Trial Outcomes & Findings for Effect of Dose, Safety, Tolerability of a New Smallpox Vaccine in Adults Without Previous Smallpox Vaccination (NCT NCT00053495)
NCT ID: NCT00053495
Last Updated: 2024-03-18
Results Overview
The severity of each reported adverse event was classified by the investigator according to the following definitions. None - no symptom; Mild - awareness of sign or symptoms, but easily tolerated; Moderate - discomfort enough to cause interference with usual activity; and Severe - incapacitating with inability to work or perform usual activity.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
353 participants
Primary outcome timeframe
Days 0 to 30 post-vaccination
Results posted on
2024-03-18
Participant Flow
Participants were enrolled from 10 January 2003 to 14 April 2003 in 4 medical centers in the US.
A total of 353 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\^8th 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
|
101
|
101
|
51
|
49
|
|
Overall Study
COMPLETED
|
51
|
101
|
101
|
51
|
49
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Dose, Safety, Tolerability of a New Smallpox Vaccine in Adults Without Previous Smallpox Vaccination
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=101 Participants
Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10\^8th plaque-forming units/mL on Day 0
|
ACAM2000 Dose 3
n=101 Participants
Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10\^7th plaque-forming units/mL on Day 0
|
ACAM2000 Dose 4
n=51 Participants
Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10\^6th plaque-forming units/mL on Day 0
|
Dryvax® Vaccine
n=49 Participants
Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10\^8th plaque-forming units/mL on Day 0
|
Total
n=353 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=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
51 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
49 Participants
n=21 Participants
|
353 Participants
n=8 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=8 Participants
|
|
Age, Continuous
|
23 Years
STANDARD_DEVIATION 2.4 • n=5 Participants
|
22 Years
STANDARD_DEVIATION 3.1 • n=7 Participants
|
22 Years
STANDARD_DEVIATION 3.2 • n=5 Participants
|
22 Years
STANDARD_DEVIATION 3.0 • n=4 Participants
|
22 Years
STANDARD_DEVIATION 3.1 • n=21 Participants
|
22 Years
STANDARD_DEVIATION 3 • n=8 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
115 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
238 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
51 participants
n=5 Participants
|
101 participants
n=7 Participants
|
101 participants
n=5 Participants
|
51 participants
n=4 Participants
|
49 participants
n=21 Participants
|
353 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Days 0 to 30 post-vaccinationPopulation: Adverse events were assessed in the safety, intent-to-treat population
The severity of each reported adverse event was classified by the investigator according to the following definitions. None - no symptom; Mild - awareness of sign or symptoms, but easily tolerated; Moderate - discomfort enough to cause interference with usual activity; and Severe - incapacitating with inability to work or perform usual activity.
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=101 Participants
Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10\^8th plaque-forming units/mL on Day 0
|
ACAM2000 Dose 3
n=101 Participants
Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10\^7th plaque-forming units/mL on Day 0
|
ACAM2000 Dose 4
n=51 Participants
Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10\^6th plaque-forming units/mL on Day 0
|
Dryvax® Vaccine
n=49 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
Lymph Node Pain
|
2 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine
Lymphadenopathy
|
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
Diarrhea Not Otherwise Specified
|
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
Nausea
|
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
Vomiting Not Otherwise Specified
|
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
Injection Site Erythema
|
1 Participants
|
6 Participants
|
14 Participants
|
11 Participants
|
15 Participants
|
|
Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine
Injection Site Swelling
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine
Injection Site Pruritus
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine
Fatigue
|
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
Injection Site Pain
|
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
Dehydration
|
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
Myalgia
|
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
Headache Not Otherwise Specified
|
1 Participants
|
0 Participants
|
4 Participants
|
1 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
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine
Dysuria
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 30 post-vaccinationPopulation: Neutralizing antibody response titers were evaluated in the antibody evaluable, per-protocol 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=100 Participants
Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10\^8th plaque-forming units/mL on Day 0
|
ACAM2000 Dose 3
n=100 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=49 Participants
Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10\^8th plaque-forming units/mL on Day 0
|
|---|---|---|---|---|---|
|
Neutralizing Antibody Response Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine.
|
212 PRNT50 Titers
Standard Deviation 536.4
|
278 PRNT50 Titers
Standard Deviation 581.6
|
425 PRNT50 Titers
Standard Deviation 947.4
|
582 PRNT50 Titers
Standard Deviation 1129.3
|
1515 PRNT50 Titers
Standard Deviation 6019.4
|
PRIMARY outcome
Timeframe: Day 30 post-vaccinationPopulation: Plaque-reduction neutralization test (PRNT50) titers were determined in the antibody evaluable, per-protocol population
Outcome measures
| Measure |
ACAM2000 Dose 1
n=50 Participants
Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10\^8th plaque-forming units/mL on Day 0
|
ACAM2000 Dose 2
n=100 Participants
Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10\^8th plaque-forming units/mL on Day 0
|
ACAM2000 Dose 3
n=100 Participants
Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10\^7th plaque-forming units/mL on Day 0
|
ACAM2000 Dose 4
n=51 Participants
Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10\^6th plaque-forming units/mL on Day 0
|
Dryvax® Vaccine
n=49 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.
