A Phase 2 interventional study of S.sonnei vaccine and Placebo in Dysentery, Bacillary, sponsored by GlaxoSmithKline. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-28.
Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Prevention
Among 23 studies in Dysentery, Bacillary with a site in United States — 2 open to participants now, 3 under way, none of them phase 3. Dysentery, Bacillary · United States.
Among the 23 studies in Dysentery, Bacillary with a site in United States, this one is the 7th largest by enrollment, is the only one that started in 2018, is one of 9 in phase 2, and was the 14th registered.
61 studies on the registry are indexed under Dysentery, Bacillary; 6 are open to participants now.
Browse Dysentery, Bacillary studies →2 of the 23 studies in Dysentery, Bacillary with a site in United States are open now. Recruiting first, the newest first:
Inventprise Inc. · Sites in United States
Eveliqure Biotechnologies GmbH · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 5 Dysentery, Bacillary studies recruiting now, 0 (0%) set no upper age limit and 5 (100%) stop at 75 or younger; 1 take children under 18; 4 take healthy volunteers.
This study: 18 Years to 50 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
23 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 14 · Phase 2 11
First in 2004; this study’s year is marked. 1 started in 2018.
This study's enrollment of 71 is close to the median of 76 across 54 interventional studies indexed under Dysentery, Bacillary.
Median enrollment 58 across the 23 interventional studies. Of the 19 that completed or were terminated, 11 (58%) have results posted.
This tab as a report to print or save as PDF → With an account.
7 of 23 have an industry lead sponsor. The 9 most frequent:
GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 118 are open to participants now.
Of its 264 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
GlaxoSmithKline has 4 studies filed under Dysentery, Bacillary — fewer than ten, so there is no comparison to draw.
1 of the studies in Dysentery, Bacillary with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07049159Eveliqure Biotechnologies GmbHSafety, and Efficacy Study of ShigETEC, a Live, Attenuated, Oral Combination Vaccine to Prevent Shigella and ETEC Disease Delivered to Healthy Adults Ages 18 to 50 Years Old | 2027-05-23 |
Among the 23 studies in Dysentery, Bacillary with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
The original study protocol has been amended due to requests from the Food and Drug Administration (FDA), requests from the funder of the study, Bill \& Melinda Gates Foundation (BMGF), to add an additional interim analysis for immunogenicity data that will accelerate the release of key results to help the planning of other studies, and to further align the protocol to other GSK studies and to the challenge model established at the Cincinnati Children's Hospital Medical Centre.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Female subjects of childbearing potential may be enrolled in the study, if the subject:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the S. sonnei study vaccine at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally.
Biological: S.sonnei vaccine · Biological: S. sonnei 53G challenge strain
Male or female subjects between, and including, 18 and 50 years of age at the time of the first vaccination, received 2 doses of the placebo at Day 1 and Day 29 respectively, by intramuscular injection into the upper deltoid region of the non-dominant arm. At 28 days after the second dose (Day 57), subjects received the challenge dose of S. sonnei 53G strain, orally.
Drug: Placebo · Biological: S. sonnei 53G challenge strain
Subjects receiving 2 doses of the study vaccine by intramuscular route, 28 days apart (at Day 1 and Day 29).
Also known as: GSK3536852A vaccine
Subjects receiving 2 doses of placebo by intramuscular route, 28 days apart (at Day 1 and Day 29).
Also known as: GAHB-Placebo
Subjects receiving the challenge dose of S. sonnei 53G strain, orally, at Day 57.
Percentage of Subjects With at Least One Episode of Shigellosis According to the Protocol Primary Case Definition
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 grams of G3 to 5 stools within 24 hours or required medical intervention. In case of severe diarrhea, medical intervention is defined as intravenous fluids administration or anticipation of antibiotic treatment before the 5th day after challenge. G3 = viscous opaque liquid or semi-liquid which assumes the shape of the bowl; G4 = watery opaque liquid; G5 = clear watery or mucoid liquid.
Time frame: Starting with the challenge visit (Day 57) and lasting up to the end of the inpatient stay (Day 64)
Percentage of Subjects With at Least One Episode of Shigellosis According to Controlled Human Infection Model (CHIM) Working Group Case Definition for Shigellosis
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°C OR \[≥ 1 moderate constitutional/enteric symptom OR \[≥ 2 episodes of vomiting in 24 hours\]; 3. Dysentery defined as \[\[≥ 2 loose stools with gross blood (hemoccult positive) in 24 hours\] AND \[oral temperature \[≥ 38.0°C OR \[≥ 1 moderate constitutional/enteric symptom OR \[≥ 2 episodes of vomiting in 24 hours\].
