The Human Immunodeficiency Virus (HIV) epidemic presents the most serious infectious disease threat worldwide. Despite effective preventative measures and improvements in Highly Active Anti-retroviral Therapy(HAART), the global pandemic of HIV remains out of control. HIV preventive vaccines are needed to contain this pandemic. RV 262 is a Phase I vaccine study of the safety and immunogenicity of two vaccine candidates; PENNVAX™-G DNA (env& gag) as prime followed by MVA-CMDR(HIV-1 CM235 env/ CM240 gag/pol) as boost in healthy, HIV-uninfected adult participants. The study will evaluate the safety and tolerability of these vaccine candidates and also their ability to induce HIV antigen specific cellular and humoral immune responses. The study also compares two DNA vaccine delivery methods, the Biojector® 2000 needless and the CELLECTRA® intramuscular electroporation devices. The comparison will evaluate the method that yields the best immune response for PENNVAX™ -G. The MVA vaccine will be given by syringe and needle. A sub-study evaluating humoral mucosal immune response will also be done. RV 262 will be done in two parts, A and B. Part A is an open-label, safety and tolerability study to be conducted at one clinical site in Rockville USA. 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. The Kericho site will enroll 20 participants to Part B who will be randomized 4:1 to active study vaccine versus placebo. The study will last 15 months (3 months for screening; 12 months after enrollment) per study participant for the active study phase and an additional 18 months passive follow up for all study participants. This study will provide new, preliminary data regarding the safety and immunogenicity of PENNVAX™-G DNA followed by MVA-CMDR using a prime/boost strategy. Combined, this DNA prime-MVA boost strategy may enhance immunogenicity without compromising safety.

The Human Immunodeficiency Virus (HIV) epidemic presents the most serious infectious disease threat worldwide. Despite effective preventative measures and improvements in Highly Active Anti-retroviral Therapy(HAART), the global pandemic of HIV remains out of control. HIV preventive vaccines are needed to contain this pandemic. RV 262 is a Phase I vaccine study of the safety and immunogenicity of two vaccine candidates; PENNVAX™-G DNA (env& gag) as prime followed by MVA-CMDR(HIV-1 CM235 env/ CM240 gag/pol) as boost in healthy, HIV-uninfected adult participants. The study will evaluate the safety and tolerability of these vaccine candidates and also their ability to induce HIV antigen specific cellular and humoral immune responses. The study also compares two DNA vaccine delivery methods, the Biojector® 2000 needless and the CELLECTRA® intramuscular electroporation devices. The comparison will evaluate the method that yields the best immune response for PENNVAX™ -G. The MVA vaccine will be given by syringe and needle. A sub-study evaluating humoral mucosal immune response will also be done. RV 262 will be done in two parts, A and B. Part A is an open-label, safety and tolerability study to be conducted at one clinical site in Rockville USA. 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. The Kericho site will enroll 20 participants to Part B who will be randomized 4:1 to active study vaccine versus placebo. The study will last 15 months (3 months for screening; 12 months after enrollment) per study participant for the active study phase and an additional 18 months passive follow up for all study participants. This study will provide new, preliminary data regarding the safety and immunogenicity of PENNVAX™-G DNA followed by MVA-CMDR using a prime/boost strategy. Combined, this DNA prime-MVA boost strategy may enhance immunogenicity without compromising safety.