|
28 Participants
|
73 Participants
|
84 Participants
|
48 Participants
|
47 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=101 Participants
Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10\^8th plaque-forming units/mL on Day 0
|
ACAM2000 Dose 3
n=101 Participants
Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10\^7th plaque-forming units/mL on Day 0
|
ACAM2000 Dose 4
n=51 Participants
Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10\^6th plaque-forming units/mL on Day 0
|
Dryvax® Vaccine
n=49 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 Not Otherwise Specified
|
3 Participants
|
10 Participants
|
9 Participants
|
5 Participants
|
7 Participants
|
|
Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine.
Rash Pruritic
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine.
Rash Pustular
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine.
Application Site Rash
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine.
Injection Site Rash
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine.
Any Rash Event
|
3 Participants
|
11 Participants
|
10 Participants
|
7 Participants
|
10 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 0 (baseline) and 15 post-vaccinationPopulation: Clinical chemistry parameters were assessed in 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=101 Participants
Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10\^8th plaque-forming units/mL on Day 0
|
ACAM2000 Dose 3
n=101 Participants
Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10\^7th plaque-forming units/mL on Day 0
|
ACAM2000 Dose 4
n=51 Participants
Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10\^6th plaque-forming units/mL on Day 0
|
Dryvax® Vaccine
n=49 Participants
Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10\^8th plaque-forming units/mL on Day 0
|
|---|---|---|---|---|---|
|
Clinical Chemistry Parameters (Aspartate Aminotransaminase and Alanine Aminotransferase) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine
Aspartate Aminotransferase (Baseline)
|
21 IU/L
Standard Deviation 7.4
|
21 IU/L
Standard Deviation 5.9
|
22 IU/L
Standard Deviation 7.1
|
23 IU/L
Standard Deviation 7.1
|
20 IU/L
Standard Deviation 5.8
|
|
Clinical Chemistry Parameters (Aspartate Aminotransaminase and Alanine Aminotransferase) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine
Aspartate Aminotransferase (Day 15)
|
23 IU/L
Standard Deviation 10.5
|
21 IU/L
Standard Deviation 7.7
|
22 IU/L
Standard Deviation 7.5
|
21 IU/L
Standard Deviation 6.3
|
22 IU/L
Standard Deviation 6.8
|
|
Clinical Chemistry Parameters (Aspartate Aminotransaminase and Alanine Aminotransferase) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine
Alanine Aminotransferase (Baseline)
|
32 IU/L
Standard Deviation 15.0
|
32 IU/L
Standard Deviation 16.2
|
33 IU/L
Standard Deviation 17.4
|
36 IU/L
Standard Deviation 18.5
|
31 IU/L
Standard Deviation 16.8
|
|
Clinical Chemistry Parameters (Aspartate Aminotransaminase and Alanine Aminotransferase) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine
Alanine Aminotransferase (Day 15)
|
33 IU/L
Standard Deviation 15.4
|
32 IU/L
Standard Deviation 17.5
|
33 IU/L
Standard Deviation 16.6
|
34 IU/L
Standard Deviation 16.2
|
33 IU/L
Standard Deviation 17.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 0 (baseline) and 15 post-vaccinationPopulation: Clinical chemistry parameters were assessed in 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=101 Participants
Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10\^8th plaque-forming units/mL on Day 0
|
ACAM2000 Dose 3
n=101 Participants
Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10\^7th plaque-forming units/mL on Day 0
|
ACAM2000 Dose 4
n=51 Participants
Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10\^6th plaque-forming units/mL on Day 0
|
Dryvax® Vaccine
n=49 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)
|
0.97 mg/dL
Standard Deviation 0.147
|
0.96 mg/dL
Standard Deviation 0.153
|
0.98 mg/dL
Standard Deviation 0.181
|
0.97 mg/dL
Standard Deviation 0.171
|
0.97 mg/dL
Standard Deviation 0.158
|
|
Clinical Chemistry Parameters (Creatinine and Glucose) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine
Creatinine (Day 15)
|
0.98 mg/dL
Standard Deviation 0.149
|
0.98 mg/dL
Standard Deviation 0.142
|
0.98 mg/dL
Standard Deviation 0.169
|
1.00 mg/dL
Standard Deviation 0.144
|
1.00 mg/dL
Standard Deviation 0.163
|
|
Clinical Chemistry Parameters (Creatinine and Glucose) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine
Glucose (Baseline)
|
85 mg/dL
Standard Deviation 7.3
|
84 mg/dL
Standard Deviation 9.8
|
86 mg/dL
Standard Deviation 7.4
|
86 mg/dL
Standard Deviation 8.3
|
87 mg/dL
Standard Deviation 18.6
|
|
Clinical Chemistry Parameters (Creatinine and Glucose) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine
Glucose (Day 15)
|
83 mg/dL
Standard Deviation 14.2
|
86 mg/dL
Standard Deviation 14.6
|
86 mg/dL
Standard Deviation 10.6
|
87 mg/dL
Standard Deviation 13.2
|
88 mg/dL
Standard Deviation 21.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 0 (baseline) and 15 post-vaccinationPopulation: Hematology parameters were evaluated 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=101 Participants
Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10\^8th plaque-forming units/mL on Day 0
|
ACAM2000 Dose 3
n=101 Participants
Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10\^7th plaque-forming units/mL on Day 0
|
ACAM2000 Dose 4
n=51 Participants
Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10\^6th plaque-forming units/mL on Day 0
|
Dryvax® Vaccine
n=49 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 on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine.
