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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00082446 |
The overall goals of this study are to expand the available data on the safety and immunogenicity of MVA-BN in vaccinia-naive adults and to determine the optimum dose of MVA-BN to induce immune responses and attenuate Dryvax take reactions. Participants will include 90 healthy volunteers, ages 18-32 years. Participants will be randomly assigned to 1 of 6 study groups (groups A-F). Participants will be involved in study related procedures for up to 2 years. During this time, volunteers will return periodically for blood draws to check immune responses.
Condition | Intervention | Phase |
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Smallpox |
Biological: Dryvax Biological: MVA-BN (IM) Biological: MVA-BN (SubQ) Drug: Placebo (SC) Drug: Placebo (Scarification) |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety Study |
Official Title: | A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of MVA-BN in a Dose Response Regimen Followed by Administration of Dryvax in Healthy Adult Volunteers |
Enrollment: | 90 |
Study Start Date: | May 2004 |
Study Completion Date: | August 2007 |
Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Subjects will receive a SC dose of MVA 2x10^7 on day 0 and day 28. On day 112 subjects will receive a dose of Dryvax® by scarification.
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Biological: Dryvax
Dryvax® is a live vaccinia virus, freeze dried, calf lymph type, smallpox vaccine. Each reconstituted vial contains 0.25 mL of vaccine with a concentration of approximately 1X 10^8 live vaccinia virus per mL. The Dryvax® will be administered by the standard route of scarification using a bifurcated needle.
Biological: MVA-BN (SubQ)
MVA-BN is a highly attenuated live vaccinia virus. The product is freeze-dried and must be reconstituted with sterile water. The reconstituted vaccine contains approximately 2x10^8 tissue cultured infectious dose 50 per mL. The following doses will be administered subcutaneously: 2x10^7, 5x10^7, 1x10^8.
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B: Experimental
Subjects will receive a SC dose of MVA 5x10^7 on day 0 and day 28. On day 112 subjects will receive a dose of Dryvax® by scarification.
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Biological: Dryvax
Dryvax® is a live vaccinia virus, freeze dried, calf lymph type, smallpox vaccine. Each reconstituted vial contains 0.25 mL of vaccine with a concentration of approximately 1X 10^8 live vaccinia virus per mL. The Dryvax® will be administered by the standard route of scarification using a bifurcated needle.
Biological: MVA-BN (SubQ)
MVA-BN is a highly attenuated live vaccinia virus. The product is freeze-dried and must be reconstituted with sterile water. The reconstituted vaccine contains approximately 2x10^8 tissue cultured infectious dose 50 per mL. The following doses will be administered subcutaneously: 2x10^7, 5x10^7, 1x10^8.
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D: Active Comparator
Subject will receive a SC dose of placebo on day 0 and day 28. On day 112 subjects will receive a dose of Dryvax® by scarification.
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Biological: Dryvax
Dryvax® is a live vaccinia virus, freeze dried, calf lymph type, smallpox vaccine. Each reconstituted vial contains 0.25 mL of vaccine with a concentration of approximately 1X 10^8 live vaccinia virus per mL. The Dryvax® will be administered by the standard route of scarification using a bifurcated needle.
Drug: Placebo (SC)
Sterile saline placebo for injection.
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E: Experimental
Subject will receive an SC dose of MVA 1x10^8 on day 0 and day 28. On day 112 subjects will receive a dose of placebo by scarification.
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Biological: MVA-BN (SubQ)
MVA-BN is a highly attenuated live vaccinia virus. The product is freeze-dried and must be reconstituted with sterile water. The reconstituted vaccine contains approximately 2x10^8 tissue cultured infectious dose 50 per mL. The following doses will be administered subcutaneously: 2x10^7, 5x10^7, 1x10^8.
Drug: Placebo (Scarification)
Sterile saline placebo for injection.
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C: Experimental
Subject will receive a SC dose of MVA 1x10^8 on day 0 and day 28. On day 112 subjects will receive a dose of Dryvax® by scarification.
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Biological: Dryvax
Dryvax® is a live vaccinia virus, freeze dried, calf lymph type, smallpox vaccine. Each reconstituted vial contains 0.25 mL of vaccine with a concentration of approximately 1X 10^8 live vaccinia virus per mL. The Dryvax® will be administered by the standard route of scarification using a bifurcated needle.
Biological: MVA-BN (SubQ)
MVA-BN is a highly attenuated live vaccinia virus. The product is freeze-dried and must be reconstituted with sterile water. The reconstituted vaccine contains approximately 2x10^8 tissue cultured infectious dose 50 per mL. The following doses will be administered subcutaneously: 2x10^7, 5x10^7, 1x10^8.
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F: Experimental
Subject will receive an IM dose of MVA 1x10^8 on day 0 and day 28. On day 112 subjects will receive a dose of Dryvax® by scarification.
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Biological: Dryvax
Dryvax® is a live vaccinia virus, freeze dried, calf lymph type, smallpox vaccine. Each reconstituted vial contains 0.25 mL of vaccine with a concentration of approximately 1X 10^8 live vaccinia virus per mL. The Dryvax® will be administered by the standard route of scarification using a bifurcated needle.
Biological: MVA-BN (IM)
MVA-BN is a highly attenuated live vaccinia virus. The product is freeze-dried and must be reconstituted with sterile water. The reconstituted vaccine contains approximately 2x10^8 tissue cultured infectious dose 50 per mL. A dose of 1x10^8 will be administered intramuscularly.
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The primary goal of this phase I trial is to expand the available data on the safety and immunogenicity of MVA-BN in vaccinia-naïve adults. The secondary goals of this vaccine trial are: to determine the optimum dose of MVA-BN, given twice, to induce an immune response and attenuate Dryvax® take reactions; and to compare the ability of 2 routes of administration of MVA-BN, subcutaneous and intramuscular, to induce an immune response at the highest tested dose. A total of 90 healthy adult volunteers ages 18-32 will participate in this study. The volunteers will be randomly assigned to 1 of 6 groups to be immunized with: MVA-BN (subcutaneously) at 1 of 3 dose levels and Dryvax® (per scarification); placebo (subcutaneously) and Dryvax® (per scarification); MVA-BN (subcutaneously) at the highest dose level and placebo scarification; or MVA-BN (intramuscularly) at the highest dose level and Dryvax® (per scarification). The study will last about 30 months. Each volunteer's participation will last 6 months for all treatment groups. Subjects randomized to treatment groups D and E will have follow-up for 2 years. During this time, volunteers will return periodically for blood draws to check immune responses.
Subjects will require visits for dressing changes as needed post-Dryvax vaccination. Variables to be investigated include: adverse events and side effects to the vaccines, and immunogenicity testing including antibody and cellular responses to the vaccines.
Ages Eligible for Study: | 18 Years to 32 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | HHS/NIAID/DMID ( Robert Johnson ) |
Study ID Numbers: | 02-017, POX-MVA-002 |
Study First Received: | May 10, 2004 |
Last Updated: | February 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00082446 History of Changes |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board; United States: Federal Government |
Smallpox, vaccine |
Virus Diseases Smallpox Poxviridae Infections DNA Virus Infections Healthy |
Virus Diseases Smallpox Poxviridae Infections DNA Virus Infections |