Shigella Sonnei InfectionPhase 2NCT02676895
A Study of the Safety and Immune Response of 2 Doses of a New Shigella Vaccine in Kenyan Adults
A Phase 2 study testing GVGH S. sonnei (1790GAHB) vaccine 25 μg, GVGH S. sonnei (1790GAHB) vaccine 100 μg and Menveo in people with Shigella Sonnei Infection, run by GlaxoSmithKline at 1 site in Kenya.
Trial summary
The purpose of this study is to evaluate the safety and the immunogenicity of two different doses of the GVGH S. sonnei vaccine in healthy adults and represents the first step towards testing of the GMMA vaccine in the vaccine target population of children from developing countries where shigellosis is endemic. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Shigella Sonnei Infection
- What is being tested?
- GVGH S. sonnei (1790GAHB) vaccine 25 μg, GVGH S. sonnei (1790GAHB) vaccine 100 μg and Menveo
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteKenya
- Study dates
- 8 Aug 2016to 10 Mar 2017
- Phase
- Phase 2
- 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
- Individuals ≥18 years to ≤45 years of age on the day of informed consent who are resident in the study area and are not planning to leave during the study period.
- Individuals who, after the nature of the study has been explained, have voluntarily given written consent according to local regulatory requirements, prior to study entry.
- Individuals who can comply with study procedures including follow-up.
- Individuals in good health as determined by the outcome of medical history, physical examination, hematology, renal function, and liver function tests, urine dipstick/urinalysis and the clinical judgment of the investigator.
- Males Or Females of childbearing potential who are using an effective birth control method which they intend to use for the duration of the study Or Females without childbearing potential (i.e. irrespective of birth control method) Prior to receipt of second study vaccination, subjects must be evaluated to confirm that they are eligible for subsequent vaccination. If subjects do not meet any of the original inclusion criteria listed above, they should not receive additional vaccinations.
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 previous Guillain-Barré syndrome.
- Individuals who, in the judgment of the investigator, may not be able to comply with all the required study procedures.
- 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 with history of reactive arthritis.
- Individuals with known HIV or hepatitis B virus infection or HIV related disease, history of an autoimmune disorder or any other known or suspected impairment /alteration of the immune system. Individuals under systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days within 90 days prior to screening.
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- Individuals with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
- Individuals with a neutrophil count lower than 1.8 x 10^9/L (applicable to the initial 18 subjects) or lower than 1.0 x 10^9/L (applicable to the additional subjects if approved by DSMB) at screening
- Individuals with any serious chronic or progressive disease according to judgment of the investigator (e.g., neoplasm, insulin dependent diabetes, Type 2 diabetes mellitus, hypertension, cardiac, renal or hepatic disease and tuberculosis).
- Individuals who have any malignancy or lymphoproliferative disorder.
- Individuals with history of allergy to vaccines components or any other allergies deemed by the investigator to increase the risk of an adverse event if they were to participate in the trial.
- Individuals participating in any clinical trial with another investigational product within 28 days prior to the screening study visit or intent to participate in another clinical study at any time during the conduct of this study.
- Individuals who received vaccines containing meningococcal A, C, W, Y or tetanus, diphtheria or pertussis antigens within 12 months before screening, or any other vaccines within 4 weeks prior to screening in this study or who are planning to receive any vaccine within the entire study duration.
- Individuals who have received blood, blood products, and/or plasma derivatives including parenteral immunoglobulin preparations in the 12 weeks prior to the first dose of the study vaccine.
- Individuals who are study personnel or immediate family members (parents, children, spouse and brothers/sisters) to the personnel conducting this study.
- Individuals with body temperature > 38.0°C within 3 days of intended study vaccination is a reason for delay of vaccination
- Individuals with Body Mass Index (BMI)> 30 kg/m^2
- 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 (for the two months preceding the 1st vaccination) and are not willing to use acceptable contraceptive measures, for the duration of the study. If subjects are women of childbearing potential, they must have a negative pregnancy test at screening visit and prior to enrollment (visit 1). For the purposes of this study acceptable methods of contraception are oral, injected or implantable contraceptives.
- Individuals who have a previously laboratory confirmed case of disease caused by S. sonnei.
- Any condition which, in the opinion of the investigator, may pose an increased and unreasonable safety risk to the subject if they participated in the study.
- Individuals with a previous history of Benign Ethnic Neutropenia or drug related neutropenia.
