Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The main purpose of this study is to evaluate the safety of a Shigella flexneri 2a detoxified artificial invasin complex (Invaplex[AR-Detox]) vaccine candidate administered by intramuscular immunization.
This is a randomized, double-blind, placebo-controlled, Phase 1 clinical trial in which a total of 60 volunteers will receive one of three doses of Invaplex[AR-DETOX] or placebo (saline). The vaccine will be administered via intramuscular (IM) injection on study days 1, 22, and 43. Each participant will receive the same formulation at each vaccination dependent upon group assignment. The study will be initiated with the lowest dose level (2.5 μg) and will proceed to the next highest dose in an escalating fashion. All safety data will be summarized and reviewed by the Protocol Safety Review Team (PSRT) prior to dose-escalation.
Specimens will be collected at prescribed intervals to examine systemic and mucosal immune responses. Vaccine safety will be actively monitored during vaccination and for 28 days following the third vaccine dose.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Invaplex[AR-Detox] 2.5 μg | Experimental | Participants received an intramuscular injection of 2.5 μg Invaplex[AR-DETOX] vaccine on Days 1, 22, and 43. |
|
| Invaplex[AR-Detox] 10 μg | Experimental | Participants received an intramuscular injection of 10 μg Invaplex[AR-DETOX] vaccine on Days 1, 22, and 43. |
|
| Invaplex[AR-Detox] 25 μg | Experimental | Participants received an intramuscular injection of 25 μg Invaplex[AR-DETOX] vaccine on Days 1, 22, and 43. |
|
| Placebo | Placebo Comparator | Participants received an intramuscular injection of placebo solution on Days 1, 22, and 43. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Invaplex[AR-DETOX] | Biological | Detoxified Shigella flexneri 2a Artificial Invasin Complex (Invaplex[AR-Detox]) Vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events | All adverse events (AEs) were assessed for severity by the investigator according to the following scale: Grade 1 (Mild): Does not interfere with routine activities, minimal level of discomfort; Grade 2 (Moderate): Interferes with routine activities, moderate level of discomfort; Grade 3 (Severe): Unable to perform routine activities, significant level of discomfort; Grade 4 (Potentially life-threatening): Hospitalization or ER visit for potentially life-threatening event. An AE was considered "serious" if it resulted in any of the following outcomes:
The Investigator assessed the relationship of each adverse event to study drug. | From first dose up to 28 days following the third immunization (71 days) |
| Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1 | The solicited AEs for this study included:
| 7 days after the first immunization (Days 1 to 7) |
| Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2 | The solicited AEs for this study included:
| 7 days after the second immunization (Days 22 to 28) |
| Number of Participants With Solicited Adverse Events After Dose 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titer (GMT) of Serum Immunoglobulin A (IgA) Antibodies to Invaplex | Days 1 (Baseline), 22, 43, 50, 57 and 71. | |
| Geometric Mean Titer (GMT) of Serum Immunoglobulin G (IgG) Antibodies to Invaplex | Days 1 (Baseline), 22, 43, 50, 57 and 71. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ramiro Gutierrez, MD, MPH | Naval Medical Research Center (NMRC) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Walter Reed Army Institute of Research Clinical Trials Center (WRAIR CTC) | Silver Spring | Maryland | 20910 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
In this dose-escalation study participants were assigned to receive 3 vaccinations of 1 of 3 doses of detoxified Shigella flexneri 2a artificial invasin complex (Invaplex[AR-Detox]) or placebo. The study was initiated with the lowest dose level (2.5 μg) and proceeded to the next highest dose in an escalating fashion after review of safety data by the Protocol Safety Review Team.
Within each dose cohort participants were randomly assigned to receive Invaplex[AR-Detox] or placebo in a 4: 1 ratio.
