Effect of Dose, Safety, Tolerability of a New Smallpox Vaccine in Adults Without Previous Smallpox Vaccination
Sponsor
Emergent BioSolutions (Industry)
Overall Status
Completed
CT.gov ID
NCT00053495
Collaborator
(none)
353
4
5
10
88.3
8.8
Study Details
Study Description
Brief Summary
The purpose of this study is to examine the safety and the effectiveness of a new vaccine for the prevention of the disease, smallpox.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
The objective of this study is to determine the minimum dose of ACAM2000 that is calculated to produce a major cutaneous reaction in at least 90% of a population of healthy adults 18-29 years of age and naïve to smallpox vaccine. Specifically, the objectives of this study are to:
-
Compare the safety and tolerability of four dose levels of ACAM2000 and a standard dose of Dryvax® in healthy adults 18-29 years of age and naïve to smallpox vaccine. Safety and tolerability will be determined by examination of the local cutaneous reaction, adverse events, physical examinations, vital signs, structured interviews, and laboratory analysis.
-
Determine the immunogenicity of four dose levels of ACAM2000 and a standard dose of
Dryvax® in healthy adults 18-29 years of age by comparing:
-
the proportion of subjects at each dose level who develop a major cutaneous reaction;
-
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.
-
Determine the minimum dose of ACAM2000 that is calculated to produce a major cutaneous reaction in at least 90% of a population of healthy adults 18-29 years of age and naïve to smallpox vaccine.
Study Design
Study Type:
Interventional
Actual Enrollment
:
353 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
The Effect of Dose On Safety, Tolerability, and Immunogenicity of ACAM2000 Smallpox Vaccine in Adults Without Previous Smallpox Vaccination
Study Start Date
:
Jan 1, 2003
Actual Primary Completion Date
:
Jun 1, 2003
Actual Study Completion Date
:
Nov 1, 2003
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group 1: ACAM2000 Dose 1 Participants will receive a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units (PFU)/mL on Day 0. |
Biological: Vaccinia virus: ACAM2000 smallpox vaccine
Group 1 dose: 1.0x10-8th PFU/ml Group 2 dose: 2.0x10-8th PFU/ml Group 3 dose: 1.0x10-7th PFU/ml Group 4 dose: 5.0x10-6th PFU/ml
|
| Experimental: Group 2: ACAM2000 Dose 2 Participants will receive a single dose of ACAM2000 smallpox vaccine, 2.0x10-8th plaque-forming units/mL on Day 0. |
Biological: Vaccinia virus: ACAM2000 smallpox vaccine
Group 1 dose: 1.0x10-8th PFU/ml Group 2 dose: 2.0x10-8th PFU/ml Group 3 dose: 1.0x10-7th PFU/ml Group 4 dose: 5.0x10-6th PFU/ml
|
| Experimental: Group 3: ACAM2000 Dose 3 Participants will receive a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0 |
Biological: Vaccinia virus: ACAM2000 smallpox vaccine
Group 1 dose: 1.0x10-8th PFU/ml Group 2 dose: 2.0x10-8th PFU/ml Group 3 dose: 1.0x10-7th PFU/ml Group 4 dose: 5.0x10-6th PFU/ml
|
| Experimental: Group 4: ACAM2000 Dose 4 Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0 |
Biological: Vaccinia virus: ACAM2000 smallpox vaccine
Group 1 dose: 1.0x10-8th PFU/ml Group 2 dose: 2.0x10-8th PFU/ml Group 3 dose: 1.0x10-7th PFU/ml Group 4 dose: 5.0x10-6th PFU/ml
|
| Active Comparator: Group 5: Dryvax® Vaccine Participants will receive a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0 |
Biological: vaccinia virus (calf lymph): Dryvax
Group 5 dose: 1.0x10-8th PFU/ml
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine [Days 0 to 30 post-vaccination]
The severity of each reported adverse event was classified by the investigator according to the following definitions. None - no symptom; Mild - awareness of sign or symptoms, but easily tolerated; Moderate - discomfort enough to cause interference with usual activity; and Severe - incapacitating with inability to work or perform usual activity.
