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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: | NCT00390078 |
At the end of 2004 there were more than 40 million people infected Worldwide with HIV, with an estimated 16,000 new infections every day (UNAIDS, 2004).
The HIV epidemic threatens whole societies particularly in Africa and Asia and rates of infections in the Western Countries have also increased over the last few years. However, despite more than 15 years of research, an effective vaccine against HIV and acquired immunodeficiency syndrome (AIDS) has still not been developed. There is considerable evidence that cellular immune responses can effectively control HIV-1 replication during acute and chronic infections thereby possibly protecting individuals from infection and preventing the spread of HIV. To be truly effective in the general population, a vaccine must induce responses specific to immunologically conserved regions. The epitope-based vaccine MVA-mBN32 represent a very logical approach to this problem because its potential to elicit a polyfunctional immune response and to focus these responses to conserved epitopes.
In this study the safety, tolerability and immunogenicity of a recombinant MVA-BN® expressing CTL and HTL epitopes of HIV-1 (MVA-mBN32) vs. the vector control MVA-BN® in 30 HIV-infected subjects will be examined. This will include a full analysis of CD4+ T helper cells and CD8+ CTL responses to these epitopes, to establish the potential of such a homologous prime-boost vaccine approach to induce a broad cell-mediated response to different HIV antigens.
Condition | Intervention | Phase |
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HIV Infections |
Biological: MVA-mBN32 Biological: IMVAMUNE |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety Study |
Official Title: | Single-Blind, Randomized, Controlled, Phase I/II Vaccination Study on Safety and Immunogenicity of a Recombinant MVA-HIV Polytope Vaccine (MVA-mBN32) in HIV-1 Infected Patients With CD4 Counts > 250/µl |
Estimated Enrollment: | 30 |
Study Start Date: | January 2007 |
Estimated Study Completion Date: | December 2007 |
Estimated Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
20 Subjects, 1x 10E8_TCID50 MVA-mBN32
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Biological: MVA-mBN32
3 immunizations: 1x 10E8_TCID50 MVA-mBN32
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2: Placebo Comparator
10 Subjects 1x 10E8_TCID50 IMVAMUNE
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Biological: IMVAMUNE
3 immunizations: 1x 10E8_TCID50 IMVAMUNE
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Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Laboratory criteria (all of the following must be fulfilled):
Adequate bone marrow reserve, Adequate renal function, Adequate hepatic function, Cardiac enzymes within normal range
EXCLUSION CRITERIA:
Responsible Party: | Bavarian Nordic ( Monika Fluer ) |
Study ID Numbers: | HIV-POL-002, NIAID Cont. No. N01-AI-40072 |
Study First Received: | October 18, 2006 |
Last Updated: | December 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00390078 History of Changes |
Health Authority: | Germany: Paul-Ehrlich-Institut |
Vaccine Safety T-cell epitope Acquired Immune Deficiency Syndrome Virus HIV Therapeutic Vaccine |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases |
Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
Communicable Diseases RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Infection |
Immunologic Deficiency Syndromes Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections |