Smallpox
Conditions
Keywords
Smallpox vaccines, Dryvax®, Orthopoxvirus, Vaccinia virus, ACAM2000
Brief summary
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.
Detailed description
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 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. 2. 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: 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 at least 28 years of age, with a history of smallpox vaccination.
Interventions
BIOLOGICALACAM2000 Smallpox Vaccine
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
BIOLOGICALVaccinia virus (calf lymph) smallpox vaccine: 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
28 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* have a history of previous smallpox vaccination greater than 10 years previous to the date of screening and presence of a vaccination scar. * 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
* children 1 year of age or younger in the household or be in close contact * smallpox vaccination within ten years * known or suspected Human immunodeficient 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 * innoculation 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 |
|---|---|---|
| The Neutralizing Antibody Response Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Day 30 post-vaccination | The neutralizing antibody response titers were determined by the Plaque-Reduction Neutralization Test (PRNT50) |
| 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 | — |
Other
| Measure | Time frame |
|---|---|
| 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 |
| 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 Transaminase and Alanine Transaminase) 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 Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | 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 |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled from 07 January 2003 to 31 March 2003 in 3 medical centers in the US.
Pre-assignment details
A total of 357 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, 2.0x10-7th plaque-forming units/mL on Day 0 | 102 |
| ACAM2000 Dose 3 Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0 | 102 |
| ACAM2000 Dose 4 Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0 | 50 |
| Dryvax® Vaccine Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0 | 52 |
| Total | 357 |
Baseline characteristics
| Characteristic | Total | ACAM2000 Dose 1 | ACAM2000 Dose 2 | ACAM2000 Dose 3 | ACAM2000 Dose 4 | Dryvax® Vaccine |
|---|---|---|---|---|---|---|
| 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 | 357 Participants | 51 Participants | 102 Participants | 102 Participants | 50 Participants | 52 Participants |
| Age, Continuous | 48 Years STANDARD_DEVIATION 10.5 | 48 Years STANDARD_DEVIATION 9.7 | 48 Years STANDARD_DEVIATION 10.1 | 50 Years STANDARD_DEVIATION 11.7 | 47 Years STANDARD_DEVIATION 9.1 | 48 Years STANDARD_DEVIATION 9.2 |
| Region of Enrollment United States | 357 participants | 51 participants | 102 participants | 102 participants | 50 participants | 52 participants |
| Sex: Female, Male Female | 175 Participants | 27 Participants | 57 Participants | 54 Participants | 18 Participants | 19 Participants |
| Sex: Female, Male Male | 182 Participants | 24 Participants | 45 Participants | 48 Participants | 32 Participants | 33 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 | 48 / 51 | 93 / 102 | 98 / 102 | 49 / 50 | 51 / 52 |
| serious Total, serious adverse events | 1 / 51 | 1 / 102 | 0 / 102 | 0 / 50 | 0 / 52 |
Outcome results
Primary
Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine
Time frame: Days 0 to 30 post-vaccination
Population: Post-vaccination 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 | Lymph Node Pain | 1 Participants |
| ACAM2000 Dose 1 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Back Pain | 0 Participants |
| 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 | Human Immunodeficiency Virus (HIV) Test Positive | 1 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 | Constipation | 0 Participants |
| ACAM2000 Dose 1 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Migraine 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 | Toothache | 0 Participants |
| ACAM2000 Dose 1 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Calculus Renal 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 | Swelling 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 | Injection Site Erythema | 0 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 | Myalgia | 1 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 2 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Injection Site Pruritus | 1 Participants |
| ACAM2000 Dose 2 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Injection Site Erythema | 1 Participants |
| ACAM2000 Dose 2 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Toothache | 1 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 | Lymphadenopathy | 0 Participants |
