NCT01371175

A Phase IIA Trial to Evaluate the Safety and Immunogenicity of a DNA HIV-1 Vaccine Followed by an MVA HIV-1 Vaccine in HIV-uninfected Volunteers

A Randomized, Placebo-Controlled, Dosage-Escalating Phase 2A Study, Double-Blinded With Respect to Assignment to Either Vaccine or Placebo, to Evaluate the Safety and Immunogenicity of a DNA HIV-1 Vaccine Administered Intramuscularly Followed by an MVA HIV-1 Vaccine Administered at Three Different Dosage Levels and by Three Different Routes to HIV-Uninfected, Healthy, Volunteers.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 115 (actual)
• Sponsor: International AIDS Vaccine Initiative · Network
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety and tolerability of plasmid DNA and recombinant MVA (Modified Vaccinia Virus Ankara) in a prime-boost regimen. Approximately 111 volunteers (90 vaccine recipients/21 placebo recipients) will be enrolled at two sites. Approximately 56 volunteers will be enrolled at each site. An over-enrolment of up to 10% (approximately 10 additional volunteers) will be permitted in the study.

Conditions

• HIV Infections

Interventions

Type	Name	Description
BIOLOGICAL	DNA.HIVA	0.5mg DNA.HIVA or placebo
BIOLOGICAL	MVA.HIVA	5x10\^6 pfu MVA or placebo
BIOLOGICAL	MVA.HIVA	5x10\^7 pfu MVA or placebo
BIOLOGICAL	MVA.HIVA	2.5x10\^8 pfu MVA or placebo

Timeline

• Start date: 2003-04-01
• Primary completion: 2005-05-01
• First posted: 2011-06-10
• Last updated: 2011-06-10

Locations

2 sites across 2 countries: Kenya, United Kingdom