Smallpox
Conditions
Keywords
Smallpox
Brief summary
The purpose of this study is to examine the safety and the effectiveness of a new vaccine for the prevention of the disease, smallpox.
Detailed description
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: 1. 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. 2. 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: 1. the proportion of subjects at each dose level who develop a major cutaneous reaction; 2. the proportion of subjects in each treatment group who develop neutralizing antibodies, including the fold-increase in antibody titer between Baseline and Day 30 sera; and the geometric mean vaccinia neutralizing antibody titer on Day 30. 3. 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.
Interventions
BIOLOGICALVaccinia virus: ACAM2000 smallpox vaccine
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
BIOLOGICALvaccinia virus (calf lymph): Dryvax
Group 5 dose: 1.0x10-8th PFU/ml
Sponsors
Emergent BioSolutions
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 29 Years
Healthy volunteers
Yes
Inclusion criteria
* females must not be pregnant, lactating and must agree to use an effective form of birth control for the 30 days following vaccination or unable to bear children. * agree to be available for the entire study and agree to comply with all requirements.
Exclusion criteria
* military service prior to 1989. * history of previous smallpox vaccination. * children 1 year of age or younger in the household or be in close contact * smallpox vaccination within ten years * known or suspected human immunodeficiency virus (HIV) infection, primary immunodeficiency disorder, leukemia, lymphoma, or current radiation treatment or use of immunosuppressive or anti-neoplastic drugs or have a household member or intimate contact with the conditions listed above. * renal disease * current or past history of eczema or a household member or direct contact who has eczema. * known allergy or past allergic reactions to latex gloves or to antibiotics which include neomycin, streptomycin, chlortetracycline, and polymyxin B * known allergy or past allergic reaction to blood products. * known allergy to cidofovir or sulfa-containing drugs. * history of allergic phenomena following smallpox vaccination in the past, including urticaria, erythema multiforme, or Stevens-Johnson syndrome. * transfusion of blood or treatment with any blood product. * current or history of drug or alcohol abuse * inoculation with any other live vaccine or participating in another drug or vaccine trial within 30 days of enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Days 0 to 30 post-vaccination | 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. |
| 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 | — |
Other
| Measure | Time frame |
|---|---|
| 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 |
| 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 (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 |
| Clinical Chemistry Parameters (Aspartate Aminotransaminase and Alanine Aminotransferase) 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 |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled from 10 January 2003 to 14 April 2003 in 4 medical centers in the US.
Pre-assignment details
A total of 353 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| ACAM2000 Dose 1 Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10\^8th plaque-forming units/mL on Day 0 | 51 |
| ACAM2000 Dose 2 Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10\^8th plaque-forming units/mL on Day 0 | 101 |
| ACAM2000 Dose 3 Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10\^7th plaque-forming units/mL on Day 0 | 101 |
| ACAM2000 Dose 4 Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10\^6th plaque-forming units/mL on Day 0 | 51 |
| Dryvax® Vaccine Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10\^8th plaque-forming units/mL on Day 0 | 49 |
| Total | 353 |
Baseline characteristics
| Characteristic | ACAM2000 Dose 2 | ACAM2000 Dose 3 | ACAM2000 Dose 4 | ACAM2000 Dose 1 | Dryvax® Vaccine | Total |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 101 Participants | 101 Participants | 51 Participants | 51 Participants | 49 Participants | 353 Participants |
| Age, Continuous | 22 Years STANDARD_DEVIATION 3.1 | 22 Years STANDARD_DEVIATION 3.2 | 22 Years STANDARD_DEVIATION 3 | 23 Years STANDARD_DEVIATION 2.4 | 22 Years STANDARD_DEVIATION 3.1 | 22 Years STANDARD_DEVIATION 3 |
| Region of Enrollment United States | 101 participants | 101 participants | 51 participants | 51 participants | 49 participants | 353 participants |
| Sex: Female, Male Female | 36 Participants | 34 Participants | 14 Participants | 18 Participants | 13 Participants | 115 Participants |
| Sex: Female, Male Male | 65 Participants | 67 Participants | 37 Participants | 33 Participants | 36 Participants | 238 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 51 / 51 | 99 / 101 | 98 / 101 | 51 / 51 | 49 / 49 |
| serious Total, serious adverse events | 1 / 51 | 1 / 101 | 0 / 101 | 1 / 51 | 0 / 49 |
Outcome results
Primary
Neutralizing Antibody Response Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine.
