Dose Study of ACAM2000 Smallpox Vaccine in Previously Vaccinated Adults
Sponsor
Emergent BioSolutions (Industry)
Overall Status
Completed
CT.gov ID
NCT00053482
Collaborator
(none)
357
3
5
9
119
13.3
Study Details
Study Description
Brief Summary
The objective of this study is to determine the minimum dose of ACAM2000 needed to produce a cutaneous reaction in at least 90% of a population of healthy adults at least 28 years of age and previously vaccinated against smallpox.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
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 at least 28 years of age and previously vaccinated to smallpox. Safety and tolerability will be determined by examination of the local cutaneous reaction, adverse events, physical examinations, vital signs, structured interviews, and laboratory analysis.
-
Determine the immunogenicity of four dose levels of ACAM2000 and a standard dose of
Dryvax® in healthy adults at least 28 years of age by comparing:
-
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 at least 28 years of age, with a history of smallpox vaccination.
Study Design
Study Type:
Interventional
Actual Enrollment
:
357 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 With Previous Smallpox Vaccination
Study Start Date
:
Jan 1, 2003
Actual Primary Completion Date
:
Apr 1, 2003
Actual Study Completion Date
:
Oct 1, 2003
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group 1: ACAM2000 Participants will receive dose 1 of the ACAM2000 smallpox vaccine |
Biological: ACAM2000 Smallpox Vaccine
Group 1 dose: 1.0x10-8th PFU/ml, Group 2 dose: 2.0x10-7th PFU/ml, Group 3 dose: 1.0x10-7th PFU/ml, Group 4 dose: 5.0x10-6th PFUL/ml
|
| Experimental: Group 2: ACAM2000 Participants will receive dose 2 of the ACAM2000 smallpox vaccine |
Biological: ACAM2000 Smallpox Vaccine
Group 1 dose: 1.0x10-8th PFU/ml, Group 2 dose: 2.0x10-7th PFU/ml, Group 3 dose: 1.0x10-7th PFU/ml, Group 4 dose: 5.0x10-6th PFUL/ml
|
| Experimental: Group 3: ACAM2000 Participants will receive dose 3 of the ACAM2000 smallpox vaccine |
Biological: ACAM2000 Smallpox Vaccine
Group 1 dose: 1.0x10-8th PFU/ml, Group 2 dose: 2.0x10-7th PFU/ml, Group 3 dose: 1.0x10-7th PFU/ml, Group 4 dose: 5.0x10-6th PFUL/ml
|
| Experimental: Group 4: ACAM2000 Participants will receive dose 4 of the ACAM2000 smallpox vaccine |
Biological: ACAM2000 Smallpox Vaccine
Group 1 dose: 1.0x10-8th PFU/ml, Group 2 dose: 2.0x10-7th PFU/ml, Group 3 dose: 1.0x10-7th PFU/ml, Group 4 dose: 5.0x10-6th PFUL/ml
|
| Active Comparator: Group 5: Dryvax® Participants will receive dose 1 of Dryvax® smallpox vaccine. |
Biological: Vaccinia virus (calf lymph) smallpox vaccine: Dryvax®
Group 5 dose: 1.0x10-8th PFU/ml
Other Names:
|
Outcome Measures
Primary Outcome Measures
- The Neutralizing Antibody Response Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine [Day 30 post-vaccination]
The neutralizing antibody response titers were determined by the Plaque-Reduction Neutralization Test (PRNT50)
- Participants With ≥ 4-fold Increase in Plaque-Reduction Neutralization Test (PRNT50) Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine. [Day 30 post-vaccination]
- Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine [Days 0 to 30 post-vaccination]
Other Outcome Measures
- Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine [Days 0 to 30 post-vaccination]
- Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine [Days 0 (Baseline) and 15 post-vaccination]
- Selected Hematology Parameters (Red Bood Cell and Platelets) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine [Days 0 (Baseline) and 15 post-vaccination]
- 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]
- Clinical Chemistry Parameters (Aspartate Transaminase and Alanine Transaminase) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine [Days 0 (Baseline) and 15 post-vaccination]
Eligibility Criteria
Criteria
Ages Eligible for Study:
28 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion criteria:
-
have a history of previous smallpox vaccination greater than 10 years previous to the date of screening and presence of a vaccination scar.
