A Phase 1 interventional study of GVGH Shigella sonnei 1790GAHB vaccine in Dysentery, Bacillary, sponsored by GlaxoSmithKline. Completed at 1 site in France. Open to participants aged 22 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-28.
Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Prevention
GVGH Shigella Sonnei 1970GAHB is a vaccine aimed at preventing the disease caused by Shigella sonnei.
A post-hoc analysis of subjects who participated in the parent study showed significantly different responses in subjects with detectable versus undetectable antibody titres at baseline, suggesting the possibility that the vaccine might not be sufficiently immunogenic in completely naïve adults.
This study was then designed to further characterize the immunogenicity profile of the vaccine and to evaluate whether it was able to induce an immunological memory response.
61 studies on the registry are indexed under Dysentery, Bacillary; 6 are open to participants now.
This study's enrollment of 35 is below the median of 76 across 54 interventional studies indexed under Dysentery, Bacillary.
Browse Dysentery, Bacillary studies →GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 118 are open to participants now.
Of its 264 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Abnormal function of the immune system resulting from:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Healthy male and female subjects, aged 22 to 50 years, previously primed with 3 doses of the GVGH Shigella sonnei 1790GAHB vaccine in the H03_01TP parent study and who had undetectable antibody titers at baseline, received one intramuscular booster dose of the same vaccine in the current study, at Day 1.
Biological: GVGH Shigella sonnei 1790GAHB vaccine
Healthy male and female subjects, aged 22 to 50 years, who previously received placebo in the H03_01TP parent study and who had undetectable antibodies at baseline, received one intramuscular GVGH Shigella sonnei 1790GAHB vaccine dose in the current study, at Day 1.
Biological: GVGH Shigella sonnei 1790GAHB vaccine
Healthy male and female subjects, aged 22 to 50 years, who were not part of H03_01TP parent study, received one intramuscular GVGH Shigella sonnei 1790GAHB vaccine dose in the current study, at Day 1.
Biological: GVGH Shigella sonnei 1790GAHB vaccine
Single dose administered at Day 1, by intramuscular injection.
Concentrations of Immunoglobulin (IgG) Against Lipopolysaccharide (LPS) S. Sonnei O-antigen
IgG concentrations are expressed as Geometric Mean Concentrations (GMCs), as determined by the Enzyme-linked immunosorbent assay (ELISA) with Shigella sonnei (S.sonnei) O-antigen containing Lipopolysaccharide (LPS) coating antigen. Concentrations are presented as GMCs expressed in ELISA units per milliliter (EU/mL).
Time frame: At Day 8 (7 days after vaccination)
Number of Subjects With Abnormal Haematological Test Values
Assessed haematological parameters are: basophils (BAS), eosinophils (EOS), erythrocytes (ERCS), hematocrit (HCT), hemoglobin (HGB), leukocytes (LKCS), lymphocytes (LYM), monocytes (MONO), neutrophils (NEU) and platelet (PLT).
Time frame: At Day 8 (7 days after vaccination) and Day 85 (84 days after vaccination)
Number of Subjects With Solicited Local Adverse Events
Assessed solicited local adverse events include injection site erythema, injection site induration and injection site pain. Any symptom = occurrence of the symptom regardless of intensity grade.
Time frame: From 30 minutes through Day 7 post-vaccination
Number of Subjects With Solicited Systemic Adverse Events
Assessed solicited systemic adverse events include arthralgia, chills, fatigue, headache, malaise, myalgia and oral fever. Other indicators of solicited adverse events include prevention of pain and/or fever and treatment of pain and/or fever. Any symptom = occurrence of the symptom regardless of intensity grade. Fever = body temperature (measured orally) equal to or above (≥) 38.0 °C.