This study was conducted at the Walter Reed Army Institute of Research (WRAIR) Clinical Trials Center (CTC) in Silver Spring, MD, USA. Healthy adults were recruited from the Baltimore/Washington, DC area.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Invaplex[AR-Detox] 2.5 μg | Participants received an intramuscular injection of 2.5 μg Invaplex[AR-DETOX] vaccine on Days 1, 22, and 43. |
| FG001 | Invaplex[AR-Detox] 10 μg | Participants received an intramuscular injection of 10 μg Invaplex[AR-DETOX] vaccine on Days 1, 22, and 43. |
| FG002 | Invaplex[AR-Detox] 25 μg | Participants received an intramuscular injection of 25 μg Invaplex[AR-DETOX] vaccine on Days 1, 22, and 43. |
| FG003 | Placebo | Participants received an intramuscular injection of placebo solution on Days 1, 22, and 43. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All enrolled and randomized participants
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Invaplex[AR-Detox] 2.5 μg | Participants received an intramuscular injection of 2.5 μg Invaplex[AR-DETOX] vaccine on Days 1, 22, and 43. |
| BG001 | Invaplex[AR-Detox] 10 μg | Participants received an intramuscular injection of 10 μg Invaplex[AR-DETOX] vaccine on Days 1, 22, and 43. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Adverse Events | All adverse events (AEs) were assessed for severity by the investigator according to the following scale: Grade 1 (Mild): Does not interfere with routine activities, minimal level of discomfort; Grade 2 (Moderate): Interferes with routine activities, moderate level of discomfort; Grade 3 (Severe): Unable to perform routine activities, significant level of discomfort; Grade 4 (Potentially life-threatening): Hospitalization or ER visit for potentially life-threatening event. An AE was considered "serious" if it resulted in any of the following outcomes:
The Investigator assessed the relationship of each adverse event to study drug. | The safety population included all participants who received at least one immunization (Invaplex[AR-Detox] or placebo). | Posted | Number | 95% Confidence Interval | percentage of participants | From first dose up to 28 days following the third immunization (71 days) |
From first dose up to 28 days following the third immunization (71 days)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Invaplex[AR-Detox] 2.5 μg | Participants received an intramuscular injection of 2.5 μg Invaplex[AR-DETOX] vaccine on Days 1, 22, and 43. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rahsan Erdem | PATH | +1 202 540 4546 | rerdem@path.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 22, 2019 | Jul 6, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 18, 2020 | Jul 7, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003967 | Diarrhea |
| D004405 | Dysentery, Bacillary |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004756 | Enterobacteriaceae Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Other | Saline |
|
The solicited AEs for this study included:
|
| 7 days after the third immunization (Days 43 to 49) |
| Number of Participants With Unsolicited Adverse Events After Each Dose | Dose 1: Days 1 to 21; Dose 2: Days 22 to 42; Dose 3: Days 43 to 71 |
| Geometric Mean Titer (GMT) of Immunoglobulin A Antibodies to Invaplex in α4β7+ Antibody in Lymphocyte Supernatant (ALS) | Days 1 (Baseline), 8, 29, and 50 |
| Geometric Mean Titer of Immunoglobulin G Antibodies to Invaplex in α4β7+ Antibody in Lymphocyte Supernatant | Days 1 (Baseline), 8, 29, and 50 |
| Percentage of Participants With a ≥ 4-fold Increase in Serum IgA Antibodies From Baseline | Seroconversion was defined as ≥ 4-fold increase in antibody titer from Baseline. | Days 1 (Baseline), 22 43, 50, 57 and 71 |
| Percentage of Participants With a ≥ 4-fold Increase in Serum IgG Antibodies From Baseline | Seroconversion was defined as ≥ 4-fold increase in antibody titer from Baseline. | Days 1 (Baseline), 22 43, 50, 57 and 71 |