Time frame: Day 30 post-vaccination
Population: Neutralizing antibody response titers were evaluated in the antibody evaluable, per-protocol population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ACAM2000 Dose 1 | Neutralizing Antibody Response Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine. | 212 PRNT50 Titers | Standard Deviation 536.4 |
| ACAM2000 Dose 2 | Neutralizing Antibody Response Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine. | 278 PRNT50 Titers | Standard Deviation 581.6 |
| ACAM2000 Dose 3 | Neutralizing Antibody Response Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine. | 425 PRNT50 Titers | Standard Deviation 947.4 |
| ACAM2000 Dose 4 | Neutralizing Antibody Response Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine. | 582 PRNT50 Titers | Standard Deviation 1129.3 |
| Dryvax® Vaccine | Neutralizing Antibody Response Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine. | 1515 PRNT50 Titers | Standard Deviation 6019.4 |
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.
Time frame: Days 0 to 30 post-vaccination
Population: Adverse events were assessed in the safety, intent-to-treat population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACAM2000 Dose 1 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Injection Site Pain | 0 Participants |
| ACAM2000 Dose 1 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Fatigue | 0 Participants |
| ACAM2000 Dose 1 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Injection Site Pruritus | 0 Participants |
| ACAM2000 Dose 1 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Lymph Node Pain | 2 Participants |
| ACAM2000 Dose 1 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Pregnancy Not Otherwise Specified | 0 Participants |
| ACAM2000 Dose 1 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Diarrhea Not Otherwise Specified | 1 Participants |
| ACAM2000 Dose 1 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Headache Not Otherwise Specified | 1 Participants |
| ACAM2000 Dose 1 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Nausea | 1 Participants |
| ACAM2000 Dose 1 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Dysuria | 1 Participants |
| ACAM2000 Dose 1 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Myalgia | 0 Participants |
| ACAM2000 Dose 1 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Vomiting Not Otherwise Specified | 1 Participants |
| ACAM2000 Dose 1 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Lymphadenopathy | 0 Participants |
| ACAM2000 Dose 1 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Dehydration | 0 Participants |
| ACAM2000 Dose 1 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Injection Site Erythema | 1 Participants |
| ACAM2000 Dose 1 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Injection Site Swelling | 0 Participants |
| ACAM2000 Dose 2 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Injection Site Erythema | 6 Participants |
| ACAM2000 Dose 2 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Injection Site Swelling | 0 Participants |
| ACAM2000 Dose 2 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Lymph Node Pain | 4 Participants |
| ACAM2000 Dose 2 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Fatigue | 0 Participants |
| ACAM2000 Dose 2 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Nausea | 0 Participants |
| ACAM2000 Dose 2 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Dehydration | 0 Participants |
| ACAM2000 Dose 2 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Injection Site Pruritus | 0 Participants |
| ACAM2000 Dose 2 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Myalgia | 0 Participants |
| ACAM2000 Dose 2 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Pregnancy Not Otherwise Specified | 1 Participants |
| ACAM2000 Dose 2 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Lymphadenopathy | 0 Participants |
| ACAM2000 Dose 2 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Injection Site Pain | 0 Participants |
| ACAM2000 Dose 2 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Diarrhea Not Otherwise Specified | 0 Participants |
| ACAM2000 Dose 2 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Dysuria | 0 Participants |
| ACAM2000 Dose 2 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Headache Not Otherwise Specified | 0 Participants |
| ACAM2000 Dose 2 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Vomiting Not Otherwise Specified | 0 Participants |
| ACAM2000 Dose 3 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Injection Site Pruritus | 1 Participants |
| ACAM2000 Dose 3 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Lymph Node Pain | 3 Participants |
| ACAM2000 Dose 3 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Lymphadenopathy | 0 Participants |
