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The objective of this study is to determine the minimum dose of ACAM2000 needed to produce a cutaneous reaction in at least 90% of a population of healthy adults at least 28 years of age and previously vaccinated against smallpox.
Specifically, the objectives of this study are to:
Compare the safety and tolerability of four dose levels of ACAM2000 and a standard dose of Dryvax® in healthy adults at least 28 years of age and previously vaccinated to smallpox. Safety and tolerability will be determined by examination of the local cutaneous reaction, adverse events, physical examinations, vital signs, structured interviews, and laboratory analysis.
Determine the immunogenicity of four dose levels of ACAM2000 and a standard dose of Dryvax® in healthy adults at least 28 years of age by comparing:
Determine the minimum dose of ACAM2000 that is calculated to produce a major cutaneous reaction in at least 90% of a population of healthy adults at least 28 years of age, with a history of smallpox vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: ACAM2000 | Experimental | Participants will receive dose 1 of the ACAM2000 smallpox vaccine |
|
| Group 2: ACAM2000 | Experimental | Participants will receive dose 2 of the ACAM2000 smallpox vaccine |
|
| Group 3: ACAM2000 | Experimental | Participants will receive dose 3 of the ACAM2000 smallpox vaccine |
|
| Group 4: ACAM2000 | Experimental | Participants will receive dose 4 of the ACAM2000 smallpox vaccine |
|
| Group 5: Dryvax® | Active Comparator | Participants will receive dose 1 of Dryvax® smallpox vaccine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACAM2000 Smallpox Vaccine | Biological | Group 1 dose: 1.0x10-8th PFU/ml, Group 2 dose: 2.0x10-7th PFU/ml, Group 3 dose: 1.0x10-7th PFU/ml, Group 4 dose: 5.0x10-6th PFUL/ml |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Neutralizing Antibody Response Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | The neutralizing antibody response titers were determined by the Plaque-Reduction Neutralization Test (PRNT50) | Day 30 post-vaccination |
| Participants With ≥ 4-fold Increase in Plaque-Reduction Neutralization Test (PRNT50) Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine. | Day 30 post-vaccination | |
| Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Days 0 to 30 post-vaccination |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Days 0 to 30 post-vaccination | |
| Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine |
Inclusion criteria:
exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Emergent BioSolutions | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRA International | Lenexa | Kansas | 66219 | United States | ||
| Bio-Kinetic Clinical Applications |
A total of 357 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Participants were enrolled from 07 January 2003 to 31 March 2003 in 3 medical centers in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | ACAM2000 Dose 1 | Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0 |
| FG001 | ACAM2000 Dose 2 | Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0 |
| FG002 | ACAM2000 Dose 3 | Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0 |
| FG003 | ACAM2000 Dose 4 | Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0 |
| FG004 | Dryvax® Vaccine | Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ACAM2000 Dose 1 | Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0 |
| BG001 | ACAM2000 Dose 2 | Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | The Neutralizing Antibody Response Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | The neutralizing antibody response titers were determined by the Plaque-Reduction Neutralization Test (PRNT50) | The neutralizing antibody response titers were assessed in the antibody evaluable, per-protocol population. | Posted | Mean | Standard Deviation | PRNT50 Titers | Day 30 post-vaccination |
|
Adverse events data were collected from the day of vaccination for up to 6 months post-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 | ACAM2000 Dose 1 | Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pregnancy Not Otherwise Specified | Pregnancy, puerperium and perinatal conditions | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymph Node Pain | Blood and lymphatic system disorders | MedDRA 6.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eddie Darton, Medical Director | Emergent BioSolutions | 240-631-3688 | dartone@ebsi.com |
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| ID | Term |
|---|---|
| D012899 | Smallpox |
| D014615 | Vaccinia |
| ID | Term |
|---|---|
| D011213 | Poxviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000588544 | ACAM2000 |
| C078786 | DryVax vaccine |
| D012900 | Smallpox Vaccine |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Vaccinia virus (calf lymph) smallpox vaccine: Dryvax® | Biological | Group 5 dose: 1.0x10-8th PFU/ml |
|
|
| Days 0 (Baseline) and 15 post-vaccination |
| Selected Hematology Parameters (Red Bood Cell and Platelets) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Days 0 (Baseline) and 15 post-vaccination |
| Clinical Chemistry Parameters (Creatinine and Glucose) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Days 0 (Baseline) and 15 post-vaccination |
| Clinical Chemistry Parameters (Aspartate Transaminase and Alanine Transaminase) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Days 0 (Baseline) and 15 post-vaccination |
| Springfield |
| Missouri |
| 65802 |
| United States |
| Memorial Hospital of Rhode Island Division of Infectious Diseases | Pawtucket | Rhode Island | 02860 | United States |
| BG002 | ACAM2000 Dose 3 | Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0 |
| BG003 | ACAM2000 Dose 4 | Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0 |
| BG004 | Dryvax® Vaccine | Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0 |
| BG005 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | ACAM2000 Dose 3 | Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0 |
| OG003 | ACAM2000 Dose 4 | Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0 |
| OG004 | Dryvax® Vaccine | Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0 |
|
|
| Primary | Participants With ≥ 4-fold Increase in Plaque-Reduction Neutralization Test (PRNT50) Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine. | Posted | Number | Participants | Day 30 post-vaccination |
|
|
|
| Primary | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Post-vaccination adverse events were assessed in the safety, intent-to-treat population. | Posted | Number | Participants | Days 0 to 30 post-vaccination |
|
|
|
| Other Pre-specified | Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Treatment-emergent rash events were assessed in the safety intent-to-treat population. | Posted | Number | Participants | Days 0 to 30 post-vaccination |
|
|
|
| Other Pre-specified | Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | The hematology parameters were assessed in the intent-to-treat safety population. | Posted | Mean | Standard Deviation | Percentage (%) | Days 0 (Baseline) and 15 post-vaccination |
|
|
|
| Other Pre-specified | Selected Hematology Parameters (Red Bood Cell and Platelets) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | The hematology parameters were assessed in the intent-to-treat safety population. | Posted | Mean | Standard Deviation | x10^6th/µL | Days 0 (Baseline) and 15 post-vaccination |
|
|
|
| Other Pre-specified | Clinical Chemistry Parameters (Creatinine and Glucose) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Clinical chemistry parameters were assessed in the intent-to-treat safety population | Posted | Mean | Standard Deviation | mg/dL | Days 0 (Baseline) and 15 post-vaccination |
|
|
|
| Other Pre-specified | Clinical Chemistry Parameters (Aspartate Transaminase and Alanine Transaminase) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Clinical chemistry parameters were assessed in the intent-to-treat safety population | Posted | Mean | Standard Deviation | IU/L | Days 0 (Baseline) and 15 post-vaccination |
|
|
|
| 1 |
| 51 |
| 48 |
| 51 |
| EG001 | ACAM2000 Dose 2 | Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0 | 1 | 102 | 93 | 102 |
| EG002 | ACAM2000 Dose 3 | Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0 | 0 | 102 | 98 | 102 |
| EG003 | ACAM2000 Dose 4 | Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0 | 0 | 50 | 49 | 50 |
| EG004 | Dryvax® Vaccine | Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0 | 0 | 52 | 51 | 52 |
| HIV test positive | Investigations | MedDRA 6.0 | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 6.0 | Systematic Assessment |
|
| Diarrhea Not Otherwise Specified | Gastrointestinal disorders | MedDRA 6.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 6.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 6.0 | Systematic Assessment |
|
| Injection Site Pruritus | General disorders | MedDRA 6.0 | Systematic Assessment |
|
| Injection Site Erythema | General disorders | MedDRA 6.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 6.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 6.0 | Systematic Assessment |
|
| Feeling Hot | General disorders | MedDRA 6.0 | Systematic Assessment |
|
| Rigors | General disorders | MedDRA 6.0 | Systematic Assessment |
|
| Injection Site Inflammation | General disorders | MedDRA 6.0 | Systematic Assessment |
|
| Injection Site Pain | General disorders | MedDRA 6.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 6.0 | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 6.0 | Systematic Assessment |
|
| Headache Not Otherwise Specified | Nervous system disorders | MedDRA 6.0 | Systematic Assessment |
|
| Pharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA 6.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 6.0 | Systematic Assessment |
|
| Rash Not Otherwise Specified | Skin and subcutaneous tissue disorders | MedDRA 6.0 | Systematic Assessment |
|
Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications
| Lymphadenopathy |
|
| Constipation |
|
| Toothache |
|
| Injection Site Erythema |
|
| Injection Site Pruritus |
|
| Injection Site Pain |
|
| Human Immunodeficiency Virus (HIV) Test Positive |
|
| Back Pain |
|
| Myalgia |
|
| Swelling Not Otherwise Specified |
|
| Migraine Not Otherwise Specified |
|
| Pregnancy Not Otherwise Specified |
|
| Calculus Renal Not Otherwise Specified |
|
| Rash Macular |
|
| Rash Papular |
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| Application Site Rash |
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| Injection Site Rash |
|
| Any Rash |
|
| Hematocrit (Day15) |
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| Lymphocytes (Baseline) |
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| Lymphocytes (Day15) |
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| Eosinophils (Baseline) |
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| Eosinophils (Day15) |
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| Red Blood Cell count (Day15) |
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| Platelets (Baseline) |
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| Platelets (Day15) |
|
| Creatinine (Day 15) |
|
| Glucose (Baseline) |
|
| Glucose (Day 15) |
|
| Aspartate transaminase (Day 15) |
|
| Alanine transaminase (Baseline) |
|
| Alanine transaminase (Day 15) |
|