- Neutralizing Antibody Response Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine. [Day 30 post-vaccination]
- Participants With ≥ 4-fold Increase in Plaque-Reduction Neutralization Test (PRNT50) Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine. [Day 30 post-vaccination]
Other Outcome Measures
- Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine. [Days 0 to 30 post-vaccination]
- Clinical Chemistry Parameters (Aspartate Aminotransaminase and Alanine Aminotransferase) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine [Days 0 (baseline) and 15 post-vaccination]
- Clinical Chemistry Parameters (Creatinine and Glucose) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine [Days 0 (baseline) and 15 post-vaccination]
- Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine. [Days 0 (baseline) and 15 post-vaccination]
- Selected Hematology Parameters (Red Blood Count and Platelets) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine. [Days 0 (baseline) and 15 post-vaccination]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 29 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion criteria:
-
females must not be pregnant, lactating and must agree to use an effective form of birth control for the 30 days following vaccination or unable to bear children.
-
agree to be available for the entire study and agree to comply with all requirements.
Exclusion criteria:
-
military service prior to 1989.
-
history of previous smallpox vaccination.
-
children 1 year of age or younger in the household or be in close contact
-
smallpox vaccination within ten years
-
known or suspected human immunodeficiency virus (HIV) infection, primary immunodeficiency disorder, leukemia, lymphoma, or current radiation treatment or use of immunosuppressive or anti-neoplastic drugs or have a household member or intimate contact with the conditions listed above.
-
renal disease
-
current or past history of eczema or a household member or direct contact who has eczema.
-
known allergy or past allergic reactions to latex gloves or to antibiotics which include neomycin, streptomycin, chlortetracycline, and polymyxin B
-
known allergy or past allergic reaction to blood products.
-
known allergy to cidofovir or sulfa-containing drugs.
-
history of allergic phenomena following smallpox vaccination in the past, including urticaria, erythema multiforme, or Stevens-Johnson syndrome.
-
transfusion of blood or treatment with any blood product.
-
current or history of drug or alcohol abuse
-
inoculation with any other live vaccine or participating in another drug or vaccine trial within 30 days of enrollment.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Orlando Clinical Research Center | Orlando | Florida | United States | 32806 |
| 2 | PRA International | Lenexa | Kansas | United States | 66219 |
| 3 | Bio-Kinetic Clinical Applications | Springfield | Missouri | United States | 65802 |
| 4 | Memorial Hospital of Rhode IslandDivision of Infectious Diseases | Pawtucket | Rhode Island | United States | 02860 |
Sponsors and Collaborators
- Emergent BioSolutions
Investigators
- Study Director: Medical Director, Emergent BioSolutions
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Emergent BioSolutions
ClinicalTrials.gov Identifier:
NCT00053495
Other Study ID Numbers:
- H-400-005
First Posted:
Jan 31, 2003
Last Update Posted:
Aug 13, 2018
Last Verified:
Aug 1, 2018
Study Results
Participant Flow
