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NCT00437021 · ClinicalTrials.gov registry record · Phase 1
MVA Post-Event: Administration Timing and Boost Study
A Phase 1 study of Smallpox, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 226
- Enrollment target
- 7
- Study locations
NCT00437021: Completed Phase 1 study of Smallpox, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00437021 is a Phase 1 study of Smallpox that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 226 participants, below the 131,019-participant average among 7 other Smallpox trials with a reported enrollment target (100% lower). The trial reports 7 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00437021, a Phase 1 study of Smallpox, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 226 participants
- Enrollment target
- 7
- Study locations
Study Summary
The purpose of this study is to evaluate an investigational smallpox vaccine, called IMVAMUNE®, with respect to safety and immune (body's defense system) response. Participants will include healthy adults, age 18 or older born after 1971, who have not had smallpox vaccine before. Participants were originally assigned to 1 of 5 groups. In July 2007, a hold was placed on the Dryvax® groups and the study was modified. Participants, 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. Participants will complete a memory aid (diary) for 15 days following vaccination. Blood samples will be collected. Participants may participate for up to 425 days.
Primary Outcome
Geometric mean of titers collected 14 days after the second vaccination.
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL Live vaccinia virus vaccine
- BIOLOGICAL MVA Smallpox Vaccine
Study Locations (7)
Iowa
- University of Iowa - Vaccine Research and Education Unit - Iowa City
Maryland
- University of Maryland, School of Medicine, Center for Vaccine Development and Global Health - Baltimore
Missouri
- Saint Louis University Center for Vaccine Development - St Louis
New York
- University of Rochester Medical Center - Strong Memorial Hospital - Infectious Diseases - Rochester
North Carolina
- Duke Translational Medicine Institute - Clinical Vaccine Unit - Durham
Ohio
- Case Western Reserve University - John T. Carey Special Immunology Unit - Cleveland
Texas
- University of Texas Medical Branch - Pediatrics - Infectious Diseases and Immunology - Galveston - Galveston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 226 participants |
| Start Date | 2007-04-16 |
| Est. Completion | 2009-04-21 |
| Phase | Phase 1 |
What the finished NCT00437021 record still lists
NCT00437021 is an interventional study that assigns participants to a tested intervention. The registered 226 participants enrollment target is mid-sized for trials with a published cap, below the 131,019-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 3 interventions - of which Placebo is the first listed.
NCT00437021 lists 7 locations in 7 states (Iowa, Maryland, Missouri).
Frequently Asked Questions
What is clinical trial NCT00437021 about?
NCT00437021 is a clinical study titled "MVA Post-Event: Administration Timing and Boost Study". The purpose of this study is to evaluate an investigational smallpox vaccine, called IMVAMUNE®, with respect to safety and immune (body's defense system) response. Participants will include healthy adults, age 18 or older born after 1971, who have not had smallpox vaccine before. Participants were o...
What is the current status of trial NCT00437021?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 226 participants. The study started on 2007-04-16. Estimated completion is 2009-04-21.
What conditions does trial NCT00437021 study?
This clinical trial studies the following conditions: Smallpox.
What interventions are being tested in trial NCT00437021?
The interventions under investigation include: Placebo (OTHER), Live vaccinia virus vaccine (BIOLOGICAL), MVA Smallpox Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00437021?
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 NCT00437021 being conducted?
This trial has 7 study locations across Iowa, Maryland, Missouri, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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