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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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The purpose of this study is to gather information on the safety and immunogenicity of an investigational smallpox vaccine in HIV infected populations. Subjects will receive two vaccinations
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy subjects | Experimental | Control group with and without a history of previous smallpox vaccination IMVAMUNE (MVA-BN) |
|
| HIV-infected, vaccinia-naive | Experimental | Subjects without a history of previous smallpox vaccination, IMVAMUNE (MVA-BN) |
|
| HIV-infected, vaccinia-experienced | Experimental | Subjects with a history of previous smallpox vaccination, IMVAMUNE (MVA-BN) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMVAMUNE (MVA-BN) | Biological | 2 immunizations, four weeks apart: 1 x 10E8 TCID50, subcutaneous |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serious Adverse Events | Incidence, relationship and intensity of any Serious Adverse Event (SAE) | within 32 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Related Grade >=3 Adverse Events | Incidence of any Grade 3 or higher adverse drug reaction (missing, unknown, not evaluable, possibly, probably, or definitely related) to the study vaccine | within 29 days after any vaccination |
| Solicited Local Adverse Events |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edgar Turner Overton, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Vaccine Research Clinic; University of Alabama at Birmingham | Birmingham | Alabama | 35294-2050 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26380340 | Result | Overton ET, Stapleton J, Frank I, Hassler S, Goepfert PA, Barker D, Wagner E, von Krempelhuber A, Virgin G, Meyer TP, Muller J, Badeker N, Grunert R, Young P, Rosch S, Maclennan J, Arndtz-Wiedemann N, Chaplin P. Safety and Immunogenicity of Modified Vaccinia Ankara-Bavarian Nordic Smallpox Vaccine in Vaccinia-Naive and Experienced Human Immunodeficiency Virus-Infected Individuals: An Open-Label, Controlled Clinical Phase II Trial. Open Forum Infect Dis. 2015 May 5;2(2):ofv040. doi: 10.1093/ofid/ofv040. eCollection 2015 Apr. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy naïve | Healthy, smallpox vaccine-naïve subjects |
| FG001 | HIV naïve | HIV-infected, smallpox vaccine-naïve subjects |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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|
Incidence and intensity of solicited local AEs (pain, erythema, swelling). Percentages based on subjects with at least one completed diary card. |
| within 8 days after any vaccination |
| Solicited General Adverse Events | Incidence of solicited general AEs (increased body temperature, headache, myalgia, chills, nausea, and fatigue): Intensity and relationship to vaccination. Percentages based on subjects with at least one completed diary card. | within 8 days after any vaccination |
| Unsolicited Adverse Events: Incidence | Incidence of any unsolicited adverse events | within 29 days after any vaccination |
| Unsolicited Adverse Events: Intensity | Occurrence of unsolicited adverse events by Intensity | within 29 days after any vaccination |
| Unsolicited Adverse Events: Relationship to Vaccination | Occurrence of unsolicited adverse events by relationship to study vaccine | within 29 days after any vaccination |
| CD4+ T-cell Counts | Median CD4+ T-cell counts over time | within 32 weeks |
| CD8+ T-cell Counts | Median CD8+ T-cell counts over time | within 32 weeks |
| Viral Load | Viral load (HIV-1 RNA levels) over time | within 32 weeks |
| PRNT Seroconversion Rate | Seroconversion rate based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (6) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available. | within 32 weeks |
| PRNT GMT | Geometric Mean Titers (GMT) based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Titers below the detection limit are included with a value of '1'. | within 32 weeks |
| ELISA Seroconversion Rate | Seroconversion rate based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (50) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available. | within 32 weeks |
| ELISA GMT | Geometric Mean Titers (GMT) based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Titers below the detection limit are included with a value of '1'. | within 32 weeks |
| ELISPOT IFN-γ: Response Rate | Response rate based on number of subjects with response in an interferon gamma (IFN-γ) ELISPOT assay. Response is defined as the appearance of a signal in subjects that had no signal at Baseline or a relative increase by a factor of ≥1.7 compared to Baseline in subjects that had a signal at Baseline. Percentages based on number of subjects with data available. | within 32 weeks |
| ELISPOT IFN-γ: SFU | Median number of interferon gamma (IFN-γ) secreting peripheral blood mononuclear cells (PBMC) in response to stimulation with MVA-BN detected by ELISPOT assay. | within 32 weeks |
| Health for Life Clinic, PLLC |
| Little Rock |
| Arkansas |
| 72207 |
| United States |
| Providence Clinical Research | Burbank | California | 91505 | United States |
| Northern California Research | Carmichael | California | 95608 | United States |
| CSI Clinical Trials, Inc. | Fountain Valley | California | 92708 | United States |