| Recruitment Details | Participants were enrolled from 10 January 2003 to 14 April 2003 in 4 medical centers in the US. |
|---|---|
| Pre-assignment Detail | A total of 353 participants who met the inclusion and exclusion criteria were enrolled and vaccinated. |
| Arm/Group Title | ACAM2000 Dose 1 | ACAM2000 Dose 2 | ACAM2000 Dose 3 | ACAM2000 Dose 4 | Dryvax® Vaccine |
|---|---|---|---|---|---|
| Arm/Group Description | Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0 | Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10^8th plaque-forming units/mL on Day 0 | Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^7th plaque-forming units/mL on Day 0 | Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10^6th plaque-forming units/mL on Day 0 | Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0 |
| Period Title: Overall Study | |||||
| STARTED | 51 | 101 | 101 | 51 | 49 |
| COMPLETED | 51 | 101 | 101 | 51 | 49 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | ACAM2000 Dose 1 | ACAM2000 Dose 2 | ACAM2000 Dose 3 | ACAM2000 Dose 4 | Dryvax® Vaccine | Total |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0 | Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10^8th plaque-forming units/mL on Day 0 | Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^7th plaque-forming units/mL on Day 0 | Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10^6th plaque-forming units/mL on Day 0 | Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0 | Total of all reporting groups |
| Overall Participants | 51 | 101 | 101 | 51 | 49 | 353 |
| Age (Count of Participants) | ||||||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
51
100%
|
101
100%
|
101
100%
|
51
100%
|
49
100%
|
353
100%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Age (Years) [Mean (Standard Deviation) ] | ||||||
| Mean (Standard Deviation) [Years] |
23
(2.4)
|
22
(3.1)
|
22
(3.2)
|
22
(3.0)
|
22
(3.1)
|
22
(3)
|
| Sex: Female, Male (Count of Participants) | ||||||
| Female |
18
35.3%
|
36
35.6%
|
34
33.7%
|
14
27.5%
|
13
26.5%
|
115
32.6%
|
| Male |
33
64.7%
|
65
64.4%
|
67
66.3%
|
37
72.5%
|
36
73.5%
|
238
67.4%
|
| Region of Enrollment (participants) [Number] | ||||||
| United States |
51
100%
|
101
100%
|
101
100%
|
51
100%
|
49
100%
|
353
100%
|
Outcome Measures
| Title | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine |
|---|---|
| Description | The severity of each reported adverse event was classified by the investigator according to the following definitions. None - no symptom; Mild - awareness of sign or symptoms, but easily tolerated; Moderate - discomfort enough to cause interference with usual activity; and Severe - incapacitating with inability to work or perform usual activity. |
| Time Frame | Days 0 to 30 post-vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Adverse events were assessed in the safety, intent-to-treat population |
| Arm/Group Title | ACAM2000 Dose 1 | ACAM2000 Dose 2 | ACAM2000 Dose 3 | ACAM2000 Dose 4 | Dryvax® Vaccine |
|---|---|---|---|---|---|
| Arm/Group Description | Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0 | Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10^8th plaque-forming units/mL on Day 0 | Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^7th plaque-forming units/mL on Day 0 | Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10^6th plaque-forming units/mL on Day 0 | Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0 |
| Measure Participants | 51 | 101 | 101 | 51 | 49 |
| Lymph Node Pain |
