ShigellosisPhase 1NCT02034500
Evaluate a New Shigella Sonnei Vaccine Administered Either by Intradermal, Intranasal or Intramuscular Route 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 United Kingdom.
Trial summary
This Phase 1 clinical trial is aimed to evaluate the safety and immunogenicity of 3 doses of a candidate vaccine against Shigella sonnei (1790GAHB vaccine) when administered at different dosages by different routes (intradermally, intranasally or intramuscularly) in healthy adults (18 to 45 years of age at… Read more about this study
- 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
- 52 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2014to Apr 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 have been explained to them, have given written consent according to local regulatory requirements.
- Individuals in good health as determined by the outcome of medical history, physical examination, hematology, renal, bone and liver panels (including negative for agglutination testing of S. sonnei), urinalysis and clinical judgment of the investigator.
- If women of childbearing potential, have a negative pregnancy test prior to study vaccination and willingness to use acceptable contraceptive measures for the entire study duration.
- Individuals available for follow-up for the duration of the study.
- Individuals registered with a general practitioner.
Who cannot join
- Individuals with a history of recurrent wheezing, asthma, respiratory allergies, allergic rhinitis, nasal surgery or significant nasal abnormalities (e.g. polyps), and Bell's palsy. Presence of nasal piercings. Symptoms of upper respiratory tract infection within 3 days of intended study vaccination is a temporary exclusion criterion.
- Individuals unwilling to abstain from medications or other agents that are applied via the nasal route from 24 hours prior to each nasal dosing through to the safety assessment 1 week later.
- 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.
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- Individuals with human leukocyte antigen (HLA) -B27 positive and/or with history of reactive arthritis
- Individuals with known HIV, HBV and HCV 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 within the previous 30 days, or were in chemotherapy treatment within the past 6 months.
- 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 90 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 4 weeks before 1st vaccination and 4 weeks 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.
- BMI > 30 kg/m2.
- Individuals with history of substance or alcohol abuse within the past 2 years.
- Women who are pregnant or breast-feeding or 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 ascertained or suspected disease caused by S. sonnei or positive S. sonnei serology at screening
- 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.
United Kingdom1 site
Surrey Clinical Research Center (Surrey CRC)
Guildford, Surrey, GU2 7XP
About this study
Official title: A Phase 1, Randomized, Placebo Controlled, Single Center, Dose Escalation Study to Evaluate the Safety and Immunogenicity of 3 Vaccinations With Shigella Sonnei Vaccine (1790GAHB) Administered Either by Intradermal, Intranasal or Intramuscular Route in Healthy Adults.
This Phase 1 clinical trial is aimed to evaluate the safety and immunogenicity of 3 doses of a candidate vaccine against Shigella sonnei (1790GAHB vaccine) when administered at different dosages by different routes (intradermally, intranasally or intramuscularly) 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 52 eligible subjects will be assigned to one of three sequential cohorts as follows:
Cohort A) 0.1 μg ID and 5 μg IN Cohort B) 1 μg ID and 20 μg IN Cohort C) 10 μg ID, 80 μg IN and 5 μg IM 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. Specifically for IN and ID administration routes, 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 group | Role | What they receive |
|---|---|---|
| S. sonnei 1790GAHB - 0.1 mcg - ID | Experimental | Subjects enrolled in COHORT A receiving 3 injections of S. sonnei 1790GAHB - 0.1 mcg intradermally (ID) Receives: Biological: S. sonnei 1790GAHB |
