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| ID | Type | Description | Link |
|---|---|---|---|
| WRAIR 1191 | Other Identifier | WRAIR ID | |
| HSRRB A-13304 | Other Identifier | IRB | |
| 62787A 810S A0235 | Other Identifier |
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| Name | Class |
|---|---|
| United States Army Medical Materiel Development Activity | FED |
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The purpose of this study is to exame the safety of a DNA vaccine against dengue-1.
Dengue is a desease that affects 100 million people throughout the world mainly in tropical countries in the South Pacific, Asia, the Caribbean, and Africa. The disease often presents with high fever, severe headache, and joint/muscle pain that usually goes away on its own, but it can also present as a sometimes deadly hemorrhagic (bleeding) disease. Humans catch this disease by being bitten by mosquitoes that have been infected with dengue virus. Scientists at the Naval Medical Research Center have been working on vaccines to prevent dengue disease. This vaccine, referred to as D1ME, is an experimental DNA vaccine that contains genes from the dengue-1 virus. The purpose of this study is to test the safety of a new experimental vaccine against dengue and to see if the vaccine can stimulate the immune system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1.0 mg of D1ME100 vaccine | Experimental | 1.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months |
|
| 5.0 mg of D1ME100 vaccine | Experimental | 5.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D1ME100 (dengue-1 premembrane/envelope DNA vaccine) | Biological | IM injection delivered by Biojector |
|
| Measure | Description | Time Frame |
|---|---|---|
| Systemic and Local Reactogenicity Rates for Ungraded Symptoms | Summary of ungraded systemic and local reactogenicity symptoms following each vaccination | Months 0, 1 and 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-dengue Antibody and T-cell and B-cell Responders | Number of participants who responded, are reported. Response or a positive ELISPOT assay was defined as >65 spot forming cells per million PBMC for T-cells and >20 spot forming cells per million PBMC for B-cells | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charmagne Beckett, MD | Naval Medical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Walter Reed Army Institute of Research, Bldg 503 | Silver Spring | Maryland | 20910 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29363446 | Derived | Danko JR, Kochel T, Teneza-Mora N, Luke TC, Raviprakash K, Sun P, Simmons M, Moon JE, De La Barrera R, Martinez LJ, Thomas SJ, Kenney RT, Smith L, Porter KR. Safety and Immunogenicity of a Tetravalent Dengue DNA Vaccine Administered with a Cationic Lipid-Based Adjuvant in a Phase 1 Clinical Trial. Am J Trop Med Hyg. 2018 Mar;98(3):849-856. doi: 10.4269/ajtmh.17-0416. Epub 2018 Jan 18. | |
| 21111785 |
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22 healthy adult volunteers enrolled to participate at the Naval Medical Research Center site
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| ID | Title | Description |
|---|---|---|
| FG000 | 1.0 mg of D1ME100 Vaccine | 1.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months D1ME100 (dengue-1 premembrane/envelope DNA vaccine): IM injection delivered by Biojector |
| FG001 | 5.0 mg of D1ME100 Vaccine | 5.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months D1ME100 (dengue-1 premembrane/envelope DNA vaccine): IM injection delivered by Biojector |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 1.0 mg of D1ME100 Vaccine | 1.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months D1ME100 (dengue-1 premembrane/envelope DNA vaccine): IM injection delivered by Biojector |
| BG001 | 5.0 mg of D1ME100 Vaccine |
| 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 | Systemic and Local Reactogenicity Rates for Ungraded Symptoms | Summary of ungraded systemic and local reactogenicity symptoms following each vaccination | Posted | Count of Participants | Participants | Months 0, 1 and 5 |
|
12 months
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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 | 1.0 mg of D1ME100 Vaccine | 1.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months D1ME100 (dengue-1 premembrane/envelope DNA vaccine): IM injection delivered by Biojector |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alcohol withdrawal | Psychiatric disorders | MedDRA (Unspecified) | Non-systematic Assessment | Not related |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Malaise | General disorders | MedDRA (Unspecified) | Systematic Assessment | Severe; Not related |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Charmagne Beckett, LCDR, MC, USNR | Naval Medical Research Center, Viral Diseases Department | 301-295-6400 | charmagne.beckett@med.navy.mil |
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| ID | Term |
|---|---|
| D003715 | Dengue |
| ID | Term |
|---|---|
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D007239 | Infections |
| D001102 | Arbovirus Infections |
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Open Label
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| Derived |
| Beckett CG, Tjaden J, Burgess T, Danko JR, Tamminga C, Simmons M, Wu SJ, Sun P, Kochel T, Raviprakash K, Hayes CG, Porter KR. Evaluation of a prototype dengue-1 DNA vaccine in a Phase 1 clinical trial. Vaccine. 2011 Jan 29;29(5):960-8. doi: 10.1016/j.vaccine.2010.11.050. Epub 2010 Nov 25. |
5.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months D1ME100 (dengue-1 premembrane/envelope DNA vaccine): IM injection delivered by Biojector |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Active Duty Military | Count of Participants | Participants |
|
| Civilian | Count of Participants | Participants |
|
|
|
| Secondary | Anti-dengue Antibody and T-cell and B-cell Responders | Number of participants who responded, are reported. Response or a positive ELISPOT assay was defined as >65 spot forming cells per million PBMC for T-cells and >20 spot forming cells per million PBMC for B-cells | Posted | Count of Participants | Participants | 12 months |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 10 |
| 10 |
| EG001 | 5.0 mg of D1ME100 Vaccine | 5.0 mg dose of DME100 vaccine delivered by Biojector IM injections at 0, 1 and 5 months D1ME100 (dengue-1 premembrane/envelope DNA vaccine): IM injection delivered by Biojector | 0 | 12 | 1 | 12 | 12 | 12 |
|
| Tenderness | General disorders | MedDRA (Unspecified) | Systematic Assessment | Mild; Probable |
|
| Echymosis right arm following trauma | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment | Mild; Not related |
|
| Right arm pain following trauma | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment | Mild; Not related |
|
| Malaise | General disorders | MedDRA (Unspecified) | Systematic Assessment | Moderate; Unlikely related |
|
| Toothache | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment | Moderate; Not related |
|
| Malaise | General disorders | MedDRA (Unspecified) | Systematic Assessment | Mild; Unlikely related |
|
| Seasonal allergic rhinitis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment | Mild; Not related |
|
| Chest pain following trauma | General disorders | MedDRA (Unspecified) | Systematic Assessment | Mild; Not related |
|
| Jaw pain following trauma | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment | Mild; Not related |
|
| Elevated CPK | Investigations | MedDRA (Unspecified) | Systematic Assessment | Severe; Unlikely related |
|
| Low blood sugar | Investigations | MedDRA (Unspecified) | Systematic Assessment | Mild; Not related |
|
| Elevated CPK | Investigations | MedDRA (Unspecified) | Systematic Assessment | Mild; Unlikely related |
|
| Elevated CPK | Investigations | MedDRA (Unspecified) | Systematic Assessment | Moderate; Unlikely related |
|
| Decreased bicarbonate level | Investigations | MedDRA (Unspecified) | Systematic Assessment | Mild; Unlikely related |
|
| Increased diastolic BP | Investigations | MedDRA (Unspecified) | Systematic Assessment | Mild; Not related |
|
| Burn left hand following trauma | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment | Mild; Not related |
|
| Increased systolic BP | Investigations | MedDRA (Unspecified) | Systematic Assessment | Mild; Not related |
|
| Urine - Trace protein | Investigations | MedDRA (Unspecified) | Systematic Assessment | Mild; Not related |
|
| Elevated eosinophilis | Investigations | MedDRA (Unspecified) | Systematic Assessment | Mild; Unlikely related |
|
| Decreased HgB | Investigations | MedDRA (Unspecified) | Systematic Assessment | Mild; Not related |
|
| Proteinuria | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment | Mild; Unlikely related |
|
| Conjunctivitis | Eye disorders | MedDRA (Unspecified) | Systematic Assessment | Mild; Unlikely related |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment | Mild; Not related |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment | Mild; Unlikely related |
|
| Right shoulder discomfort | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment | Mild; Unlikely related |
|
| Elevated CK | Investigations | MedDRA (Unspecified) | Systematic Assessment | Severe; Unlikely related |
|
| Elevated CPK | Investigations | MedDRA (Unspecified) | Systematic Assessment | Mild; Not related |
|
| Tenderness | General disorders | MedDRA (Unspecified) | Systematic Assessment | Moderate; Probable |
|
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment | Mild; Not related |
|
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment | Mild; Not related |
|
| Flu illness | General disorders | MedDRA (Unspecified) | Systematic Assessment | Moderate; Not related |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment | Mild; Not related |