2
3.9%
|
4
4%
|
3
3%
|
4
7.8%
|
2
4.1%
|
| Lymphadenopathy |
0
0%
|
0
0%
|
0
0%
|
1
2%
|
0
0%
|
| Diarrhea Not Otherwise Specified |
1
2%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Nausea |
1
2%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Vomiting Not Otherwise Specified |
1
2%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Injection Site Erythema |
1
2%
|
6
5.9%
|
14
13.9%
|
11
21.6%
|
15
30.6%
|
| Injection Site Swelling |
0
0%
|
0
0%
|
1
1%
|
1
2%
|
0
0%
|
| Injection Site Pruritus |
0
0%
|
0
0%
|
1
1%
|
0
0%
|
1
2%
|
| Fatigue |
0
0%
|
0
0%
|
1
1%
|
0
0%
|
0
0%
|
| Injection Site Pain |
0
0%
|
0
0%
|
1
1%
|
0
0%
|
0
0%
|
| Dehydration |
0
0%
|
0
0%
|
1
1%
|
0
0%
|
0
0%
|
| Myalgia |
0
0%
|
0
0%
|
0
0%
|
1
2%
|
0
0%
|
| Headache Not Otherwise Specified |
1
2%
|
0
0%
|
4
4%
|
1
2%
|
0
0%
|
| Pregnancy Not Otherwise Specified |
0
0%
|
1
1%
|
0
0%
|
1
2%
|
0
0%
|
| Dysuria |
1
2%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Neutralizing Antibody Response Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine. |
|---|---|
| Description | |
| Time Frame | Day 30 post-vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Neutralizing antibody response titers were evaluated in the antibody evaluable, per-protocol population. |
| Arm/Group Title | ACAM2000 Dose 1 | ACAM2000 Dose 2 | ACAM2000 Dose 3 | ACAM2000 Dose 4 | Dryvax® Vaccine |
|---|---|---|---|---|---|
| Arm/Group Description | Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0 | Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10^8th plaque-forming units/mL on Day 0 | Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^7th plaque-forming units/mL on Day 0 | Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10^6th plaque-forming units/mL on Day 0 | Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0 |
| Measure Participants | 51 | 100 | 100 | 50 | 49 |
| Mean (Standard Deviation) [PRNT50 Titers] |
212
(536.4)
|
278
(581.6)
|
425
(947.4)
|
582
(1129.3)
|
1515
(6019.4)
|
| Title | Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine. |
|---|---|
| Description | |
| Time Frame | Days 0 to 30 post-vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Treatment-emergent rash events were assessed in the safety, intent-to-treat population. |
| Arm/Group Title | ACAM2000 Dose 1 | ACAM2000 Dose 2 | ACAM2000 Dose 3 | ACAM2000 Dose 4 | Dryvax® Vaccine |
|---|---|---|---|---|---|
| Arm/Group Description | Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0 | Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10^8th plaque-forming units/mL on Day 0 | Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^7th plaque-forming units/mL on Day 0 | Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10^6th plaque-forming units/mL on Day 0 | Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0 |
| Measure Participants | 51 | 101 | 101 | 51 | 49 |
| Rash Not Otherwise Specified |
3
5.9%
|
10
9.9%
|
9
8.9%
|
5
9.8%
|
7
14.3%
|
| Rash Pruritic |
0
0%
|
1
1%
|
0
0%
|
0
0%
|
0
0%
|
| Rash Pustular |
0
0%
|
1
1%
|
0
0%
|
0
0%
|
1
2%
|
| Application Site Rash |
0
0%
|
1
1%
|
1
1%
|
3
5.9%
|
2
4.1%
|
| Injection Site Rash |
0
0%
|
0
0%
|
1
1%
|
0
0%
|
1
2%
|
| Any Rash Event |
3
5.9%
|
11
10.9%
|
10
9.9%
|
7
13.7%
|
10
20.4%
|
| Title | Clinical Chemistry Parameters (Aspartate Aminotransaminase and Alanine Aminotransferase) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine |
|---|---|
| Description | |
| Time Frame | Days 0 (baseline) and 15 post-vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Clinical chemistry parameters were assessed in safety, intent-to-treat population |
| Arm/Group Title | ACAM2000 Dose 1 | ACAM2000 Dose 2 | ACAM2000 Dose 3 | ACAM2000 Dose 4 | Dryvax® Vaccine |
|---|---|---|---|---|---|
| Arm/Group Description | Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0 | Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10^8th plaque-forming units/mL on Day 0 | Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^7th plaque-forming units/mL on Day 0 | Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10^6th plaque-forming units/mL on Day 0 | Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0 |
| Measure Participants | 51 | 101 | 101 | 51 | 49 |
| Aspartate Aminotransferase (Baseline) |
21
(7.4)
|
21
(5.9)
|
22
(7.1)
|
23
(7.1)
|
20
(5.8)
|
| Aspartate Aminotransferase (Day 15) |
23
(10.5)
|
21
(7.7)
|
22
(7.5)
|
21
(6.3)
|
22
(6.8)
|
| Alanine Aminotransferase (Baseline) |
32
(15.0)
|
32
(16.2)
|
33
(17.4)
|
36
(18.5)
|
31
(16.8)
|
| Alanine Aminotransferase (Day 15) |
33
(15.4)
|
32
(17.5)
|
33
(16.6)
|
34
(16.2)
|
33
(17.9)
|
| Title | Clinical Chemistry Parameters (Creatinine and Glucose) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine |
|---|---|
| Description | |
| Time Frame | Days 0 (baseline) and 15 post-vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Clinical chemistry parameters were assessed in safety, intent-to-treat population |
| Arm/Group Title | ACAM2000 Dose 1 | ACAM2000 Dose 2 | ACAM2000 Dose 3 | ACAM2000 Dose 4 | Dryvax® Vaccine |
|---|---|---|---|---|---|
| Arm/Group Description | Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0 | Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10^8th plaque-forming units/mL on Day 0 | Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^7th plaque-forming units/mL on Day 0 | Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10^6th plaque-forming units/mL on Day 0 | Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0 |
| Measure Participants | 51 | 101 | 101 | 51 | 49 |
| Creatinine (Baseline) |
0.97
(0.147)
|
0.96
(0.153)
|
0.98
(0.181)
|
0.97
(0.171)
|
0.97
(0.158)
|
| Creatinine (Day 15) |
0.98
(0.149)
|
0.98
(0.142)
|
0.98
(0.169)
|
1.00
(0.144)
|
1.00
(0.163)
|
| Glucose (Baseline) |
85
(7.3)
|
84
(9.8)
|
86
(7.4)
|
86
(8.3)
|
87
(18.6)
|
| Glucose (Day 15) |
83
(14.2)
|
86
(14.6)
|
86
(10.6)
|
87
(13.2)
|
88
(21.4)
|
| Title | Participants With ≥ 4-fold Increase in Plaque-Reduction Neutralization Test (PRNT50) Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine. |
|---|---|
| Description | |
| Time Frame | Day 30 post-vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Plaque-reduction neutralization test (PRNT50) titers were determined in the antibody evaluable, per-protocol population |
| Arm/Group Title | ACAM2000 Dose 1 | ACAM2000 Dose 2 | ACAM2000 Dose 3 | ACAM2000 Dose 4 | Dryvax® Vaccine |
|---|---|---|---|---|---|
| Arm/Group Description | Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0 | Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10^8th plaque-forming units/mL on Day 0 | Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^7th plaque-forming units/mL on Day 0 | Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10^6th plaque-forming units/mL on Day 0 | Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0 |
| Measure Participants | 50 | 100 | 100 | 51 | 49 |
| Number [Participants] |
28
54.9%
|
73
72.3%
|
84
