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Sponsors and Collaborators: |
Bavarian Nordic National Institutes of Health (NIH) |
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Information provided by: | Bavarian Nordic |
ClinicalTrials.gov Identifier: | NCT00316589 |
The purpose of this study is to gather information on the safety and immunogenicity of an investigational smallpox vaccine in HIV infected populations. Subjects will receive two vaccinations
Condition | Intervention | Phase |
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HIV Infections |
Biological: IMVAMUNE (MVA-BN) Biological: IMVAMUNE |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Open-Label, Controlled Phase II Study to Evaluate Safety and Immunogenicity of MVA-BN® (IMVAMUNE) Smallpox Vaccine in 18-55 Year Old Naive and Previously Vaccinated HIV Infected Subjects With CD4 Counts >200 - 750/µl. |
Enrollment: | 581 |
Study Start Date: | June 2006 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Biological: IMVAMUNE (MVA-BN)
2 immunizations: 1 x 10E8_TCID50, healthy subjects
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2: Experimental |
Biological: IMVAMUNE
2 immunizations: 1 x 10E8_TCID50, HIV infected subjects (200-750 CD4 cts/µl, vaccinia naive)
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3: Experimental |
Biological: IMVAMUNE
2 immunizations: 1 x 10E8_TCID50, HIV infected subjects (200-750 CD4 cts/µl, vaccinia experienced)
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Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Principal Investigator: | Edgar Turner Overton, MD | Washington University, St. Louis |
Responsible Party: | Bavarian Nordic ( Monika Fluer ) |
Study ID Numbers: | POX-MVA-011 |
Study First Received: | April 19, 2006 |
Last Updated: | January 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00316589 |
Health Authority: | United States: Food and Drug Administration |
HIV treatment experienced treatment vaccinia naive |
Virus Diseases Smallpox Sexually Transmitted Diseases, Viral Vaccinia HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |