NCT00390078

Single-Blind, Controlled Safety and Immunogenicity Study of Recombinant MVA Virus to Treat HIV Infection

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Bavarian Nordic · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• HIV Infections

Interventions

Type	Name	Description
BIOLOGICAL	MVA-mBN32	3 immunizations: 1x 10E8\_TCID50 MVA-mBN32
BIOLOGICAL	IMVAMUNE	3 immunizations: 1x 10E8\_TCID50 IMVAMUNE

Timeline

• Start date: 2007-01-01
• Primary completion: 2007-12-01
• Completion: 2009-01-01
• First posted: 2006-10-19
• Last updated: 2009-07-10

Locations

1 site across 1 country: Germany