Time frame: Starting with the challenge visit (Day 57) and lasting up to the end of the inpatient stay (Day 64)
Percentage of Subjects With at Least One Episode of Shigellosis
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 \[≥ 1 reportable constitutional/enteric symptom\]\].
Time frame: Starting with the challenge visit (Day 57) and lasting up to the end of the inpatient stay (Day 64)
Percentage of Subjects With at Least One Episode of More Severe Shigellosis
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 \[oral temperature ≥ 38.0°C OR ≥ 1 severe constitutional/enteric symptom\]\].
Time frame: Starting with the challenge visit (Day 57) and lasting up to the end of the inpatient stay (Day 64)
Percentage of Subjects With Specific Disease Symptoms
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 definition for shigellosis associated or not with mild to moderate symptoms including: ≥1 stool and no moderate or severe diarrhea evidence, abdominal pain, abdominal cramps, gas, anorexia, nausea, headache, myalgia, malaise, arthralgia, fever, vomiting and intravenous fluid administration. Any=any symptom regardless of intensity grade or relation to study vaccination and/or challenge administration.
Time frame: Starting with the challenge visit (Day 57) and lasting up to the end of the inpatient stay (Day 64)
Mean Number of Grade 3-5 Stools Per Subject
The mean number of grade 3-5 stools (and standard deviation) were calculated per subject from challenge to discharge.
Time frame: Starting with the challenge visit (Day 57) and lasting up to the end of the inpatient stay (Day 64)
Weight of Grade 3-5 Stools
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).
Time frame: Starting with the challenge visit (Day 57) and lasting up to the end of the inpatient stay (Day 64)
Time (Days) From Challenge Administration to Onset of Shigellosis, According to the Primary Case Definition
Median time to onset of shigellosis was to be estimated with Kaplan-Meier method among subjects who received the challenge agent. The day associated to the first shigellosis was the time of onset of shigellosis. Subjects who did not have shigellosis were censored at the time on the day of discharge. Median time (in days) to onset of shigellosis and 90% confidence interval (CI) could not be calculated in any of the groups because less than 50% of subjects experienced the event (shigellosis) during the observation period.
Time frame: Starting with the challenge visit (Day 57) and lasting up to the end of the inpatient stay (Day 64)
Number of Subjects With Any Solicited Local Adverse Events (AEs)
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.
Time frame: During the 7-day period after each vaccination (vaccine/placebo administered at Day 1 and Day 29)
Number of Subjects With Any Solicited Systemic AEs
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.
Time frame: During the 7-day period after each vaccination (vaccine/placebo administered at Day 1 and Day 29)
Number of Subjects With Any Unsolicited AEs During the 28-day Post-vaccination Period
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.
Time frame: During the 28-day period across doses (vaccine/placebo administered at Day 1 and Day 29)
Number of Subjects With Any Unsolicited AEs During the 28-day Follow-up Period After Challenge
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.
Time frame: During the 28-day follow-up period after challenge (challenge administered at Day 57)
Number of Subjects With Any Serious Adverse Events (SAEs) and Related SAEs
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.
Time frame: From Day 1 up to study end at Day 237
Number of Subjects With Any Adverse Events of Special Interest (AESI) (i.e., Symptomatic Neutropenia)
AESI are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation in order to characterize and understand it.
Time frame: From Day 1 up to study end at Day 237
Number of Subjects With Change From Baseline in Hematological Laboratory Parameters With Respect to Normal Laboratory Ranges
Among hematological parameters assessed are: Basophils, Eosinophils, Erythrocytes, Hematocrit, Hemoglobin, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets. Below = below the normal laboratory range defined for the specified laboratory parameter; Above = above the normal laboratory range defined for the specified laboratory parameter; Within = within the normal laboratory range defined for the specified laboratory parameter. Category naming has been defined as follows: Parameter, time point, range indicator at Baseline, range indicator at the specified time point: e.g.: "Basophils, Day 8, Within, Within ". Note: All subjects whose neutrophil value was below the threshold defined in the Protocol, at any time during the study, were re-tested until neutropenia resolution.