| AltaMed Health Services | Los Angeles | California | 90022 | United States |
| Alta Bates Summit Medical Center, East Bay AIDS Center | Oakland | California | 94609 | United States |
| Benchmark Clinical Research | San Francisco | California | 94102 | United States |
| Clinical Research of West Florida | Clearwater | Florida | 33765 | United States |
| Consultive Medicine | Daytona Beach | Florida | 32117 | United States |
| Northpoint Medical, PA | Fort Lauderdale | Florida | 33308 | United States |
| The Kinder Medical Group | Miami | Florida | 33133 | United States |
| Infectious Diseases of NW Florida | Pensacola | Florida | 32504 | United States |
| Palm Beach Center | West Palm Beach | Florida | 33409 | United States |
| Atlanta ID Group | Atlanta | Georgia | 30309 | United States |
| The CORE Center | Chicago | Illinois | 60612 | United States |
| Northstar Medical Center | Chicago | Illinois | 60657 | United States |
| Indiana University School of Medicine; Division of Infectious Disease | Indianapolis | Indiana | 46202-2859 | United States |
| University of Iowa, Division of Infectious Diseases | Iowa City | Iowa | 52242 | United States |
| Nemechek Health Renewal | Kansas City | Missouri | 64111 | United States |
| St. Louis University, Center for Vaccine Dev. | St Louis | Missouri | 63104 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198-5130 | United States |
| Immuniodeficiency Clinic, ECMC | Buffalo | New York | 14260 | United States |
| Universtity of Rochester School of Medicine | Rochester | New York | 14642 | United States |
| University of Oklahoma | Oklahoma City | Oklahoma | 73104 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104-6073 | United States |
| Clinical Trials Research Services | Pittsburgh | Pennsylvania | 15206 | United States |
| Brown Medical School | Providence | Rhode Island | 02906 | United States |
| University of South Carolina | Columbia | South Carolina | 29203 | United States |
| Vanderbilt University, AIDS Clinical Trials Center | Nashville | Tennessee | 37203 | United States |
| Nicholaos C. Bellos, MD PA | Dallas | Texas | 75204 | United States |
| Valley AIDS Council | Harlingen | Texas | 78550 | United States |
| Diversified Medical Practices | Houston | Texas | 77027 | United States |
| Clinical Research P.R., Inc. | San Juan | 00909 | Puerto Rico |
| Maternal Infant Studies Center (CEMI) | San Juan | 00936-5067 | Puerto Rico |
| FG002 | Healthy Experienced | Healthy, smallpox vaccine-experienced subjects |
| FG003 | HIV Experienced | HIV-infected, smallpox vaccine-experienced subjects |
| COMPLETED | active study period |
|
| NOT COMPLETED |
|
|
Full Analysis Set
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Healthy naïve | Healthy, smallpox vaccine-naïve subjects |
| BG001 | HIV naïve | HIV-infected, smallpox vaccine-naïve subjects |
| BG002 | Healthy Experienced | Healthy, smallpox vaccine-experienced subjects |
| BG003 | HIV Experienced | HIV-infected, smallpox vaccine-experienced subjects |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Serious Adverse Events | Incidence, relationship and intensity of any Serious Adverse Event (SAE) | Full Analysis Set | Posted | Count of Participants | Participants | within 32 weeks |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Related Grade >=3 Adverse Events | Incidence of any Grade 3 or higher adverse drug reaction (missing, unknown, not evaluable, possibly, probably, or definitely related) to the study vaccine | Full Analysis set | Posted | Count of Participants | Participants | within 29 days after any vaccination |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Solicited Local Adverse Events | Incidence and intensity of solicited local AEs (pain, erythema, swelling). Percentages based on subjects with at least one completed diary card. | Full Analysis Set | Posted | Count of Participants | Participants | within 8 days after any vaccination |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Solicited General Adverse Events | Incidence of solicited general AEs (increased body temperature, headache, myalgia, chills, nausea, and fatigue): Intensity and relationship to vaccination. Percentages based on subjects with at least one completed diary card. | Full Analysis Set | Posted | Count of Participants | Participants | within 8 days after any vaccination |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Unsolicited Adverse Events: Incidence | Incidence of any unsolicited adverse events | Full Analysis Set | Posted | Count of Participants | Participants | within 29 days after any vaccination |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Unsolicited Adverse Events: Intensity | Occurrence of unsolicited adverse events by Intensity | Full Analysis Set | Posted | Number | events | within 29 days after any vaccination |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Unsolicited Adverse Events: Relationship to Vaccination | Occurrence of unsolicited adverse events by relationship to study vaccine | Full Analysis Set | Posted | Number | events | within 29 days after any vaccination |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | CD4+ T-cell Counts | Median CD4+ T-cell counts over time | Full Analysis Set (HIV infected subjects) | Posted | Median | Full Range | CD4 count (cells/µL) | within 32 weeks |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | CD8+ T-cell Counts | Median CD8+ T-cell counts over time | Full Analysis Set (HIV infected subjects) | Posted | Median | Full Range | CD8 count (cells/µL) | within 32 weeks |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Viral Load | Viral load (HIV-1 RNA levels) over time | Full Analysis Set (HIV infected subjects) | Posted | Count of Participants | Participants | within 32 weeks |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | PRNT Seroconversion Rate | Seroconversion rate based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (6) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available. | Per-protocol set | Posted | Number | 95% Confidence Interval | percentage of subjects | within 32 weeks |
