Dose Safety, Tolerability, and Immunogenicity of a New Smallpox Vaccine in Adults Without Previous Smallpox Vaccination
NCT ID: NCT00053508
Last Updated: 2014-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
274 participants
INTERVENTIONAL
2002-09-30
2003-09-30
Brief Summary
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Detailed Description
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1. Compare the safety and tolerability of three dose levels of ACAM1000 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.
2. Determine the immunogenicity of three dose levels of ACAM1000 and a standard dose of Dryvax® in healthy adults 18-29 years of age by comparing: (a)the proportion of subjects at each dose level who develop a major cutaneous reaction; (b)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.
3. Determine the minimum dose of ACAM1000 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Group 1
ACAM1000
ACAM1000
Group 1 dose: 1.4 x 10-8th PFU/ml (350,000 PFU) Group 2 dose: 2.8 x 10-7th PFU/ml (70,000 PFU) Group 3 dose: 5.6 x 10-6th PFU/ml (14,000 PFU)
Group 2
ACAM1000
ACAM1000
Group 1 dose: 1.4 x 10-8th PFU/ml (350,000 PFU) Group 2 dose: 2.8 x 10-7th PFU/ml (70,000 PFU) Group 3 dose: 5.6 x 10-6th PFU/ml (14,000 PFU)
Group 3
ACAM1000
ACAM1000
Group 1 dose: 1.4 x 10-8th PFU/ml (350,000 PFU) Group 2 dose: 2.8 x 10-7th PFU/ml (70,000 PFU) Group 3 dose: 5.6 x 10-6th PFU/ml (14,000 PFU)
Group 4
Dryvax
vaccinia virus (calf lymph) smallpox vaccine: Dryvax
group 4 dose: 1.6 x 10-8th PFU/ml (250,000 PFU)
Interventions
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ACAM1000
Group 1 dose: 1.4 x 10-8th PFU/ml (350,000 PFU) Group 2 dose: 2.8 x 10-7th PFU/ml (70,000 PFU) Group 3 dose: 5.6 x 10-6th PFU/ml (14,000 PFU)
vaccinia virus (calf lymph) smallpox vaccine: Dryvax
group 4 dose: 1.6 x 10-8th PFU/ml (250,000 PFU)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* not pregnant and using effective birth control
* agreed to participate in entire study and comply with protocol requirements.
Exclusion Criteria
* no previous smallpox vaccination.
* no contact with with children 1 year of age or younger
* immunodeficiency individuals or close contacts who are immunodeficient
* past history or current renal disease
* diagnosis or past history of eczema
* known allergy or past allergic reactions to latex gloves or to some antibiotics (neomycin, streptomycin, chlortetracycline, and polymyxin B).
* known allergy or past allergic to blood products.
* known allergy or past allergic reaction to cidofovir or sulfa-containing drugs.
* transfusion of blood or treatment with any blood product, including intramuscular or intravenous serum globulin within six months of the Screening Visit.
* serology positive for HIV, hepatitis B or hepatitis C.
* current diagnosis or history within six months of drug or alcohol abuse disorders, psychiatric illness.
* inoculation with any other live vaccine within 30 days of Day 0 or participation in another drug or vaccine trial within 30 days of Day 0.
18 Years
29 Years
ALL
Yes
Sponsors
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Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Sanofi Pasteur Inc
Locations
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Orlando Clinical Research Center
Orlando, Florida, United States
Mayo Vaccine Research Group
Rochester, Minnesota, United States
Radiant Research
Cincinnati, Ohio, United States
Countries
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Related Links
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Related Info
Other Identifiers
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H-300-002
Identifier Type: -
Identifier Source: org_study_id
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