Time frame: At Day 8, at Day 36 and at Day 237
Anti-S. Sonnei Lipopolysaccharide (LPS) Immunoglobulin G (IgG) Antibody Concentrations at Pre-vaccination and After the First and Second Vaccination
Anti-S. sonnei LPS IgG antibody concentrations are presented as geometric mean concentrations (GMCs), determined by Enzyme-linked immunosorbent assay (ELISA) and expressed in ELISA units per milliliter (EU/mL). Note: regarding the "28 days after second vaccination" protocol timing, sample collection could have been performed either at Day 56 or at Day 57. For all the subjects, samples were collected at Day 56, and therefore, results are presented for "Day 56 (27 days after the second vaccination)" timing.
Time frame: At Day 1 (pre-vaccination), at Day 8 (7 days after the first vaccination), at Day 29 (28 days after the first vaccination), at Day 36 (7 days after the second vaccination) and at Day 56 (27 days after the second vaccination)
Anti-S. Sonnei LPS IgG Antibody Concentrations at Pre-challenge and After Challenge
Anti-S. sonnei LPS IgG antibody concentrations are presented as GMCs, as determined by ELISA and expressed in EU/mL. Note: regarding the "28 days after second vaccination" protocol timing, sample collection could have been performed either at Day 56 or at Day 57. For all the subjects, samples were collected at Day 56, and therefore, results are presented for "Day 56 (27 days after the second vaccination)" timing.
Time frame: At Day 56 (pre-challenge), at Day 64 (7 days after challenge) and at Day 85 (28 days after challenge)
Number of Subjects Achieving a Post-vaccination Anti-S. Sonnei LPS Concentration ≥ 268 EU/mL
This antibody response cut-off was based on the results of the previous Phase I studies and estimated results of the median antibody titer after natural infection by S. sonnei. The threshold 121 EU/mL planned per protocol has been recalibrated to 268 EU/mL following an investigation of reliability of the ELISA assay. Note: regarding the "28 days after second vaccination" protocol timing, sample collection could have been performed either at Day 56 or at Day 57. For all the subjects, samples were collected at Day 56, and therefore, results are presented for "Day 56 (27 days after the second vaccination)" timing.
Time frame: At Day 29 (28 days after the first vaccination) and at Day 56 (27 days after the second vaccination)
Number of Seroresponders for Anti-S. Sonnei LPS
Seroresponse definition as reported in the protocol was assay specific and specifically related to assay, as run in Marburg Lab for the previous GVGH Shigella studies. This assay was further characterized and optimized before being used in GVGH for the current Phase 2b study. Since the assay used in current study is not comparable with the assay used in previous GVGH studies, the seroresponse definition is no longer appropriate (as it is valid only for Marburg assay). With the acknowledgment that seroresponse results are no longer meaningful, the study team choose to report the results for transparency. Note: regarding the "28 days after second vaccination" protocol timing, sample collection could have been performed either at Day 56 or at Day 57. For all the subjects, samples were collected at Day 56, and therefore, results are presented for "Day 56 (27 days after the second vaccination" timing.
Time frame: At Day 29 (28 days after the first vaccination) and at Day 56 (27 days after the second vaccination)
This study was conducted at one center in the United States of America (USA).
| Milestone | S. Sonnei Group | Placebo Group |
|---|---|---|
| Started | 36 | 35 |
| Completed | 29 | 28 |
| Not completed | 7 | 7 |
| Withdrew: Lost to follow-up | 4 | 2 |
| Withdrew: Eligibility criteria not fulfilled | 1 | 0 |
| Withdrew: Consent withdrawal not due to adv. event | 1 | 5 |
| Withdrew: Not willing to participate this visit | 1 | 0 |
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 grams of G3 to 5 stools within 24 hours or required medical intervention. In case of severe diarrhea, medical intervention is defined as intravenous fluids administration or anticipation of antibiotic treatment before the 5th day after challenge. G3 = viscous opaque liquid or semi-liquid which assumes the shape of the bowl; G4 = watery opaque liquid; G5 = clear watery or mucoid liquid.
| Percentage of subjects | S. Sonnei Group | Placebo Group |
|---|---|---|
| Percentage of Subjects With at Least One Episode of Shigellosis According to the Protocol Primary Case Definition | 46.9 (31.5 to 62.7) | 42.9 (26.9 to 60.0) |
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°C OR \[≥ 1 moderate constitutional/enteric symptom OR \[≥ 2 episodes of vomiting in 24 hours\]; 3. Dysentery defined as \[\[≥ 2 loose stools with gross blood (hemoccult positive) in 24 hours\] AND \[oral temperature \[≥ 38.0°C OR \[≥ 1 moderate constitutional/enteric symptom OR \[≥ 2 episodes of vomiting in 24 hours\].