-
females must not be pregnant, lactating and must agree to use an effective form of birth control for the 30 days following vaccination or unable to bear children.
-
agree to be available for the entire study and agree to comply with all requirements.
exclusion criteria:
-
children 1 year of age or younger in the household or be in close contact
-
smallpox vaccination within ten years
-
known or suspected Human immunodeficient virus (HIV) infection, primary immunodeficiency disorder, leukemia, lymphoma, or current radiation treatment or use of immunosuppressive or anti-neoplastic drugs or have a household member or intimate contact with the conditions listed above.
-
renal disease
-
current or past history of eczema or a household member or direct contact who has eczema.
-
known allergy or past allergic reactions to latex gloves or to antibiotics which include neomycin, streptomycin, chlortetracycline, and polymyxin B
-
known allergy or past allergic reaction to blood products.
-
known allergy to cidofovir or sulfa-containing drugs.
-
history of allergic phenomena following smallpox vaccination in the past, including urticaria, erythema multiforme, or Stevens-Johnson syndrome.
-
transfusion of blood or treatment with any blood product.
-
current or history of drug or alcohol abuse
-
innoculation with any other live vaccine or participating in another drug or vaccine trial within 30 days of enrollment.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | PRA International | Lenexa | Kansas | United States | 66219 |
| 2 | Bio-Kinetic Clinical Applications | Springfield | Missouri | United States | 65802 |
| 3 | Memorial Hospital of Rhode Island Division 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:
NCT00053482
Other Study ID Numbers:
- H-400-003
First Posted:
Jan 31, 2003
Last Update Posted:
Aug 13, 2018
Last Verified:
Aug 1, 2018
Keywords provided by Emergent BioSolutions
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Participants were enrolled from 07 January 2003 to 31 March 2003 in 3 medical centers in the US. |
|---|---|
| Pre-assignment Detail | A total of 357 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, 2.0x10-7th 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 | 102 | 102 | 50 | 52 |
| COMPLETED | 51 | 102 | 102 | 50 | 52 |
| 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, 2.0x10-7th 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 | 102 | 102 | 50 | 52 | 357 |
| 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%
|
102
100%
|
102
100%
|
50
100%
|
52
100%
|
357
100%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Age (Years) [Mean (Standard Deviation) ] | ||||||
| Mean (Standard Deviation) [Years] |
48
(9.7)
|
48
(10.1)
|
50
(11.7)
|
47
(9.1)
|
48
(9.2)
|
48
(10.5)
|
| Sex: Female, Male (Count of Participants) | ||||||
| Female |
27
52.9%
|
57
55.9%
|
54
52.9%
|
18
36%
|
19
36.5%
|
175
49%
|
| Male |
24
47.1%
|
45
44.1%
|
48
47.1%
|
32
64%
|
33
63.5%
|
182
51%
|