Time frame: From 30 minutes through Day 7 post-vaccination
Number of Subjects With Unsolicited Adverse Events
An unsolicited adverse event (AE) is an adverse event that was not solicited using a Subject Diary 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. Any = occurrence of the symptom regardless of intensity grade. Grade 3 AE = AE that prevented daily activity. Possibly/probably related AE = AE determined by the investigator as possibly related (the administration of the investigational vaccine and AE are considered reasonably related in time and the AE could be explained by exposure to the investigational vaccine or by other causes) or probably related (exposure to the investigational vaccine and AE are reasonably related in time and no alternative explanation has been identified) to the study vaccination.
Time frame: Throughout the study period (From Day 1 up to Day 85)
Number of Subjects With Serious Adverse Events (SAEs)
A serious adverse event is defined as an untoward medical occurrence that at any dose resulted in death, was life-threatening, required hospitalization or prolonged hospitalization, resulted in persistent or significant disability/incapacity, or in a congenital anomaly/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.
Time frame: Throughout the study period (from Day 1 up to Day 85)
Concentrations of IgG Against LPS S. Sonnei O-antigen
Concentrations of IgG against S.sonnei O-antigen are presented as GMCs, expressed in ELISA units per milliliter (EU/mL).
Time frame: At Days 15, 29 and 85 (14, 28 and 84 days after vaccination)
Anti-LPS S. Sonnei IgG Geometric Mean Ratios
Within-subject Geometric mean ratios (GMRs) were computed for GMCs at 7, 14, 28 and 84 days after vaccination versus baseline (Day 1). The GMRs and 95% confidence intervals (CIs) were constructed by exponentiating the mean within-subject differences in log-transformed concentrations and the corresponding 95% CIs.
Time frame: At Days 8, 15, 29 and 85 (7, 14, 28 and 84 days after vaccination)
Percentage of Subjects With Seroresponse for Anti-LPS S. Sonnei
Seroresponse is aimed to define a significant increase in post-vaccination samples based on the biological performance of this specific serology assay and it is defined as follows: - If the baseline value is greater than 50 ELISA Units (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 is 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. (Postvac minus baseline) ≥ 25 EU.
Time frame: At Days 8, 15, 29 and 85 (7, 14, 28 and 84 days after vaccination)
Percentage of Subjects With Anti-LPS S. Sonnei Concentrations Equal to or Above (≥) 121 EU/mL
Anti-LPS S.sonnei antibody concentrations were assessed by ELISA. The assay cut-off value was 121 EU/mL.
Time frame: At Days 8, 15, 29 and 85 (7, 14, 28 and 84 days after vaccination)
A total of 35 subjects were enrolled into the study. Of these, 7 and 2 eligible subjects from the H03_01TP parent study were enrolled into the Shigella Group and Placebo Group, respectively. 26 subjects were enrolled into the Naïve Group. All 35 subjects were vaccinated and analyzed for immunogenicity and safety.
| Milestone | Shigella Group | Placebo Group | Naïve Group |
|---|---|---|---|
| Started | 7 | 2 | 26 |
| Completed | 7 | 2 | 26 |
| Not completed | 0 | 0 | 0 |
IgG concentrations are expressed as Geometric Mean Concentrations (GMCs), as determined by the Enzyme-linked immunosorbent assay (ELISA) with Shigella sonnei (S.sonnei) O-antigen containing Lipopolysaccharide (LPS) coating antigen. Concentrations are presented as GMCs expressed in ELISA units per milliliter (EU/mL).
| EU/mL | Shigella Group | Placebo Group | Naïve Group |
|---|---|---|---|
| Concentrations of Immunoglobulin (IgG) Against Lipopolysaccharide (LPS) S. Sonnei O-antigen | 168 (32 to 889) | 5.17 (0.033 to 810) | 38 (20 to 72) |
Assessed haematological parameters are: basophils (BAS), eosinophils (EOS), erythrocytes (ERCS), hematocrit (HCT), hemoglobin (HGB), leukocytes (LKCS), lymphocytes (LYM), monocytes (MONO), neutrophils (NEU) and platelet (PLT).
