Back to resultsEffect of Dose, Safety, Tolerability of a New Smallpox Vaccine in Adults Without Previous Smallpox Vaccination
Primary Purpose
Smallpox
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Vaccinia virus: ACAM2000 smallpox vaccine
vaccinia virus (calf lymph): Dryvax
Sponsored by
About this trial
This is an interventional prevention trial for Smallpox focused on measuring Smallpox
Eligibility Criteria
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.
Sites / Locations
- Orlando Clinical Research Center
- PRA International
- Bio-Kinetic Clinical Applications
- Memorial Hospital of Rhode IslandDivision of Infectious Diseases
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Active Comparator
Arm Label
Group 1: ACAM2000 Dose 1
Group 2: ACAM2000 Dose 2
Group 3: ACAM2000 Dose 3
Group 4: ACAM2000 Dose 4
Group 5: Dryvax® Vaccine
Arm Description
Participants will receive a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units (PFU)/mL on Day 0.
Participants will receive a single dose of ACAM2000 smallpox vaccine, 2.0x10-8th plaque-forming units/mL on Day 0.
Participants will receive 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 will receive a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
Outcomes
Primary Outcome Measures
Number of Participants Reporting Adverse Events of Severe Intensity Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine
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.
Participants With ≥ 4-fold Increase in Plaque-Reduction Neutralization Test (PRNT50) Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00053495
Brief Title
Effect of Dose, Safety, Tolerability of a New Smallpox Vaccine in Adults Without Previous Smallpox Vaccination
Official Title
The Effect of Dose On Safety, Tolerability, and Immunogenicity of ACAM2000 Smallpox Vaccine in Adults Without Previous Smallpox Vaccination
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
June 2003 (Actual)
Study Completion Date
November 2003 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Emergent BioSolutions
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smallpox
Keywords
Smallpox
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
353 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1: ACAM2000 Dose 1
Arm Type
Experimental
Arm Description
Participants will receive a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units (PFU)/mL on Day 0.
Arm Title
Group 2: ACAM2000 Dose 2
Arm Type
Experimental
Arm Description
Participants will receive a single dose of ACAM2000 smallpox vaccine, 2.0x10-8th plaque-forming units/mL on Day 0.
Arm Title
Group 3: ACAM2000 Dose 3
Arm Type
Experimental
Arm Description
Participants will receive a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
Arm Title
Group 4: ACAM2000 Dose 4
Arm Type
Experimental
Arm Description
Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
Arm Title
Group 5: Dryvax® Vaccine
Arm Type
Active Comparator
Arm Description
Participants will receive a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
Intervention Type
Biological
Intervention Name(s)
Vaccinia virus: ACAM2000 smallpox vaccine
Intervention Description
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
Intervention Type
Biological
Intervention Name(s)
vaccinia virus (calf lymph): Dryvax
Other Intervention Name(s)
Dryvax®
Intervention Description
Group 5 dose: 1.0x10-8th PFU/ml
Primary Outcome Measure Information:
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
Title
Neutralizing Antibody Response Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine.
Time Frame
Day 30 post-vaccination
Title
Participants With ≥ 4-fold Increase in Plaque-Reduction Neutralization Test (PRNT50) Titers Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine.
Time Frame
Day 30 post-vaccination
Other Pre-specified Outcome Measures:
Title
Number of Participants With Treatment-Emergent Rash Events Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine.
Time Frame
Days 0 to 30 post-vaccination
Title
Clinical Chemistry Parameters (Aspartate Aminotransaminase and Alanine Aminotransferase) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine
Time Frame
Days 0 (baseline) and 15 post-vaccination
Title
Clinical Chemistry Parameters (Creatinine and Glucose) at Baseline and Day 15 Post-vaccination With ACAM2000 or Dryvax® Smallpox Vaccine
Time Frame
Days 0 (baseline) and 15 post-vaccination
Title
Selected Hematology Parameters (Hematocrit, Lymphocyte, and Eosinophil) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine.
Time Frame
Days 0 (baseline) and 15 post-vaccination
Title
Selected Hematology Parameters (Red Blood Count and Platelets) at Baseline and on Day 15 in Participants Vaccinated With ACAM2000 or Dryvax® Smallpox Vaccine.
Time Frame
Days 0 (baseline) and 15 post-vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Emergent BioSolutions
Official's Role
Study Director
Facility Information:
Facility Name
Orlando Clinical Research Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
PRA International
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States
Facility Name
Bio-Kinetic Clinical Applications
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65802
Country
United States
Facility Name
Memorial Hospital of Rhode IslandDivision of Infectious Diseases
City
Pawtucket
State/Province
Rhode Island
ZIP/Postal Code
02860
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of Dose, Safety, Tolerability of a New Smallpox Vaccine in Adults Without Previous Smallpox Vaccination
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