|
| Hypoglycemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment | Moderate; Not related |
|
| Right lower wisdom tooth pain / impaction | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment | Moderate; Not related |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment | Mild; Not related |
|
| Diarrhea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment | Mild; Not related |
|
| Intermittent left arm pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment | Moderate; Unlikely related |
|
| Intermittent left arm weakness | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment | Moderate; Unlikely related |
|
| Black out (syncope) episode | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment | Moderate; Not related |
|
| Herpes zoster (shingles) | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment | Moderate; Not related |
|
| Elevated calcium | Investigations | MedDRA (Unspecified) | Systematic Assessment | Mild; Not related |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment | Mild; Probable |
|
| Malaise | General disorders | MedDRA (Unspecified) | Systematic Assessment | Mild; Probable |
|
| Induration | General disorders | MedDRA (Unspecified) | Systematic Assessment | Mild; Probable |
|
| Elevated systolic BP | Investigations | MedDRA (Unspecified) | Systematic Assessment | Mild; Unlikely related |
|
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment | Severe; Unlikely related |
|
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment | Moderate; Suspected |
|
| Photophobia | Eye disorders | MedDRA (Unspecified) | Systematic Assessment | Moderate; Suspected |
|
| Right shoulder pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment | Mild; Unlikely related |
|
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment | Moderate; Suspected |
|
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment | Moderate; Unlikely related |
|
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment | Mild; Unlikely related |
|
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment | Mild; Unlikely related |
|
| Photophobia | Eye disorders | MedDRA (Unspecified) | Systematic Assessment | Mild; Unlikely related |
|
| Flu-like syndrome (fever, chills) | General disorders | MedDRA (Unspecified) | Systematic Assessment | Moderate; Unlikely related |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment | Mild; Probable |
|
| Increased respiratory rate | Investigations | MedDRA (Unspecified) | Systematic Assessment | Mild; Not related |
|
| Loss of taste | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment | Mild; Probable |
|
| Malaise | General disorders | MedDRA (Unspecified) | Systematic Assessment | Mild; Suspected |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment | Mild; Suspected |
|
| Papule (skin lesion) at vaccination site | General disorders | MedDRA (Unspecified) | Systematic Assessment | Mild; Suspected |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment | Mild; Suspected |
|
| Cold | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment | Mild; Not related |
|
| Burn on left ankle | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment | Mild; Not related |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment | Moderate; Not related |
|
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment | Moderate; Not related |
|
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment | Mild; Not related |
|
| Trace proteinuria | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment | Mild; Unlikely related |
|
| Toothache | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment | Mild; Not related |
|
| Tooth infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment | Mild; Not related |
|
| Eye pain | Eye disorders | MedDRA (Unspecified) | Systematic Assessment | Mild; Suspected |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment | Mild; Not related |
|
| Weird dreams (nightmares) | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment | Mild; Not related |
|
| Malaise | General disorders | MedDRA (Unspecified) | Systematic Assessment | Moderate; Suspected |
|
| Anemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment | Mild; Unlikely related |
|
| Left forearm injury and pain | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment | Mild; Not related |
|
| Decreased WBC - 3.3 | Investigations | MedDRA (Unspecified) | Systematic Assessment | Mild; Not related |
|
| Elevated systolic BP (142) | Investigations | MedDRA (Unspecified) | Systematic Assessment | Mild; Not related |
|
| Decreased lymphocytes (818) | Investigations | MedDRA (Unspecified) | Systematic Assessment | Mild; Not related |
|
| Tooth abscess | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment | Mild; Not related |
|
| Hypoglycemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment | Mild; Not related |
|