| Participants | Shigella Group | Placebo + Naïve Group |
|---|---|---|
| BAS, Below (baseline) - Within (Day 8) | 0 | 0 |
| BAS, Within (baseline) - Within (Day 8) | 7 | 28 |
| BAS, Above (baseline) - Within (Day 8) | 0 | 0 |
| BAS, Below (baseline) - Within (Day 85) | 0 | 0 |
| BAS, Within (baseline) - Within (Day 85) | 7 | 28 |
| BAS, Above (baseline) - Within (Day 85) | 0 | 0 |
| EOS, Below (baseline) - Below (Day 8) | 1 | 2 |
| EOS, Within (baseline) - Below (Day 8) | 0 | 1 |
| EOS, Above (baseline) - Below (Day 8) | 0 | 0 |
| EOS, Below (baseline) - Within (Day 8) | 1 | 3 |
| EOS, Within (baseline) - Within (Day 8) | 5 | 21 |
| EOS, Above (baseline) - Within (Day 8) | 0 | 1 |
| EOS, Below (baseline) - Below (Day 85) | 1 | 1 |
| EOS, Within (baseline) - Below (Day 85) | 0 | 0 |
| EOS, Above (baseline) - Below (Day 85) | 0 | 0 |
| EOS, Below (baseline) - Within (Day 85) | 1 | 4 |
| EOS, Within (baseline) - Within (Day 85) | 4 | 22 |
| EOS, Above (baseline) - Within (Day 85) | 0 | 0 |
| EOS, Below (baseline) - Above (Day 85) | 0 | 0 |
| EOS, Within (baseline) - Above (Day 85) | 1 | 0 |
| EOS, Above (baseline) - Above (Day 85) | 0 | 1 |
| ERCS, Below (baseline) - Below (Day 8) | 0 | 1 |
| ERCS, Within (baseline) - Below (Day 8) | 1 | 1 |
| ERCS, Above (baseline) - Below (Day 8) | 0 | 0 |
| ERCS, Below (baseline) - Within (Day 8) | 0 | 0 |
| ERCS, Within (baseline) - Within (Day 8) | 6 | 26 |
| ERCS, Above (baseline) - Within (Day 8) | 0 | 0 |
| ERCS, Below (baseline) - Below (Day 85) | 0 | 1 |
| ERCS, Within (baseline) - Below (Day 85) | 2 | 0 |
| ERCS, Above (baseline) - Below (Day 85) | 0 | 0 |
| ERCS, Below (baseline) - Within (Day 85) | 0 | 0 |
| ERCS, Within (baseline) - Within (Day 85) | 5 | 27 |
| ERCS, Above (baseline) - Within (Day 85) | 0 | 0 |
| HCT, Below (baseline) - Below (Day 8) | 2 | 1 |
| HCT, Within (baseline) - Below (Day 8) | 0 | 0 |
| HCT, Above (baseline) - Below (Day 8) | 0 | 0 |
| HCT, Below (baseline) - Within (Day 8) | 0 | 1 |
| HCT, Within (baseline) - Within (Day 8) | 5 | 26 |
| HCT, Above (baseline) - Within (Day 8) | 0 | 0 |
| HCT, Below (baseline) - Below (Day 85) | 2 | 2 |
| HCT, Within (baseline) - Below (Day 85) | 1 | 0 |
| HCT, Above (baseline) - Below (Day 85) | 0 | 0 |
| HCT, Below (baseline) - Within (Day 85) | 0 | 0 |
| HCT, Within (baseline) - Within (Day 85) | 4 | 26 |
| HCT, Above (baseline) - Within (Day 85) | 0 | 0 |
| HGB, Below (baseline) - Below (Day 8) | 2 | 1 |
| HGB, Within (baseline) - Below (Day 8) | 0 | 0 |
| HGB, Above (baseline) - Below (Day 8) | 0 | 0 |
| HGB, Below (baseline) - Within (Day 8) | 0 | 0 |
| HGB, Within (baseline) - Within (Day 8) | 5 | 27 |
| HGB, Above (baseline) - Within (Day 8) | 0 | 0 |
| HGB, Below (baseline) - Below (Day 85) | 2 | 1 |
| HGB, Within (baseline) - Below (Day 85) | 1 | 1 |
| HGB, Above (baseline) - Below (Day 85) | 0 | 0 |
