ShigellosisPhase 1NCT02017899

A Phase 1, Dose Escalation Study, to Evaluate a New Shigella Sonnei Vaccine in Healthy Adults.

A Phase 1 study testing S. sonnei 1790GAHB in people with Shigellosis, run by GSK Vaccines Institute For Global Health S.r.l. at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Shigellosis
What is being tested?: S. sonnei 1790GAHB
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 50 participants
Where: 1 siteFrance
Study dates: Feb 2014to Mar 2015
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Males and females of age ≥18 years to ≤45 years.
Individuals who, after the nature of the study has been explained to them, and prior to any protocol specific procedures being performed, have given written consent according to local regulatory requirements.
Individuals in good health as determined by the outcome of medical history, physical examination, hematological / hematochemical blood tests (including presence of high antibody titers against S. sonnei by agglutination test), urinalysis and clinical judgment of the investigator.
If women of child-bearing potential, have a negative pregnancy test prior study vaccination and willingness to use acceptable birth control measures for the entire study duration.
Individuals affiliated to a social security regimen.

Who cannot join

Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study.
Individuals with any progressive or severe neurological disorder, seizure disorder or Guillain-Barré syndrome.
Individuals who are not able to understand and to follow all required study procedures for the whole period of the study.
Individuals with history of any illness that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study.
Individuals human leukocyte antigen (HLA) -B27 positive and/or with history of reactive arthritis.
Individuals with known or suspected HIV infection or HIV related disease, with history of an autoimmune disorder or any other known or suspected impairment /alteration of the immune system, or under immunosuppressive therapy including use of systemic corticosteroids or chronic use of inhaled high-potency corticosteroids (i.e. prednisone, or equivalent ≥10 mg/day) within the previous 28 days, or in chemotherapy treatment within the past 168 days.

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Individuals with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
Individuals with any serious chronic or progressive disease according to judgment of the investigator (e.g., neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease).
Individuals who have any malignancy or lymphoproliferative disorder.
Individuals with history of allergy to vaccine components.
Individuals participating in any clinical trial with another investigational product 28 days prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study.
Individuals who received any other vaccines within 4 weeks prior to enrollment in this study or who are planning to receive any vaccine within the entire study duration except influenza vaccination, which is not allowed within the period included between 28 days before 1st vaccination and 28 days after 3rd vaccination.
Individuals who have received blood, blood products, and/or plasma derivatives including parenteral immunoglobulin preparations in the past 12 weeks.
Individuals who are part of study personnel or close family members to the personnel conducting this study or employees of the clinical trial site institution.
Individuals with body temperature > 38.0 degrees Celsius within 3 days of intended study vaccination.
Individuals with Body Mass Index (BMI)> 30 kg/m2
Individuals with history of substance or alcohol abuse within the past 2 years.
Women who are pregnant or are breast-feeding, or are of childbearing age who have not used or do not plan to use acceptable birth control measures, for the duration of the study.
Females with history of stillbirth, neonatal loss, or previous infant with anomaly.
Individuals who have a previously laboratory confirmed or suspected disease caused by S. sonnei.
Individuals who have had household contact with/and or intimate exposure to an individual with laboratory confirmed S. sonnei.
Any condition, which, in the opinion of the investigator may pose an increased and unreasonable safety risk to the subject if participating to the present study

Trial locations and contacts

1 site in 1 country.

France1 site

Centre d'Investigation Clinique en Vaccinologie Cochin-Pasteur (CIC1417)
Paris, Paris Cedex 14, 75679

Other trials in France

About this study

Official title: A Phase 1, Randomized, Observer Blinded, Placebo Controlled, Single Center, Dose Escalation Study to Evaluate the Safety and Immunogenicity of 3 Vaccinations With Shigella Sonnei Vaccine (1790GAHB) Administered Intramuscularly in Healthy Adults.