| Percentage of subjects | S. Sonnei Group | Placebo Group |
|---|---|---|
| Percentage of Subjects With at Least One Episode of Shigellosis According to Controlled Human Infection Model (CHIM) Working Group Case Definition for Shigellosis | 46.9 (31.5 to 62.7) | 32.1 (17.9 to 49.4) |
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 \[≥ 1 reportable constitutional/enteric symptom\]\].
| Percentage of subjects | S. Sonnei Group | Placebo Group |
|---|---|---|
| Percentage of Subjects With at Least One Episode of Shigellosis | 46.9 (31.5 to 62.7) | 35.7 (20.8 to 53.0) |
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 \[oral temperature ≥ 38.0°C OR ≥ 1 severe constitutional/enteric symptom\]\].
| Percentage of subjects | S. Sonnei Group | Placebo Group |
|---|---|---|
| Percentage of Subjects With at Least One Episode of More Severe Shigellosis | 15.6 (6.4 to 30.1) | 14.3 (5.0 to 29.8) |
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 definition for shigellosis associated or not with mild to moderate symptoms including: ≥1 stool and no moderate or severe diarrhea evidence, abdominal pain, abdominal cramps, gas, anorexia, nausea, headache, myalgia, malaise, arthralgia, fever, vomiting and intravenous fluid administration. Any=any symptom regardless of intensity grade or relation to study vaccination and/or challenge administration.
| Percentage of subjects | S. Sonnei Group | Placebo Group |
|---|---|---|
| Shedding of S. sonnei strain 53G | 96.9 (86.0 to 99.8) | 100 (89.9 to 100.0) |
| Severe diarrhea | 40.6 (26.0 to 56.7) | 25 (12.4 to 41.9) |
| More severe diarrhea | 34.4 (20.6 to 50.4) | 17.9 (7.3 to 33.9) |
| Dysentery | 34.4 (20.6 to 50.4) | 28.6 (15.1 to 45.7) |
| Shedding of S. sonnei 53G and [… | 46.9 (31.5 to 62.7) | 42.9 (26.9 to 60.0) |
| ≥1 stool and no moderate/severe diarrhea evidence | 50.0 (34.4 to 65.6) | 60.7 (43.5 to 76.2) |
| Any Abdominal pain | 50.0 (34.4 to 65.6) | 46.4 (30.1 to 63.4) |
| Any Abdominal cramps | 53.1 (37.3 to 68.5) | 50.0 (33.3 to 66.7) |
| Any Gas | 40.6 (26.0 to 56.7) | 57.1 (40.0 to 73.1) |
| Any Anorexia | 43.8 (28.7 to 59.7) | 46.4 (30.1 to 63.4) |
| Any Nausea | 34.4 (20.6 to 50.4) | 32.1 (17.9 to 49.4) |
| Any Headache | 53.1 (37.3 to 68.5) | 60.7 (43.5 to 76.2) |
| Any Myalgia | 34.4 (20.6 to 50.4) | 46.4 (30.1 to 63.4) |
| Any Malaise | 46.9 (31.5 to 62.7) | 57.1 (40.0 to 73.1) |
| Any Arthralgia | 28.1 (15.5 to 43.9) | 32.1 (17.9 to 49.4) |
| Any Fever | 9.4 (2.6 to 22.5) | 17.9 (7.3 to 33.9) |
| Any Vomiting | 21.9 (10.7 to 37.2) | 7.1 (1.3 to 20.8) |
| Intravenous fluid administration | 0 (0.0 to 0.0) | 0 (0.0 to 0.0) |
The mean number of grade 3-5 stools (and standard deviation) were calculated per subject from challenge to discharge.
| grade 3-5 stools | S. Sonnei Group | Placebo Group |
|---|---|---|
| Mean Number of Grade 3-5 Stools Per Subject | 28 ± 13.0 | 13.9 ± 6.6 |
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).
| Grams | S. Sonnei Group | Placebo Group |
|---|---|---|
| Weight/all subjects | 87.4 ± 68.3 | 91.3 ± 54.7 |
| Weight/subj. with at least 1 grade 3-5 stool | 127.2 ± 39.8 | 116.3 ± 28.5 |
| Cumulative weight/all subjects | 1161.1 ± 1416.9 | 766.9 ± 884.9 |
Median time to onset of shigellosis was to be estimated with Kaplan-Meier method among subjects who received the challenge agent. The day associated to the first shigellosis was the time of onset of shigellosis. Subjects who did not have shigellosis were censored at the time on the day of discharge. Median time (in days) to onset of shigellosis and 90% confidence interval (CI) could not be calculated in any of the groups because less than 50% of subjects experienced the event (shigellosis) during the observation period.
