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COMPLETED Phase 1

MVA Post-Event: Administration Timing and Boost Study

NCT00437021 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 226 participants
Start Date 2007-04-16
Est. Completion 2009-04-21
Phase Phase 1

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00437021

The ClinicalTrials.gov registry entry for NCT00437021 describes a study currently listed as completed. It is categorized as Phase 1, 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 226 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 3 interventions — of which Placebo 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: NCT00437021 reports 7 study locations spanning 7 distinct geographic areas — top geographies include Iowa, Maryland, Missouri. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00437021?

The interventions under investigation include: Placebo (OTHER), Live vaccinia virus vaccine (BIOLOGICAL), MVA Smallpox Vaccine (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00437021?

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 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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial