NCT00082446

Combination Study With MVA BN and Dryvax

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 91 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years – 32 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Smallpox

Interventions

Type	Name	Description
BIOLOGICAL	Live vaccinia virus vaccine	Dryvax®: 0.25 mL of vaccine will be administered by the standard route of scarification using a bifurcated needle on day 112 for Groups A, B, C, D and F.
BIOLOGICAL	MVA Smallpox Vaccine	Imvamune/MVA-BN 1x10\^8 will be administered intramuscularly to Group F on day 0 and day 28.
BIOLOGICAL	MVA Smallpox Vaccine	Imvamune/MVA-BN Groups A, B C and E will be administered subcutaneously: 2x10\^7, 5x10\^7, 1x10\^8, 1x10\^8, respectively, on days 0 and day 28.
OTHER	Placebo	Group E will receive sterile saline placebo for injection via scarification on day 112.
OTHER	Placebo	Group D will receive sterile saline placebo for injection subcutaneously on day 0 and day 28.

Timeline

• Start date: 2004-05-01
• Primary completion: 2007-08-01
• Completion: 2007-08-01
• First posted: 2004-05-11
• Last updated: 2014-12-19

Locations

1 site across 1 country: United States