Hematocrit (Baseline)
|
43.7 Percentage (%)
Standard Deviation 4.20
|
43.2 Percentage (%)
Standard Deviation 3.71
|
43.2 Percentage (%)
Standard Deviation 4.44
|
44.2 Percentage (%)
Standard Deviation 3.29
|
44.1 Percentage (%)
Standard Deviation 3.54
|
|
Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine.
Hematocrit (Day 15)
|
42.8 Percentage (%)
Standard Deviation 3.74
|
42.3 Percentage (%)
Standard Deviation 3.59
|
42.7 Percentage (%)
Standard Deviation 3.21
|
43.2 Percentage (%)
Standard Deviation 2.55
|
43.1 Percentage (%)
Standard Deviation 3.13
|
|
Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine.
Lymphocytes (Baseline)
|
30.6 Percentage (%)
Standard Deviation 8.26
|
31.5 Percentage (%)
Standard Deviation 8.33
|
30.7 Percentage (%)
Standard Deviation 7.00
|
29.6 Percentage (%)
Standard Deviation 7.45
|
31.6 Percentage (%)
Standard Deviation 7.99
|
|
Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine.
Lymphocytes (Day 15)
|
33.9 Percentage (%)
Standard Deviation 8.62
|
34.0 Percentage (%)
Standard Deviation 7.41
|
34.7 Percentage (%)
Standard Deviation 7.93
|
33.9 Percentage (%)
Standard Deviation 6.83
|
33.8 Percentage (%)
Standard Deviation 7.58
|
|
Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine.
Eosinophils (Baseline)
|
2.5 Percentage (%)
Standard Deviation 1.61
|
2.5 Percentage (%)
Standard Deviation 1.95
|
2.4 Percentage (%)
Standard Deviation 1.69
|
2.3 Percentage (%)
Standard Deviation 1.42
|
2.4 Percentage (%)
Standard Deviation 1.72
|
|
Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine.
Eosinophils (Day 15)
|
2.8 Percentage (%)
Standard Deviation 2.07
|
2.8 Percentage (%)
Standard Deviation 2.11
|
2.6 Percentage (%)
Standard Deviation 1.65
|
2.7 Percentage (%)
Standard Deviation 1.42
|
2.7 Percentage (%)
Standard Deviation 1.61
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 0 (baseline) and 15 post-vaccinationPopulation: Hematology parameters were evaluated 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=101 Participants
Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10\^8th plaque-forming units/mL on Day 0
|
ACAM2000 Dose 3
n=101 Participants
Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10\^7th plaque-forming units/mL on Day 0
|
ACAM2000 Dose 4
n=51 Participants
Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10\^6th plaque-forming units/mL on Day 0
|
Dryvax® Vaccine
n=49 Participants
Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10\^8th plaque-forming units/mL on Day 0
|
|---|---|---|---|---|---|
|
Selected Hematology Parameters (Red Blood Count and Platelets) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine.
Red Blood Cell Count (Baseline)
|
5.1 x10-6th/μL
Standard Deviation 0.53
|
5.0 x10-6th/μL
Standard Deviation 0.47
|
5.1 x10-6th/μL
Standard Deviation 0.44
|
5.1 x10-6th/μL
Standard Deviation 0.45
|
5.1 x10-6th/μL
Standard Deviation 0.44
|
|
Selected Hematology Parameters (Red Blood Count and Platelets) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine.
Red Blood Cell Count (Day 15)
|
5.0 x10-6th/μL
Standard Deviation 0.50
|
4.9 x10-6th/μL
Standard Deviation 0.44
|
5.0 x10-6th/μL
Standard Deviation 0.39
|
5.0 x10-6th/μL
Standard Deviation 0.37
|
5.0 x10-6th/μL
Standard Deviation 0.38
|
|
Selected Hematology Parameters (Red Blood Count and Platelets) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine.
