Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00082446
Status:
COMPLETED
Last Update Posted:
2014-12-19
First Post:
2004-05-10
Brief Title:
Combination Study With MVA BN and Dryvax
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2008-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 volunteers 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| POX-MVA-002 | None | None | None |