| ACAM2000 Dose 3 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Diarrhea Not Otherwise Specified | 0 Participants |
| ACAM2000 Dose 3 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Nausea | 0 Participants |
| ACAM2000 Dose 3 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Vomiting Not Otherwise Specified | 0 Participants |
| ACAM2000 Dose 3 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Injection Site Erythema | 14 Participants |
| ACAM2000 Dose 3 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Injection Site Swelling | 1 Participants |
| ACAM2000 Dose 3 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Fatigue | 1 Participants |
| ACAM2000 Dose 3 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Injection Site Pain | 1 Participants |
| ACAM2000 Dose 3 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Dehydration | 1 Participants |
| ACAM2000 Dose 3 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Myalgia | 0 Participants |
| ACAM2000 Dose 3 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Headache Not Otherwise Specified | 4 Participants |
| ACAM2000 Dose 3 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Pregnancy Not Otherwise Specified | 0 Participants |
| ACAM2000 Dose 3 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Dysuria | 0 Participants |
| ACAM2000 Dose 4 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Dehydration | 0 Participants |
| ACAM2000 Dose 4 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Diarrhea Not Otherwise Specified | 0 Participants |
| ACAM2000 Dose 4 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Injection Site Pain | 0 Participants |
| ACAM2000 Dose 4 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Headache Not Otherwise Specified | 1 Participants |
| ACAM2000 Dose 4 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Vomiting Not Otherwise Specified | 0 Participants |
| ACAM2000 Dose 4 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Nausea | 0 Participants |
| ACAM2000 Dose 4 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Lymphadenopathy | 1 Participants |
| ACAM2000 Dose 4 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Dysuria | 0 Participants |
| ACAM2000 Dose 4 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Injection Site Pruritus | 0 Participants |
| ACAM2000 Dose 4 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Lymph Node Pain | 4 Participants |
| ACAM2000 Dose 4 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Myalgia | 1 Participants |
| ACAM2000 Dose 4 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Injection Site Swelling | 1 Participants |
| ACAM2000 Dose 4 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Pregnancy Not Otherwise Specified | 1 Participants |
| ACAM2000 Dose 4 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Fatigue | 0 Participants |
| ACAM2000 Dose 4 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Injection Site Erythema | 11 Participants |
| Dryvax® Vaccine | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Fatigue | 0 Participants |
| Dryvax® Vaccine | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Pregnancy Not Otherwise Specified | 0 Participants |
| Dryvax® Vaccine | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Injection Site Pain | 0 Participants |
| Dryvax® Vaccine | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Vomiting Not Otherwise Specified | 0 Participants |
| Dryvax® Vaccine | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Lymph Node Pain | 2 Participants |
| Dryvax® Vaccine | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Dehydration | 0 Participants |
| Dryvax® Vaccine | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Nausea | 0 Participants |
| Dryvax® Vaccine | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Myalgia | 0 Participants |
| Dryvax® Vaccine | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Diarrhea Not Otherwise Specified | 0 Participants |
| Dryvax® Vaccine | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Dysuria | 0 Participants |
| Dryvax® Vaccine | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Headache Not Otherwise Specified | 0 Participants |
| Dryvax® Vaccine | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Lymphadenopathy | 0 Participants |
| Dryvax® Vaccine | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Injection Site Pruritus | 1 Participants |
| Dryvax® Vaccine | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Injection Site Swelling | 0 Participants |
| Dryvax® Vaccine | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Injection Site Erythema | 15 Participants |
Primary
Participants With ≥ 4-fold Increase in Plaque-Reduction Neutralization Test (PRNT50) Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine.
