Ignite Creation Date:
2024-05-05 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00437021
Status:
COMPLETED
Last Update Posted:
2013-11-18
First Post:
2007-02-16
Brief Title:
MVA Post-Event Administration Timing and Boost Study
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Evaluation of IMVAMUNE Smallpox Vaccine With Respect to Safety and Optimization of Immune Responses by Different Vaccination Regimens in Vaccinia-Naïve Adults
Status:
COMPLETED
Status Verified Date:
2010-03
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 purpose of this study is to evaluate an investigational smallpox vaccine called IMVAMUNE with respect to safety and immune bodys defense system response Participants will include healthy adults age 18 or older born after 1971 who have not had smallpox vaccine before Volunteers were originally assigned to 1 of 5 groups In July 2007 a hold was placed on the Dryvax groups and the study was modified Volunteers numbering 197 will be assigned by chance to one of 3 groups to be vaccinated twice with IMVAMUNE vaccine or placebo inactive substance in Groups A and B or to receive a single vaccination with IMVAMUNE or placebo in Group F Volunteers will complete a memory aid diary for 15 days following vaccination Blood samples will be collected Volunteers may participate for up to 425 days
Detailed Description:
The study will evaluate the IMVAMUNE smallpox vaccine with respect to safety and optimization of immune responses by different vaccination regimens in vaccinia-naïve adults Study subjects must be age 18 and older and born after 1971 Originally 215 subjects were planned to be randomly assigned to 1 of 5 groups to be immunized twice with IMVAMUNE vaccine or placebo subcutaneously in Groups A and B or Dryvax or placebo by scarification in Group C or both IMVAMUNE and Dryvax or 2 placebos in Groups D and Group E In July 2007 enrollment was halted at the request of Center for Biologics Evaluation and Research CBER At that time enrollment included zero subjects in Group A 2 subjects in Group B 8 subjects in Group C 6 subjects in Group D and 4 subjects in Group E CBER placed an official hold on the enrollment into the Groups that would administer Dryvax ie Groups C D and E Subjects previously enrolled into Groups C D and E will be followed according to the protocol The protocol has been modified as follows One hundred and ninety-five subjects will be randomly assigned to 1 of 3 groups to be immunized twice with IMVAMUNE vaccine or placebo subcutaneously in Groups A and B or to receive a single immunization with IMVAMUNE or placebo subcutaneously in Group F NOTE A total of 197 subjects will be randomly assigned to Groups A B and F as 2 subjects were previously enrolled in Group B Group A will receive IMVAMUNE vaccine or placebo on Days 0 and 7 Group B will receive IMVAMUNE vaccine or placebo on Days 0 and 28 Group F will receive a single dose of IMVAMUNE at Day 0 All subjects will complete a memory aid for 15 days following each vaccination Groups C D and E will have the appropriate reactogenicity information collected until the vaccination lesion if present is well dried Adverse events will be collected for 28 days after each vaccination Specimens will be collected for immunologic assays at the noted clinic visits as well as 1 year post last vaccination Serious adverse events will be collected throughout the study period The primary safety objective is to evaluate the safety of IMVAMUNE given as a single dose IMVAMUNE given in a 2 dose prime-boost regimen at Day 0 and 7 or Day 0 and 28 IMVAMUNE followed by a boost with Dryvax and IMVAMUNE given simultaneously with Dryvax The primary immunogenicity objective is to determine if the Geometric Mean Titer GMT of neutralizing antibody using Modified Vaccinia Ankara MVA as the target antigen among subjects receiving a regimen of 2 doses of IMVAMUNE 1108 Days 0 and 7 Group A is non-inferior to that among subjects receiving 2 doses of IMVAMUNE 1108 Days 0 and 28 Group B at Day 14 following the 2nd dose The secondary immunogenicity objective is to determine if the GMT as assessed by enzyme linked immunosorbent assay ELISA using MVA as the target antigen among subjects receiving a regimen of 2 doses of IMVAMUNE 1108 Days 0 and 7 Group A is non-inferior to that among subjects receiving 2 doses of IMVAMUNE 1108 Days 0 and 28 Group B at Day 14 following the 2nd dose The tertiary immunogenicity objective is to characterize the kinetics magnitude and duration of cellular and humoral immune responses to IMVAMUNE alone or IMVAMUNE as a prime followed by a boost with IMVAMUNE or Dryvax or Dryvax alone
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 |
|---|---|---|---|
| N01AI80003C | None | None | None |
| POX-MVA-009 | None | None | None |