| Region of Enrollment (participants) [Number] | ||||||
| United States |
51
100%
|
102
100%
|
102
100%
|
50
100%
|
52
100%
|
357
100%
|
Outcome Measures
| Title | The Neutralizing Antibody Response Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine |
|---|---|
| Description | The neutralizing antibody response titers were determined by the Plaque-Reduction Neutralization Test (PRNT50) |
| Time Frame | Day 30 post-vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| The neutralizing antibody response titers were assessed 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, 2.0x10-7th 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 | 102 | 102 | 50 | 52 |
| Baseline |
77
(119.4)
|
112
(280.5)
|
76
(108.7)
|
91
(145.4)
|
186
(709.8)
|
| Day 15 |
244
(485.4)
|
259
(449.1)
|
802
(4111.6)
|
546
(829.9)
|
1287
(2198.4)
|
| 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 |
|---|
| [Not Specified] |
| 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, 2.0x10-7th 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 | 102 | 102 | 50 | 52 |
| Number [Participants] |
13
25.5%
|
31
30.4%
|
41
40.2%
|
38
76%
|
39
75%
|
| Title | Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine |
|---|---|
| Description | |
| Time Frame | Days 0 to 30 post-vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Post-vaccination 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, 2.0x10-7th 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 | 102 | 102 | 50 | 52 |
| Lymph Node Pain |
1
2%
|
1
1%
|
1
1%
|
1
2%
|
0
0%
|
| Lymphadenopathy |
0
0%
|
0
0%
|
1
1%
|
0
0%
|
0
0%
|
| Constipation |
0
0%
|
0
0%
|
1
1%
|
0
0%
|
0
0%
|
| Toothache |
0
0%
|
1
1%
|
0
0%
|
0
0%
|
0
0%
|
| Injection Site Erythema |
0
0%
|
1
1%
|
3
2.9%
|
4
8%
|
3
5.8%
|
| Injection Site Pruritus |
0
0%
|
1
1%
|
0
0%
|
0
0%
|
1
1.9%
|
| Injection Site Pain |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
1.9%
|
| Human Immunodeficiency Virus (HIV) Test Positive |
1
2%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Back Pain |
0
0%
|
1
1%
|
0
0%
|
0
0%
|
0
0%
|
| Myalgia |
1
2%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Swelling Not Otherwise Specified |
0
0%
|
0
0%
|
0
0%
|
1
2%
|
0
0%
|
| Migraine Not Otherwise Specified |
0
0%
|
1
1%
|
0
0%
|
0
0%
|
0
0%
|
| Pregnancy Not Otherwise Specified |
0
0%
|
1
1%
|
0
0%
|
0
0%
|
0
0%
|
| Calculus Renal Not Otherwise Specified |
0
0%
|
1
1%
|
0
0%
|
0
0%
|
0
0%
|
| 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, 2.0x10-7th 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 | 102 | 102 | 50 | 52 |
| Rash Not Otherwise Specified |
2
3.9%
|
5
4.9%
|
5
4.9%
|
5
10%
|
3
5.8%
|
| Rash Macular |
0
0%
|
0
0%
|
0
0%
|
1
2%
|
0
0%
|
| Rash Papular |
0
0%
|
0
0%
|
1
1%
|
0
0%
|
0
0%
|
| Application Site Rash |
0
0%
|
0
0%
|
1
1%
|
1
2%
|
2
3.8%
|
| Injection Site Rash |
1
2%
|
0
0%
|
1
1%
|
0
0%
|
2
3.8%
|
| Any Rash |
3
5.9%
|
5
4.9%
|
8
7.8%
|
7
14%
|
5
9.6%
|
| Title | Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) 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 |
