NCT01407497

Safety and Immunogenicity Study of a DNA Priming and MVA Boosting Strategy of HIV Vaccine

A Phase I Trial to Assess Safety and Immunogenicity of i.d. DNA Priming and i.m. MVA Boosting in Healthy Volunteers in Mozambique and to Develop Further HIV Vaccine Trial Capacity Building in Mozambique

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Instituto Nacional de Saúde, Mozambique · Other Government
• Sex: All
• Age: 18 Years – 26 Years
• Healthy volunteers: Accepted

Summary

While antiretroviral drugs have shown great promise in reducing HIV replication and thus in reducing HIV/AIDS associated morbi-mortality and HIV transmission, the cost is substantial and side effects are a potentially limiting factor. Development of an effective safe-affordable vaccine is likely to be the best way to stop further virus spread. The study aims to determine safety and immunogenicity of the DNA-vaccine at a dose of 600µg and 1200µg delivered id in combination with MVA-CMDR boost im.

Conditions

• HIV Infections

Interventions

Type	Name	Description
BIOLOGICAL	DNA HIVIS and MVA-CMDR	600 µg i.d. (separate plasmids pools) of DNA priming at weeks 0, 4 and 12; 108 pfu i.m. MVA boosting at weeks 24 and 36
BIOLOGICAL	DNA HIVIS and MVA-CMDR	1200 µg i.d. (separate plasmids pools) of DNA priming at weeks 0, 4 and 12 ; 108 pfu i.m. MVA boosting at weeks 24 and 36
BIOLOGICAL	Saline solution	2 x 0.1 ml of saline solution i.d at weeks 0, 4 and 12 ; saline solution i.m at weeks 24 and 36
BIOLOGICAL	Saline solution	2 x 0.2 ml of saline solution i.d at weeks 0, 4 and 12 ; saline solution i.m at weeks 24 and 36

Timeline

• Start date: 2011-08-01
• Primary completion: 2013-03-01
• Completion: 2013-08-01
• First posted: 2011-08-02
• Last updated: 2013-12-04

Locations

1 site across 1 country: Mozambique