| Low WBC | Investigations | MedDRA (Unspecified) | Systematic Assessment | Mild; Not related |
|
| Low lymphocyte count | Investigations | MedDRA (Unspecified) | Systematic Assessment | Mild; Not related |
|
| Right knee pain (increased) | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment | Moderate; Not related |
|
| Elevated creatinine | Investigations | MedDRA (Unspecified) | Systematic Assessment | Moderate; Unlikely related |
|
| Elevated creatinine | Investigations | MedDRA (Unspecified) | Systematic Assessment | Mild; Unlikely related |
|
| Low hemoglobin | Investigations | MedDRA (Unspecified) | Systematic Assessment | Mild; Suspected |
|
| Mild anemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Systematic Assessment | Mild; Unlikely related |
|
| Decreased absolute lymphocytes | Investigations | MedDRA (Unspecified) | Systematic Assessment | Mild; Not related |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment | Mild; Not related |
|
| Elevated creatine kinase | Investigations | MedDRA (Unspecified) | Systematic Assessment | Mild; Unlikely related |
|
| Indegestion | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment | Moderate; Not related |
|
| Proteinuria | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment | Mild; Unlikely related |
|
| Elevated DBP (93) | Investigations | MedDRA (Unspecified) | Systematic Assessment | Mild; Not related |
|
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment | Mild; Suspected |
|
| Elevated diastolic blood pressure | Investigations | MedDRA (Unspecified) | Systematic Assessment | Moderate; Not related |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment | Mild; Suspected |
|
| Elevated AST | Investigations | MedDRA (Unspecified) | Systematic Assessment | Mild; Not related |
|
| Low bicarbonate | Investigations | MedDRA (Unspecified) | Systematic Assessment | Mild; Unlikely related |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment | Mild; Unlikely related |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment | Moderate; Suspected |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment | Moderate; Suspected |
|
| Elevated diastolic BP | Investigations | MedDRA (Unspecified) | Systematic Assessment | Severe; Unlikely related |
|
| Elevated systolic BP | Investigations | MedDRA (Unspecified) | Systematic Assessment | Moderate; Unlikely related |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment | Mild; Not related |
|
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment | Moderate; Suspected |
|
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment | Mild; Suspected |
|
| Decreased CO2 | Investigations | MedDRA (Unspecified) | Systematic Assessment | Mild; Not related |
|
| Right thigh pain (s/p fall) | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment | Mild; Not related |
|
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment | Mild; Not related |
|
| Chills | General disorders | MedDRA (Unspecified) | Systematic Assessment | Mild; Suspected |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment | Mild; Unlikely related |
|
| Trace protein on uA | Investigations | MedDRA (Unspecified) | Systematic Assessment | Mild; Unlikely related |
|
| Elevated BUN | Investigations | MedDRA (Unspecified) | Systematic Assessment | Mild; Not related |
|
| Increased CPK | Investigations | MedDRA (Unspecified) | Systematic Assessment | Moderate; Unlikely related |
|
| Increased HR (109) | Investigations | MedDRA (Unspecified) | Systematic Assessment | Mild; Not related |
|
| Increased diastolic BP | Investigations | MedDRA (Unspecified) | Systematic Assessment | Moderate; Not related |
|
| Tooth pain | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment | Mild; Not related |
|
| Trace proteinuria | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment | Mild; Not related |
|
| Decreased hemoglobin | Investigations | MedDRA (Unspecified) | Systematic Assessment | Mild; Not related |
|
| Increased respiratory rate - 22 | Investigations | MedDRA (Unspecified) | Systematic Assessment | Moderate; Not related |
|
| Back ache | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment | Mild; Not related |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment | Mild; Unlikely related |
|
| Decreased hemoglobin | Investigations | MedDRA (Unspecified) | Systematic Assessment | Mild; Unlikely related |
|
| Decreased blood glucose | Investigations | MedDRA (Unspecified) | Systematic Assessment | Mild; Not related |
|
| Elevated creatinine | Investigations | MedDRA (Unspecified) | Systematic Assessment | Mild; Not related |
|
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| D014777 |
| Virus Diseases |
| D018177 | Flavivirus Infections |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006482 | Hemorrhagic Fevers, Viral |
| B-Cell : DEN-2 |
|
| B-Cell : DEN-3 |
|
| B-Cell : DEN-4 |
|
| T-Cell : All |
|
| T-Cell : DEN-1 |
|
| T-Cell : DEN-2 |
|
| T-Cell : DEN-3 |
|
| T-Cell : DEN-4 |
|