|---|
| The hematology parameters were assessed in the intent-to-treat safety 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, 2.0x10-7th 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 | 102 | 102 | 50 | 52 |
| Hematocrit (Baseline) |
41.7
(3.58)
|
42.4
(3.87)
|
42.2
(3.66)
|
42.8
(3.69)
|
43.3
(3.62)
|
| Hematocrit (Day15) |
41.2
(3.53)
|
41.6
(3.86)
|
41.5
(3.68)
|
42.1
(3.30)
|
42.8
(3.27)
|
| Lymphocytes (Baseline) |
31.8
(7.27)
|
30.8
(6.68)
|
30.6
(7.87)
|
30.4
(6.98)
|
30.9
(6.27)
|
| Lymphocytes (Day15) |
32.4
(6.88)
|
30.8
(7.19)
|
31.3
(8.26)
|
31.2
(7.36)
|
33.4
(7.00)
|
| Eosinophils (Baseline) |
2.8
(1.89)
|
2.5
(2.09)
|
2.5
(1.50)
|
2.3
(1.37)
|
2.8
(1.84)
|
| Eosinophils (Day15) |
2.5
(1.43)
|
2.5
(2.02)
|
2.6
(1.66)
|
2.5
(1.55)
|
3.1
(2.2)
|
| Title | Selected Hematology Parameters (Red Bood Cell and Platelets) 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 |
|---|
| The hematology parameters were assessed in the intent-to-treat safety 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, 2.0x10-7th 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 | 102 | 102 | 50 | 52 |
| Red Blood Cell count (Baseline) |
4.7
(0.35)
|
4.8
(0.47)
|
4.8
(0.46)
|
4.9
(0.40)
|
4.9
(0.45)
|
| Red Blood Cell count (Day15) |
4.7
(0.36)
|
4.7
(0.50)
|
4.7
(0.50)
|
4.8
(0.36)
|
4.8
(0.41)
|
| Platelets (Baseline) |
279
(69.7)
|
276
(54.5)
|
277
(71.5)
|
285
(58.4)
|
280
(75.7)
|
| Platelets (Day15) |
286
(66.7)
|
281
(61.3)
|
276
(67.2)
|
284
(63.2)
|
284
(77.0)
|
| 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 the intent-to-treat safety 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, 2.0x10-7th 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 | 102 | 102 | 50 | 52 |
| Creatinine (Baseline) |
0.90
(0.122)
|
0.94
(0.167)
|
0.92
(0.187)
|
0.94
(0.184)
|
0.97
(0.156)
|
| Creatinine (Day 15) |
0.91
(0.145)
|
0.96
(0.181)
|
0.95
(0.184)
|
0.96
(0.184)
|
0.98
(0.138)
|
| Glucose (Baseline) |
91
(11.7)
|
87
(8.7)
|
92
(15.3)
|
92
(13.4)
|
88
(10.7)
|
| Glucose (Day 15) |
94
(22.6)
|
90
(18.9)
|
90
(16.3)
|
94
(28.4)
|
95
(27.3)
|
| Title | Clinical Chemistry Parameters (Aspartate Transaminase and Alanine Transaminase) 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 the intent-to-treat safety 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, 2.0x10-7th 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 | 102 | 102 | 50 | 52 |
| Aspartate transaminase (Baseline) |
27
(13.2)
|
24
(9.9)
|
23
(10.3)
|
22
(6.9)
|
22
(6.2)
|
| Aspartate transaminase (Day 15) |
24
(11.5)
|
23
(8.7)
|
24
(10.7)
|
21
(10.4)
|
21
(5.8)
|
| Alanine transaminase (Baseline) |
39
(16.3)
|
39
(19.5)
|
37
(17.3)
|
37
(15.7)
|
36
(12.9)
|
| Alanine transaminase (Day 15) |
39
(20.1)
|
38
(20.4)
|
37
(19.2)
|
37
(16.0)
|
34
(13.8)
|
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, 2.0x10-7th 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%) | 1/102 (1%) | 0/102 (0%) | 0/50 (0%) | 0/52 (0%) | |||||
