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NCT00914732 · ClinicalTrials.gov registry record · Phase 2
Lyophilized IMVAMUNE® (1x10^8 TCID50) Versus Liquid IMVAMUNE® (1x10^8 TCID50) Administered Subcutaneously and a Lower Dose Liquid IMVAMUNE® (2x10^7 TCID50) Administered Intradermally
A Phase 2 study of Smallpox, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 523
- Enrollment target
- 8
- Study locations
NCT00914732: Completed Phase 2 study of Smallpox, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00914732 is a Phase 2 study of Smallpox that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 523 participants, below the 130,977-participant average among 7 other Smallpox trials with a reported enrollment target (100% lower). The trial reports 8 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00914732, a Phase 2 study of Smallpox, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 523 participants
- Enrollment target
- 8
- Study locations
Study Summary
Due to recent concern of biowarfare and bioterrorism, the US government is making efforts to improve its ability to protect citizens against the smallpox virus. This study will evaluate safety of IMVAMUNE®, an investigational smallpox vaccine, and its ability to stimulate the immune system (the body's defense system). Two vaccine preparations have the same name but one is a liquid and one is a powder that has liquid added just before it is given. The vaccine that comes as a liquid will be injected (given as a shot) just under the skin (subcutaneously) or injected between the layers of the skin (intradermally). The powder formulation is only injected just under the skin. Approximately 495 adults, age 18 older born after 1971, which have not had smallpox vaccine before, may participate in the study for about 7 months.
Primary Outcome
Blood was collected from participants for testing in the PRNT assay with vaccinia-Western Reserve (replicating vaccinia) as the assay antigen. The geometric mean titers were calculated for each participant's individual peak titer after second vaccination. Titer values below limit of detection were replaced by 7.5 (half the lower limit of detection) for analysis.
Conditions Studied
Interventions
- BIOLOGICAL MVA Smallpox Vaccine
Study Locations (8)
Washington
- Group Health Research Institute - Seattle - Seattle
- The University of Washington - Virology Research Clinic - Seattle
Georgia
- Emory Vaccine Center - The Hope Clinic - Decatur
Iowa
- University of Iowa - Vaccine Research & Education Unit - Iowa City
Maryland
- University of Maryland School of Medicine - Center for Vaccine Development - Baltimore - Baltimore
Missouri
- Saint Louis University - Center for Vaccine Development - St Louis
Tennessee
- Vanderbilt University Hospital - Pediatric Clinical Research - Nashville
Texas
- Baylor College of Medicine - Molecular Virology and Microbiology - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 523 participants |
| Start Date | 2010-02 |
| Est. Completion | 2011-04 |
| Phase | Phase 2 |
What the finished NCT00914732 record still lists
NCT00914732 is an interventional study that assigns participants to a tested intervention. The registered 523 participants enrollment target is mid-sized for trials with a published cap, below the 130,977-participant average among 7 other Smallpox trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Smallpox appearing as the primary indexed condition, and to 1 intervention - of which MVA Smallpox Vaccine is the first listed.
NCT00914732 lists 8 locations in 7 states (Washington, Georgia, Iowa).
Frequently Asked Questions
What is clinical trial NCT00914732 about?
NCT00914732 is a clinical study titled "Lyophilized IMVAMUNE® (1x10^8 TCID50) Versus Liquid IMVAMUNE® (1x10^8 TCID50) Administered Subcutaneously and a Lower Dose Liquid IMVAMUNE® (2x10^7 TCID50) Administered Intradermally". Due to recent concern of biowarfare and bioterrorism, the US government is making efforts to improve its ability to protect citizens against the smallpox virus. This study will evaluate safety of IMVAMUNE®, an investigational smallpox vaccine, and its ability to stimulate the immune system (the body...
What is the current status of trial NCT00914732?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 523 participants. The study started on 2010-02. Estimated completion is 2011-04.
What conditions does trial NCT00914732 study?
This clinical trial studies the following conditions: Smallpox.
What interventions are being tested in trial NCT00914732?
The interventions under investigation include: MVA Smallpox Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00914732?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00914732 being conducted?
This trial has 8 study locations across Georgia, Iowa, Maryland, Missouri, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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