Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Lyophilized IMVAMUNE® (1x10^8 TCID50) Versus Liquid IMVAMUNE® (1x10^8 TCID50) Administered Subcutaneously and a Lower Dose Liquid IMVAMUNE® (2x10^7 TCID50) Administered Intradermally
NCT00914732 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00914732
The ClinicalTrials.gov registry entry for NCT00914732 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 523 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00914732 reports 8 study locations spanning 7 distinct geographic areas — top geographies include Washington, Georgia, Iowa. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00914732?
The interventions under investigation include: MVA Smallpox Vaccine (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00914732?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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