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The purpose of this study is to examine the safety and the effectiveness of a new vaccine for the prevention of the disease, smallpox.
The objective of this study is to 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 18-29 years of age and naïve to smallpox vaccine. 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 18-29 years of age and naïve to smallpox vaccine. 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 18-29 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 18-29 years of age and naïve to smallpox vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: ACAM2000 Dose 1 | Experimental | Participants will receive a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units (PFU)/mL on Day 0. |
|
| Group 2: ACAM2000 Dose 2 | Experimental | Participants will receive a single dose of ACAM2000 smallpox vaccine, 2.0x10-8th plaque-forming units/mL on Day 0. |
|
| Group 3: ACAM2000 Dose 3 | Experimental | Participants will receive a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0 |
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| Group 4: ACAM2000 Dose 4 | Experimental | Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0 |
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| Group 5: Dryvax® Vaccine | Active Comparator | Participants will receive a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vaccinia virus: ACAM2000 smallpox vaccine | Biological | Group 1 dose: 1.0x10-8th PFU/ml Group 2 dose: 2.0x10-8th PFU/ml Group 3 dose: 1.0x10-7th PFU/ml Group 4 dose: 5.0x10-6th PFU/ml |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | The severity of each reported adverse event was classified by the investigator according to the following definitions. None - no symptom; Mild - awareness of sign or symptoms, but easily tolerated; Moderate - discomfort enough to cause interference with usual activity; and Severe - incapacitating with inability to work or perform usual activity. | Days 0 to 30 post-vaccination |
| Neutralizing Antibody Response Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine. | 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 |
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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 | |
| Clinical Chemistry Parameters (Aspartate Aminotransaminase and Alanine Aminotransferase) 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 |
|---|---|---|---|---|---|---|
| Orlando Clinical Research Center | Orlando | Florida | 32806 | United States | ||
| PRA International |
A total of 353 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Participants were enrolled from 10 January 2003 to 14 April 2003 in 4 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, 2.0x10^8th plaque-forming units/mL on Day 0 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| vaccinia virus (calf lymph): Dryvax | Biological | Group 5 dose: 1.0x10-8th PFU/ml |
|
|
| 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 |
| Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine. | Days 0 (baseline) and 15 post-vaccination |
| Selected Hematology Parameters (Red Blood Count and Platelets) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine. | Days 0 (baseline) and 15 post-vaccination |
| Lenexa |
| Kansas |
| 66219 |
| United States |
| Bio-Kinetic Clinical Applications | Springfield | Missouri | 65802 | United States |
| Memorial Hospital of Rhode IslandDivision of Infectious Diseases | Pawtucket | Rhode Island | 02860 | United States |
| 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 |
| COMPLETED |
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| NOT COMPLETED |
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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, 2.0x10^8th plaque-forming units/mL on Day 0 |
| 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| 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 Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | The severity of each reported adverse event was classified by the investigator according to the following definitions. None - no symptom; Mild - awareness of sign or symptoms, but easily tolerated; Moderate - discomfort enough to cause interference with usual activity; and Severe - incapacitating with inability to work or perform usual activity. | Adverse events were assessed in the safety, intent-to-treat population | Posted | Number | Participants | Days 0 to 30 post-vaccination |
|
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| ||||||||||||||||||||||||||||||||||||||
| Primary | Neutralizing Antibody Response Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine. | Neutralizing antibody response titers were evaluated in the antibody evaluable, per-protocol population. | Posted | Mean | Standard Deviation | PRNT50 Titers | Day 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 | Clinical Chemistry Parameters (Aspartate Aminotransaminase and Alanine Aminotransferase) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Clinical chemistry parameters were assessed in safety, intent-to-treat population | Posted | Mean | Standard Deviation | IU/L | 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 safety, intent-to-treat population | Posted | Mean | Standard Deviation | mg/dL | Days 0 (baseline) and 15 post-vaccination |
| ||||||||||||||||||||||||||||||||||||||||
| Primary | Participants With ≥ 4-fold Increase in Plaque-Reduction Neutralization Test (PRNT50) Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine. | Plaque-reduction neutralization test (PRNT50) titers were determined in the antibody evaluable, per-protocol population | Posted | Number | Participants | Day 30 post-vaccination |
| |||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine. | Hematology parameters were evaluated in the safety, intent-to-treat population. | Posted | Mean | Standard Deviation | Percentage (%) | Days 0 (baseline) and 15 post-vaccination |
| ||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Selected Hematology Parameters (Red Blood Count and Platelets) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine. | Hematology parameters were evaluated in the safety, intent-to-treat population. | Posted | Mean | Standard Deviation | x10-6th/μL | Days 0 (baseline) and 15 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 | 1 | 51 | 51 | 51 | ||
| EG001 | ACAM2000 Dose 2 | Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10^8th plaque-forming units/mL on Day 0 | 1 | 101 | 99 | 101 | ||
| EG002 | ACAM2000 Dose 3 | Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^7th plaque-forming units/mL on Day 0 | 0 | 101 | 98 | 101 | ||
| EG003 | ACAM2000 Dose 4 | Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10^6th plaque-forming units/mL on Day 0 | 1 | 51 | 51 | 51 | ||
| EG004 | Dryvax® Vaccine | Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0 | 0 | 49 | 49 | 49 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pregnancy Not Otherwise Specified | Pregnancy, puerperium and perinatal conditions | MedDRA | Systematic Assessment |
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| 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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| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 6.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 6.0 | Systematic Assessment |
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| Diarrhea Not Otherwise Specified | Gastrointestinal disorders | MedDRA 6.0 | Systematic Assessment |
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| Vomiting Not Otherwise Specified | Gastrointestinal disorders | MedDRA 6.0 | Systematic Assessment |
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| Injection Site Pruritus | General disorders | MedDRA 6.0 | Systematic Assessment |
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| Injection Site Erythema | General disorders | MedDRA 6.0 | Systematic Assessment |
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| Injection Site Pain | General disorders | MedDRA 6.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 6.0 | Systematic Assessment |
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| Malaise | General disorders | MedDRA 6.0 | Systematic Assessment |
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| Feeling Hot | General disorders | MedDRA 6.0 | Systematic Assessment |
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| Rigors | General disorders | MedDRA 6.0 | Systematic Assessment |
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| Injection Site Swelling | General disorders | MedDRA 6.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 6.0 | Systematic Assessment |
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| Headache Not Otherwise Specified | Nervous system disorders | MedDRA 6.0 | Systematic Assessment |
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| Pharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA 6.0 | Systematic Assessment |
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| Rash Not Otherwise Specified | Skin and subcutaneous tissue disorders | MedDRA 6.0 | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eddie Darton, Medical Director | Emergent BioSolutions | 240-631-3688 | dartone@ebsi.com |
| ID | Term |
|---|---|
| D012899 | Smallpox |
| ID | Term |
|---|---|
| D011213 | Poxviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D012900 | Smallpox Vaccine |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Lymphadenopathy |
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| Diarrhea Not Otherwise Specified |
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| Nausea |
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| Vomiting Not Otherwise Specified |
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| Injection Site Erythema |
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| Injection Site Swelling |
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| Injection Site Pruritus |
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| Fatigue |
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| Injection Site Pain |
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| Dehydration |
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| Myalgia |
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| Headache Not Otherwise Specified |
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| Pregnancy Not Otherwise Specified |
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| Dysuria |
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Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0 |
|
|
Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0 |
|
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| OG004 |
| Dryvax® Vaccine |
Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0 |
|
|
| Dryvax® Vaccine |
Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0 |
|
|
| Dryvax® Vaccine |
Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10^8th 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 |
|
|
| Dryvax® Vaccine |
Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0 |
|
|