| ||||||||||||||||||||||||||||||||||||
| Secondary | PRNT GMT | Geometric Mean Titers (GMT) based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Titers below the detection limit are included with a value of '1'. | Per-protocol Set | Posted | Geometric Mean | 95% Confidence Interval | Titer | within 32 weeks |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | ELISA Seroconversion Rate | Seroconversion rate based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (50) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available. | Per-protocol set | Posted | Number | 95% Confidence Interval | percentage of subjects | within 32 weeks |
| ||||||||||||||||||||||||||||||||||||
| Secondary | ELISA GMT | Geometric Mean Titers (GMT) based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Titers below the detection limit are included with a value of '1'. | Per-protocol Set | Posted | Geometric Mean | 95% Confidence Interval | Titer | within 32 weeks |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | ELISPOT IFN-γ: Response Rate | Response rate based on number of subjects with response in an interferon gamma (IFN-γ) ELISPOT assay. Response is defined as the appearance of a signal in subjects that had no signal at Baseline or a relative increase by a factor of ≥1.7 compared to Baseline in subjects that had a signal at Baseline. Percentages based on number of subjects with data available. | Elispot Analysis Set (subset of the Per-protocol Set with ELISPOT data available) | Posted | Number | 95% Confidence Interval | percentage of subjects | within 32 weeks |
| ||||||||||||||||||||||||||||||||||||
| Secondary | ELISPOT IFN-γ: SFU | Median number of interferon gamma (IFN-γ) secreting peripheral blood mononuclear cells (PBMC) in response to stimulation with MVA-BN detected by ELISPOT assay. | Elispot Analysis Set (subset of the Per-protocol Set with ELISPOT data available) | Posted | Median | Full Range | Spot Forming Units / 10^6 PBMC | within 32 weeks |
|
|
Not provided
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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 | Healthy naïve | Healthy, smallpox vaccine-naïve subjects | 0 | 88 | 0 | 88 | 51 | 88 |
| EG001 | HIV naïve | HIV-infected, smallpox vaccine-naïve subjects | 1 | 351 | 17 | 351 | 172 | 351 |
| EG002 | Healthy Experienced | Healthy, smallpox vaccine-experienced subjects | 0 | 9 | 0 | 9 | 3 | 9 |
| EG003 | HIV Experienced | HIV-infected, smallpox vaccine-experienced subjects | 0 | 131 | 6 | 131 | 45 | 131 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neurosyphilis | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Peritonsillar abscess | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA (9.0) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Jaw fracture | Injury, poisoning and procedural complications | MedDRA (9.0) | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Bronchitis acute | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Status asthmaticus | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Back injury | Injury, poisoning and procedural complications | MedDRA (9.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Anticonvulsant toxicity | Injury, poisoning and procedural complications | MedDRA (9.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Gangrene | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Injection site bruising | General disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Injection site nodule | General disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Injection site pruritis | General disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Injection site warmth | General disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA (9.0) | Systematic Assessment |
| |
| Electrocardiogram abnormal | Investigations | MedDRA (9.0) | Systematic Assessment |
| |
| Troponin I increased | Investigations | MedDRA (9.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Pruritis | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Program Lead, Clinical Operations | Bavarian Nordic A/S | +45 3326 | 8383 | info@bavarian-nordic.com |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C527606 | smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic |
Not provided
Not provided
Not provided
| Male |
|
| United States |
|
| Any SAE with intensity >= Grade 3 |
|
| Any SAE assessed as related to vaccine |
|
| Participants |
|
|
|
|
| Counts |
|---|
| Participants |
|
|
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Participants |
|
|
| 400 - <1000 |
|
| 1000 - <10000 |
|
| >=10000 |
|
| 400 - <1000 |
|
| 1000 - <10000 |
|
| >=10000 |
|
| 400 - <1000 |
|
| 1000 - <10000 |
|
| >=10000 |
|