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Sponsored by: |
Bavarian Nordic |
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Information provided by: | Bavarian Nordic |
ClinicalTrials.gov Identifier: | NCT00623259 |
Monocentric study to assess the safety and immunogenicity of the recombinant MVA-HIV multiantigen vaccine MVA-mBN120B in HIV-infected subjects. 15 subjects will receive immunizations at day 0, after 4 and 12 weeks at a dose of 2E8 TCID50 MVA-mBN120B. The vaccine will be administered subcutaneously.
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Biological: MVA-mBN120B |
Phase I |
Study Type: | Interventional |
Study Design: | Diagnostic, Safety Study |
Official Title: | Phase I Vaccination Study Testing the Safety and Reactogenicity of a Recombinant MVA HIV Multiantigen Vaccine (MVA-mBN120B) in HIV-Infected Subjects With CD4 Count > 350/µL |
Estimated Enrollment: | 15 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | July 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental | Biological: MVA-mBN120B |
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate renal function defined as:
Adequate hepatic function defined as:
Exclusion Criteria:
Responsible Party: | Bavarian Nordic ( Monika Fluer ) |
Study ID Numbers: | HIV-MAG-001 |
Study First Received: | February 19, 2008 |
Last Updated: | January 22, 2009 |
ClinicalTrials.gov Identifier: | NCT00623259 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
Virus Diseases Sexually Transmitted Diseases, Viral RNA Virus Infections Slow Virus Diseases Immune System Diseases HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Lentivirus Infections Infection Retroviridae Infections Immunologic Deficiency Syndromes |