| S. sonnei 1790GAHB - 1 mcg - ID | Experimental | Subjects enrolled in COHORT B receiving 3 injections of S. sonnei 1790GAHB - 1 mcg intradermally (ID) Receives: Biological: S. sonnei 1790GAHB |
| S. sonnei 1790GAHB - 10 mcg - ID | Experimental | Subjects enrolled in COHORT C receiving 3 injections of S. sonnei 1790GAHB - 10 mcg intradermally (ID) Receives: Biological: S. sonnei 1790GAHB |
| S. sonnei 1790GAHB - 5 mcg - IN | Experimental | Subjects enrolled in COHORT A receiving 3 injections of S. sonnei 1790GAHB - 5 mcg intranasally (IN) Receives: Biological: S. sonnei 1790GAHB |
| S. sonnei 1790GAHB - 20 mcg - IN | Experimental | Subjects enrolled in COHORT B receiving 3 injections of S. sonnei 1790GAHB - 20 mcg intranasally (IN) Receives: Biological: S. sonnei 1790GAHB |
| S. sonnei 1790GAHB - 80 mcg - IN | Experimental | Subjects enrolled in COHORT C receiving 3 injections of S. sonnei 1790GAHB - 80 mcg intranasally (IN) Receives: Biological: S. sonnei 1790GAHB |
| S. sonnei 1790GAHB - 5 mcg - IM | Experimental | Subjects enrolled in COHORT C receiving 3 injections of S. sonnei 1790GAHB - 5 mcg intramuscularly (IM) Receives: Biological: S. sonnei 1790GAHB |
| Placebo - ID | Placebo comparator | 2 subjects enrolled in each COHORT A, B and C receiving 3 injections of Placebo intradermally (ID). These were pooled in one Placebo group in the analyses Receives: Biological: Placebo |
| Placebo - IN | Placebo comparator | 2 subjects enrolled in each COHORT A, B and C receiving 3 injections of Placebo intranasally (IN). These were pooled in one Placebo group in the analyses Receives: Biological: Placebo |
| Placebo - IM | Placebo comparator | 2 subjects enrolled in COHORT C receiving 3 injections of Placebo intramuscularly (IM) 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/swelling refers to: ≥25 mm in diameter. Grade 3 (severe) refers to erythema/induration/swelling >100 mm in diameter.
Grade 3 (severe) for injection site pain/nasal pain/facial edema/rhinorrhea 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. (1989 J. Clin. Microbiol. 27:162). 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.
- First posted13 Jan 2014 (estimated)
- Study startMar 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- GSK Vaccines Institute For Global Health S.r.l.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David JM Lewis, MD, Principal investigator, University of Surrey, Guildford, GU2 7XP United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02034500
- Sponsor's protocol ID
- H03_02TP
- Status last verified
- Jun 2016
- First submitted
- 2 Jan 2014
- Last updated
- 21 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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 28735965Muturi-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
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Placebo Controlled, Single Center, Dose Escalation Study to Evaluate the Safety and Immunogenicity of 3 Vaccinations With Shigella Sonnei Vaccine (1790GAHB) Administered Either by Intradermal, Intranasal or Intramuscular Route in Healthy Adults.
- ClinicalTrials.gov ID
- NCT02034500
- Acronym / sponsor ID
- H03_02TP
- Conditions
- Shigellosis
- Keywords
- prevention, Shigella sonnei
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- GSK Vaccines Institute For Global Health S.r.l.Industry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 13 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase 1 clinical trial is aimed to evaluate the safety and immunogenicity of 3 doses of a candidate vaccine against Shigella sonnei (1790GAHB vaccine) when administered at different dosages by different routes (intradermally, intranasally or intramuscularly) 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 52 eligible subjects will be assigned to one of three sequential cohorts as follows:
Cohort A) 0.1 μg ID and 5 μg IN Cohort B) 1 μg ID and 20 μg IN Cohort C) 10 μg ID, 80 μg IN and 5 μg IM 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. Specifically for IN and ID administration routes, 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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| S. sonnei 1790GAHB - 0.1 mcg - ID | Experimental | Biological: S. sonnei 1790GAHBSubjects enrolled in COHORT A receiving 3 injections of S. sonnei 1790GAHB - 0.1 mcg intradermally (ID) |
