NCT00902824

Safety and Immunogenicity of TBC-M4, a MVA HIV Vaccine Alone or in a Prime-Boost Regimen With ADVAX DNA HIV Vaccine

Phase I Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of TBC-M4 (MVA Based HIV Vaccine) Alone or in a Prime-Boost Regimen With ADVAX, DNA HIV Vaccine

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: International AIDS Vaccine Initiative · Network
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This trial will study a prime-boost vaccine approach designed mainly to induce cell-mediated immune (CTL) responses.

Detailed description

Two vaccine candidates will be used in two different prime-boost regimens: ADVAX (DNA) + TBC-M4 (MVA) and TBC-M4 (MVA) alone. Both these vaccines have already been tested in humans and both were found to be well tolerated and immunogenic. Approximately 32 volunteers (24 vaccine /8 placebo recipients) will be included in the study.

Conditions

• HIV Infections

Interventions

Type	Name	Description
BIOLOGICAL	ADVAX	Receive 4mg ADVAX at Months 0, 1, and 2 (Biojector), and receive boost of 5x10\^7 pfu TBC-M4 (IM)
BIOLOGICAL	TBC-M4	Receive 5x10\^7 pfu TBC-M4 (IM) at Months 0, 1, and 6.
OTHER	Placebo	Group A (n=4) will receive the ADVAX placebo (formulation buffer) via Biojector. Group B (n=4) will receive the TBC-M4 placebo (formulation buffer) via IM.

Timeline

• Start date: 2008-11-01
• Primary completion: 2010-04-01
• Completion: 2010-04-01
• First posted: 2009-05-15
• Last updated: 2013-02-11

Locations

1 site across 1 country: United Kingdom