnei Group
10
Placebo Group
8
Dose 2, Headache
Group
Value
95% CI
S. Sonnei Group
4
Placebo Group
4
Number of Subjects With Any Unsolicited AEs During the 28-day Post-vaccination PeriodSecondary· During the 28-day period across doses (vaccine/placebo administered at Day 1 and Day 29)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to study vaccination.
Group
Value
95% CI
S. Sonnei Group
18
Placebo Group
13
Number of Subjects With Any Unsolicited AEs During the 28-day Follow-up Period After ChallengeSecondary· During the 28-day follow-up period after challenge (challenge administered at Day 57)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to study vaccination and/or challenge agent administration.
Group
Value
95% CI
S. Sonnei Group
20
Placebo Group
17
Number of Subjects With Any Serious Adverse Events (SAEs) and Related SAEsSecondary· From Day 1 up to study end at Day 237
Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Related SAEs = SAEs assessed by the investigator as related to the study vaccination and/or challenge agent administration.
Any SAE(s)
Group
Value
95% CI
S. Sonnei Group
0
Placebo Group
1
Related SAE(s)
Group
Value
95% CI
S. Sonnei Group
0
Placebo Group
0
Adverse events — posted to ClinicalTrials.gov
Time frame: Solicited AEs were collected within the 7-day post-vaccination period or 8-day post-challenge period. Unsolicited AEs were collected within the 28-day post-vaccination or post-challenge period. SAEs were collected from Day 1 up to study end at Day 237..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this study is to evaluate the efficacy, safety and immunogenicity of the GSK3536852A vaccine, which was designed to protect against shigellosis caused by Shigella sonnei (S. sonnei) and is using the new Generalized Modules for Membrane Antigens (GMMA) platform technology developed by GlaxoSmithKline (GSK) Vaccines Institute for Global Health (GVGH).
The study vaccine could be the stepping stone for the development of a multivalent broadly protective Shigella vaccine for vaccination of impoverished communities where shigellosis is endemic. However, a standalone monovalent vaccine against S. sonnei could be used to protect travelers against diarrheal shigellosis, as the vast majority of travelers' shigellosis is caused by S. sonnei, and even to protect infants in endemic regions where shigellosis is primarily caused by S. sonnei.
The GSK3536852A vaccine has been tested in two Phase I dose escalation studies in Europe to assess its safety and immunogenicity via three routes of administration: intramuscular (IM), intranasal (IN) and intradermal (ID). The results from the first study (dose escalation with IM vaccination) have shown that the vaccine has an acceptable safety profile and is well-tolerated up to a dose of 100 micrograms (µg). The results from the second study (dose escalation with ID, IN and IM vaccination) showed that GSK3536852A vaccine is well-tolerated also when administered by the ID and IN routes of vaccination. However, immunogenicity data have shown that GSK3536852A vaccine administered by the ID and IN routes is not as immunogenic as GSK3536852A vaccine administered by the IM route. Therefore, it has been decided to proceed with the clinical development program of this vaccine only using the IM vaccination route. In terms of dosage, the regimen tested in Phase I studies (three doses given one month apart) did not show any significant benefit from the third dose in terms of immunogenicity, therefore a two dose schedule was selected for next studies.
A Phase IIa study, conducted in endemic regions of Africa (i.e., Kenya), has been completed and confirmed the acceptable safety profile and immunogenicity of GSK3536852A vaccine.
Performing this vaccine-human challenge study may give the opportunity to establish evidence of clinical protection induced by the candidate S. sonnei vaccine (GSK3536852A vaccine) at an early development stage.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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· Phase 2, PHASE3
· not yet recruiting
NCT07406347 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose
· Phase 1
· not yet recruiting
NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH
· Phase 3
· not yet recruiting
NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E
· Phase 3
· not yet recruiting
NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months
· Phase 1
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 28 July 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03527173.