| S. sonnei 1790GAHB - 1 mcg - ID | Experimental | Biological: S. sonnei 1790GAHBSubjects enrolled in COHORT B receiving 3 injections of S. sonnei 1790GAHB - 1 mcg intradermally (ID) |
| S. sonnei 1790GAHB - 10 mcg - ID | Experimental | Biological: S. sonnei 1790GAHBSubjects enrolled in COHORT C receiving 3 injections of S. sonnei 1790GAHB - 10 mcg intradermally (ID) |
| S. sonnei 1790GAHB - 5 mcg - IN | Experimental | Biological: S. sonnei 1790GAHBSubjects enrolled in COHORT A receiving 3 injections of S. sonnei 1790GAHB - 5 mcg intranasally (IN) |
| S. sonnei 1790GAHB - 20 mcg - IN | Experimental | Biological: S. sonnei 1790GAHBSubjects enrolled in COHORT B receiving 3 injections of S. sonnei 1790GAHB - 20 mcg intranasally (IN) |
| S. sonnei 1790GAHB - 80 mcg - IN | Experimental | Biological: S. sonnei 1790GAHBSubjects enrolled in COHORT C receiving 3 injections of S. sonnei 1790GAHB - 80 mcg intranasally (IN) |
| S. sonnei 1790GAHB - 5 mcg - IM | Experimental | Biological: S. sonnei 1790GAHBSubjects enrolled in COHORT C receiving 3 injections of S. sonnei 1790GAHB - 5 mcg intramuscularly (IM) |
| Placebo - ID | Placebo comparator | Biological: Placebo2 subjects enrolled in each COHORT A, B and C receiving 3 injections of Placebo intradermally (ID). These were pooled in one Placebo group in the analyses |
| Placebo - IN | Placebo comparator | Biological: Placebo2 subjects enrolled in each COHORT A, B and C receiving 3 injections of Placebo intranasally (IN). These were pooled in one Placebo group in the analyses |
| Placebo - IM | Placebo comparator | Biological: Placebo2 subjects enrolled in COHORT C receiving 3 injections of Placebo intramuscularly (IM) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Males and females of age ≥18 years to ≤45 years.
- Individuals who, after the nature of the study have been explained to them, have given written consent according to local regulatory requirements.
- Individuals in good health as determined by the outcome of medical history, physical examination, hematology, renal, bone and liver panels (including negative for agglutination testing of S. sonnei), urinalysis and clinical judgment of the investigator.
- If women of childbearing potential, have a negative pregnancy test prior to study vaccination and willingness to use acceptable contraceptive measures for the entire study duration.
- Individuals available for follow-up for the duration of the study.
Key exclusion criteria (24 listed)
- Individuals with a history of recurrent wheezing, asthma, respiratory allergies, allergic rhinitis, nasal surgery or significant nasal abnormalities (e.g. polyps), and Bell's palsy. Presence of nasal piercings. Symptoms of upper respiratory tract infection within 3 days of intended study vaccination is a temporary exclusion criterion.
- Individuals unwilling to abstain from medications or other agents that are applied via the nasal route from 24 hours prior to each nasal dosing through to the safety assessment 1 week later.
- 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.
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 - 0.1 mcg - ID, S. sonnei 1790GAHB - 1 mcg - ID, S. sonnei 1790GAHB - 10 mcg - ID, S. sonnei 1790GAHB - 20 mcg - IN, S. sonnei 1790GAHB - 5 mcg - IM, S. sonnei 1790GAHB - 5 mcg - IN, S. sonnei 1790GAHB - 80 mcg - IN |
| Placebo | Biological | Placebo - ID, Placebo - IM, Placebo - IN |
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/swelling refers to: ≥25 mm in diameter. Grade 3 (severe) refers to erythema/induration/swelling >100 mm in diameter. Grade 3 (severe) for injection site pain/nasal pain/facial edema/rhinorrhea 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
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2016.
- 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.
David JM Lewis, MD principal investigator
University of Surrey, Guildford, GU2 7XP United Kingdom
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 United Kingdom.
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 6 inclusion and 24 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 21 Jun 2016. 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 NCT02034500, which also lists 2 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 21 Jun 2016; AzTrials last refreshed its copy on 7 Nov 2026.