| Percentage of Participants With a ≥ 4-fold Increase in ALS IgA From Baseline | Seroconversion was defined as ≥ 4-fold increase in antibody titer from Baseline. | Days 1 (Baseline), 8, 29, and 50 |
| Percentage of Participants With a ≥ 4-fold Increase in ALS IgG From Baseline | Seroconversion was defined as ≥ 4-fold increase in antibody titer from Baseline. | Days 1 (Baseline), 8, 29, and 50 |
| Geometric Mean Fold-rise (GMFR) in Serum IgA From Baseline | Days 1 (Baseline), 22, 43, 50, 57 and 71. |
| Geometric Mean Fold-rise in Serum IgG From Baseline | Days 1 (Baseline), 22, 43, 50, 57 and 71. |
| Geometric Mean Fold-rise in ALS IgA From Baseline | Days 1 (Baseline), 8, 29, and 50 |
| Geometric Mean Fold-rise in ALS IgG From Baseline | Days 1 (Baseline), 8, 29, and 50 |
| Pregnancy |
|
| Physician Decision |
|
| BG002 | Invaplex[AR-Detox] 25 μg | Participants received an intramuscular injection of 25 μg Invaplex[AR-DETOX] vaccine on Days 1, 22, and 43. |
| BG003 | Placebo | Participants received an intramuscular injection of placebo solution on Days 1, 22, and 43. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| ID | Title | Description |
|---|
| OG000 | Invaplex[AR-Detox] 2.5 μg | Participants received an intramuscular injection of 2.5 μg Invaplex[AR-DETOX] vaccine on Days 1, 22, and 43. |
| OG001 | Invaplex[AR-Detox] 10 μg | Participants received an intramuscular injection of 10 μg Invaplex[AR-DETOX] vaccine on Days 1, 22, and 43. |
| OG002 | Invaplex[AR-Detox] 25 μg | Participants received an intramuscular injection of 25 μg Invaplex[AR-DETOX] vaccine on Days 1, 22, and 43. |
| OG003 | Placebo | Participants received an intramuscular injection of placebo solution on Days 1, 22, and 43. |
|
|
| Primary | Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 1 | The solicited AEs for this study included:
| All participants who received the first dose (Invaplex[AR-Detox] or placebo). | Posted | Count of Participants | Participants | 7 days after the first immunization (Days 1 to 7) |
|
|
|
| Primary | Number of Participants With Solicited Adverse Events Up to 7 Days After Dose 2 | The solicited AEs for this study included:
| All participants who received the second dose (Invaplex[AR-Detox] or placebo). | Posted | Count of Participants | Participants | 7 days after the second immunization (Days 22 to 28) |
|
|
|
| Primary | Number of Participants With Solicited Adverse Events After Dose 3 | The solicited AEs for this study included:
| All participants who received the third dose (Invaplex[AR-Detox] or placebo). | Posted | Count of Participants | Participants | 7 days after the third immunization (Days 43 to 49) |
|
|
|
| Primary | Number of Participants With Unsolicited Adverse Events After Each Dose | Participants who received each dose (Invaplex[AR-Detox] or placebo). | Posted | Count of Participants | Participants | Dose 1: Days 1 to 21; Dose 2: Days 22 to 42; Dose 3: Days 43 to 71 |
|
|
|
| Secondary | Geometric Mean Titer (GMT) of Serum Immunoglobulin A (IgA) Antibodies to Invaplex | The immunogenicity population includes all participants who received at least two vaccinations, who had baseline and post-vaccination data for the immunogenicity variable of interest | Posted | Geometric Mean | 95% Confidence Interval | titer | Days 1 (Baseline), 22, 43, 50, 57 and 71. |
|
|
|
|
| Secondary | Geometric Mean Titer (GMT) of Serum Immunoglobulin G (IgG) Antibodies to Invaplex | The immunogenicity population includes all participants who received at least two vaccinations, who had baseline and post-vaccination data for the immunogenicity variable of interest | Posted | Geometric Mean | 95% Confidence Interval | titer | Days 1 (Baseline), 22, 43, 50, 57 and 71. |
|
|
|
|
