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Combination Study With MVA BN and Dryvax

NCT00082446 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2014-12-19

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
32 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-05-31
Primary Completion
2007-08-31
Completion
2007-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00082446 on ClinicalTrials.gov