| ACAM2000 Dose 2 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Human Immunodeficiency Virus (HIV) Test Positive | 0 Participants |
| ACAM2000 Dose 2 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Back Pain | 1 Participants |
| ACAM2000 Dose 2 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Lymph Node Pain | 1 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 | Swelling 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 | Myalgia | 0 Participants |
| ACAM2000 Dose 2 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Constipation | 0 Participants |
| ACAM2000 Dose 2 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Calculus Renal 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 | Migraine Not Otherwise Specified | 1 Participants |
| ACAM2000 Dose 3 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Injection Site Pruritus | 0 Participants |
| ACAM2000 Dose 3 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Lymph Node Pain | 1 Participants |
| ACAM2000 Dose 3 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Lymphadenopathy | 1 Participants |
| ACAM2000 Dose 3 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Constipation | 1 Participants |
| ACAM2000 Dose 3 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Toothache | 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 | 3 Participants |
| ACAM2000 Dose 3 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Injection Site Pain | 0 Participants |
| ACAM2000 Dose 3 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Human Immunodeficiency Virus (HIV) Test Positive | 0 Participants |
| ACAM2000 Dose 3 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Back Pain | 0 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 | Swelling 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 | Migraine 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 | 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 | Calculus Renal 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 Pruritus | 0 Participants |
| ACAM2000 Dose 4 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Back Pain | 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 | 4 Participants |
| ACAM2000 Dose 4 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Myalgia | 0 Participants |
| ACAM2000 Dose 4 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Toothache | 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 | 1 Participants |
| ACAM2000 Dose 4 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Swelling 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 | Constipation | 0 Participants |
| ACAM2000 Dose 4 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Migraine 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 | Lymphadenopathy | 0 Participants |
| ACAM2000 Dose 4 | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Calculus Renal 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 | Pregnancy 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 | Human Immunodeficiency Virus (HIV) Test Positive | 0 Participants |
| Dryvax® Vaccine | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Injection Site Pain | 1 Participants |
| Dryvax® Vaccine | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Calculus Renal Not Otherwise Specified | 0 Participants |
| Dryvax® Vaccine | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Back Pain | 0 Participants |
| Dryvax® Vaccine | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Injection Site Erythema | 3 Participants |
| Dryvax® Vaccine | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Human Immunodeficiency Virus (HIV) Test Positive | 0 Participants |
| Dryvax® Vaccine | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Lymph Node Pain | 0 Participants |
| Dryvax® Vaccine | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Migraine Not Otherwise Specified | 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 | Toothache | 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 | 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 | Swelling Not Otherwise Specified | 0 Participants |
| Dryvax® Vaccine | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Constipation | 0 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
| 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. | 13 Participants |
| ACAM2000 Dose 2 | Participants With ≥ 4-fold Increase in Plaque-Reduction Neutralization Test (PRNT50) Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine. | 31 Participants |
| ACAM2000 Dose 3 | Participants With ≥ 4-fold Increase in Plaque-Reduction Neutralization Test (PRNT50) Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine. | 41 Participants |
| ACAM2000 Dose 4 | Participants With ≥ 4-fold Increase in Plaque-Reduction Neutralization Test (PRNT50) Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine. | 38 Participants |
| Dryvax® Vaccine | Participants With ≥ 4-fold Increase in Plaque-Reduction Neutralization Test (PRNT50) Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine. | 39 Participants |
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)
Time frame: Day 30 post-vaccination