83.2%
|
48
94.1%
|
47
95.9%
|
| Title | Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine. |
|---|---|
| Description | |
| Time Frame | Days 0 (baseline) and 15 post-vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Hematology parameters were evaluated in the safety, intent-to-treat population. |
| Arm/Group Title | ACAM2000 Dose 1 | ACAM2000 Dose 2 | ACAM2000 Dose 3 | ACAM2000 Dose 4 | Dryvax® Vaccine |
|---|---|---|---|---|---|
| Arm/Group Description | Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0 | Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10^8th plaque-forming units/mL on Day 0 | Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^7th plaque-forming units/mL on Day 0 | Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10^6th plaque-forming units/mL on Day 0 | Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0 |
| Measure Participants | 51 | 101 | 101 | 51 | 49 |
| Hematocrit (Baseline) |
43.7
(4.20)
|
43.2
(3.71)
|
43.2
(4.44)
|
44.2
(3.29)
|
44.1
(3.54)
|
| Hematocrit (Day 15) |
42.8
(3.74)
|
42.3
(3.59)
|
42.7
(3.21)
|
43.2
(2.55)
|
43.1
(3.13)
|
| Lymphocytes (Baseline) |
30.6
(8.26)
|
31.5
(8.33)
|
30.7
(7.00)
|
29.6
(7.45)
|
31.6
(7.99)
|
| Lymphocytes (Day 15) |
33.9
(8.62)
|
34.0
(7.41)
|
34.7
(7.93)
|
33.9
(6.83)
|
33.8
(7.58)
|
| Eosinophils (Baseline) |
2.5
(1.61)
|
2.5
(1.95)
|
2.4
(1.69)
|
2.3
(1.42)
|
2.4
(1.72)
|
| Eosinophils (Day 15) |
2.8
(2.07)
|
2.8
(2.11)
|
2.6
(1.65)
|
2.7
(1.42)
|
2.7
(1.61)
|
| Title | Selected Hematology Parameters (Red Blood Count and Platelets) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine. |
|---|---|
| Description | |
| Time Frame | Days 0 (baseline) and 15 post-vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Hematology parameters were evaluated in the safety, intent-to-treat population. |
| Arm/Group Title | ACAM2000 Dose 1 | ACAM2000 Dose 2 | ACAM2000 Dose 3 | ACAM2000 Dose 4 | Dryvax® Vaccine |
|---|---|---|---|---|---|
| Arm/Group Description | Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0 | Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10^8th plaque-forming units/mL on Day 0 | Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^7th plaque-forming units/mL on Day 0 | Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10^6th plaque-forming units/mL on Day 0 | Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0 |
| Measure Participants | 51 | 101 | 101 | 51 | 49 |
| Red Blood Cell Count (Baseline) |
5.1
(0.53)
|
5.0
(0.47)
|
5.1
(0.44)
|
5.1
(0.45)
|
5.1
(0.44)
|
| Red Blood Cell Count (Day 15) |
5.0
(0.50)
|
4.9
(0.44)
|
5.0
(0.39)
|
5.0
(0.37)
|
5.0
(0.38)
|
| Platelets (Baseline) |
274
(64.0)
|
282
(60.1)
|
281
(68.1)
|
274
(52.4)
|
267
(51.6)
|
| Platelets (Day 15) |
284
(58.6)
|
280
(57.7)
|
281
(65.1)
|
284
(59.3)
|
285
(52.1)
|
Adverse Events
| Time Frame | Adverse events data were collected from the day of vaccination for up to 6 months post-vaccination. | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||
| Arm/Group Title | ACAM2000 Dose 1 | ACAM2000 Dose 2 | ACAM2000 Dose 3 | ACAM2000 Dose 4 | Dryvax® Vaccine | |||||
| Arm/Group Description | Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0 | Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10^8th plaque-forming units/mL on Day 0 | Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^7th plaque-forming units/mL on Day 0 | Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10^6th plaque-forming units/mL on Day 0 | Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0 | |||||