| HGB, Below (baseline) - Within (Day 85) | 0 | 0 |
| HGB, Within (baseline) - Within (Day 85) | 4 | 26 |
| HGB, Above (baseline) - Within (Day 85) | 0 | 0 |
| LKCS, Below (baseline) - Below (Day 8) | 1 | 0 |
| LKCS, Within (baseline) - Below (Day 8) | 0 | 2 |
| LKCS, Above (baseline) - Below (Day 8) | 0 | 0 |
| LKCS, Below (baseline) - Within (Day 8) | 0 | 0 |
| LKCS, Within (baseline) - Within (Day 8) | 6 | 25 |
| LKCS, Above (baseline) - Within (Day 8) | 0 | 0 |
| LKCS, Below (baseline) - Above (Day 8) | 0 | 0 |
| LKCS, Within (baseline) - Above (Day 8) | 0 | 1 |
| LKCS, Above (baseline) - Above (Day 8) | 0 | 0 |
| LKCS, Below (baseline) - Below (Day 85) | 1 | 0 |
| LKCS, Within (baseline) - Below (Day 85) | 0 | 1 |
| LKCS, Above (baseline) - Below (Day 85) | 0 | 0 |
| LKCS, Below (baseline) - Within (Day 85) | 0 | 0 |
| LKCS, Within (baseline) - Within (Day 85) | 6 | 26 |
| LKCS, Above (baseline) - Within (Day 85) | 0 | 0 |
| LKCS, Below (baseline) - Above (Day 85) | 0 | 0 |
| LKCS, Within (baseline) - Above (Day 85) | 0 | 1 |
| LKCS, Above (baseline) - Above (Day 85) | 0 | 0 |
| LYM, Below (baseline) - Below (Day 8) | 2 | 3 |
| LYM, Within (baseline) - Below (Day 8) | 0 | 1 |
| LYM, Above (baseline) - Below (Day 8) | 0 | 0 |
| LYM, Below (baseline) - Within (Day 8) | 0 | 3 |
| LYM, Within (baseline) - Within (Day 8) | 5 | 21 |
| LYM, Above (baseline) - Within (Day 8) | 0 | 0 |
| LYM, Below (baseline) - Below (Day 85) | 1 | 2 |
| LYM, Within (baseline) - Below (Day 85) | 0 | 2 |
| LYM, Above (baseline) - Below (Day 85) | 0 | 0 |
| LYM, Below (baseline) - Within (Day 85) | 1 | 4 |
| LYM, Within (baseline) - Within (Day 85) | 5 | 20 |
| LYM, Above (baseline) - Within (Day 85) | 0 | 0 |
| MONO, Below (baseline) - Within (Day 8) | 0 | 0 |
| MONO, Within (baseline) - Within (Day 8) | 7 | 28 |
| MONO, Above (baseline) - Within (Day 8) | 0 | 0 |
| MONO, Below (baseline) - Within (Day 85) | 0 | 0 |
| MONO, Within (baseline) - Within (Day 85) | 7 | 28 |
| MONO, Above (baseline) - Within (Day 85) | 0 | 0 |
| NEU, Below (baseline) - Within (Day 8) | 0 | 0 |
| NEU, Within (baseline) - Within (Day 8) | 7 | 28 |
| NEU, Above (baseline) - Within (Day 8) | 0 | 0 |
| NEU, Below (baseline) - Within (Day 85) | 0 | 0 |
| NEU, Within (baseline) - Within (Day 85) | 7 | 28 |
| NEU, Above (baseline) - Within (Day 85) | 0 | 0 |
| PLT, Below (baseline) - Within (Day 8) | 0 | 0 |
| PLT, Within (baseline) - Within (Day 8) | 7 | 28 |
| PLT, Above (baseline) - Within (Day 8) | 0 | 0 |
| PLT, Below (baseline) - Within (Day 85) | 0 | 0 |
| PLT, Within (baseline) - Within (Day 85) | 7 | 28 |
| PLT, Above (baseline) - Within (Day 85) | 0 | 0 |
Assessed solicited local adverse events include injection site erythema, injection site induration and injection site pain. Any symptom = occurrence of the symptom regardless of intensity grade.