Time frame: Day 30 post-vaccination
Population: Plaque-reduction neutralization test (PRNT50) titers were determined in the antibody evaluable, per-protocol population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ACAM2000 Dose 1 | Participants With ≥ 4-fold Increase in Plaque-Reduction Neutralization Test (PRNT50) Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine. | 28 Participants |
| ACAM2000 Dose 2 | Participants With ≥ 4-fold Increase in Plaque-Reduction Neutralization Test (PRNT50) Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine. | 73 Participants |
| ACAM2000 Dose 3 | Participants With ≥ 4-fold Increase in Plaque-Reduction Neutralization Test (PRNT50) Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine. | 84 Participants |
| ACAM2000 Dose 4 | Participants With ≥ 4-fold Increase in Plaque-Reduction Neutralization Test (PRNT50) Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine. | 48 Participants |
| Dryvax® Vaccine | Participants With ≥ 4-fold Increase in Plaque-Reduction Neutralization Test (PRNT50) Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine. | 47 Participants |
Other Pre-specified
Clinical Chemistry Parameters (Aspartate Aminotransaminase and Alanine Aminotransferase) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine
Time frame: Days 0 (baseline) and 15 post-vaccination
Population: Clinical chemistry parameters were assessed in safety, intent-to-treat population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ACAM2000 Dose 1 | Clinical Chemistry Parameters (Aspartate Aminotransaminase and Alanine Aminotransferase) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Aspartate Aminotransferase (Baseline) | 21 IU/L | Standard Deviation 7.4 |
| ACAM2000 Dose 1 | Clinical Chemistry Parameters (Aspartate Aminotransaminase and Alanine Aminotransferase) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Aspartate Aminotransferase (Day 15) | 23 IU/L | Standard Deviation 10.5 |
| ACAM2000 Dose 1 | Clinical Chemistry Parameters (Aspartate Aminotransaminase and Alanine Aminotransferase) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Alanine Aminotransferase (Baseline) | 32 IU/L | Standard Deviation 15 |
| ACAM2000 Dose 1 | Clinical Chemistry Parameters (Aspartate Aminotransaminase and Alanine Aminotransferase) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Alanine Aminotransferase (Day 15) | 33 IU/L | Standard Deviation 15.4 |
| ACAM2000 Dose 2 | Clinical Chemistry Parameters (Aspartate Aminotransaminase and Alanine Aminotransferase) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Aspartate Aminotransferase (Baseline) | 21 IU/L | Standard Deviation 5.9 |
| ACAM2000 Dose 2 | Clinical Chemistry Parameters (Aspartate Aminotransaminase and Alanine Aminotransferase) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Alanine Aminotransferase (Day 15) | 32 IU/L | Standard Deviation 17.5 |
| ACAM2000 Dose 2 | Clinical Chemistry Parameters (Aspartate Aminotransaminase and Alanine Aminotransferase) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Aspartate Aminotransferase (Day 15) | 21 IU/L | Standard Deviation 7.7 |
| ACAM2000 Dose 2 | Clinical Chemistry Parameters (Aspartate Aminotransaminase and Alanine Aminotransferase) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Alanine Aminotransferase (Baseline) | 32 IU/L | Standard Deviation 16.2 |
| ACAM2000 Dose 3 | Clinical Chemistry Parameters (Aspartate Aminotransaminase and Alanine Aminotransferase) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Alanine Aminotransferase (Day 15) | 33 IU/L | Standard Deviation 16.6 |
| ACAM2000 Dose 3 | Clinical Chemistry Parameters (Aspartate Aminotransaminase and Alanine Aminotransferase) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Aspartate Aminotransferase (Day 15) | 22 IU/L | Standard Deviation 7.5 |
| ACAM2000 Dose 3 | Clinical Chemistry Parameters (Aspartate Aminotransaminase and Alanine Aminotransferase) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Alanine Aminotransferase (Baseline) | 33 IU/L | Standard Deviation 17.4 |
| ACAM2000 Dose 3 | Clinical Chemistry Parameters (Aspartate Aminotransaminase and Alanine Aminotransferase) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Aspartate Aminotransferase (Baseline) | 22 IU/L | Standard Deviation 7.1 |
| ACAM2000 Dose 4 | Clinical Chemistry Parameters (Aspartate Aminotransaminase and Alanine Aminotransferase) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Aspartate Aminotransferase (Baseline) | 23 IU/L | Standard Deviation 7.1 |
| ACAM2000 Dose 4 | Clinical Chemistry Parameters (Aspartate Aminotransaminase and Alanine Aminotransferase) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Aspartate Aminotransferase (Day 15) | 21 IU/L | Standard Deviation 6.3 |
| ACAM2000 Dose 4 | Clinical Chemistry Parameters (Aspartate Aminotransaminase and Alanine Aminotransferase) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Alanine Aminotransferase (Day 15) | 34 IU/L | Standard Deviation 16.2 |
| ACAM2000 Dose 4 | Clinical Chemistry Parameters (Aspartate Aminotransaminase and Alanine Aminotransferase) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Alanine Aminotransferase (Baseline) | 36 IU/L | Standard Deviation 18.5 |