Platelets (Baseline)
|
274 x10-6th/μL
Standard Deviation 64.0
|
282 x10-6th/μL
Standard Deviation 60.1
|
281 x10-6th/μL
Standard Deviation 68.1
|
274 x10-6th/μL
Standard Deviation 52.4
|
267 x10-6th/μL
Standard Deviation 51.6
|
|
Selected Hematology Parameters (Red Blood Count and Platelets) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine.
Platelets (Day 15)
|
284 x10-6th/μL
Standard Deviation 58.6
|
280 x10-6th/μL
Standard Deviation 57.7
|
281 x10-6th/μL
Standard Deviation 65.1
|
284 x10-6th/μL
Standard Deviation 59.3
|
285 x10-6th/μL
Standard Deviation 52.1
|
Adverse Events
ACAM2000 Dose 1
Serious events: 1 serious events
Other events: 51 other events
Deaths: 0 deaths
ACAM2000 Dose 2
Serious events: 1 serious events
Other events: 99 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: 1 serious events
Other events: 51 other events
Deaths: 0 deaths
Dryvax® Vaccine
Serious events: 0 serious events
Other events: 49 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=101 participants at risk
Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10\^8th plaque-forming units/mL on Day 0
|
ACAM2000 Dose 3
n=101 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=51 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=49 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
|
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.
|
0.99%
1/101 • Number of events 1 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
0.00%
0/101 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
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%
0/49 • 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=101 participants at risk
Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10\^8th plaque-forming units/mL on Day 0
|
ACAM2000 Dose 3
n=101 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=51 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=49 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
|
43.1%
22/51 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
58.4%
59/101 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
60.4%
61/101 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
76.5%
39/51 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
89.8%
44/49 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
21.6%
11/51 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
25.7%
26/101 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
24.8%
25/101 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
37.3%
19/51 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
34.7%
17/49 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
|
Gastrointestinal disorders
Nausea
|
25.5%
13/51 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
20.8%
21/101 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
20.8%
21/101 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
21.6%
11/51 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
28.6%
14/49 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
|
Gastrointestinal disorders
Diarrhea Not Otherwise Specified
|
17.6%
9/51 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
12.9%
13/101 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
20.8%
21/101 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
9.8%
5/51 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
14.3%
7/49 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
|
Gastrointestinal disorders
Vomiting Not Otherwise Specified
|
9.8%
5/51 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
2.0%
2/101 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
9.9%
10/101 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
7.8%
4/51 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
6.1%
3/49 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
|
General disorders
Injection Site Pruritus
|
84.3%
43/51 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
88.1%
89/101 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
81.2%
82/101 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
100.0%
51/51 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
100.0%
49/49 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
|
General disorders
Injection Site Erythema
|
52.9%
27/51 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
64.4%
65/101 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
63.4%
64/101 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
72.5%
37/51 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
75.5%
37/49 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
|
General disorders
Injection Site Pain
|
43.1%
22/51 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
58.4%
59/101 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
57.4%
58/101 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
68.6%
35/51 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
71.4%
35/49 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
|
General disorders
Fatigue
|
45.1%
23/51 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
40.6%
41/101 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
54.5%
55/101 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
56.9%
29/51 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
57.1%
28/49 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
|
General disorders
Malaise
|
35.3%
18/51 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
26.7%
27/101 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
28.7%
29/101 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
35.3%
18/51 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
46.9%
23/49 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
|
General disorders
Feeling Hot
|
27.5%
14/51 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
25.7%
26/101 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
23.8%
24/101 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
25.5%
13/51 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
38.8%
19/49 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
|
General disorders
Rigors
|
13.7%
7/51 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
13.9%
14/101 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
18.8%
19/101 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
25.5%
13/51 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
28.6%
14/49 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
|
General disorders
Injection Site Swelling
|
5.9%
3/51 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
5.9%
6/101 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
5.9%
6/101 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
9.8%
5/51 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
4.1%
2/49 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
41.2%
21/51 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
39.6%
40/101 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
46.5%
47/101 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
51.0%
26/51 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
55.1%
27/49 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
|
Nervous system disorders
Headache Not Otherwise Specified
|
58.8%
30/51 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
50.5%
51/101 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
48.5%
49/101 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
47.1%
24/51 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
57.1%
28/49 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
2.0%
1/51 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
10.9%
11/101 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
7.9%
8/101 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
3.9%
2/51 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
2.0%
1/49 • 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
|
5.9%
3/51 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
9.9%
10/101 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
8.9%
9/101 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
9.8%
5/51 • Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination.
|
14.3%
7/49 • 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