This Phase 1 clinical trial is aimed to evaluate the safety and immunogenicity of 3 doses of 5 sequentially escalating dosages of a candidate vaccine against Shigella sonnei (1790GAHB vaccine) administered by intramuscular route in healthy adults (18 to 45 years of age at enrollment). The safety profile of the 1790GAHB vaccine is evaluated in comparison to that of placebo (GAHB-Placebo), constituted by an aluminum hydroxide suspension having the same concentration as study vaccine formulations. A total of 50 eligible subjects will be assigned to one of five sequential cohorts of 10 subjects each.

Within each cohort, in an observer-blind fashion, subjects will be randomized to receive three vaccinations, four weeks apart, of either 1790GAHB vaccine (at five antigen concentrations) or GAHB placebo. A Data Safety Monitoring Board will be in place to receive a summary of all safety data obtained during one week follow-up post-first vaccination with the lower dose. Based on evaluation of the safety data, the Data Safety Monitoring Board will make a recommendation, as to whether the next cohort should be vaccinated with higher antigen concentration or not.

Expected duration of the study for an individual subject is 9 months. Each subject will be followed-up for 6 months after the 3rd vaccination.

Conditions: Shigellosis
Being tested: S. sonnei 1790GAHB, Placebo
Keywords: prevention, Shigella sonnei
Medical subject headings: Dysentery, Bacillary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

S. sonnei 1790GAHBBiological
Also called Shigella sonnei vaccine
PlaceboBiological

Study groups in NCT02017899
Study group	Role	What they receive
S. sonnei 1790GAHB - 1 mcg	Experimental	Subjects enrolled in COHORT A receiving 3 injections of S. sonnei 1790GAHB - 1 mcg Receives: Biological: S. sonnei 1790GAHB
S. sonnei 1790GAHB - 5 mcg	Experimental	Subjects enrolled in COHORT B receiving 3 injections of S. sonnei 1790GAHB - 5 mcg Receives: Biological: S. sonnei 1790GAHB
S. sonnei 1790GAHB - 25 mcg	Experimental	Subjects enrolled in COHORT C receiving 3 injections of S. sonnei 1790GAHB - 25 mcg Receives: Biological: S. sonnei 1790GAHB
S. sonnei 1790GAHB - 50 mcg	Experimental	Subjects enrolled in COHORT D receiving 3 injections of S. sonnei 1790GAHB - 50 mcg Receives: Biological: S. sonnei 1790GAHB
S. sonnei 1790GAHB - 100 mcg	Experimental	Subjects enrolled in COHORT E receiving 3 injections of S. sonnei 1790GAHB - 100 mcg Receives: Biological: S. sonnei 1790GAHB
Placebo	Placebo comparator	2 subjects enrolled in each COHORT A, B, C, D, E receiving 3 injections of Placebo. These were pooled in one Placebo group in the analyses Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Subjects With Solicited Local Reaction After Any Vaccination
Any erythema/induration refers to: ≥25 mm in diameter. Grade 3 (severe) refers to erythema/induration >100 mm in diameter. Grade 3 (severe) for injection site pain refers to: prevents daily activity
Measured: During a 7-day (Days 1-7) post vaccination period following any injection
Number of Subjects With Solicited Systemic Reaction After Any Vaccination
Any= Incidence of any symptom regardless of intensity grade. Grade 3 = symptom that prevented daily activities
Measured: During a 7-day (Days 1 to 7) post vaccination period following any injection
Number of Subjects With Neutrophils Results Below and Above the Normal Ranges
Day 8: VISIT 2 (D7 post 1st vac)
Measured: At Day 8
Number of Subjects With Neutrophils Results Below and Above the Normal
Day 36: VISIT 3.1 (D7 post 2nd vac.)
Measured: At Day 36
Number of Subjects With Neutrophils Results Below and Above the Normal
Day 57: VISIT 4 (3rd vac.)
Measured: At Day 57
Number of Subjects With Neutrophils Results Below and Above the Normal
Day 64: VISIT 4.1 (D7 post 3rd vac.)
Measured: At Day 64
Number of Subjects With Neutrophils Results Below and Above the Normal
Day 85: VISIT 5 (1 month post 3rd vac.)
Measured: At Day 85
Number of Subjects With Neutrophils Results Below and Above the Normal
Day 225: VISIT 6 (6 months post 3rd vac.)
Measured: At Day 225