No measurements were reported for this outcome.
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.
| Participants | S. Sonnei Group | Placebo Group |
|---|---|---|
| Dose 1, Pain | 29 | 12 |
| Dose 2, Pain | 24 | 5 |
| Dose 1, Erythema | 0 | 0 |
| Dose 2, Erythema | 0 | 0 |
| Dose 1, Induration | 0 | 1 |
| Dose 2, Induration | 0 | 0 |
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.
| Participants | S. Sonnei Group | Placebo Group |
|---|---|---|
| Dose 1, Arthralgia | 6 | 3 |
| Dose 2, Arthralgia | 7 | 2 |
| Dose 1, Chills | 5 | 2 |
| Dose 2, Chills | 3 | 1 |
| Dose 1, Fatigue | 6 | 8 |
| Dose 2, Fatigue | 7 | 3 |
| Dose 1, Headache | 10 | 8 |
| Dose 2, Headache | 4 | 4 |
| Dose 1, Malaise | 8 | 4 |
| Dose 2, Malaise | 6 | 4 |
| Dose 1, Myalgia | 15 | 8 |
| Dose 2, Myalgia | 9 | 7 |
| Dose 1, Fever | 1 | 0 |
| Dose 2, Fever | 0 | 0 |
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.
| Participants | S. Sonnei Group | Placebo Group |
|---|---|---|
| Number of Subjects With Any Unsolicited AEs During the 28-day Post-vaccination Period | 18 | 13 |
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.
| Participants | S. Sonnei Group | Placebo Group |
|---|---|---|
| Number of Subjects With Any Unsolicited AEs During the 28-day Follow-up Period After Challenge | 20 | 17 |
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.
| Participants | S. Sonnei Group | Placebo Group |
|---|---|---|
| Any SAE(s) | 0 | 1 |
| Related SAE(s) | 0 | 0 |
AESI are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation in order to characterize and understand it.
| Participants | S. Sonnei Group | Placebo Group |
|---|---|---|
| Number of Subjects With Any Adverse Events of Special Interest (AESI) (i.e., Symptomatic Neutropenia) | 0 | 0 |
Among hematological parameters assessed are: Basophils, Eosinophils, Erythrocytes, Hematocrit, Hemoglobin, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets. Below = below the normal laboratory range defined for the specified laboratory parameter; Above = above the normal laboratory range defined for the specified laboratory parameter; Within = within the normal laboratory range defined for the specified laboratory parameter. Category naming has been defined as follows: Parameter, time point, range indicator at Baseline, range indicator at the specified time point: e.g.: "Basophils, Day 8, Within, Within ". Note: All subjects whose neutrophil value was below the threshold defined in the Protocol, at any time during the study, were re-tested until neutropenia resolution.