Population: The neutralizing antibody response titers were assessed in the antibody evaluable, per-protocol population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ACAM2000 Dose 1 | The Neutralizing Antibody Response Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Baseline | 77 PRNT50 Titers | Standard Deviation 119.4 |
| ACAM2000 Dose 1 | The Neutralizing Antibody Response Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Day 15 | 244 PRNT50 Titers | Standard Deviation 485.4 |
| ACAM2000 Dose 2 | The Neutralizing Antibody Response Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Baseline | 112 PRNT50 Titers | Standard Deviation 280.5 |
| ACAM2000 Dose 2 | The Neutralizing Antibody Response Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Day 15 | 259 PRNT50 Titers | Standard Deviation 449.1 |
| ACAM2000 Dose 3 | The Neutralizing Antibody Response Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Baseline | 76 PRNT50 Titers | Standard Deviation 108.7 |
| ACAM2000 Dose 3 | The Neutralizing Antibody Response Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Day 15 | 802 PRNT50 Titers | Standard Deviation 4111.6 |
| ACAM2000 Dose 4 | The Neutralizing Antibody Response Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Day 15 | 546 PRNT50 Titers | Standard Deviation 829.9 |
| ACAM2000 Dose 4 | The Neutralizing Antibody Response Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Baseline | 91 PRNT50 Titers | Standard Deviation 145.4 |
| Dryvax® Vaccine | The Neutralizing Antibody Response Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Baseline | 186 PRNT50 Titers | Standard Deviation 709.8 |
| Dryvax® Vaccine | The Neutralizing Antibody Response Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Day 15 | 1287 PRNT50 Titers | Standard Deviation 2198.4 |
Other Pre-specified
Clinical Chemistry Parameters (Aspartate Transaminase and Alanine Transaminase) 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 the intent-to-treat safety population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ACAM2000 Dose 1 | Clinical Chemistry Parameters (Aspartate Transaminase and Alanine Transaminase) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Aspartate transaminase (Baseline) | 27 IU/L | Standard Deviation 13.2 |
| ACAM2000 Dose 1 | Clinical Chemistry Parameters (Aspartate Transaminase and Alanine Transaminase) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Aspartate transaminase (Day 15) | 24 IU/L | Standard Deviation 11.5 |
| ACAM2000 Dose 1 | Clinical Chemistry Parameters (Aspartate Transaminase and Alanine Transaminase) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Alanine transaminase (Baseline) | 39 IU/L | Standard Deviation 16.3 |
| ACAM2000 Dose 1 | Clinical Chemistry Parameters (Aspartate Transaminase and Alanine Transaminase) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Alanine transaminase (Day 15) | 39 IU/L | Standard Deviation 20.1 |
| ACAM2000 Dose 2 | Clinical Chemistry Parameters (Aspartate Transaminase and Alanine Transaminase) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Aspartate transaminase (Baseline) | 24 IU/L | Standard Deviation 9.9 |
| ACAM2000 Dose 2 | Clinical Chemistry Parameters (Aspartate Transaminase and Alanine Transaminase) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Alanine transaminase (Day 15) | 38 IU/L | Standard Deviation 20.4 |
| ACAM2000 Dose 2 | Clinical Chemistry Parameters (Aspartate Transaminase and Alanine Transaminase) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Aspartate transaminase (Day 15) | 23 IU/L | Standard Deviation 8.7 |
| ACAM2000 Dose 2 | Clinical Chemistry Parameters (Aspartate Transaminase and Alanine Transaminase) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Alanine transaminase (Baseline) | 39 IU/L | Standard Deviation 19.5 |
| ACAM2000 Dose 3 | Clinical Chemistry Parameters (Aspartate Transaminase and Alanine Transaminase) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Alanine transaminase (Day 15) | 37 IU/L | Standard Deviation 19.2 |
| ACAM2000 Dose 3 | Clinical Chemistry Parameters (Aspartate Transaminase and Alanine Transaminase) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Aspartate transaminase (Day 15) | 24 IU/L | Standard Deviation 10.7 |
| ACAM2000 Dose 3 | Clinical Chemistry Parameters (Aspartate Transaminase and Alanine Transaminase) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Alanine transaminase (Baseline) | 37 IU/L | Standard Deviation 17.3 |
| ACAM2000 Dose 3 | Clinical Chemistry Parameters (Aspartate Transaminase and Alanine Transaminase) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Aspartate transaminase (Baseline) | 23 IU/L | Standard Deviation 10.3 |
| ACAM2000 Dose 4 | Clinical Chemistry Parameters (Aspartate Transaminase and Alanine Transaminase) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Aspartate transaminase (Baseline) | 22 IU/L | Standard Deviation 6.9 |
| ACAM2000 Dose 4 | Clinical Chemistry Parameters (Aspartate Transaminase and Alanine Transaminase) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Aspartate transaminase (Day 15) | 21 IU/L | Standard Deviation 10.4 |