| Investigations | ||||||||||
| HIV test positive | 1/51 (2%) | 1 | 0/102 (0%) | 0 | 0/102 (0%) | 0 | 0/50 (0%) | 0 | 0/52 (0%) | 0 |
| Pregnancy, puerperium and perinatal conditions | ||||||||||
| Pregnancy Not Otherwise Specified | 0/51 (0%) | 0 | 1/102 (1%) | 1 | 0/102 (0%) | 0 | 0/50 (0%) | 0 | 0/52 (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 | 48/51 (94.1%) | 93/102 (91.2%) | 98/102 (96.1%) | 49/50 (98%) | 51/52 (98.1%) | |||||
| Blood and lymphatic system disorders | ||||||||||
| Lymph Node Pain | 5/51 (9.8%) | 8/102 (7.8%) | 20/102 (19.6%) | 14/50 (28%) | 12/52 (23.1%) | |||||
| Lymphadenopathy | 3/51 (5.9%) | 5/102 (4.9%) | 6/102 (5.9%) | 1/50 (2%) | 5/52 (9.6%) | |||||
| Gastrointestinal disorders | ||||||||||
| Diarrhea Not Otherwise Specified | 8/51 (15.7%) | 17/102 (16.7%) | 11/102 (10.8%) | 12/50 (24%) | 9/52 (17.3%) | |||||
| Nausea | 7/51 (13.7%) | 8/102 (7.8%) | 11/102 (10.8%) | 8/50 (16%) | 5/52 (9.6%) | |||||
| Constipation | 4/51 (7.8%) | 5/102 (4.9%) | 9/102 (8.8%) | 3/50 (6%) | 3/52 (5.8%) | |||||
| General disorders | ||||||||||
| Injection Site Pruritus | 29/51 (56.9%) | 59/102 (57.8%) | 77/102 (75.5%) | 38/50 (76%) | 43/52 (82.7%) | |||||
| Injection Site Erythema | 20/51 (39.2%) | 42/102 (41.2%) | 48/102 (47.1%) | 24/50 (48%) | 30/52 (57.7%) | |||||
| Fatigue | 15/51 (29.4%) | 28/102 (27.5%) | 41/102 (40.2%) | 18/50 (36%) | 18/52 (34.6%) | |||||
| Malaise | 17/51 (33.3%) | 20/102 (19.6%) | 29/102 (28.4%) | 18/50 (36%) | 15/52 (28.8%) | |||||
| Feeling Hot | 12/51 (23.5%) | 15/102 (14.7%) | 14/102 (13.7%) | 13/50 (26%) | 6/52 (11.5%) | |||||
| Rigors | 9/51 (17.6%) | 11/102 (10.8%) | 13/102 (12.7%) | 10/50 (20%) | 8/52 (15.4%) | |||||
| Injection Site Inflammation | 0/51 (0%) | 3/102 (2.9%) | 7/102 (6.9%) | 7/50 (14%) | 11/52 (21.2%) | |||||
| Injection Site Pain | 13/51 (25.5%) | 27/102 (26.5%) | 36/102 (35.3%) | 16/50 (32%) | 19/52 (36.5%) | |||||
| Infections and infestations | ||||||||||
| Nasopharyngitis | 1/51 (2%) | 1/102 (1%) | 11/102 (10.8%) | 7/50 (14%) | 3/52 (5.8%) | |||||
| Musculoskeletal and connective tissue disorders | ||||||||||
| Myalgia | 14/51 (27.5%) | 33/102 (32.4%) | 30/102 (29.4%) | 15/50 (30%) | 7/52 (13.5%) | |||||
| Back Pain | 3/51 (5.9%) | 6/102 (5.9%) | 4/102 (3.9%) | 1/50 (2%) | 4/52 (7.7%) | |||||
| Nervous system disorders | ||||||||||
| Headache Not Otherwise Specified | 24/51 (47.1%) | 39/102 (38.2%) | 46/102 (45.1%) | 25/50 (50%) | 21/52 (40.4%) | |||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| Pharyngitis | 3/51 (5.9%) | 5/102 (4.9%) | 7/102 (6.9%) | 2/50 (4%) | 2/52 (3.8%) | |||||
| Skin and subcutaneous tissue disorders | ||||||||||
| Rash Not Otherwise Specified | 2/51 (3.9%) | 5/102 (4.9%) | 5/102 (4.9%) | 5/50 (10%) | 3/52 (5.8%) | |||||
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:
NCT00053482
Other Study ID Numbers:
- H-400-003
First Posted:
Jan 31, 2003
Last Update Posted:
Aug 13, 2018
Last Verified:
Aug 1, 2018