| Dryvax® Vaccine | Clinical Chemistry Parameters (Aspartate Aminotransaminase and Alanine Aminotransferase) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Alanine Aminotransferase (Day 15) | 33 IU/L | Standard Deviation 17.9 |
| Dryvax® Vaccine | Clinical Chemistry Parameters (Aspartate Aminotransaminase and Alanine Aminotransferase) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Alanine Aminotransferase (Baseline) | 31 IU/L | Standard Deviation 16.8 |
| Dryvax® Vaccine | Clinical Chemistry Parameters (Aspartate Aminotransaminase and Alanine Aminotransferase) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Aspartate Aminotransferase (Day 15) | 22 IU/L | Standard Deviation 6.8 |
| Dryvax® Vaccine | Clinical Chemistry Parameters (Aspartate Aminotransaminase and Alanine Aminotransferase) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Aspartate Aminotransferase (Baseline) | 20 IU/L | Standard Deviation 5.8 |
Other Pre-specified
Clinical Chemistry Parameters (Creatinine and Glucose) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine
Time frame: Days 0 (baseline) and 15 post-vaccination
Population: Clinical chemistry parameters were assessed in safety, intent-to-treat population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ACAM2000 Dose 1 | Clinical Chemistry Parameters (Creatinine and Glucose) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Creatinine (Baseline) | 0.97 mg/dL | Standard Deviation 0.147 |
| ACAM2000 Dose 1 | Clinical Chemistry Parameters (Creatinine and Glucose) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Creatinine (Day 15) | 0.98 mg/dL | Standard Deviation 0.149 |
| ACAM2000 Dose 1 | Clinical Chemistry Parameters (Creatinine and Glucose) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Glucose (Baseline) | 85 mg/dL | Standard Deviation 7.3 |
| ACAM2000 Dose 1 | Clinical Chemistry Parameters (Creatinine and Glucose) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Glucose (Day 15) | 83 mg/dL | Standard Deviation 14.2 |
| ACAM2000 Dose 2 | Clinical Chemistry Parameters (Creatinine and Glucose) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Creatinine (Baseline) | 0.96 mg/dL | Standard Deviation 0.153 |
| ACAM2000 Dose 2 | Clinical Chemistry Parameters (Creatinine and Glucose) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Glucose (Day 15) | 86 mg/dL | Standard Deviation 14.6 |
| ACAM2000 Dose 2 | Clinical Chemistry Parameters (Creatinine and Glucose) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Creatinine (Day 15) | 0.98 mg/dL | Standard Deviation 0.142 |
| ACAM2000 Dose 2 | Clinical Chemistry Parameters (Creatinine and Glucose) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Glucose (Baseline) | 84 mg/dL | Standard Deviation 9.8 |
| ACAM2000 Dose 3 | Clinical Chemistry Parameters (Creatinine and Glucose) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Glucose (Day 15) | 86 mg/dL | Standard Deviation 10.6 |
| ACAM2000 Dose 3 | Clinical Chemistry Parameters (Creatinine and Glucose) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Creatinine (Day 15) | 0.98 mg/dL | Standard Deviation 0.169 |
| ACAM2000 Dose 3 | Clinical Chemistry Parameters (Creatinine and Glucose) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Glucose (Baseline) | 86 mg/dL | Standard Deviation 7.4 |
| ACAM2000 Dose 3 | Clinical Chemistry Parameters (Creatinine and Glucose) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Creatinine (Baseline) | 0.98 mg/dL | Standard Deviation 0.181 |
| ACAM2000 Dose 4 | Clinical Chemistry Parameters (Creatinine and Glucose) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Creatinine (Baseline) | 0.97 mg/dL | Standard Deviation 0.171 |
| ACAM2000 Dose 4 | Clinical Chemistry Parameters (Creatinine and Glucose) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Creatinine (Day 15) | 1.00 mg/dL | Standard Deviation 0.144 |
| ACAM2000 Dose 4 | Clinical Chemistry Parameters (Creatinine and Glucose) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Glucose (Day 15) | 87 mg/dL | Standard Deviation 13.2 |
| ACAM2000 Dose 4 | Clinical Chemistry Parameters (Creatinine and Glucose) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Glucose (Baseline) | 86 mg/dL | Standard Deviation 8.3 |
| Dryvax® Vaccine | Clinical Chemistry Parameters (Creatinine and Glucose) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Glucose (Day 15) | 88 mg/dL | Standard Deviation 21.4 |
| Dryvax® Vaccine | Clinical Chemistry Parameters (Creatinine and Glucose) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Glucose (Baseline) | 87 mg/dL | Standard Deviation 18.6 |
| Dryvax® Vaccine | Clinical Chemistry Parameters (Creatinine and Glucose) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Creatinine (Day 15) | 1.00 mg/dL | Standard Deviation 0.163 |
| Dryvax® Vaccine | Clinical Chemistry Parameters (Creatinine and Glucose) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Creatinine (Baseline) | 0.97 mg/dL | Standard Deviation 0.158 |
Other Pre-specified
Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine.