All Cause Mortality |
||||||||||
| ACAM2000 Dose 1 | ACAM2000 Dose 2 | ACAM2000 Dose 3 | ACAM2000 Dose 4 | Dryvax® Vaccine | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | |||||
Serious Adverse Events |
||||||||||
| ACAM2000 Dose 1 | ACAM2000 Dose 2 | ACAM2000 Dose 3 | ACAM2000 Dose 4 | Dryvax® Vaccine | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/51 (2%) | 1/101 (1%) | 0/101 (0%) | 1/51 (2%) | 0/49 (0%) | |||||
| Pregnancy, puerperium and perinatal conditions | ||||||||||
| Pregnancy Not Otherwise Specified | 1/51 (2%) | 1 | 1/101 (1%) | 1 | 0/101 (0%) | 0 | 1/51 (2%) | 1 | 0/49 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||||
| ACAM2000 Dose 1 | ACAM2000 Dose 2 | ACAM2000 Dose 3 | ACAM2000 Dose 4 | Dryvax® Vaccine | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 51/51 (100%) | 99/101 (98%) | 98/101 (97%) | 51/51 (100%) | 49/49 (100%) | |||||
| Blood and lymphatic system disorders | ||||||||||
| Lymph Node Pain | 22/51 (43.1%) | 59/101 (58.4%) | 61/101 (60.4%) | 39/51 (76.5%) | 44/49 (89.8%) | |||||
| Lymphadenopathy | 11/51 (21.6%) | 26/101 (25.7%) | 25/101 (24.8%) | 19/51 (37.3%) | 17/49 (34.7%) | |||||
| Gastrointestinal disorders | ||||||||||
| Nausea | 13/51 (25.5%) | 21/101 (20.8%) | 21/101 (20.8%) | 11/51 (21.6%) | 14/49 (28.6%) | |||||
| Diarrhea Not Otherwise Specified | 9/51 (17.6%) | 13/101 (12.9%) | 21/101 (20.8%) | 5/51 (9.8%) | 7/49 (14.3%) | |||||
| Vomiting Not Otherwise Specified | 5/51 (9.8%) | 2/101 (2%) | 10/101 (9.9%) | 4/51 (7.8%) | 3/49 (6.1%) | |||||
| General disorders | ||||||||||
| Injection Site Pruritus | 43/51 (84.3%) | 89/101 (88.1%) | 82/101 (81.2%) | 51/51 (100%) | 49/49 (100%) | |||||
| Injection Site Erythema | 27/51 (52.9%) | 65/101 (64.4%) | 64/101 (63.4%) | 37/51 (72.5%) | 37/49 (75.5%) | |||||
| Injection Site Pain | 22/51 (43.1%) | 59/101 (58.4%) | 58/101 (57.4%) | 35/51 (68.6%) | 35/49 (71.4%) | |||||
| Fatigue | 23/51 (45.1%) | 41/101 (40.6%) | 55/101 (54.5%) | 29/51 (56.9%) | 28/49 (57.1%) | |||||
| Malaise | 18/51 (35.3%) | 27/101 (26.7%) | 29/101 (28.7%) | 18/51 (35.3%) | 23/49 (46.9%) | |||||
| Feeling Hot | 14/51 (27.5%) | 26/101 (25.7%) | 24/101 (23.8%) | 13/51 (25.5%) | 19/49 (38.8%) | |||||
| Rigors | 7/51 (13.7%) | 14/101 (13.9%) | 19/101 (18.8%) | 13/51 (25.5%) | 14/49 (28.6%) | |||||
| Injection Site Swelling | 3/51 (5.9%) | 6/101 (5.9%) | 6/101 (5.9%) | 5/51 (9.8%) | 2/49 (4.1%) | |||||
| Musculoskeletal and connective tissue disorders | ||||||||||
| Myalgia | 21/51 (41.2%) | 40/101 (39.6%) | 47/101 (46.5%) | 26/51 (51%) | 27/49 (55.1%) | |||||
| Nervous system disorders | ||||||||||
| Headache Not Otherwise Specified | 30/51 (58.8%) | 51/101 (50.5%) | 49/101 (48.5%) | 24/51 (47.1%) | 28/49 (57.1%) | |||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| Pharyngitis | 1/51 (2%) | 11/101 (10.9%) | 8/101 (7.9%) | 2/51 (3.9%) | 1/49 (2%) | |||||
| Skin and subcutaneous tissue disorders | ||||||||||
| Rash Not Otherwise Specified | 3/51 (5.9%) | 10/101 (9.9%) | 9/101 (8.9%) | 5/51 (9.8%) | 7/49 (14.3%) | |||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | Eddie Darton, Medical Director |
|---|---|
| Organization | Emergent BioSolutions |
| Phone | 240-631-3688 |
| dartone@ebsi.com |
Responsible Party:
Emergent BioSolutions
ClinicalTrials.gov Identifier:
NCT00053495
Other Study ID Numbers:
- H-400-005
First Posted:
Jan 31, 2003
Last Update Posted:
Aug 13, 2018
Last Verified:
Aug 1, 2018