| Secondary | Geometric Mean Titer (GMT) of Immunoglobulin A Antibodies to Invaplex in α4β7+ Antibody in Lymphocyte Supernatant (ALS) | The immunogenicity population includes all participants who received at least two vaccinations, who had baseline and post-vaccination data for the immunogenicity variable of interest | Posted | Geometric Mean | 95% Confidence Interval | titer | Days 1 (Baseline), 8, 29, and 50 |
|
|
|
|
| Secondary | Geometric Mean Titer of Immunoglobulin G Antibodies to Invaplex in α4β7+ Antibody in Lymphocyte Supernatant | The immunogenicity population includes all participants who received at least two vaccinations, who had baseline and post-vaccination data for the immunogenicity variable of interest | Posted | Geometric Mean | 95% Confidence Interval | titer | Days 1 (Baseline), 8, 29, and 50 |
|
|
|
|
| Secondary | Percentage of Participants With a ≥ 4-fold Increase in Serum IgA Antibodies From Baseline | Seroconversion was defined as ≥ 4-fold increase in antibody titer from Baseline. | The immunogenicity population includes all participants who received at least two vaccinations, who had baseline and post-vaccination data for the immunogenicity variable of interest. | Posted | Number | 95% Confidence Interval | percentage of participants | Days 1 (Baseline), 22 43, 50, 57 and 71 |
|
|
|
|
| Secondary | Percentage of Participants With a ≥ 4-fold Increase in Serum IgG Antibodies From Baseline | Seroconversion was defined as ≥ 4-fold increase in antibody titer from Baseline. | The immunogenicity population includes all participants who received at least two vaccinations, who had baseline and post-vaccination data for the immunogenicity variable of interest | Posted | Number | 95% Confidence Interval | percentage of participants | Days 1 (Baseline), 22 43, 50, 57 and 71 |
|
|
|
|
| Secondary | Percentage of Participants With a ≥ 4-fold Increase in ALS IgA From Baseline | Seroconversion was defined as ≥ 4-fold increase in antibody titer from Baseline. | The immunogenicity population includes all participants who received at least two vaccinations, who had baseline and post-vaccination data for the immunogenicity variable of interest. | Posted | Number | 95% Confidence Interval | percentage of participants | Days 1 (Baseline), 8, 29, and 50 |
|
|
|
|
| Secondary | Percentage of Participants With a ≥ 4-fold Increase in ALS IgG From Baseline | Seroconversion was defined as ≥ 4-fold increase in antibody titer from Baseline. | The immunogenicity population includes all participants who received at least two vaccinations, who had baseline and post-vaccination data for the immunogenicity variable of interest | Posted | Number | 95% Confidence Interval | percentage of participants | Days 1 (Baseline), 8, 29, and 50 |
|
|
|
|
| Secondary | Geometric Mean Fold-rise (GMFR) in Serum IgA From Baseline | The immunogenicity population includes all participants who received at least two vaccinations, who had baseline and post-vaccination data for the immunogenicity variable of interest | Posted | Geometric Mean | 95% Confidence Interval | fold-rise | Days 1 (Baseline), 22, 43, 50, 57 and 71. |
|
|
|
|
| Secondary | Geometric Mean Fold-rise in Serum IgG From Baseline | The immunogenicity population includes all participants who received at least two vaccinations, who had baseline and post-vaccination data for the immunogenicity variable of interest | Posted | Geometric Mean | 95% Confidence Interval | fold-rise | Days 1 (Baseline), 22, 43, 50, 57 and 71. |
|
|
|
|
| Secondary | Geometric Mean Fold-rise in ALS IgA From Baseline | The immunogenicity population includes all participants who received at least two vaccinations, who had baseline and post-vaccination data for the immunogenicity variable of interest | Posted | Geometric Mean | 95% Confidence Interval | fold-rise | Days 1 (Baseline), 8, 29, and 50 |
|
|
|