| Participants | Shigella Group | Placebo + Naïve Group |
|---|---|---|
| Any Erythema | 1 | 0 |
| Any Induration | 0 | 1 |
| Any Pain | 6 | 24 |
Assessed solicited systemic adverse events include arthralgia, chills, fatigue, headache, malaise, myalgia and oral fever. Other indicators of solicited adverse events include prevention of pain and/or fever and treatment of pain and/or fever. Any symptom = occurrence of the symptom regardless of intensity grade. Fever = body temperature (measured orally) equal to or above (≥) 38.0 °C.
| Participants | Shigella Group | Placebo + Naïve Group |
|---|---|---|
| Any Arthralgia | 1 | 3 |
| Any Chills | 1 | 1 |
| Any Fatigue | 3 | 11 |
| Any Headache | 1 | 5 |
| Any Malaise | 1 | 2 |
| Any Myalgia | 2 | 8 |
| Fever | 0 | 0 |
| Prevention of Pain and/or Fever | 0 | 0 |
| Treatment of Pain and/or Fever | 3 | 5 |
An unsolicited adverse event (AE) is an adverse event that was not solicited using a Subject Diary 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. Any = occurrence of the symptom regardless of intensity grade. Grade 3 AE = AE that prevented daily activity. Possibly/probably related AE = AE determined by the investigator as possibly related (the administration of the investigational vaccine and AE are considered reasonably related in time and the AE could be explained by exposure to the investigational vaccine or by other causes) or probably related (exposure to the investigational vaccine and AE are reasonably related in time and no alternative explanation has been identified) to the study vaccination.
| Participants | Shigella Group | Placebo + Naïve Group |
|---|---|---|
| Any AE(s) | 4 | 7 |
| Grade 3 AE(s) | 0 | 0 |
| Possibly/probably related AE(s) | 0 | 1 |
A serious adverse event is defined as an untoward medical occurrence that at any dose resulted in death, was life-threatening, required hospitalization or prolonged hospitalization, resulted in persistent or significant disability/incapacity, or in a congenital anomaly/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.
| Participants | Shigella Group | Placebo + Naive Group |
|---|---|---|
| Number of Subjects With Serious Adverse Events (SAEs) | 0 | 0 |
Concentrations of IgG against S.sonnei O-antigen are presented as GMCs, expressed in ELISA units per milliliter (EU/mL).
| EU/mL | Shigella Group | Placebo Group | Naïve Group |
|---|---|---|---|
| Day 15 | 883 (249 to 3126) | 36 (0.89 to 1474) | 106 (53 to 211) |
| Day 29 | 623 (159 to 2446) | 35 (2.36 to 531) | 110 (56 to 213) |
| Day 85 | 451 (113 to 1797) | 47 (0.51 to 4250) | 94 (48 to 184) |
Within-subject Geometric mean ratios (GMRs) were computed for GMCs at 7, 14, 28 and 84 days after vaccination versus baseline (Day 1). The GMRs and 95% confidence intervals (CIs) were constructed by exponentiating the mean within-subject differences in log-transformed concentrations and the corresponding 95% CIs.
| Ratio | Shigella Group | Placebo Group | Naïve Group |
|---|---|---|---|
| Day 8/Day 1 | 6.87 (2.69 to 18) | 1.49 (0.0095 to 233) | 2.32 (1.42 to 3.82) |
| Day 15/Day 1 | 36 (14 to 93) | 10 (0.26 to 424) | 6.88 (3.77 to 13) |
| Day 29/Day 1 | 26 (8.88 to 73) | 10 (0.68 to 153) | 7.21 (4.03 to 13) |
| Day 85/Day 1 | 18 (5.37 to 64) | 13 (0.15 to 1223) | 6.11 (3.43 to 11) |
Seroresponse is aimed to define a significant increase in post-vaccination samples based on the biological performance of this specific serology assay and it is defined as follows: - If the baseline value is greater than 50 ELISA Units (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 is 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. (Postvac minus baseline) ≥ 25 EU.