- Individuals who have or are likely to require concomitant treatment with neutropenic agents.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2a, Observer Blind, Randomized, Controlled, Single Center Study To Evaluate The Safety, Reactogenicity And Immunogenicity Of 2 Doses Of The GVGH 1790GAHB Vaccine Against Shigella Sonnei, Administered Intramuscularly In Adult Subjects From A Country Endemic For Shigellosis
The purpose of this study is to evaluate the safety and the immunogenicity of two different doses of the GVGH S. sonnei vaccine in healthy adults and represents the first step towards testing of the GMMA vaccine in the vaccine target population of children from developing countries where shigellosis is endemic.
- Conditions
- Shigella Sonnei Infection
- Being tested
- GVGH S. sonnei (1790GAHB) vaccine 25 μg, GVGH S. sonnei (1790GAHB) vaccine 100 μg, Menveo, Boostrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GVGH S. sonnei (1790GAHB) vaccine 25 μgBiological
Two injections of the study vaccine were administered 28 days apart.
GVGH S. sonnei (1790GAHB) vaccine 100 μgBiological
Two injections of the study vaccine were administered 28 days apart.
MenveoBiological
One injection of Menveo was administered in subjects in the Control Group.
BoostrixBiological
One injection of Boostrix was administered in subjects in the Control Group.
| Study group | Role | What they receive |
|---|---|---|
| 1790GAHB 25 μg Group | Experimental | Subjects who received 2 injections of 1790GAHB vaccine containing 25 μg of S. sonnei. Receives: Biological: GVGH S. sonnei (1790GAHB) vaccine 25 μg |
| 1790GAHB 100 μg Group | Experimental | Subjects who received 2 injections of 1790GAHB vaccine containing 100 μg of S. sonnei. Receives: Biological: GVGH S. sonnei (1790GAHB) vaccine 100 μg |
| Control Group | Active comparator | Subjects who received one dose of Menveo vaccine and a second dose of Boostrix vaccine. Receives: Biological: Menveo; Biological: Boostrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination
Assessed solicited local adverse reactions were injection site erythema, induration, pain. Assessed systemic adverse reactions were headache, arthralgia, chills, fatigue, malaise, myalgia and temperature (body temperature measured axillary). Any = occurrence of the symptom regardless of intensity grade. Any temperature = body temperature ≥ 38.0°C. Severe symptom = pain, headache, arthralgia, chills, fatigue, malaise and myalgia that prevented normal activity. Severe redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Severe temperature = body temperature > 40.0 °C.
Measured: From 30 minutes up to 7 days following each vaccination
Number of Subjects With Any Unsolicited Adverse Events (AEs)
An unsolicited AE is an AE that was not solicited using the Diary Card and that was spontaneously communicated by a subject who has signed the informed consent. Potential unsolicited AEs may be medically attended (defined as symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider), or were of concern to the subject.
Note: *disruptions= dose reduction, interruption or delay in study vaccination.
Measured: During 28 days following each vaccination
Number of Subjects With Serious Adverse Events (SAEs)
An SAE is defined as any untoward medical occurrence that at any dose results in one or more of the following: death; is life-threatening (i.e., the subject was, in the opinion of the investigator, at immediate risk of death from the event as it occurred); it does not refer to an event which hypothetically might have caused death if it were more severe; required or prolonged hospitalization; persistent or significant disability/incapacity (i.e., the event causes a substantial disruption of a person's ability to conduct normal life functions); congenital anomaly/or birth defect; an important and significant medical event that may not be immediately life-threatening or resulting in death or hospitalization but, based upon appropriate medical judgment, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above.
Measured: Throughout the whole study period (from Day 1 up to Day 57)
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
The safety laboratory data included haematological parameters (basophils, eosinophils, erytrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, monocytes, platelets and neutrophils), and chemical parameters (Alkaline Phosphatase [ALP], Alanine Aminotransferase [ALA], Aspartate Aminotransferase [AST], Bilirubin [BILI], Blood Urea Nitrogen [BUN], Creatinine [CREAT], Gamma Glutamyl Transferase [GGT], Glucose [GLUC], Potassium [K], Lactate Dehydrogenase [LDH] and Sodium [Na]).
Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Measured: At Day 8 (7 days after first vaccination)
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
The safety laboratory data included haematological parameters (basophils, eosinophils, erytrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, monocytes, platelets and neutrophils), and chemical parameters (Alkaline Phosphatase [ALP], Alanine Aminotransferase [ALA], Aspartate Aminotransferase [AST], Bilirubin [BILI], Blood Urea Nitrogen [BUN], Creatinine [CREAT], Gamma Glutamyl Transferase [GGT], Glucose [GLUC], Potassium [K], Lactate Dehydrogenase [LDH] and Sodium [Na]).
Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Measured: At Day 29 (28 days after the first vaccination)
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
The safety laboratory data included haematological parameters (basophils, eosinophils, erytrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, monocytes, platelets and neutrophils), and chemical parameters (Alkaline Phosphatase [ALP], Alanine Aminotransferase [ALA], Aspartate Aminotransferase [AST], Bilirubin [BILI], Blood Urea Nitrogen [BUN], Creatinine [CREAT], Gamma Glutamyl Transferase [GGT], Glucose [GLUC], Potassium [K], Lactate Dehydrogenase [LDH] and Sodium [Na]). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Measured: At Day 36 (7 days after the second vaccination)
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
The safety laboratory data included haematological parameters (basophils, eosinophils, erytrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, monocytes, platelets and neutrophils), and chemical parameters (Alkaline Phosphatase [ALP], Alanine Aminotransferase [ALA], Aspartate Aminotransferase [AST], Bilirubin [BILI], Blood Urea Nitrogen [BUN], Creatinine [CREAT], Gamma Glutamyl Transferase [GGT], Glucose [GLUC], Potassium [K], Lactate Dehydrogenase [LDH] and Sodium [Na]). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Measured: At Day 57 (28 days after the second vaccination)
Number of Subjects With Reported Reactive Arthritis or Neutropenia (AESIs)
Reactive arthritis is defined as non-purulent joint inflammation that develops in response to an infection in another part of the body. Since the inflammation is triggered by a previous condition, it is termed "reactive". Intestinal pathogens that have been associated with reactive arthritis include Campylobacter, Salmonella, Yersinia, Clostridium difficile, and Shigella. If reactive arthritis is caused by an auto immune response, there is at least a possibility that it could be initiated by vaccination of susceptible people with the 1790GAHB vaccine.
Measured: Throughout the whole study period (from Day 1 up to Day 57)
Secondary outcomes (4)
Anti-LPS S.Sonnei IgG ELISA Geometric Mean Concentrations (GMCs), by Baseline Titer
Anti-LPS S.Sonnei IgG ELISA concentrations were tabulated as unadjusted geometric mean concentrations (GMCs) and expressed as ELISA units (EU) per milliliter (mL), presented with their 95% confidence intervals (CIs). Since all subjects in the study were from an endemic country, they had pre-vaccination titers equal to or above (≥) LLOQ (limit of detection).
Measured: At Day 1, Day 29 (28 days after the first vaccination) and Day 57 (28 days after the second vaccination)
Anti-LPS S. Sonnei Geometric Mean Ratios (GMRs) Between Post- and Pre-vaccination Samples
The ratio was expressed as unadjusted geometric mean ratio (GMR) and presented with its 95% confidence interval (CI).
Measured: At Day 1, Day 29 (28 days after the first vaccination) and Day 57 (28 days after the second vaccination)
Number of Subjects With Seroresponse to Anti-LPS S. Sonnei IgG ELISA, by Baseline Titer
Seroresponse was defined as: if the baseline value was greater than 50 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 the baseline value was less or equal to 50 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).
Since all subjects in the study were from an endemic country, they had pre-vaccination titers equal to or above (≥) LLOQ (limit of detection).
Measured: At Day 29 (28 days after the first vaccination) and Day 57 (28 days after the second vaccination)
Number of Subjects With Titers Post Vaccination Concentration for Anti-LPS S. Sonnei ≥ 121 U/mL
The analysis cut-off value (121 U/mL) was expressed in units per milliliter (U/mL), as assessed by the Enzyme-Linked Immunosorbent Assay (ELISA).
Measured: At Day 1, Day 29 (28 days after the first vaccination) and Day 57 (28 days after the second vaccination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2016 (estimated)
- Study start8 Aug 2016
- Primary completion10 Mar 2017
- Study completion10 Mar 2017
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.
- Other trials for Shigella Sonnei InfectionStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02676895
- Sponsor's protocol ID
- 205494
- Other IDs
- H03_04TP
- Status last verified
- Oct 2018
- First submitted
- 1 Feb 2016
- Last updated
- 18 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: IPD for this study will be made available via the Clinical Study Data Request site.