| Secondary | Geometric Mean Fold-rise in ALS IgG From Baseline | The immunogenicity population includes all participants who received at least two vaccinations, who had baseline and post-vaccination data for the immunogenicity variable of interest. | Posted | Geometric Mean | 95% Confidence Interval | fold-rise | Days 1 (Baseline), 8, 29, and 50 |
|
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 14 |
| 14 |
| EG001 | Invaplex[AR-Detox] 10 μg | Participants received an intramuscular injection of 10 μg Invaplex[AR-DETOX] vaccine on Days 1, 22, and 43. | 0 | 16 | 0 | 16 | 16 | 16 |
| EG002 | Invaplex[AR-Detox] 25 μg | Participants received an intramuscular injection of 25 μg Invaplex[AR-DETOX] vaccine on Days 1, 22, and 43. | 0 | 16 | 0 | 16 | 16 | 16 |
| EG003 | Placebo | Participants received an intramuscular injection of placebo solution on Days 1, 22, and 43. | 0 | 12 | 0 | 12 | 11 | 12 |
| Lymph node pain | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA 20.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Gingival pain | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Gingival swelling | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Vaccination site erythema | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Vaccination site induration | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Vaccination site pain | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Vaccination site pruritus | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Vaccination site swelling | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Stress fracture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Appetite disorder | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
|
Not provided
Not provided
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D004403 | Dysentery |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| Abdominal pain |
|
| Appetite disorder |
|
| Arthralgia |
|
| Diarrhoea |
|
| Fatigue |
|
| Headache |
|
| Malaise |
|
| Myalgia |
|
| Nausea |
|
| Pyrexia |
|
| Vaccination site erythema |
|
| Vaccination site induration |
|
| Vaccination site pain |
|
| Vaccination site pruritus |
|
| Vaccination site swelling |
|
| Abdominal pain |
|
| Appetite disorder |
|
| Arthralgia |
|
| Diarrhoea |
|
| Fatigue |
|
| Headache |
|
| Malaise |
|
| Myalgia |
|
| Nausea |
|
| Vaccination site erythema |
|
| Vaccination site induration |
|
| Vaccination site pain |
|
| Vaccination site pruritus |
|
| Vaccination site swelling |
|
| Abdominal pain |
|
| Appetite disorder |
|
| Arthralgia |
|
| Fatigue |
|
| Headache |
|
| Malaise |
|
| Myalgia |
|
| Nausea |
|
| Vaccination site erythema |
|
| Vaccination site induration |
|
| Vaccination site pain |
|
| Vaccination site pruritus |
|
| Vaccination site swelling |
|
|
| Unsolicited adverse events after second dose |
|
|
| Unsolicited adverse events after third dose |
|
|
|
| Day 22 (pre-dose 2) |
|
|
| Day 43 (pre-dose 3) |
|
|
| Day 50 (7 days after dose 3) |
|
|
| Day 57 (14 days after dose 3) |
|
|
| Day 71 (28 days after dose 3) |
|
|
| Kruskal-Wallis |
| 0.010 |
| Other |
| Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 43 | Kruskal-Wallis | 0.038 | Other |
| Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 50 | Kruskal-Wallis | 0.016 | Other |
| Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 57 | Kruskal-Wallis | 0.058 | Other |
| Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 71 | Kruskal-Wallis | 0.038 | Other |
|
| Day 22 (pre-dose 2) |
|
|
| Day 43 (pre-dose 3) |
|
|
| Day 50 (7 days after dose 3) |
|
|
| Day 57 (14 days after dose 3) |
|
|
| Day 71 (28 days after dose 3) |
|
|
| Kruskal-Wallis |
| 0.017 |
| Other |
| Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 43 | Kruskal-Wallis | 0.008 | Other |
| Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 50 | Kruskal-Wallis | 0.011 | Other |
| Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 57 | Kruskal-Wallis | 0.029 | Other |
| Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 71 | Kruskal-Wallis | 0.042 | Other |
|
| Day 8 (7 days after dose 1) |
|
|
| Day 29 (7 days after dose 2) |
|
|
| Day 50 (7 days after dose 3) |
|
|
| Kruskal-Wallis |
| 0.601 |
| Other |
| Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 29 | Kruskal-Wallis | 0.628 | Other |
| Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 50 | Kruskal-Wallis | 0.878 | Other |
|
| Day 8 (7 days after dose 1) |
|
|
| Day 29 (7 days after dose 2) |
|
|
| Day 50 (7 days after dose 3) |
|
|
| Kruskal-Wallis |
| 0.335 |
| Other |
| Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 29 | Kruskal-Wallis | 0.229 | Other |
| Kruskal-Wallis test of any difference between the 3 active dose groups in GMT at Day 50 | Kruskal-Wallis | 0.102 | Other |
|
| Day 43 (pre-dose 3) |
|
|
| Day 50 (7 days after dose 3) |
|
|
| Day 57 (14 days after dose 3) |
|
|
| Day 71 (28 days after dose 3) |
|
|
| Fisher Exact |
| 0.629 |
| Other |
| Fisher's exact 2-tail test of the difference between the 3 Invaplex[AR-Detox] dose groups in seroconversion rates at Day 50 | Fisher Exact | >0.999 | Other |
| Fisher's exact 2-tail test of the difference between the 3 Invaplex[AR-Detox] dose groups in seroconversion rates at Day 57 | Fisher Exact | >0.999 | Other |
| Fisher's exact 2-tail test of the difference between the 3 Invaplex[AR-Detox] dose groups in seroconversion rates at Day 71 | Fisher Exact | 0.825 | Other |
|
| Day 43 (pre-dose 3) |
|
|
| Day 50 (7 days after dose 3) |
|
|
| Day 57 (14 days after dose 3) |
|
|
| Day 71 (28 days after dose 3) |
|
|
| Fisher Exact |
| 0.082 |
| Other |
| Fisher's exact 2-tail test of the difference between the 3 Invaplex[AR-Detox] dose groups in seroconversion rates at Day 50 | Fisher Exact | 0.293 | Other |
| Fisher's exact 2-tail test of the difference between the 3 Invaplex[AR-Detox] dose groups in seroconversion rates at Day 57 | Fisher Exact | >0.999 | Other |
| Fisher's exact 2-tail test of the difference between the 3 Invaplex[AR-Detox] dose groups in seroconversion rates at Day 71 | Fisher Exact | >0.999 | Other |
|
| Day 29 (7 days after dose 2) |
|
|
| Day 50 (7 days after dose 3) |
|
|
| Fisher Exact |
| 0.913 |
| Other |
| Fisher's exact 2-tail tests of differences between the 3 Invaplex[AR-Detox] dose groups in seroconversion rates at Day 50 | Fisher Exact | 0.924 | Other |
|
| Day 29 (7 days after dose 2) |
|
|
| Day 50 (7 days after dose 3) |
|
|
| Fisher Exact |
| 0.412 |
| Other |
| Fisher's exact 2-tail tests of differences between the 3 Invaplex[AR-Detox] dose groups in seroconversion rates at Day 50 | Fisher Exact | 0.847 | Other |
|
| Day 43 (pre-dose 3) |
|
|
| Day 50 (7 days after dose 3) |
|
|
| Day 57 (14 days after dose 3) |
|
|
| Day 71 (28 days after dose 3) |
|
|
| Kruskal-Wallis |
| 0.037 |
| Other |
| Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 50 | Kruskal-Wallis | 0.009 | Other |
| Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 57 | Kruskal-Wallis | 0.036 | Other |
| Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 71 | Kruskal-Wallis | 0.042 | Other |
|
| Day 43 (pre-dose 3) |
|
|
| Day 50 (7 days after dose 3) |
|
|
| Day 57 (14 days after dose 3) |
|
|
| Day 71 (28 days after dose 3) |
|
|
| Kruskal-Wallis |
| 0.088 |
| Other |
| Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 50 | Kruskal-Wallis | 0.146 | Other |
| Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 57 | Kruskal-Wallis | 0.126 | Other |
| Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 71 | Kruskal-Wallis | 0.273 | Other |
|
| Day 29 (7 days after dose 2) |
|
|
| Day 50 (7 days after dose 3) |
|
|
|
| Day 29 (7 days after dose 2) |
|
|
| Day 50 (7 days after dose 3) |
|
|
| Kruskal-Wallis |
| 0.179 |
| Other |
| Kruskal-Wallis test of any difference between the 3 active dose groups in GMFR at Day 50 | Kruskal-Wallis | 0.089 | Other |