Trial Outcomes & Findings for Dose Study of ACAM2000 Smallpox Vaccine in Previously Vaccinated Adults (NCT NCT00053482)
NCT ID: NCT00053482
Last Updated: 2024-03-18
Results Overview
The neutralizing antibody response titers were determined by the Plaque-Reduction Neutralization Test (PRNT50)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
357 participants
Primary outcome timeframe
Day 30 post-vaccination
Results posted on
2024-03-18
Participant Flow
Participants were enrolled from 07 January 2003 to 31 March 2003 in 3 medical centers in the US.
A total of 357 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Participant milestones
| Measure |
ACAM2000 Dose 1
Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
|
ACAM2000 Dose 2
Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
|
ACAM2000 Dose 3
Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
|
ACAM2000 Dose 4
Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
|
Dryvax® Vaccine
Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
51
|
102
|
102
|
50
|
52
|
|
Overall Study
COMPLETED
|
51
|
102
|
102
|
50
|
52
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dose Study of ACAM2000 Smallpox Vaccine in Previously Vaccinated Adults
Baseline characteristics by cohort
| Measure |
ACAM2000 Dose 1
n=51 Participants
Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
|
ACAM2000 Dose 2
n=102 Participants
Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
|
ACAM2000 Dose 3
n=102 Participants
Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
|
ACAM2000 Dose 4
n=50 Participants
Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
|
Dryvax® Vaccine
n=52 Participants
Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
|
Total
n=357 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
51 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
52 Participants
n=21 Participants
|
357 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Age, Continuous
|
48 Years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
48 Years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
50 Years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
47 Years
STANDARD_DEVIATION 9.1 • n=4 Participants
|
48 Years
STANDARD_DEVIATION 9.2 • n=21 Participants
|
48 Years
STANDARD_DEVIATION 10.5 • n=10 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
175 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
182 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
51 participants
n=5 Participants
|
102 participants
n=7 Participants
|
102 participants
n=5 Participants
|
50 participants
n=4 Participants
|
52 participants
n=21 Participants
|
357 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Day 30 post-vaccinationPopulation: The neutralizing antibody response titers were assessed in the antibody evaluable, per-protocol population.
The neutralizing antibody response titers were determined by the Plaque-Reduction Neutralization Test (PRNT50)
Outcome measures
| Measure |
ACAM2000 Dose 1
n=51 Participants
Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
|
ACAM2000 Dose 2
n=102 Participants
Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
|
ACAM2000 Dose 3
n=102 Participants
Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
|
ACAM2000 Dose 4
n=50 Participants
Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
|
Dryvax® Vaccine
n=52 Participants
Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
|
|---|---|---|---|---|---|
|
The Neutralizing Antibody Response Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine
Baseline
|
77 PRNT50 Titers
Standard Deviation 119.4
|
112 PRNT50 Titers
Standard Deviation 280.5
|
76 PRNT50 Titers
Standard Deviation 108.7
|
91 PRNT50 Titers
Standard Deviation 145.4
|
186 PRNT50 Titers
Standard Deviation 709.8
|
|
The Neutralizing Antibody Response Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine
Day 15
|
244 PRNT50 Titers
Standard Deviation 485.4
|
259 PRNT50 Titers
Standard Deviation 449.1
|
802 PRNT50 Titers
Standard Deviation 4111.6
|
546 PRNT50 Titers
Standard Deviation 829.9
|
1287 PRNT50 Titers
Standard Deviation 2198.4
|
PRIMARY outcome
Timeframe: Day 30 post-vaccinationOutcome measures
| Measure |
ACAM2000 Dose 1
n=51 Participants
Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
|
ACAM2000 Dose 2
n=102 Participants
Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
|
ACAM2000 Dose 3
n=102 Participants
Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
|
ACAM2000 Dose 4
n=50 Participants
Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
|
Dryvax® Vaccine
n=52 Participants
Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
|
|---|---|---|---|---|---|
|
Participants With ≥ 4-fold Increase in Plaque-Reduction Neutralization Test (PRNT50) Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine.
|
13 Participants
|
31 Participants
|
41 Participants
|
38 Participants
|
39 Participants
|
PRIMARY outcome
Timeframe: Days 0 to 30 post-vaccinationPopulation: Post-vaccination adverse events were assessed in the safety, intent-to-treat population.
Outcome measures
| Measure |
ACAM2000 Dose 1
n=51 Participants
Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
|
ACAM2000 Dose 2
n=102 Participants
Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
|
ACAM2000 Dose 3
n=102 Participants
Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
|
ACAM2000 Dose 4
n=50 Participants
Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
|
Dryvax® Vaccine
n=52 Participants
Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
|
|---|---|---|---|---|---|
|
Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine
Myalgia
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine
Lymph Node Pain
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine
Lymphadenopathy
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine
Constipation
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine
Toothache
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine
Injection Site Erythema
|
0 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
|
Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine
Injection Site Pruritus
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine
Injection Site Pain
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine
Back Pain
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine
Swelling Not Otherwise Specified
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine
Migraine Not Otherwise Specified
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine
Pregnancy Not Otherwise Specified
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine
Calculus Renal Not Otherwise Specified
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 0 to 30 post-vaccinationPopulation: Treatment-emergent rash events were assessed in the safety intent-to-treat population.
Outcome measures
| Measure |
ACAM2000 Dose 1
n=51 Participants
Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
|
ACAM2000 Dose 2
n=102 Participants
Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
|
ACAM2000 Dose 3
n=102 Participants
Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
|
ACAM2000 Dose 4
n=50 Participants
Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
|
Dryvax® Vaccine
n=52 Participants
Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine
Rash Macular
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine
Rash Not Otherwise Specified
|
2 Participants
|
5 Participants
|
5 Participants
|
5 Participants
|
3 Participants
|
|
Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine
Rash Papular
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine
Application Site Rash
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine
Injection Site Rash
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine
Any Rash
|
3 Participants
|
5 Participants
|
8 Participants
|
7 Participants
|
5 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 0 (Baseline) and 15 post-vaccinationPopulation: The hematology parameters were assessed in the intent-to-treat safety population.
Outcome measures
| Measure |
ACAM2000 Dose 1
n=51 Participants
Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
|
ACAM2000 Dose 2
n=102 Participants
Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
|
ACAM2000 Dose 3
n=102 Participants
Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
|
ACAM2000 Dose 4
n=50 Participants
Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
|
Dryvax® Vaccine
n=52 Participants
Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
|
|---|---|---|---|---|---|
|
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
|
42.4 Percentage (%)
Standard Deviation 3.87
|
42.2 Percentage (%)
Standard Deviation 3.66
|
42.8 Percentage (%)
Standard Deviation 3.69
|
43.3 Percentage (%)
Standard Deviation 3.62
|
|
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
|
41.6 Percentage (%)
Standard Deviation 3.86
|
41.5 Percentage (%)
Standard Deviation 3.68
|
42.1 Percentage (%)
Standard Deviation 3.30
|
42.8 Percentage (%)
Standard Deviation 3.27
|
|
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
|
30.8 Percentage (%)
Standard Deviation 6.68
|
30.6 Percentage (%)
Standard Deviation 7.87
|
30.4 Percentage (%)
Standard Deviation 6.98
|
30.9 Percentage (%)
Standard Deviation 6.27
|
|
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
|
30.8 Percentage (%)
Standard Deviation 7.19
|
31.3 Percentage (%)
Standard Deviation 8.26
|
31.2 Percentage (%)
Standard Deviation 7.36
|
33.4 Percentage (%)
Standard Deviation 7.00
|
|
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
|
2.5 Percentage (%)
Standard Deviation 2.09
|
2.5 Percentage (%)
Standard Deviation 1.50
|
2.3 Percentage (%)
Standard Deviation 1.37
|
2.8 Percentage (%)
Standard Deviation 1.84
|
|
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
|
2.5 Percentage (%)
Standard Deviation 2.02
|
2.6 Percentage (%)
Standard Deviation 1.66
|
2.5 Percentage (%)
Standard Deviation 1.55
|
3.1 Percentage (%)
Standard Deviation 2.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 0 (Baseline) and 15 post-vaccinationPopulation: The hematology parameters were assessed in the intent-to-treat safety population.