Secondary outcomes (3)

Anti-LPS S. Sonnei Serum IgG Geometric Mean Concentration (GMCs)
Measured: At baseline, at 28 days after each vaccination and at 168 days after last vaccination
Number of Subjects With Seroresponse for Anti-LPS S. Sonnei
Seroresponse is defined as: If half of the baseline value is greater than 25 ELISA Unit (EU) then an increase of at least 50% in the post-vaccination sample as compared to baseline [i.e. ((Post-vac minus baseline)/baseline)100% ≥ 50%]. If half of the baseline value is less or equal to 25 EU then an increase of at least 25 EU in the post-vaccination sample as compared to baseline (i.e. [post-vac minus baseline] ≥25 EU)
Measured: At 28 days after each vaccination and 168 days after last vaccination
Number of Subjects With High Seroresponse for Anti-LPS S. Sonnei (IgG ELISA ≥121 EU)
High seroresponse is defined as a post vaccination titer ≥X anti-LPS serum IgG units in the GSK (former Novartis) ELISA that correspond to a titer of 1:800 in the ELISA method used by Cohen et al. To determine the value for 'X' the GSK (former Novartis) anti-LPS ELISA was calibrated against the Cohen ELISA and it was found that a concentration of 121 EU EU/mL corresponds to a titer of 1:800 in the Cohen assay
Measured: At baseline, at 28 days after each vaccination and at 168 days after last vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2014Mar 2015

First posted23 Dec 2013 (estimated)
Study startFeb 2014
Primary completionMar 2015
Study completionMar 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for ShigellosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02017899
Sponsor's protocol ID: H03_01TP
Status last verified: Aug 2018
First submitted: 17 Dec 2013
Last updated: 23 Jan 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Micoli F, Rossi O, Conti V, Launay O, Scire AS, Aruta MG, Nakakana UN, Marchetti E, Rappuoli R, Saul A, Martin LB, Necchi F, Podda A. Antibodies Elicited by the Shigella sonnei GMMA Vaccine in Adults Trigger Complement-Mediated Serum Bactericidal Activity: Results From a Phase 1 Dose Escalation Trial Followed by a Booster Extension. Front Immunol. 2021 May 4;12:671325. doi: 10.3389/fimmu.2021.671325. eCollection 2021.
PubMed 34017343
Launay O, Lewis DJM, Anemona A, Loulergue P, Leahy J, Scire AS, Maugard A, Marchetti E, Zancan S, Huo Z, Rondini S, Marhaba R, Finco O, Martin LB, Auerbach J, Cohen D, Saul A, Gerke C, Podda A. Safety Profile and Immunologic Responses of a Novel Vaccine Against Shigella sonnei Administered Intramuscularly, Intradermally and Intranasally: Results From Two Parallel Randomized Phase 1 Clinical Studies in Healthy Adult Volunteers in Europe. EBioMedicine. 2017 Aug;22:164-172. doi: 10.1016/j.ebiom.2017.07.013. Epub 2017 Jul 15.
PubMed 28735965
Muturi-Kioi V, Lewis D, Launay O, Leroux-Roels G, Anemona A, Loulergue P, Bodinham CL, Aerssens A, Groth N, Saul A, Podda A. Neutropenia as an Adverse Event following Vaccination: Results from Randomized Clinical Trials in Healthy Adults and Systematic Review. PLoS One. 2016 Aug 4;11(8):e0157385. doi: 10.1371/journal.pone.0157385. eCollection 2016.
PubMed 27490698