| Participants | S. Sonnei Group | Placebo Group |
|---|---|---|
| Basophils, Day 8, Within, Within | 31 | 28 |
| Basophils, Day 8, Within, Above | 2 | 2 |
| Basophils, Day 8, Above, Within | 2 | 5 |
| Basophils, Day 8, Above, Above | 1 | 0 |
| Basophils, Day 36, Within, Within | 32 | 26 |
| Basophils, Day 36, Within, Above | 1 | 3 |
| Basophils, Day 36, Above, Within | 2 | 4 |
| Basophils, Day 36, Above, Above | 1 | 1 |
| Basophils, Day 237, Within, Within | 25 | 22 |
| Basophils, Day 237, Within, Above | 1 | 2 |
| Basophils, Day 237, Above, Within | 3 | 4 |
| Eosinophils, Day 8, Within, Within | 35 | 34 |
| Eosinophils, Day 8, Within, Above | 1 | 0 |
| Eosinophils, Day 8, Above, Within | — | 1 |
| Eosinophils, Day 36, Within, Within | 36 | 32 |
| Eosinophils, Day 36, Within, Above | 0 | 1 |
| Eosinophils, Day 36, Above, Within | — | 1 |
| Eosinophils, Day 237, Within, Within | 29 | 27 |
| Eosinophils, Day 237, Above, Within | — | 1 |
| Erythrocytes, Day 8, Below, Below | 4 | — |
| Erythrocytes, Day 8, Below, Within | 1 | — |
| Erythrocytes, Day 8, Within, Below | 2 | 2 |
| Erythrocytes, Day 8, Within, Within | 29 | 31 |
| Erythrocytes, Day 8, Above, Within | — | 2 |
| Erythrocytes, Day 36, Below, Below | 4 | — |
| Erythrocytes, Day 36, Below, Within | 1 | — |
| Erythrocytes, Day 36, Within, Below | 2 | 2 |
| Erythrocytes, Day 36, Within, Within | 29 | 30 |
| Erythrocytes, Day 36, Above, Within | — | 2 |
| Erythrocytes, Day 237, Below, Below | 3 | — |
| Erythrocytes, Day 237, Below, Within | 2 | — |
| Erythrocytes, Day 237, Within, Below | 1 | 0 |
| Erythrocytes, Day 237, Within, Within | 22 | 25 |
| Erythrocytes, Day 237, Within, Above | 1 | 1 |
| Erythrocytes, Day 237, Above, Within | — | 1 |
| Erythrocytes, Day 237, Above, Above | — | 1 |
| Hematocrit, Day 8, Below, Below | 3 | 1 |
| Hematocrit, Day 8, Below, Within | 1 | 0 |
| Hematocrit, Day 8, Within, Below | 3 | 1 |
| Hematocrit, Day 8, Within, Within | 29 | 31 |
| Hematocrit, Day 8, Above, Within | — | 2 |
| Hematocrit, Day 36, Below, Below | 2 | 1 |
| Hematocrit, Day 36, Below, Within | 2 | 0 |
| Hematocrit, Day 36, Within, Below | 3 | 2 |
| Hematocrit, Day 36, Within, Within | 29 | 29 |
| Hematocrit, Day 36, Above, Within | — | 2 |
| Hematocrit, Day 237, Below, Below | 3 | — |
| Hematocrit, Day 237, Below, Within | 1 | — |
| Hematocrit, Day 237, Within, Below | 1 | 2 |
| Hematocrit, Day 237, Within, Within | 24 | 24 |
| Hematocrit, Day 237, Above, Within | — | 1 |
| Hematocrit, Day 237, Above, Above | — | 1 |
| Hemoglobin, Day 8, Below, Below | 4 | 1 |
| Hemoglobin, Day 8, Within, Below | 3 | 2 |
| Hemoglobin, Day 8, Within, Within | 29 | 32 |
| Hemoglobin, Day 36, Below, Below | 3 | 1 |
| Hemoglobin, Day 36, Below, Within | 1 | 0 |
| Hemoglobin, Day 36, Within, Below | 3 | 1 |
| Hemoglobin, Day 36, Within, Within | 29 | 32 |
| Hemoglobin, Day 237, Below, Below | 3 | — |
| Hemoglobin, Day 237, Within, Below | 3 | 7 |
| Hemoglobin, Day 237, Within, Within | 23 | 21 |
| Leukocytes, Day 8, Below, Below | 2 | 2 |
| Leukocytes, Day 8, Below, Within | 3 | 2 |
| Leukocytes, Day 8, Within, Below | 2 | 1 |
| Leukocytes, Day 8, Within, Within | 28 | 28 |
| Leukocytes, Day 8, Within, Above | 1 | 1 |
| Leukocytes, Day 8, Above, Within | — | 1 |
| Leukocytes, Day 36, Below, Below | 2 | 3 |
| Leukocytes, Day 36, Below, Within | 3 | 1 |
| Leukocytes, Day 36, Within, Below | 1 | 2 |
| Leukocytes, Day 36, Within, Within | 28 | 27 |
| Leukocytes, Day 36, Within, Above | 2 | 0 |
| Leukocytes, Day 36, Above, Above | — | 1 |
| Leukocytes, Day 237, Below, Below | 2 | 1 |
| Leukocytes, Day 237, Below, Within | 2 | 3 |