Outcome measures
| Measure |
ACAM2000 Dose 1
n=51 Participants
Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
|
ACAM2000 Dose 2
n=102 Participants
Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
|
ACAM2000 Dose 3
n=102 Participants
Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
|
ACAM2000 Dose 4
n=50 Participants
Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
|
Dryvax® Vaccine
n=52 Participants
Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
|
|---|---|---|---|---|---|
|
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
|
4.7 x10^6th/µL
Standard Deviation 0.50
|
4.7 x10^6th/µL
Standard Deviation 0.50
|
4.8 x10^6th/µL
Standard Deviation 0.36
|
4.8 x10^6th/µL
Standard Deviation 0.41
|
|
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
|
4.8 x10^6th/µL
Standard Deviation 0.47
|
4.8 x10^6th/µL
Standard Deviation 0.46
|
4.9 x10^6th/µL
Standard Deviation 0.40
|
4.9 x10^6th/µL
Standard Deviation 0.45
|
|
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
|
276 x10^6th/µL
Standard Deviation 54.5
|
277 x10^6th/µL
Standard Deviation 71.5
|
285 x10^6th/µL
Standard Deviation 58.4
|
280 x10^6th/µL
Standard Deviation 75.7
|
|
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
|
281 x10^6th/µL
Standard Deviation 61.3
|
276 x10^6th/µL
Standard Deviation 67.2
|
284 x10^6th/µL
Standard Deviation 63.2
|
284 x10^6th/µL
Standard Deviation 77.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 0 (Baseline) and 15 post-vaccinationPopulation: Clinical chemistry parameters were assessed in the intent-to-treat safety population
Outcome measures
| Measure |
ACAM2000 Dose 1
n=51 Participants
Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
|
ACAM2000 Dose 2
n=102 Participants
Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
|
ACAM2000 Dose 3
n=102 Participants
Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
|
ACAM2000 Dose 4
n=50 Participants
Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
|
Dryvax® Vaccine
n=52 Participants
Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
|
|---|---|---|---|---|---|
|
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
|
0.94 mg/dL
Standard Deviation 0.167
|
0.92 mg/dL
Standard Deviation 0.187
|
0.94 mg/dL
Standard Deviation 0.184
|
0.97 mg/dL
Standard Deviation 0.156
|
|
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
|
0.96 mg/dL
Standard Deviation 0.181
|
0.95 mg/dL
Standard Deviation 0.184
|
0.96 mg/dL
Standard Deviation 0.184
|
0.98 mg/dL
Standard Deviation 0.138
|
|
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
|
87 mg/dL
Standard Deviation 8.7
|
92 mg/dL
Standard Deviation 15.3
|
92 mg/dL
Standard Deviation 13.4
|
88 mg/dL
Standard Deviation 10.7
|
|
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
|
90 mg/dL
Standard Deviation 18.9
|
90 mg/dL
Standard Deviation 16.3
|
94 mg/dL
Standard Deviation 28.4
|
95 mg/dL
Standard Deviation 27.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 0 (Baseline) and 15 post-vaccinationPopulation: Clinical chemistry parameters were assessed in the intent-to-treat safety population
Outcome measures
| Measure |
ACAM2000 Dose 1
n=51 Participants
Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
|
ACAM2000 Dose 2
n=102 Participants
Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
|
ACAM2000 Dose 3
n=102 Participants
Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
|
ACAM2000 Dose 4
n=50 Participants
Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
|
Dryvax® Vaccine
n=52 Participants
Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
|
|---|---|---|---|---|---|
|
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
|
24 IU/L
Standard Deviation 9.9
|
23 IU/L
Standard Deviation 10.3
|
22 IU/L
Standard Deviation 6.9
|
22 IU/L
Standard Deviation 6.2
|
|
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)
|
24 IU/L
Standard Deviation 11.5
|
23 IU/L
Standard Deviation 8.7
|
24 IU/L
Standard Deviation 10.7
|
21 IU/L
Standard Deviation 10.4
|
21 IU/L
Standard Deviation 5.8
|
|
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
|
39 IU/L
Standard Deviation 19.5
|
37 IU/L
Standard Deviation 17.3
|
37 IU/L
Standard Deviation 15.7
|
36 IU/L
Standard Deviation 12.9
|
|
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
|
38 IU/L
Standard Deviation 20.4
|
37 IU/L
Standard Deviation 19.2
|
37 IU/L
Standard Deviation 16.0
|
34 IU/L
Standard Deviation 13.8
|
Adverse Events
ACAM2000 Dose 1
Serious events: 1 serious events
Other events: 48 other events
Deaths: 0 deaths
ACAM2000 Dose 2
Serious events: 1 serious events
Other events: 93 other events
Deaths: 0 deaths
ACAM2000 Dose 3
Serious events: 0 serious events
Other events: 98 other events
Deaths: 0 deaths
ACAM2000 Dose 4
Serious events: 0 serious events
Other events: 49 other events
Deaths: 0 deaths
Dryvax® Vaccine
Serious events: 0 serious events
Other events: 51 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ACAM2000 Dose 1
n=51 participants at risk
Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
|
ACAM2000 Dose 2
n=102 participants at risk
Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
|
ACAM2000 Dose 3
n=102 participants at risk
Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
|
ACAM2000 Dose 4
n=50 participants at risk
Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
|
Dryvax® Vaccine
n=52 participants at risk
Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
|
|---|---|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy Not Otherwise Specified
|
0.00%
0/51 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
0.98%
1/102 • Number of events 1 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
0.00%
0/102 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
0.00%
0/50 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
0.00%
0/52 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
|
Investigations
HIV test positive
|
2.0%
1/51 • Number of events 1 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
0.00%
0/102 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
0.00%
0/102 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
0.00%
0/50 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
0.00%
0/52 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
Other adverse events
| Measure |
ACAM2000 Dose 1
n=51 participants at risk
Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
|
ACAM2000 Dose 2
n=102 participants at risk
Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
|
ACAM2000 Dose 3
n=102 participants at risk
Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
|
ACAM2000 Dose 4
n=50 participants at risk
Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
|
Dryvax® Vaccine
n=52 participants at risk
Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymph Node Pain
|
9.8%
5/51 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
7.8%