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Shigellosis trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Randomized, Observer Blinded, Placebo Controlled, Single Center, Dose Escalation Study to Evaluate the Safety and Immunogenicity of 3 Vaccinations With Shigella Sonnei Vaccine (1790GAHB) Administered Intramuscularly in Healthy Adults.
ClinicalTrials.gov ID: NCT02017899
Acronym / sponsor ID: H03_01TP
Conditions: Shigellosis
Keywords: prevention, Shigella sonnei
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: GSK Vaccines Institute For Global Health S.r.l.Industry (pharma, biotech, devices)
Study start: Feb 2014
Primary completion: Mar 2015 (actual)
Study completion: Mar 2015 (actual)
First posted: 23 Dec 2013 (estimated)
Results: Posted 23 Jan 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Expected duration of the study for an individual subject is 9 months. Each subject will be followed-up for 6 months after the 3rd vaccination.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
S. sonnei 1790GAHB - 1 mcg	Experimental	Biological: S. sonnei 1790GAHBSubjects enrolled in COHORT A receiving 3 injections of S. sonnei 1790GAHB - 1 mcg
S. sonnei 1790GAHB - 5 mcg	Experimental	Biological: S. sonnei 1790GAHBSubjects enrolled in COHORT B receiving 3 injections of S. sonnei 1790GAHB - 5 mcg
S. sonnei 1790GAHB - 25 mcg	Experimental	Biological: S. sonnei 1790GAHBSubjects enrolled in COHORT C receiving 3 injections of S. sonnei 1790GAHB - 25 mcg
S. sonnei 1790GAHB - 50 mcg	Experimental	Biological: S. sonnei 1790GAHBSubjects enrolled in COHORT D receiving 3 injections of S. sonnei 1790GAHB - 50 mcg
S. sonnei 1790GAHB - 100 mcg	Experimental	Biological: S. sonnei 1790GAHBSubjects enrolled in COHORT E receiving 3 injections of S. sonnei 1790GAHB - 100 mcg
Placebo	Placebo comparator	Biological: Placebo2 subjects enrolled in each COHORT A, B, C, D, E receiving 3 injections of Placebo. These were pooled in one Placebo group in the analyses

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Males and females of age ≥18 years to ≤45 years.
Individuals who, after the nature of the study has been explained to them, and prior to any protocol specific procedures being performed, have given written consent according to local regulatory requirements.
Individuals in good health as determined by the outcome of medical history, physical examination, hematological / hematochemical blood tests (including presence of high antibody titers against S. sonnei by agglutination test), urinalysis and clinical judgment of the investigator.
If women of child-bearing potential, have a negative pregnancy test prior study vaccination and willingness to use acceptable birth control measures for the entire study duration.
Individuals affiliated to a social security regimen.

Key exclusion criteria (22 listed)

Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study.
Individuals with any progressive or severe neurological disorder, seizure disorder or Guillain-Barré syndrome.
Individuals who are not able to understand and to follow all required study procedures for the whole period of the study.
Individuals with history of any illness that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study.
Individuals human leukocyte antigen (HLA) -B27 positive and/or with history of reactive arthritis.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
S. sonnei 1790GAHBAlso: Shigella sonnei vaccine	Biological	S. sonnei 1790GAHB - 1 mcg, S. sonnei 1790GAHB - 100 mcg, S. sonnei 1790GAHB - 25 mcg, S. sonnei 1790GAHB - 5 mcg, S. sonnei 1790GAHB - 50 mcg
Placebo	Biological	Placebo

Primary outcome

Number of Subjects With Solicited Local Reaction After Any Vaccination
Time frame: During a 7-day (Days 1-7) post vaccination period following any injection
Any erythema/induration refers to: ≥25 mm in diameter. Grade 3 (severe) refers to erythema/induration >100 mm in diameter. Grade 3 (severe) for injection site pain refers to: prevents daily activity
Number of Subjects With Solicited Systemic Reaction After Any Vaccination
Time frame: During a 7-day (Days 1 to 7) post vaccination period following any injection
Any= Incidence of any symptom regardless of intensity grade. Grade 3 = symptom that prevented daily activities
Number of Subjects With Neutrophils Results Below and Above the Normal Ranges
Time frame: At Day 8
Day 8: VISIT 2 (D7 post 1st vac)
Number of Subjects With Neutrophils Results Below and Above the Normal
Time frame: At Day 36
Day 36: VISIT 3.1 (D7 post 2nd vac.)
Number of Subjects With Neutrophils Results Below and Above the Normal
Time frame: At Day 57
Day 57: VISIT 4 (3rd vac.)
Number of Subjects With Neutrophils Results Below and Above the Normal
Time frame: At Day 64
Day 64: VISIT 4.1 (D7 post 3rd vac.)
Number of Subjects With Neutrophils Results Below and Above the Normal
Time frame: At Day 85
Day 85: VISIT 5 (1 month post 3rd vac.)
Number of Subjects With Neutrophils Results Below and Above the Normal
Time frame: At Day 225
Day 225: VISIT 6 (6 months post 3rd vac.)