| ACAM2000 Dose 4 | Clinical Chemistry Parameters (Aspartate Transaminase and Alanine Transaminase) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Alanine transaminase (Day 15) | 37 IU/L | Standard Deviation 16 |
| ACAM2000 Dose 4 | Clinical Chemistry Parameters (Aspartate Transaminase and Alanine Transaminase) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Alanine transaminase (Baseline) | 37 IU/L | Standard Deviation 15.7 |
| Dryvax® Vaccine | Clinical Chemistry Parameters (Aspartate Transaminase and Alanine Transaminase) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Alanine transaminase (Day 15) | 34 IU/L | Standard Deviation 13.8 |
| Dryvax® Vaccine | Clinical Chemistry Parameters (Aspartate Transaminase and Alanine Transaminase) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Alanine transaminase (Baseline) | 36 IU/L | Standard Deviation 12.9 |
| Dryvax® Vaccine | Clinical Chemistry Parameters (Aspartate Transaminase and Alanine Transaminase) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Aspartate transaminase (Day 15) | 21 IU/L | Standard Deviation 5.8 |
| Dryvax® Vaccine | Clinical Chemistry Parameters (Aspartate Transaminase and Alanine Transaminase) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Aspartate transaminase (Baseline) | 22 IU/L | Standard Deviation 6.2 |
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 the intent-to-treat safety 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) | 0.90 mg/dL | Standard Deviation 0.122 |
| 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) | 0.91 mg/dL | Standard Deviation 0.145 |
| ACAM2000 Dose 1 | Clinical Chemistry Parameters (Creatinine and Glucose) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Glucose (Baseline) | 91 mg/dL | Standard Deviation 11.7 |
| 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) | 94 mg/dL | Standard Deviation 22.6 |
| ACAM2000 Dose 2 | Clinical Chemistry Parameters (Creatinine and Glucose) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Creatinine (Baseline) | 0.94 mg/dL | Standard Deviation 0.167 |
| 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) | 90 mg/dL | Standard Deviation 18.9 |
| 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) | 0.96 mg/dL | Standard Deviation 0.181 |
| ACAM2000 Dose 2 | 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 8.7 |
| 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) | 90 mg/dL | Standard Deviation 16.3 |
| 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) | 0.95 mg/dL | Standard Deviation 0.184 |
| ACAM2000 Dose 3 | Clinical Chemistry Parameters (Creatinine and Glucose) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Glucose (Baseline) | 92 mg/dL | Standard Deviation 15.3 |
| ACAM2000 Dose 3 | Clinical Chemistry Parameters (Creatinine and Glucose) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Creatinine (Baseline) | 0.92 mg/dL | Standard Deviation 0.187 |
| ACAM2000 Dose 4 | Clinical Chemistry Parameters (Creatinine and Glucose) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Creatinine (Baseline) | 0.94 mg/dL | Standard Deviation 0.184 |
| 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) | 0.96 mg/dL | Standard Deviation 0.184 |
| 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) | 94 mg/dL | Standard Deviation 28.4 |
| ACAM2000 Dose 4 | Clinical Chemistry Parameters (Creatinine and Glucose) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Glucose (Baseline) | 92 mg/dL | Standard Deviation 13.4 |
| Dryvax® Vaccine | Clinical Chemistry Parameters (Creatinine and Glucose) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Glucose (Day 15) | 95 mg/dL | Standard Deviation 27.3 |
| Dryvax® Vaccine | Clinical Chemistry Parameters (Creatinine and Glucose) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Glucose (Baseline) | 88 mg/dL | Standard Deviation 10.7 |
| Dryvax® Vaccine | 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 0.138 |
| 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 0.156 |
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 | Any Rash | 3 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 | Rash Papular | 0 Participants |
| ACAM2000 Dose 1 | Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Injection Site Rash | 1 Participants |
| ACAM2000 Dose 1 | Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Rash Not Otherwise Specified | 2 Participants |
| ACAM2000 Dose 1 | Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Rash Macular | 0 Participants |
| ACAM2000 Dose 2 | Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Application Site Rash | 0 Participants |
| ACAM2000 Dose 2 | Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Rash Not Otherwise Specified | 5 Participants |
| ACAM2000 Dose 2 | Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Rash Macular | 0 Participants |
| ACAM2000 Dose 2 | Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Rash Papular | 0 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 | 5 Participants |
| ACAM2000 Dose 3 | Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Rash Papular | 1 Participants |