8/102 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
19.6%
20/102 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
28.0%
14/50 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
23.1%
12/52 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
5.9%
3/51 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
4.9%
5/102 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
5.9%
6/102 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
2.0%
1/50 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
9.6%
5/52 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
|
Gastrointestinal disorders
Diarrhea Not Otherwise Specified
|
15.7%
8/51 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
16.7%
17/102 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
10.8%
11/102 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
24.0%
12/50 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
17.3%
9/52 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
|
Gastrointestinal disorders
Nausea
|
13.7%
7/51 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
7.8%
8/102 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
10.8%
11/102 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
16.0%
8/50 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
9.6%
5/52 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
|
Gastrointestinal disorders
Constipation
|
7.8%
4/51 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
4.9%
5/102 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
8.8%
9/102 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
6.0%
3/50 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
5.8%
3/52 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
|
General disorders
Injection Site Pruritus
|
56.9%
29/51 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
57.8%
59/102 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
75.5%
77/102 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
76.0%
38/50 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
82.7%
43/52 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
|
General disorders
Injection Site Erythema
|
39.2%
20/51 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
41.2%
42/102 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
47.1%
48/102 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
48.0%
24/50 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
57.7%
30/52 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
|
General disorders
Fatigue
|
29.4%
15/51 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
27.5%
28/102 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
40.2%
41/102 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
36.0%
18/50 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
34.6%
18/52 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
|
General disorders
Malaise
|
33.3%
17/51 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
19.6%
20/102 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
28.4%
29/102 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
36.0%
18/50 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
28.8%
15/52 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
|
General disorders
Feeling Hot
|
23.5%
12/51 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
14.7%
15/102 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
13.7%
14/102 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
26.0%
13/50 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
11.5%
6/52 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
|
General disorders
Rigors
|
17.6%
9/51 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
10.8%
11/102 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
12.7%
13/102 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
20.0%
10/50 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
15.4%
8/52 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
|
General disorders
Injection Site Inflammation
|
0.00%
0/51 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
2.9%
3/102 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
6.9%
7/102 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
14.0%
7/50 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
21.2%
11/52 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
|
General disorders
Injection Site Pain
|
25.5%
13/51 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
26.5%
27/102 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
35.3%
36/102 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
32.0%
16/50 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
36.5%
19/52 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
27.5%
14/51 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
32.4%
33/102 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
29.4%
30/102 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
30.0%
15/50 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
13.5%
7/52 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.9%
3/51 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
5.9%
6/102 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
3.9%
4/102 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
2.0%
1/50 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
7.7%
4/52 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
|
Nervous system disorders
Headache Not Otherwise Specified
|
47.1%
24/51 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
38.2%
39/102 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
45.1%
46/102 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
50.0%
25/50 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
40.4%
21/52 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
5.9%
3/51 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
4.9%
5/102 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
6.9%
7/102 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
4.0%
2/50 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
3.8%
2/52 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
|
Infections and infestations
Nasopharyngitis
|
2.0%
1/51 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
0.98%
1/102 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
10.8%
11/102 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
14.0%
7/50 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
5.8%
3/52 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
|
Skin and subcutaneous tissue disorders
Rash Not Otherwise Specified
|
3.9%
2/51 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
4.9%
5/102 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
4.9%
5/102 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
10.0%
5/50 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
5.8%
3/52 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications
- Publication restrictions are in place
Restriction type: OTHER