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Observer Blind, Randomized, Controlled, Single Center Study To Evaluate The Safety, Reactogenicity And Immunogenicity Of 2 Doses Of The GVGH 1790GAHB Vaccine Against Shigella Sonnei, Administered Intramuscularly In Adult Subjects From A Country Endemic For Shigellosis
- ClinicalTrials.gov ID
- NCT02676895
- Acronym / sponsor ID
- 205494
- Conditions
- Shigella Sonnei Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 8 Aug 2016 (actual)
- Primary completion
- 10 Mar 2017 (actual)
- Study completion
- 10 Mar 2017 (actual)
- First posted
- 8 Feb 2016 (estimated)
- Results
- Posted 18 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and the immunogenicity of two different doses of the GVGH S. sonnei vaccine in healthy adults and represents the first step towards testing of the GMMA vaccine in the vaccine target population of children from developing countries where shigellosis is endemic.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1790GAHB 25 μg Group | Experimental | Biological: GVGH S. sonnei (1790GAHB) vaccine 25 μgSubjects who received 2 injections of 1790GAHB vaccine containing 25 μg of S. sonnei. |
| 1790GAHB 100 μg Group | Experimental | Biological: GVGH S. sonnei (1790GAHB) vaccine 100 μgSubjects who received 2 injections of 1790GAHB vaccine containing 100 μg of S. sonnei. |
| Control Group | Active comparator | Biological: Menveo, Biological: BoostrixSubjects who received one dose of Menveo vaccine and a second dose of Boostrix vaccine. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Individuals ≥18 years to ≤45 years of age on the day of informed consent who are resident in the study area and are not planning to leave during the study period.
- Individuals who, after the nature of the study has been explained, have voluntarily given written consent according to local regulatory requirements, prior to study entry.
- Individuals who can comply with study procedures including follow-up.
- Individuals in good health as determined by the outcome of medical history, physical examination, hematology, renal function, and liver function tests, urine dipstick/urinalysis and the clinical judgment of the investigator.
- Males Or Females of childbearing potential who are using an effective birth control method which they intend to use for the duration of the study Or Females without childbearing potential (i.e. irrespective of birth control method) Prior to receipt of second study vaccination, subjects must be evaluated to confirm that they are eligible for subsequent vaccination. If subjects do not meet any of the original inclusion criteria listed above, they should not receive additional vaccinations.
Key exclusion criteria (23 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 previous Guillain-Barré syndrome.
- Individuals who, in the judgment of the investigator, may not be able to comply with all the required study procedures.
- 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 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 |
|---|---|---|
| GVGH S. sonnei (1790GAHB) vaccine 25 μgTwo injections of the study vaccine were administered 28 days apart. | Biological | 1790GAHB 25 μg Group |
| GVGH S. sonnei (1790GAHB) vaccine 100 μgTwo injections of the study vaccine were administered 28 days apart. | Biological | 1790GAHB 100 μg Group |
| MenveoOne injection of Menveo was administered in subjects in the Control Group. | Biological | Control Group |
| BoostrixOne injection of Boostrix was administered in subjects in the Control Group. | Biological | Control Group |
Primary outcome
Number of Subjects With Solicited Local and Systemic Adverse Reactions After Each Vaccination
Time frame: From 30 minutes up to 7 days following each vaccination
Assessed solicited local adverse reactions were injection site erythema, induration, pain. Assessed systemic adverse reactions were headache, arthralgia, chills, fatigue, malaise, myalgia and temperature (body temperature measured axillary). Any = occurrence of the symptom regardless of intensity grade. Any temperature = body temperature ≥ 38.0°C. Severe symptom = pain, headache, arthralgia, chills, fatigue, malaise and myalgia that prevented normal activity. Severe redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Severe temperature = body temperature > 40.0 °C.
Number of Subjects With Any Unsolicited Adverse Events (AEs)
Time frame: During 28 days following each vaccination
An unsolicited AE is an AE that was not solicited using the Diary Card and that was spontaneously communicated by a subject who has signed the informed consent. Potential unsolicited AEs may be medically attended (defined as symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider), or were of concern to the subject. Note: *disruptions= dose reduction, interruption or delay in study vaccination.
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: Throughout the whole study period (from Day 1 up to Day 57)
An SAE is defined as any untoward medical occurrence that at any dose results in one or more of the following: death; is life-threatening (i.e., the subject was, in the opinion of the investigator, at immediate risk of death from the event as it occurred); it does not refer to an event which hypothetically might have caused death if it were more severe; required or prolonged hospitalization; persistent or significant disability/incapacity (i.e., the event causes a substantial disruption of a person's ability to conduct normal life functions); congenital anomaly/or birth defect; an important and significant medical event that may not be immediately life-threatening or resulting in death or hospitalization but, based upon appropriate medical judgment, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above.