Time frame: Days 0 to 30 post-vaccination
Population: Treatment-emergent rash events were assessed in the safety, intent-to-treat population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACAM2000 Dose 1 | Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine. | Rash Not Otherwise Specified | 3 Participants |
| ACAM2000 Dose 1 | Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine. | Rash Pruritic | 0 Participants |
| ACAM2000 Dose 1 | Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine. | Rash Pustular | 0 Participants |
| ACAM2000 Dose 1 | Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine. | Application Site Rash | 0 Participants |
| ACAM2000 Dose 1 | Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine. | Injection Site Rash | 0 Participants |
| ACAM2000 Dose 1 | Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine. | Any Rash Event | 3 Participants |
| ACAM2000 Dose 2 | Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine. | Injection Site Rash | 0 Participants |
| ACAM2000 Dose 2 | Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine. | Any Rash Event | 11 Participants |
| ACAM2000 Dose 2 | Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine. | Rash Not Otherwise Specified | 10 Participants |
| ACAM2000 Dose 2 | Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine. | Rash Pustular | 1 Participants |
| ACAM2000 Dose 2 | Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine. | Application Site Rash | 1 Participants |
| ACAM2000 Dose 2 | Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine. | Rash Pruritic | 1 Participants |
| ACAM2000 Dose 3 | Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine. | Application Site Rash | 1 Participants |
| ACAM2000 Dose 3 | Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine. | Injection Site Rash | 1 Participants |
| ACAM2000 Dose 3 | Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine. | Rash Not Otherwise Specified | 9 Participants |
| ACAM2000 Dose 3 | Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine. | Rash Pustular | 0 Participants |
| ACAM2000 Dose 3 | Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine. | Rash Pruritic | 0 Participants |
| ACAM2000 Dose 3 | Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine. | Any Rash Event | 10 Participants |
| ACAM2000 Dose 4 | Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine. | Application Site Rash | 3 Participants |
| ACAM2000 Dose 4 | Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine. | Rash Pruritic | 0 Participants |
| ACAM2000 Dose 4 | Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine. | Rash Pustular | 0 Participants |
| ACAM2000 Dose 4 | Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine. | Any Rash Event | 7 Participants |
| ACAM2000 Dose 4 | Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine. | Injection Site Rash | 0 Participants |
| ACAM2000 Dose 4 | Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine. | Rash Not Otherwise Specified | 5 Participants |
| Dryvax® Vaccine | Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine. | Injection Site Rash | 1 Participants |
| Dryvax® Vaccine | Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine. | Rash Pustular | 1 Participants |
| Dryvax® Vaccine | Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine. | Rash Pruritic | 0 Participants |
| Dryvax® Vaccine | Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine. | Any Rash Event | 10 Participants |
| Dryvax® Vaccine | Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine. | Application Site Rash | 2 Participants |
| Dryvax® Vaccine | Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine. | Rash Not Otherwise Specified | 7 Participants |
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.
