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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: | NCT00189930 |
The objective of the study is to compare two doses of MVA-nef vs. MVA-BN to induce Nef-specific cellular immune response in HIV-1 infected patients
Condition | Intervention | Phase |
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HIV Infection |
Biological: MVA-nef Biological: IMVAMUNE |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Single-Blind, Randomized, Controlled, Phase II Study to Evaluate Immunogenicity and Safety of Two Doses of the MVA-Nef HIV Vaccine in HIV-1 Infected Patients With CD4 > 250/µl |
Enrollment: | 75 |
Study Start Date: | April 2005 |
Study Completion Date: | December 2006 |
Arms | Assigned Interventions |
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1: Active Comparator
High dose
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Biological: MVA-nef
3 imm.: 5E8_TCID50 MVA-nef, 1E8_TCID50 MVA-nef in non-dominant upper arm
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2: Active Comparator
Low dose
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Biological: MVA-nef
3 imm.: 5E8_TCID50 MVA-nef, 1E8_TCID50 MVA-nef in non-dominant upper arm
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3: Placebo Comparator |
Biological: IMVAMUNE
3 immunizations: 1E8_TCID50 IMVAMUNE
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Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
3 or more of the following risk factors:
Germany, Bavaria | |
University of Erlangen | |
Erlangen, Bavaria, Germany, 91054 | |
Doctor's Practice | |
Fuerth, Bavaria, Germany, 90762 | |
Doctor's Practice | |
Nürnberg, Bavaria, Germany, 90641 | |
Doctor's Practice | |
Munich, Bavaria, Germany, 80335 | |
Doctor's Practice | |
Munich, Bavaria, Germany, 80801 |
Principal Investigator: | Thomas Harrer, MD | University of Erlangen, Germany |
Responsible Party: | Bavarian Nordic ( Monika Fluer ) |
Study ID Numbers: | HIV-NEF-004, HHSN266200400072C |
Study First Received: | September 12, 2005 |
Last Updated: | December 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00189930 |
Health Authority: | Germany: Paul-Ehrlich-Institut |
Treatment Experienced |
Virus Diseases Sexually Transmitted Diseases, Viral 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 |