Combination Study With MVA BN and Dryvax
Condition: Smallpox
MeSH terms: Smallpox
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): Live vaccinia virus vaccine; MVA Smallpox Vaccine; MVA Smallpox Vaccine; Placebo; Placebo
Intervention type(s): Biological; Biological; Biological; Other; Other
Intervention description(s): 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.; Imvamune/MVA-BN 1x10^8 will be administered intramuscularly to Group F on day 0 and day 28.; 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.; Group E will receive sterile saline placebo for injection via scarification on day 112.; Group D will receive sterile saline placebo for injection subcutaneously on day 0 and day 28.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Smallpox, vaccine