| ACAM2000 Dose 3 | Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Rash Macular | 0 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 | 5 Participants |
| ACAM2000 Dose 3 | Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Any Rash | 8 Participants |
| ACAM2000 Dose 4 | Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Application Site Rash | 1 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 |
| 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 Macular | 1 Participants |
| ACAM2000 Dose 4 | Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Rash Papular | 0 Participants |
| ACAM2000 Dose 4 | Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Any Rash | 7 Participants |
| Dryvax® Vaccine | Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Rash Not Otherwise Specified | 3 Participants |
| Dryvax® Vaccine | Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Rash Papular | 0 Participants |
| Dryvax® Vaccine | Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Any Rash | 5 Participants |
| Dryvax® Vaccine | Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Rash Macular | 0 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 | Injection Site Rash | 2 Participants |
Other Pre-specified
Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine
Time frame: Days 0 (Baseline) and 15 post-vaccination
Population: The hematology parameters were assessed in the intent-to-treat safety population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ACAM2000 Dose 1 | Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Hematocrit (Baseline) | 41.7 Percentage (%) | Standard Deviation 3.58 |
| ACAM2000 Dose 1 | Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Hematocrit (Day15) | 41.2 Percentage (%) | Standard Deviation 3.53 |
| ACAM2000 Dose 1 | Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Lymphocytes (Baseline) | 31.8 Percentage (%) | Standard Deviation 7.27 |
| ACAM2000 Dose 1 | Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Lymphocytes (Day15) | 32.4 Percentage (%) | Standard Deviation 6.88 |
| ACAM2000 Dose 1 | Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Eosinophils (Baseline) | 2.8 Percentage (%) | Standard Deviation 1.89 |
| ACAM2000 Dose 1 | Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Eosinophils (Day15) | 2.5 Percentage (%) | Standard Deviation 1.43 |
| ACAM2000 Dose 2 | Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Eosinophils (Baseline) | 2.5 Percentage (%) | Standard Deviation 2.09 |
| ACAM2000 Dose 2 | Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Eosinophils (Day15) | 2.5 Percentage (%) | Standard Deviation 2.02 |
| ACAM2000 Dose 2 | Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Hematocrit (Baseline) | 42.4 Percentage (%) | Standard Deviation 3.87 |
| ACAM2000 Dose 2 | Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Lymphocytes (Baseline) | 30.8 Percentage (%) | Standard Deviation 6.68 |
| ACAM2000 Dose 2 | Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Lymphocytes (Day15) | 30.8 Percentage (%) | Standard Deviation 7.19 |
| ACAM2000 Dose 2 | Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Hematocrit (Day15) | 41.6 Percentage (%) | Standard Deviation 3.86 |
| ACAM2000 Dose 3 | Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Lymphocytes (Day15) | 31.3 Percentage (%) | Standard Deviation 8.26 |
| ACAM2000 Dose 3 | Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Eosinophils (Baseline) | 2.5 Percentage (%) | Standard Deviation 1.5 |
| ACAM2000 Dose 3 | Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Hematocrit (Baseline) | 42.2 Percentage (%) | Standard Deviation 3.66 |
| ACAM2000 Dose 3 | Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Lymphocytes (Baseline) | 30.6 Percentage (%) | Standard Deviation 7.87 |
| ACAM2000 Dose 3 | Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Hematocrit (Day15) | 41.5 Percentage (%) | Standard Deviation 3.68 |
| ACAM2000 Dose 3 | Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Eosinophils (Day15) | 2.6 Percentage (%) | Standard Deviation 1.66 |
| ACAM2000 Dose 4 | Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Lymphocytes (Day15) | 31.2 Percentage (%) | Standard Deviation 7.36 |
| ACAM2000 Dose 4 | Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Hematocrit (Day15) | 42.1 Percentage (%) | Standard Deviation 3.3 |
| ACAM2000 Dose 4 | Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Lymphocytes (Baseline) | 30.4 Percentage (%) | Standard Deviation 6.98 |
| ACAM2000 Dose 4 | Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Eosinophils (Day15) | 2.5 Percentage (%) | Standard Deviation 1.55 |
| ACAM2000 Dose 4 | Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Eosinophils (Baseline) | 2.3 Percentage (%) | Standard Deviation 1.37 |
| ACAM2000 Dose 4 | Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Hematocrit (Baseline) | 42.8 Percentage (%) | Standard Deviation 3.69 |
| Dryvax® Vaccine | Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Eosinophils (Baseline) | 2.8 Percentage (%) | Standard Deviation 1.84 |
