NCT01697007

A Phase II Trial to Assess the Safety and Immunogenicity of DNA Priming Administered by the ID Zetajet® With or Without ID Derma Vax™ Electroporation Followed by IM MVA Boosting in Healthy Volunteers in Tanzania and Mozambique

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 198 (actual)
• Sponsor: Muhimbili University of Health and Allied Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

Electroporation will increase the efficiency of DNA priming in terms of immune responses and will lead to a dose sparing DNA vaccine regimen. Furthermore increased DNA vaccine concentration will reduce the number of shots necessary to deliver the full dose and induce comparable immune responses as with lower DNA vaccine concentrations.

Conditions

• Vaccines
• HIV
• Safety
• Immunogenicity

Interventions

Type	Name	Description
BIOLOGICAL	HIVIS DNA vaccine
DEVICE	Zetajet
DEVICE	Derma Vax Electroporation
BIOLOGICAL	Modified Vaccinia Ankara (MVA-CDMR)

Timeline

• Start date: 2012-11-01
• Primary completion: 2014-12-01
• Completion: 2015-06-01
• First posted: 2012-10-02
• Last updated: 2015-06-29

Locations

3 sites across 2 countries: Mozambique, Tanzania