Approach
The study consists of two parts:
Part A is an open-label, safety and tolerability study to be conducted at one clinical site at the Rockville Vaccine Assessment Clinic (RVAC), USA in 12 healthy, HIV-uninfected adult volunteers. Participants are randomized 1:1 to either the Biojector of the Electroporation delivery group. This part started in October 2010.
Part B is a randomized, placebo-controlled, double blind study to start after the product has been assessed as safe and tolerable in Part A. Part B will be conducted at three East African sites in Kenya, Uganda and Mbeya, Tanzania as well as in one site in Thailand enrolling overall 80 healthy, HIV negative. Low risk volunteers. Participants will be randomized 4:1 to active study drug versus placebo. This part is expected to start in July 2011. The NIMR Mbeya Medical Research Center (MMRC) in Tanzania will participate in the trial enrolling 20 participants.
The vaccine candidates are the PENNVAX™-G DNA (HIV-1 env A, C and D, and consensus gag plasmids) and MVA-CMDR Live attenuated Modified Vaccinia Ankara vector expressing HIV-1 CM235 env/ CM240 gag/pol. PENNVAX™-G DNA priming will be performed at months 0 and 1, MVA-CMDR boosting at months 3 and 6 of the vaccination schedule.
The Biojector® 2000 needle-free injection device delivers the study agent under pressure through a micro-orifice at high velocity using a compressed carbon dioxide cartridge.
Electroporation (EP) uses a needle to deliver the study agent intramuscular associated with short electric impulses. This delivery method is thought to increase the transfection of DNA into antigen-presenting cells (APCs) by creating transient pores in the cell membranes as well as to create mild tissue damage recruiting APCs locally and initiate an inflammatory response thus creating an adjuvant effect.
Sponsor
U.S. Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Health (NIH)
Partners
The trial will be lead by the Walter Reed Army Institute of Research (WRAIR) and the U.S. Military HIV Research Program (MHRP). The study site partners are the:
• U.S. Army Medical Research Unit-Kenya and Kenya Medical Research Institute in Kericho, Kenya
• Makerere University-Walter Reed Project in Kampala,Uganda,
• NIMR-Mbeya Medical Research Center (MMRC) in Mbeya,Tanzania
• Armed Forces Research Institute of Medical Services (AFRIMS) in Bangkok, Thailand
The LMU Department of Infectious Diseases and Tropical Medicine participate in this trial providing study coordination and management of the laboratory and immunology services. Logistical support is provided through the Munich office within the NIMR-MMRC collaboration.