| Dryvax® Vaccine | Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Lymphocytes (Baseline) | 30.9 Percentage (%) | Standard Deviation 6.27 |
| Dryvax® Vaccine | Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Hematocrit (Day15) | 42.8 Percentage (%) | Standard Deviation 3.27 |
| Dryvax® Vaccine | Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Eosinophils (Day15) | 3.1 Percentage (%) | Standard Deviation 2.2 |
| Dryvax® Vaccine | Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Lymphocytes (Day15) | 33.4 Percentage (%) | Standard Deviation 7 |
| Dryvax® Vaccine | Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Hematocrit (Baseline) | 43.3 Percentage (%) | Standard Deviation 3.62 |
Other Pre-specified
Selected Hematology Parameters (Red Bood Cell and Platelets) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine
Time frame: Days 0 (Baseline) and 15 post-vaccination
Population: The hematology parameters were assessed in the intent-to-treat safety population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ACAM2000 Dose 1 | Selected Hematology Parameters (Red Bood Cell and Platelets) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Red Blood Cell count (Baseline) | 4.7 x10^6th/µL | Standard Deviation 0.35 |
| ACAM2000 Dose 1 | Selected Hematology Parameters (Red Bood Cell and Platelets) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Red Blood Cell count (Day15) | 4.7 x10^6th/µL | Standard Deviation 0.36 |
| ACAM2000 Dose 1 | Selected Hematology Parameters (Red Bood Cell and Platelets) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Platelets (Baseline) | 279 x10^6th/µL | Standard Deviation 69.7 |
| ACAM2000 Dose 1 | Selected Hematology Parameters (Red Bood Cell and Platelets) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Platelets (Day15) | 286 x10^6th/µL | Standard Deviation 66.7 |
| ACAM2000 Dose 2 | Selected Hematology Parameters (Red Bood Cell and Platelets) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Red Blood Cell count (Baseline) | 4.8 x10^6th/µL | Standard Deviation 0.47 |
| ACAM2000 Dose 2 | Selected Hematology Parameters (Red Bood Cell and Platelets) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Platelets (Day15) | 281 x10^6th/µL | Standard Deviation 61.3 |
| ACAM2000 Dose 2 | Selected Hematology Parameters (Red Bood Cell and Platelets) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Red Blood Cell count (Day15) | 4.7 x10^6th/µL | Standard Deviation 0.5 |
| ACAM2000 Dose 2 | Selected Hematology Parameters (Red Bood Cell and Platelets) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Platelets (Baseline) | 276 x10^6th/µL | Standard Deviation 54.5 |
| ACAM2000 Dose 3 | Selected Hematology Parameters (Red Bood Cell and Platelets) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Platelets (Day15) | 276 x10^6th/µL | Standard Deviation 67.2 |
| ACAM2000 Dose 3 | Selected Hematology Parameters (Red Bood Cell and Platelets) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Red Blood Cell count (Day15) | 4.7 x10^6th/µL | Standard Deviation 0.5 |
| ACAM2000 Dose 3 | Selected Hematology Parameters (Red Bood Cell and Platelets) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Platelets (Baseline) | 277 x10^6th/µL | Standard Deviation 71.5 |
| ACAM2000 Dose 3 | Selected Hematology Parameters (Red Bood Cell and Platelets) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Red Blood Cell count (Baseline) | 4.8 x10^6th/µL | Standard Deviation 0.46 |
| ACAM2000 Dose 4 | Selected Hematology Parameters (Red Bood Cell and Platelets) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Red Blood Cell count (Baseline) | 4.9 x10^6th/µL | Standard Deviation 0.4 |
| ACAM2000 Dose 4 | Selected Hematology Parameters (Red Bood Cell and Platelets) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Red Blood Cell count (Day15) | 4.8 x10^6th/µL | Standard Deviation 0.36 |
| ACAM2000 Dose 4 | Selected Hematology Parameters (Red Bood Cell and Platelets) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Platelets (Day15) | 284 x10^6th/µL | Standard Deviation 63.2 |
| ACAM2000 Dose 4 | Selected Hematology Parameters (Red Bood Cell and Platelets) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Platelets (Baseline) | 285 x10^6th/µL | Standard Deviation 58.4 |
| Dryvax® Vaccine | Selected Hematology Parameters (Red Bood Cell and Platelets) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Platelets (Day15) | 284 x10^6th/µL | Standard Deviation 77 |
| Dryvax® Vaccine | Selected Hematology Parameters (Red Bood Cell and Platelets) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Platelets (Baseline) | 280 x10^6th/µL | Standard Deviation 75.7 |
| Dryvax® Vaccine | Selected Hematology Parameters (Red Bood Cell and Platelets) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Red Blood Cell count (Day15) | 4.8 x10^6th/µL | Standard Deviation 0.41 |
| Dryvax® Vaccine | Selected Hematology Parameters (Red Bood Cell and Platelets) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine | Red Blood Cell count (Baseline) | 4.9 x10^6th/µL | Standard Deviation 0.45 |