Time frame: Days 0 (baseline) and 15 post-vaccination
Population: Hematology parameters were evaluated in the safety, intent-to-treat population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ACAM2000 Dose 1 | Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine. | Hematocrit (Baseline) | 43.7 Percentage (%) | Standard Deviation 4.2 |
| ACAM2000 Dose 1 | Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine. | Hematocrit (Day 15) | 42.8 Percentage (%) | Standard Deviation 3.74 |
| ACAM2000 Dose 1 | Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine. | Lymphocytes (Baseline) | 30.6 Percentage (%) | Standard Deviation 8.26 |
| ACAM2000 Dose 1 | Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine. | Lymphocytes (Day 15) | 33.9 Percentage (%) | Standard Deviation 8.62 |
| ACAM2000 Dose 1 | Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine. | Eosinophils (Baseline) | 2.5 Percentage (%) | Standard Deviation 1.61 |
| ACAM2000 Dose 1 | Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine. | Eosinophils (Day 15) | 2.8 Percentage (%) | Standard Deviation 2.07 |
| ACAM2000 Dose 2 | Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine. | Eosinophils (Baseline) | 2.5 Percentage (%) | Standard Deviation 1.95 |
| ACAM2000 Dose 2 | Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine. | Eosinophils (Day 15) | 2.8 Percentage (%) | Standard Deviation 2.11 |
| ACAM2000 Dose 2 | Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine. | Hematocrit (Baseline) | 43.2 Percentage (%) | Standard Deviation 3.71 |
| ACAM2000 Dose 2 | Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine. | Lymphocytes (Baseline) | 31.5 Percentage (%) | Standard Deviation 8.33 |
| ACAM2000 Dose 2 | Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine. | Lymphocytes (Day 15) | 34.0 Percentage (%) | Standard Deviation 7.41 |
| ACAM2000 Dose 2 | Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine. | Hematocrit (Day 15) | 42.3 Percentage (%) | Standard Deviation 3.59 |
| ACAM2000 Dose 3 | Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine. | Lymphocytes (Day 15) | 34.7 Percentage (%) | Standard Deviation 7.93 |
| ACAM2000 Dose 3 | Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine. | Eosinophils (Baseline) | 2.4 Percentage (%) | Standard Deviation 1.69 |
| ACAM2000 Dose 3 | Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine. | Hematocrit (Baseline) | 43.2 Percentage (%) | Standard Deviation 4.44 |
| ACAM2000 Dose 3 | Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine. | Lymphocytes (Baseline) | 30.7 Percentage (%) | Standard Deviation 7 |
| ACAM2000 Dose 3 | Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine. | Hematocrit (Day 15) | 42.7 Percentage (%) | Standard Deviation 3.21 |
| ACAM2000 Dose 3 | Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine. | Eosinophils (Day 15) | 2.6 Percentage (%) | Standard Deviation 1.65 |
| ACAM2000 Dose 4 | Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine. | Lymphocytes (Day 15) | 33.9 Percentage (%) | Standard Deviation 6.83 |
| ACAM2000 Dose 4 | Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine. | Hematocrit (Day 15) | 43.2 Percentage (%) | Standard Deviation 2.55 |
| ACAM2000 Dose 4 | Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine. | Lymphocytes (Baseline) | 29.6 Percentage (%) | Standard Deviation 7.45 |
| ACAM2000 Dose 4 | Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine. | Eosinophils (Day 15) | 2.7 Percentage (%) | Standard Deviation 1.42 |
| ACAM2000 Dose 4 | Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine. | Eosinophils (Baseline) | 2.3 Percentage (%) | Standard Deviation 1.42 |
| ACAM2000 Dose 4 | Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine. | Hematocrit (Baseline) | 44.2 Percentage (%) | Standard Deviation 3.29 |
| Dryvax® Vaccine | Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine. | Eosinophils (Baseline) | 2.4 Percentage (%) | Standard Deviation 1.72 |
| Dryvax® Vaccine | Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine. | Lymphocytes (Baseline) | 31.6 Percentage (%) | Standard Deviation 7.99 |
| Dryvax® Vaccine | Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine. | Hematocrit (Day 15) | 43.1 Percentage (%) | Standard Deviation 3.13 |
| Dryvax® Vaccine | Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine. | Eosinophils (Day 15) | 2.7 Percentage (%) | Standard Deviation 1.61 |
| Dryvax® Vaccine | Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine. | Lymphocytes (Day 15) | 33.8 Percentage (%) | Standard Deviation 7.58 |
| Dryvax® Vaccine | Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine. | Hematocrit (Baseline) | 44.1 Percentage (%) | Standard Deviation 3.54 |
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.