3 secondary outcomes

Anti-LPS S. Sonnei Serum IgG Geometric Mean Concentration (GMCs)
Time frame: At baseline, at 28 days after each vaccination and at 168 days after last vaccination
Number of Subjects With Seroresponse for Anti-LPS S. Sonnei
Time frame: At 28 days after each vaccination and 168 days after last vaccination
Number of Subjects With High Seroresponse for Anti-LPS S. Sonnei (IgG ELISA ≥121 EU)
Time frame: At baseline, at 28 days after each vaccination and at 168 days after last vaccination

Results and safety

Results posted to the registry on 23 Jan 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
S. Sonnei 1790GAHB - 1 mcg	8	8
S. Sonnei 1790GAHB - 5 mcg	9	9
S. Sonnei 1790GAHB - 25 mcg	8	8
S. Sonnei 1790GAHB - 50 mcg	8	7
S. Sonnei 1790GAHB - 100 mcg	9	8
Placebo	8	8

Primary outcome: Number of Subjects With Solicited Local Reaction After Any Vaccination

Time frame: During a 7-day (Days 1-7) post vaccination period following any injection. Count of participants. Unit: Participants

Measure	S. Sonnei 1790GAHB - 1 mcg n = 8	S. Sonnei 1790GAHB - 5 mcg n = 9	S. Sonnei 1790GAHB - 25 mcg n = 8	S. Sonnei 1790GAHB - 50 mcg n = 8	S. Sonnei 1790GAHB - 100 mcg n = 9	Placebo n = 8
Any Pain	8	9	8	8	9	6
Grade 3 Pain	0	0	0	1	1	0
Any Erythema	0	0	0	0	3	1
Grade 3 Erythema	0	0	0	0	1	0
Any Induration	0	0	0	2	2	0
Grade 3 Induration	0	0	0	1	0	0

Population analysed: Analysis was done on as treated safety population

Primary outcome: Number of Subjects With Solicited Systemic Reaction After Any Vaccination

Time frame: During a 7-day (Days 1 to 7) post vaccination period following any injection. Count of participants. Unit: Participants

Measure	S. Sonnei 1790GAHB - 1 mcg n = 8	S. Sonnei 1790GAHB - 5 mcg n = 9	S. Sonnei 1790GAHB - 25 mcg n = 8	S. Sonnei 1790GAHB - 50 mcg n = 8	S. Sonnei 1790GAHB - 100 mcg n = 9	Placebo n = 8
Any Headache	3	3	2	4	2	3
Grade 3 Headache	0	1	0	1	0	0
Any Arthralgia	2	0	2	3	3	1
Grade 3 Arthralgia	0	0	0	1	0	0
Any Chills	2	0	1	1	0	1
Grade 3 Chills	0	0	0	1	0	0
Any Fatigue	4	3	6	5	5	5
Grade 3 Fatigue	0	0	0	1	1	0

Population analysed: Analysis was done on as treated population

Primary outcome: Number of Subjects With Neutrophils Results Below and Above the Normal Ranges

Time frame: At Day 8. Count of participants. Unit: Participants

Measure	S. Sonnei 1790GAHB - 1 mcg n = 8	S. Sonnei 1790GAHB - 5 mcg n = 9	S. Sonnei 1790GAHB - 25 mcg n = 8	S. Sonnei 1790GAHB - 50 mcg n = 8	S. Sonnei 1790GAHB - 100 mcg n = 9	Placebo n = 8
Neutrophils Results Below Normal Ranges	0	1	0	1	0	0
Neutrophils Results Above Normal Ranges	0	0	0	0	1	0

Primary outcome: Number of Subjects With Neutrophils Results Below and Above the Normal