| Percentage of subjects | Shigella Group | Placebo Group | Naïve Group |
|---|---|---|---|
| Day 8 | 86 (42.1 to 99.64) | 0 (0 to 84.2) | 26 (10.2 to 48.4) |
| Day 15 | 100 (59.0 to 100.0) | 50 (1.3 to 98.7) | 72 (50.6 to 87.9) |
| Day 29 | 100 (59.0 to 100.0) | 100 (15.8 to 100.0) | 67 (44.7 to 84.4) |
| Day 85 | 100 (59.0 to 100.0) | 100 (15.8 to 100.0) | 64 (42.5 to 82.0) |
Anti-LPS S.sonnei antibody concentrations were assessed by ELISA. The assay cut-off value was 121 EU/mL.
| Percentage of subjects | Shigella Group | Placebo Group | Naïve Group |
|---|---|---|---|
| Day 8 | 71 (29.0 to 96.3) | 0 (0.0 to 84.2) | 30 (13.2 to 52.9) |
| Day 15 | 86 (42.1 to 99.64) | 0 (0.0 to 84.2) | 40 (21.1 to 61.3) |
| Day 29 | 86 (42.1 to 99.64) | 0 (0.0 to 84.2) | 42 (22.1 to 63.4) |
| Day 85 | 86 (42.1 to 99.64) | 0 (0.0 to 84.2) | 40 (21.1 to 61.3) |
Collected over Solicited local and systemic adverse events: from 30 minutes up to Day 7 post-vaccination; Unsolicited adverse events: throughout the study period (from Day 1 up to Day 85); Serious adverse events: throughout the study period (from Day 1 up to Day 85).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Shigella Group | 0/7 (0%) | 0/7 (0%) | 7/7 (100%) |
| Placebo + Naïve Group | 0/28 (0%) | 0/28 (0%) | 25/28 (89.3%) |
| Event | Shigella Group | Placebo + Naïve Group |
|---|---|---|
| Injection site painGeneral disorders | 6/7 | 24/28 |
| FatigueGeneral disorders | 3/7 | 11/28 |
| Injection site indurationGeneral disorders | 2/7 | 10/28 |
| Injection site erythemaGeneral disorders | 2/7 | 8/28 |
| MyalgiaMusculoskeletal and connective tissue disorders | 2/7 | 8/28 |
| HeadacheNervous system disorders | 2/7 | 6/28 |
| ChillsGeneral disorders | 1/7 | 1/28 |
| MalaiseGeneral disorders | 1/7 | 2/28 |
| NasopharyngitisInfections and infestations | 1/7 | 0/28 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 1/7 | 3/28 |
| Age, Continuous(Years) | Shigella Group | Placebo Group | Naïve Group | Total |
|---|---|---|---|---|
| Mean | 37.7 ± 7.89 | 40.5 ± 10.61 | 33.8 ± 8.41 | 34.9 ± 8.41 |
| Sex: Female, Male(Participants) | Shigella Group | Placebo Group | Naïve Group | Total |
|---|---|---|---|---|
| Female | 4 | 2 | 9 | 15 |
| Male | 3 | 0 | 17 | 20 |
| Race/Ethnicity, Customized(Participants) | Shigella Group | Placebo Group | Naïve Group | Total |
|---|---|---|---|---|
| Black or African American | 1 | 0 | 1 | 2 |
| White | 6 | 2 | 24 | 32 |
| Unspecified | 0 | 0 | 1 | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Data sharing details ↗ · www.clinicalstudydatarequest.com
Ran from Mar 2017 to primary completion in Aug 2017, 5 months.
Results were first posted in Mar 2019, 1 year 6 months after primary completion.
Of 15 phase 1 interventional studies under Dysentery, Bacillary, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 24. This study's 5 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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