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| Name | Class |
|---|---|
| US Army Medical Research Institute of Infectious Diseases | FED |
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This study is a Phase 1, escalating, multiple-dose, single-center study to evaluate the safety and immunogenicity of the RVEc vaccine.
The two principal hypotheses to be tested are: RVEc vaccine will display an acceptable safety profile as determined by adverse event data and RVEc vaccine will elicit ELISA immunoglobulin G (IgG) titers greater than or equal to 1:500 and toxin-neutralizing antibody (TNA) anti-ricin toxin-neutralizing antibody titers greater than or equal to 1:50 in vaccine recipients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | RVEc vaccine 20 μg/dose x 3 doses |
|
| Group 2 | Experimental | RVEc vaccine 50 μg/dose x 3 doses |
|
| Group 3 | Experimental | RVEc vaccine 100 μg/dose x 1 dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RVEc | Biological |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Vaccinated Subjects Any Averse Events and by Location and Severity | Days 1, 3, 7, 14, and 28 after each vaccination and at 6 and 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Over Response Rates and Comparisons for ELISA and TNA Titers | Overall response is defined as a subject having a response at any time after vaccination. A response is defined as subjects who developed total ELISA IgG titers (≥ 1:500) and TNA anti-ricin toxin-neutralizing antibody titers (≥ 1:50) at each scheduled time point for which blood samples were taken for each group and over the entire study period to study completion. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Phillip R Pittman, MD, MPH | US Army Medical Research Institute of Infectious Diseases | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Clinical Research, U.S. Army Medical Research Institute of Infectious Diseases | Fort Deterick | Maryland | 21702 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26546259 | Result | Pittman PR, Reisler RB, Lindsey CY, Guerena F, Rivard R, Clizbe DP, Chambers M, Norris S, Smith LA. Safety and immunogenicity of ricin vaccine, RVEc, in a Phase 1 clinical trial. Vaccine. 2015 Dec 16;33(51):7299-7306. doi: 10.1016/j.vaccine.2015.10.094. Epub 2015 Nov 3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 | RVEc vaccine 20 μg/dose x 3 doses |
| FG001 | Group 2 | RVEc vaccine 50 μg/dose x 3 doses |
| FG002 | Group 3 | RVEc vaccine 100 μg/dose x 1 dose |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 | RVEc vaccine 20 μg/dose x 3 doses |
| BG001 | Group 2 | RVEc vaccine 50 μg/dose x 3 doses |
| 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 | Number of Vaccinated Subjects Any Averse Events and by Location and Severity | Safety population: any subject receiving a vaccination | Posted | Number | participants | Days 1, 3, 7, 14, and 28 after each vaccination and at 6 and 9 months |
|
9 months
Safety population: any subject receiving a vaccination
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 | RVEc vaccine 20 μg/dose x 3 doses |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypernatraemia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Denise P Clizbe, RN, CCRC | US Army Medical Research Institute of Infectious Diseases (USAMRIID) | 301.619.6869 | denise.p.clizbe.civ@mail.mil |
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| ID | Term |
|---|---|
| D014612 | Vaccines |
| ID | Term |
|---|---|
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Day 7, 14, 28, 35, 42, 56, 63, 70, 84, month 6, 9, and 12 |
| BG002 |
| Group 3 |
RVEc vaccine 100 μg/dose x 1 dose |
| BG003 | 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 |
|
|
|
| Secondary | Over Response Rates and Comparisons for ELISA and TNA Titers | Overall response is defined as a subject having a response at any time after vaccination. A response is defined as subjects who developed total ELISA IgG titers (≥ 1:500) and TNA anti-ricin toxin-neutralizing antibody titers (≥ 1:50) at each scheduled time point for which blood samples were taken for each group and over the entire study period to study completion. | Per-protocol population. Only observations or specimens collected according to the protocol were included in the immunogenicity analyses. | Posted | Number | participants | Day 7, 14, 28, 35, 42, 56, 63, 70, 84, month 6, 9, and 12 |
|
|
|
| 1 |
| 10 |
| 10 |
| 10 |
| EG001 | Group 2 | RVEc vaccine 50 μg/dose x 3 doses | 0 | 10 | 10 | 10 |
| EG002 | Group 3 | RVEc vaccine 100 μg/dose x 1 dose | 1 | 10 | 9 | 10 |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Hypophosphataemia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Vitamin D deficiency | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Injection site pain | General disorders | Non-systematic Assessment |
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| Cyst | General disorders | Non-systematic Assessment |
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| Injection site haemorrhage | General disorders | Non-systematic Assessment |
|
| Injection site papule | General disorders | Non-systematic Assessment |
|
| Blood urea increased | Investigations | Non-systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | Non-systematic Assessment |
|
| Alanine aminotransferase increased | General disorders | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Musculoskeletal pain | Investigations | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | Non-systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | Non-systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Joint sprain | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Haematuria | Renal and urinary disorders | Non-systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Upper respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Haematoma | Vascular disorders | Non-systematic Assessment |
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| Bradycardia | Cardiac disorders | Non-systematic Assessment |
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| Hypothyroidism | Endocrine disorders | Non-systematic Assessment |
|
| Eye swelling | Eye disorders | Non-systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | Non-systematic Assessment |
|
| Infected neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Hyperphosphataemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Axillary pain | General disorders | Non-systematic Assessment |
|
| Chills | General disorders | Non-systematic Assessment |
|
| Urine leukocyte esterase | Investigations | Non-systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | Non-systematic Assessment |
|
| White blood cells urine | Investigations | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | Non-systematic Assessment |
|
| Blood testosterone decreased | Investigations | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Muscle twitching | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Acute sinusitis | Infections and infestations | Non-systematic Assessment |
|
| Folliculitis | Infections and infestations | Non-systematic Assessment |
|
| Herpes simplex | Infections and infestations | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | Non-systematic Assessment |
|
| Neutrophilia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Diastolic hypertension | Vascular disorders | Non-systematic Assessment |
|
| Amenorrhoea | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | Non-systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | Non-systematic Assessment |
|
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| Title | Measurements |
|---|---|
|