Time frame: At Day 36. Count of participants. Unit: Participants

Measure	S. Sonnei 1790GAHB - 1 mcg n = 0	S. Sonnei 1790GAHB - 5 mcg n = 0	S. Sonnei 1790GAHB - 25 mcg n = 0	S. Sonnei 1790GAHB - 50 mcg n = 5	S. Sonnei 1790GAHB - 100 mcg n = 8	Placebo n = 3
Neutrophils Results Below Normal Ranges	0	0	0	0	0	0
Neutrophils Results Above Normal Ranges	0	0	0	0	1	0

Population analysed: Some Arms have zero subjects attending visit 3.1, as complete blood counts testing 7 days after 2nd and 3rd vaccination was introduced following a protocol amendment while the study was ongoing.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited reactions were reported in 7-day post vaccination period (i.e. Day 1 to Day 7, Day 29 to Day 35, and Day 57 to Day 63). Unsolicited Adverse Events were reported during a 28-day post vaccination period (i.e. Day 1 to Day 28, Day 29 to Day 56, and Day 57 to Day 84). AEs leading to study withdrawal, SAEs and AEs of special interest (reactive arthritis) were reported during all study period (i.e. Day 1 to Day 225).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
S. Sonnei 1790GAHB - 1 mcg	0 of 8 (0%)	8 of 8 (100%)	Not reported
S. Sonnei 1790GAHB - 5 mcg	0 of 9 (0%)	9 of 9 (100%)	Not reported
S. Sonnei 1790GAHB - 25 mcg	0 of 8 (0%)	8 of 8 (100%)	Not reported
S. Sonnei 1790GAHB - 50 mcg	0 of 8 (0%)	8 of 8 (100%)	Not reported
S. Sonnei 1790GAHB - 100 mcg	0 of 9 (0%)	9 of 9 (100%)	Not reported
Placebo	0 of 8 (0%)	8 of 8 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34017343Micoli F, Rossi O, Conti V, Launay O, Scire AS, Aruta MG, Nakakana UN, Marchetti E, Rappuoli R, Saul A, Martin LB, Necchi F, Podda A. Antibodies Elicited by the Shigella sonnei GMMA Vaccine in Adults Trigger Complement-Mediated Serum Bactericidal Activity: Results From a Phase 1 Dose Escalation Trial Followed by a Booster Extension. Front Immunol. 2021 May 4;12:671325. doi: 10.3389/fimmu.2021.671325. eCollection 2021.
Derived from this study: PubMed 28735965Launay O, Lewis DJM, Anemona A, Loulergue P, Leahy J, Scire AS, Maugard A, Marchetti E, Zancan S, Huo Z, Rondini S, Marhaba R, Finco O, Martin LB, Auerbach J, Cohen D, Saul A, Gerke C, Podda A. Safety Profile and Immunologic Responses of a Novel Vaccine Against Shigella sonnei Administered Intramuscularly, Intradermally and Intranasally: Results From Two Parallel Randomized Phase 1 Clinical Studies in Healthy Adult Volunteers in Europe. EBioMedicine. 2017 Aug;22:164-172. doi: 10.1016/j.ebiom.2017.07.013. Epub 2017 Jul 15.
Derived from this study: PubMed 27490698Muturi-Kioi V, Lewis D, Launay O, Leroux-Roels G, Anemona A, Loulergue P, Bodinham CL, Aerssens A, Groth N, Saul A, Podda A. Neutropenia as an Adverse Event following Vaccination: Results from Randomized Clinical Trials in Healthy Adults and Systematic Review. PLoS One. 2016 Aug 4;11(8):e0157385. doi: 10.1371/journal.pone.0157385. eCollection 2016.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Odile Launay, Prof principal investigator

Centre d'Investigation Clinique en Vaccinologie Cochin-Pasteur (CIC1417)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing S. sonnei 1790GAHB in people with Shigellosis, run by GSK Vaccines Institute For Global Health S.r.l. at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects With Solicited Local Reaction After Any Vaccination (time frame: During a 7-day (Days 1-7) post vaccination period following any injection). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02017899, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2019.