Time frame: Days 0 (baseline) and 15 post-vaccination
Population: Hematology parameters were evaluated in the safety, intent-to-treat population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ACAM2000 Dose 1 | Selected Hematology Parameters (Red Blood Count and Platelets) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine. | Red Blood Cell Count (Baseline) | 5.1 x10-6th/μL | Standard Deviation 0.53 |
| ACAM2000 Dose 1 | Selected Hematology Parameters (Red Blood Count and Platelets) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine. | Red Blood Cell Count (Day 15) | 5.0 x10-6th/μL | Standard Deviation 0.5 |
| ACAM2000 Dose 1 | Selected Hematology Parameters (Red Blood Count and Platelets) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine. | Platelets (Baseline) | 274 x10-6th/μL | Standard Deviation 64 |
| ACAM2000 Dose 1 | Selected Hematology Parameters (Red Blood Count and Platelets) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine. | Platelets (Day 15) | 284 x10-6th/μL | Standard Deviation 58.6 |
| ACAM2000 Dose 2 | Selected Hematology Parameters (Red Blood Count and Platelets) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine. | Red Blood Cell Count (Baseline) | 5.0 x10-6th/μL | Standard Deviation 0.47 |
| ACAM2000 Dose 2 | Selected Hematology Parameters (Red Blood Count and Platelets) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine. | Platelets (Day 15) | 280 x10-6th/μL | Standard Deviation 57.7 |
| ACAM2000 Dose 2 | Selected Hematology Parameters (Red Blood Count and Platelets) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine. | Red Blood Cell Count (Day 15) | 4.9 x10-6th/μL | Standard Deviation 0.44 |
| ACAM2000 Dose 2 | Selected Hematology Parameters (Red Blood Count and Platelets) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine. | Platelets (Baseline) | 282 x10-6th/μL | Standard Deviation 60.1 |
| ACAM2000 Dose 3 | Selected Hematology Parameters (Red Blood Count and Platelets) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine. | Platelets (Day 15) | 281 x10-6th/μL | Standard Deviation 65.1 |
| ACAM2000 Dose 3 | Selected Hematology Parameters (Red Blood Count and Platelets) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine. | Red Blood Cell Count (Day 15) | 5.0 x10-6th/μL | Standard Deviation 0.39 |
| ACAM2000 Dose 3 | Selected Hematology Parameters (Red Blood Count and Platelets) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine. | Platelets (Baseline) | 281 x10-6th/μL | Standard Deviation 68.1 |
| ACAM2000 Dose 3 | Selected Hematology Parameters (Red Blood Count and Platelets) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine. | Red Blood Cell Count (Baseline) | 5.1 x10-6th/μL | Standard Deviation 0.44 |
| ACAM2000 Dose 4 | Selected Hematology Parameters (Red Blood Count and Platelets) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine. | Red Blood Cell Count (Baseline) | 5.1 x10-6th/μL | Standard Deviation 0.45 |
| ACAM2000 Dose 4 | Selected Hematology Parameters (Red Blood Count and Platelets) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine. | Red Blood Cell Count (Day 15) | 5.0 x10-6th/μL | Standard Deviation 0.37 |
| ACAM2000 Dose 4 | Selected Hematology Parameters (Red Blood Count and Platelets) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine. | Platelets (Day 15) | 284 x10-6th/μL | Standard Deviation 59.3 |
| ACAM2000 Dose 4 | Selected Hematology Parameters (Red Blood Count and Platelets) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine. | Platelets (Baseline) | 274 x10-6th/μL | Standard Deviation 52.4 |
| Dryvax® Vaccine | Selected Hematology Parameters (Red Blood Count and Platelets) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine. | Platelets (Day 15) | 285 x10-6th/μL | Standard Deviation 52.1 |
| Dryvax® Vaccine | Selected Hematology Parameters (Red Blood Count and Platelets) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine. | Platelets (Baseline) | 267 x10-6th/μL | Standard Deviation 51.6 |
| Dryvax® Vaccine | Selected Hematology Parameters (Red Blood Count and Platelets) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine. | Red Blood Cell Count (Day 15) | 5.0 x10-6th/μL | Standard Deviation 0.38 |
| Dryvax® Vaccine | Selected Hematology Parameters (Red Blood Count and Platelets) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine. | Red Blood Cell Count (Baseline) | 5.1 x10-6th/μL | Standard Deviation 0.44 |