NCT01461447

Safety Study of an Additional MVA Vaccine in Volunteers Who Received 3 DNA Vaccines Followed by 2 MVA Vaccines

Safety and Immunogenicity Following Further Boosting With HIV-1 MVA-CMDR Vaccine to HIVIS03 Volunteers Who Were Primed With HIV-1 DNA Low Dose Intradermally or 'Standard' Dose Intramuscularly and Boosted With MVA-CMDR Vaccine

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Muhimbili University of Health and Allied Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to determine the safety and immunogenecity of a third MVA in the HIVIS 03 volunteers who have received 3 HIVIS DNA vaccines followed by boosting with 2 MVA vaccines. The investigators postulate that the Immune responses that were observed in the HIVIS 03 trial are likely to wane over time. To date it is unknown how these responses should best be maintained. In this study the investigators seek to boost immune responses, especially the antibody responses induced by the second MVA boost. Since the HIV specific antibodies were induced only after the second MVA injection, it is hypothesized that a 3rd MVA will give rise to even higher and sustained antibody titers.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
BIOLOGICAL	Modified Vaccinia Ankara	Healthy volunteers will receive intramuscularly 1 injection of MVA-CMDR 1ml (Total 10 power 8 pfu) boost injection in the left deltoid muscle.

Timeline

• Start date: 2012-03-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2011-10-28
• Last updated: 2012-05-24

Locations

1 site across 1 country: Tanzania