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Sponsored by: |
Acambis |
Information provided by: | Acambis |
ClinicalTrials.gov Identifier: | NCT00053495 |
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 | Intervention | Phase |
Smallpox |
Biological: vaccinia virus: ACAM2000 smallpox vaccine Biological: vaccinia virus (calf lymph): Dryvax |
Phase II |
MedlinePlus related topics: | Smallpox |
ChemIDplus related topics: | PANVAC-V |
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 Without Previous Smallpox Vaccination |
Enrollment: | 353 |
Study Start Date: | January 2003 |
Study Completion Date: | November 2003 |
Primary Completion Date: | June 2003 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
Group 1: Experimental
Group 1: ACAM2000
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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
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Group 2: Experimental
Group 2: ACAM2000
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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
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Group 3: Experimental
Group 3: ACAM2000
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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
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Group 4: Experimental
Group 4: ACAM2000
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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
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Group 5: Active Comparator
Group 5: Dryvax
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Biological: vaccinia virus (calf lymph): Dryvax
Group 5 dose: 1.0x10-8th PFU/ml
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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:
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:
Ages Eligible for Study: | 18 Years to 29 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
inclusion criteria:
exclusion criteria:
United States, Florida | |||||
Orlando Clinical Research Center | |||||
Orlando, Florida, United States, 32806 | |||||
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 IslandDivision of Infectious Diseases | |||||
Pawtucket, Rhode Island, United States, 02860 |
Acambis |
Study Director: | Paul S. Blum, PhD | Acambis |
Acambis Website 
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Responsible Party: | Acambis ( Thomas Monath, MD/Chief Scientific Officer ) |
Study ID Numbers: | H-400-005 |
First Received: | January 30, 2003 |
Last Updated: | September 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00053495 |
Health Authority: | United States: Food and Drug Administration |
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