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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00053482 |
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 | Intervention | Phase |
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Smallpox |
Biological: ACAM2000 Smallpox Vaccine Biological: Vaccinia virus (calf lymph) smallpox vaccine: Dryvax |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | The Effect of Dose on Safety, Tolerability, and Immunogenicity of ACAM2000 Smallpox Vaccine in Adults With Previous Smallpox Vaccination |
Enrollment: | 357 |
Study Start Date: | January 2003 |
Study Completion Date: | October 2003 |
Primary Completion Date: | April 2003 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group 1: Experimental
Group 1: ACAM2000
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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
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Group 2: Experimental
Group 2: ACAM2000
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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
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Group 3: Experimental
Group 3: ACAM2000
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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
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Group 4: Experimental
Group 4: ACAM2000
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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
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Group 5: Active Comparator
Group 5: Dryvax
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Biological: Vaccinia virus (calf lymph) smallpox vaccine: Dryvax
Group 5 dose: 1.0x10-8th PFU/ml
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Specifically, the objectives of this study are to:
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:
Ages Eligible for Study: | 28 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion criteria:
exclusion criteria:
United States, Kansas | |
PRA International | |
Lenexa, Kansas, United States, 66219 | |
United States, Missouri | |
Bio-Kinetic Clinical Applications | |
Springfield, Missouri, United States, 65802 | |
United States, Rhode Island | |
Memorial Hospital of Rhode Island Division of Infectious Diseases | |
Pawtucket, Rhode Island, United States, 02860 |
Study Director: | Medical Director | Sanofi Pasteur Inc. |
Responsible Party: | Sanofi pasteur Inc ( Medical Director ) |
Study ID Numbers: | H-400-003 |
Study First Received: | January 30, 2003 |
Last Updated: | January 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00053482 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Smallpox, vaccines, Dryvax, Orthopoxvirus, Vaccinia virus |
Virus Diseases Smallpox Poxviridae Infections Vaccinia DNA Virus Infections |
Virus Diseases Smallpox Poxviridae Infections DNA Virus Infections |