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Completed Phase 1Phase 2 Interventional Accepts healthy volunteers Results available

MVA Post-Event: Administration Timing and Boost Study

ClinicalTrials.gov ID: NCT00437021

Public ClinicalTrials.gov record NCT00437021. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 8:26 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Evaluation of IMVAMUNE® Smallpox Vaccine With Respect to Safety and Optimization of Immune Responses by Different Vaccination Regimens in Vaccinia-Naïve Adults

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00437021
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1, Phase 2
Enrollment
226 participants

Conditions and interventions

Conditions

Interventions

Biological · Other

Eligibility (public fields only)

Age range
18 Years to 38 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 16, 2007 (Actual)
Primary completion
Apr 21, 2009 (Actual)
Completion
Apr 21, 2009 (Actual)
Last update posted
Sep 19, 2025

2007 – 2009

United States locations

U.S. sites
7
U.S. states
7
U.S. cities
7
Facility City State ZIP Site status
University of Iowa - Vaccine Research and Education Unit Iowa City Iowa 52242-2600 —
University of Maryland, School of Medicine, Center for Vaccine Development and Global Health Baltimore Maryland 21201-1509 —
Saint Louis University Center for Vaccine Development St Louis Missouri 63104-1015 —
University of Rochester Medical Center - Strong Memorial Hospital - Infectious Diseases Rochester New York 14642-0001 —
Duke Translational Medicine Institute - Clinical Vaccine Unit Durham North Carolina 27704-2120 —
Case Western Reserve University - John T. Carey Special Immunology Unit Cleveland Ohio 44106-3808 —
University of Texas Medical Branch - Pediatrics - Infectious Diseases and Immunology - Galveston Galveston Texas 77555-5302 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00437021, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 19, 2025 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00437021 live on ClinicalTrials.gov.

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