| Leukocytes, Day 237, Within, Below | 0 | 1 |
| Leukocytes, Day 237, Within, Within | 24 | 21 |
| Leukocytes, Day 237, Within, Above | 1 | 1 |
| Leukocytes, Day 237, Above, Within | — | 1 |
| Lymphocytes, Day 8, Unknown, Within | 1 | — |
| Lymphocytes, Day 8, Below, Above | — | 1 |
| Lymphocytes, Day 8, Within, Below | 1 | 0 |
| Lymphocytes, Day 8, Within, Within | 33 | 34 |
| Lymphocytes, Day 8, Within, Above | 1 | 0 |
| Lymphocytes, Day 36, Unknown, Within | 1 | — |
| Lymphocytes, Day 36, Below, Below | — | 1 |
| Lymphocytes, Day 36, Within, Within | 35 | 33 |
| Lymphocytes, Day 237, Unknown, Within | 1 | — |
| Lymphocytes, Day 237, Below, Below | — | 1 |
| Lymphocytes, Day 237, Within, Within | 28 | 27 |
| Monocytes, Day 8, Within, Within | 27 | 25 |
| Monocytes, Day 8, Within, Above | 2 | 5 |
| Monocytes, Day 8, Above, Within | 2 | 1 |
| Monocytes, Day 8, Above, Above | 5 | 4 |
| Monocytes, Day 36, Within, Within | 25 | 25 |
| Monocytes, Day 36, Within, Above | 4 | 4 |
| Monocytes, Day 36, Above, Within | 3 | 1 |
| Monocytes, Day 36, Above, Above | 4 | 4 |
| Monocytes, Day 237, Within, Within | 19 | 13 |
| Monocytes, Day 237, Within, Above | 5 | 10 |
| Monocytes, Day 237, Above, Within | 0 | 2 |
| Monocytes, Day 237, Above, Above | 5 | 3 |
| Neutrophils, Day 8, Below, Within | 1 | — |
| Neutrophils, Day 8, Within, Below | 1 | 4 |
| Neutrophils, Day 8, Within, Within | 34 | 29 |
| Neutrophils, Day 8, Within, Above | 0 | 1 |
| Neutrophils, Day 8, Above, Within | — | 1 |
| Neutrophils, Day 36, Below, Within | 1 | — |
| Neutrophils, Day 36, Within, Below | 1 | 2 |
| Neutrophils, Day 36, Within, Within | 33 | 31 |
| Neutrophils, Day 36, Within, Above | 1 | 0 |
| Neutrophils, Day 36, Above, Within | — | 1 |
| Neutrophils, Day 237, Within, Below | 0 | 1 |
| Neutrophils, Day 237, Within, Within | 28 | 25 |
| Neutrophils, Day 237, Within, Above | 1 | 1 |
| Neutrophils, Day 237, Above, Within | — | 1 |
| Platelets, Day 8, Below, Below | — | 1 |
| Platelets, Day 8, Within, Within | 36 | 34 |
| Platelets, Day 36, Below, Below | — | 1 |
| Platelets, Day 36, Within, Within | 36 | 33 |
| Platelets, Day 237, Below, Within | — | 1 |
| Platelets, Day 237, Within, Below | 0 | 1 |
| Platelets, Day 237, Within, Within | 29 | 25 |
| Platelets, Day 237, Within, Above | 0 | 1 |
Anti-S. sonnei LPS IgG antibody concentrations are presented as geometric mean concentrations (GMCs), determined by Enzyme-linked immunosorbent assay (ELISA) and expressed in ELISA units per milliliter (EU/mL). Note: regarding the "28 days after second vaccination" protocol timing, sample collection could have been performed either at Day 56 or at Day 57. For all the subjects, samples were collected at Day 56, and therefore, results are presented for "Day 56 (27 days after the second vaccination)" timing.
| EU/mL | S. Sonnei Group | Placebo Group |
|---|---|---|
| Day 1 | 99.32 (62.39 to 158.11) | 124.07 (77.30 to 199.13) |
| Day 8 | 229.18 (135.69 to 387.09) | 128.24 (81.43 to 201.96) |
| Day 29 | 523.21 (304.08 to 900.24) | 124.48 (76.16 to 203.46) |
| Day 36 | 577.86 (345.36 to 966.90) | 123.57 (77.31 to 197.50) |
| Day 56 | 548.75 (325.13 to 926.18) | 134.24 (85.12 to 211.70) |
Anti-S. sonnei LPS IgG antibody concentrations are presented as GMCs, as determined by ELISA and expressed in EU/mL. Note: regarding the "28 days after second vaccination" protocol timing, sample collection could have been performed either at Day 56 or at Day 57. For all the subjects, samples were collected at Day 56, and therefore, results are presented for "Day 56 (27 days after the second vaccination)" timing.
| EU/mL | S. Sonnei Group | Placebo Group |
|---|---|---|
| Day 56 | 529.4 (296.83 to 944.20) | 150.59 (90.55 to 250.42) |
| Day 64 | 537.92 (295.66 to 978.71) | 216.11 (132.83 to 351.61) |
| Day 85 | 1039.07 (601.00 to 1796.46) | 810.97 (419.53 to 1567.65) |
This antibody response cut-off was based on the results of the previous Phase I studies and estimated results of the median antibody titer after natural infection by S. sonnei. The threshold 121 EU/mL planned per protocol has been recalibrated to 268 EU/mL following an investigation of reliability of the ELISA assay. Note: regarding the "28 days after second vaccination" protocol timing, sample collection could have been performed either at Day 56 or at Day 57. For all the subjects, samples were collected at Day 56, and therefore, results are presented for "Day 56 (27 days after the second vaccination)" timing.
| Participants | S. Sonnei Group | Placebo Group |
|---|---|---|
| Day 29 | 24 | 7 |
| Day 56 | 24 | 7 |
Seroresponse definition as reported in the protocol was assay specific and specifically related to assay, as run in Marburg Lab for the previous GVGH Shigella studies. This assay was further characterized and optimized before being used in GVGH for the current Phase 2b study. Since the assay used in current study is not comparable with the assay used in previous GVGH studies, the seroresponse definition is no longer appropriate (as it is valid only for Marburg assay). With the acknowledgment that seroresponse results are no longer meaningful, the study team choose to report the results for transparency. Note: regarding the "28 days after second vaccination" protocol timing, sample collection could have been performed either at Day 56 or at Day 57. For all the subjects, samples were collected at Day 56, and therefore, results are presented for "Day 56 (27 days after the second vaccination" timing.
| Participants | S. Sonnei Group | Placebo Group |
|---|---|---|
| Day 29 | 32 | 0 |
| Day 56 | 31 | 0 |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| S. Sonnei Group | 0/36 (0%) | 0/36 (0%) | 34/36 (94.4%) |
| Placebo Group | 0/35 (0%) | 1/35 (2.9%) | 33/35 (94.3%) |
| Event | S. Sonnei Group | Placebo Group |
|---|---|---|
| Carotid artery aneurysmNervous system disorders | 0/36 | 1/35 |
| Deep vein thrombosisVascular disorders | 0/36 | 1/35 |
| HaematomaVascular disorders | 0/36 | 1/35 |
| Pelvic venous thrombosisVascular disorders | 0/36 | 1/35 |
| Event | S. Sonnei Group | Placebo Group |
|---|---|---|
| Injection site painGeneral disorders | 31/36 | 13/35 |
| MyalgiaMusculoskeletal and connective tissue disorders | 25/36 | 16/35 |
| DiarrhoeaGastrointestinal disorders | 22/36 | 22/35 |
| HeadacheNervous system disorders | 22/36 | 22/35 |
| MalaiseGeneral disorders | 19/36 | 16/35 |
| Abdominal painGastrointestinal disorders | 18/36 | 15/35 |
| FlatulenceGastrointestinal disorders | 13/36 | 16/35 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 16/36 | 10/35 |
| Decreased appetiteMetabolism and nutrition disorders | 14/36 | 13/35 |
| FatigueGeneral disorders | 13/36 | 12/35 |
| Age, Continuous(Years) | S. Sonnei Group | Placebo Group | Total |
|---|---|---|---|
| Mean | 36.2 ± 9.9 | 35.2 ± 8.5 | 35.7 ± 9.2 |
| Sex: Female, Male(Participants) | S. Sonnei Group | Placebo Group | Total |
|---|---|---|---|
| Female | 14 | 17 | 31 |
| Male | 22 | 18 | 40 |
| Race/Ethnicity, Customized(Participants) | S. Sonnei Group | Placebo Group | Total |
|---|---|---|---|
| BLACK OR AFRICAN AMERICAN | 24 | 28 | 52 |
| OTHER - UNSPECIFIED | 2 | 1 | 3 |
| WHITE | 10 | 6 | 16 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints 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.
Data sharing details ↗ · clinicalstudydatarequest.com
Ran from Aug 2018 to primary completion in May 2019, 8 months.
Results were first posted in May 2020, 1 year after primary completion.
Of 11 phase 2 interventional studies under Dysentery, Bacillary, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 30. This study's 8 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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