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 8 by Baseline Ranges
Time frame: At Day 8 (7 days after first vaccination)
The safety laboratory data included haematological parameters (basophils, eosinophils, erytrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, monocytes, platelets and neutrophils), and chemical parameters (Alkaline Phosphatase [ALP], Alanine Aminotransferase [ALA], Aspartate Aminotransferase [AST], Bilirubin [BILI], Blood Urea Nitrogen [BUN], Creatinine [CREAT], Gamma Glutamyl Transferase [GGT], Glucose [GLUC], Potassium [K], Lactate Dehydrogenase [LDH] and Sodium [Na]). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 29 by Baseline Ranges
Time frame: At Day 29 (28 days after the first vaccination)
The safety laboratory data included haematological parameters (basophils, eosinophils, erytrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, monocytes, platelets and neutrophils), and chemical parameters (Alkaline Phosphatase [ALP], Alanine Aminotransferase [ALA], Aspartate Aminotransferase [AST], Bilirubin [BILI], Blood Urea Nitrogen [BUN], Creatinine [CREAT], Gamma Glutamyl Transferase [GGT], Glucose [GLUC], Potassium [K], Lactate Dehydrogenase [LDH] and Sodium [Na]). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 36 by Baseline Ranges
Time frame: At Day 36 (7 days after the second vaccination)
The safety laboratory data included haematological parameters (basophils, eosinophils, erytrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, monocytes, platelets and neutrophils), and chemical parameters (Alkaline Phosphatase [ALP], Alanine Aminotransferase [ALA], Aspartate Aminotransferase [AST], Bilirubin [BILI], Blood Urea Nitrogen [BUN], Creatinine [CREAT], Gamma Glutamyl Transferase [GGT], Glucose [GLUC], Potassium [K], Lactate Dehydrogenase [LDH] and Sodium [Na]). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Number of Subjects With Deviations From Normal Ranges of Safety Laboratory Data at Day 57 by Baseline Ranges
Time frame: At Day 57 (28 days after the second vaccination)
The safety laboratory data included haematological parameters (basophils, eosinophils, erytrocytes, hematocrit, hemoglobin, leukocytes, lymphocytes, monocytes, platelets and neutrophils), and chemical parameters (Alkaline Phosphatase [ALP], Alanine Aminotransferase [ALA], Aspartate Aminotransferase [AST], Bilirubin [BILI], Blood Urea Nitrogen [BUN], Creatinine [CREAT], Gamma Glutamyl Transferase [GGT], Glucose [GLUC], Potassium [K], Lactate Dehydrogenase [LDH] and Sodium [Na]). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Number of Subjects With Reported Reactive Arthritis or Neutropenia (AESIs)
Time frame: Throughout the whole study period (from Day 1 up to Day 57)
Reactive arthritis is defined as non-purulent joint inflammation that develops in response to an infection in another part of the body. Since the inflammation is triggered by a previous condition, it is termed "reactive". Intestinal pathogens that have been associated with reactive arthritis include Campylobacter, Salmonella, Yersinia, Clostridium difficile, and Shigella. If reactive arthritis is caused by an auto immune response, there is at least a possibility that it could be initiated by vaccination of susceptible people with the 1790GAHB vaccine.
4 secondary outcomes
Anti-LPS S.Sonnei IgG ELISA Geometric Mean Concentrations (GMCs), by Baseline Titer
Time frame: At Day 1, Day 29 (28 days after the first vaccination) and Day 57 (28 days after the second vaccination)
Anti-LPS S. Sonnei Geometric Mean Ratios (GMRs) Between Post- and Pre-vaccination Samples
Time frame: At Day 1, Day 29 (28 days after the first vaccination) and Day 57 (28 days after the second vaccination)
Number of Subjects With Seroresponse to Anti-LPS S. Sonnei IgG ELISA, by Baseline Titer
Time frame: At Day 29 (28 days after the first vaccination) and Day 57 (28 days after the second vaccination)
Number of Subjects With Titers Post Vaccination Concentration for Anti-LPS S. Sonnei ≥ 121 U/mL
Time frame: At Day 1, Day 29 (28 days after the first vaccination) and Day 57 (28 days after the second vaccination)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- IPD for this study will be made available via the Clinical Study Data Request site.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.
Related trials for Shigella Sonnei Infection
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RecruitingPhase 1
Shigella Sonnei 53G Human Infection Study in Kenyan Adults
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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.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GVGH S. sonnei (1790GAHB) vaccine 25 μg, GVGH S. sonnei (1790GAHB) vaccine 100 μg and Menveo in people with Shigella Sonnei Infection, run by GlaxoSmithKline at 1 site in Kenya.
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 23 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 18 Feb 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 Kenya. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 18 Feb 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 and Systemic Adverse Reactions After Each Vaccination (time frame: From 30 minutes up to 7 days following each vaccination). 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?
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 18 Feb 2019.