HIVAX is a patented replication-defective HIV-1 vaccine which is capable of stimulating both cellular and antibody immune responses in both mouse and primate models.

About HIVAX™

Since the discovery of HIV (human immunodeficiency virus) as the agent responsible for AIDS (acquired immunodeficiency syndrome), HIV/AIDS has become the most serious global epidemic. Approximately 40 million individuals globally are living with HIV/AIDS, 5 million of which became infected in 2003, and there were 3 million deaths in 2003 due to AIDS (http://www.unaids.org/). Yet even twenty years after the identification of HIV, we have still failed to develop a safe and effective vaccine to prevent or treat the disease.

To date the best protective immunity against HIV infection has been demonstrated by live attenuated (weakened) virus vaccines; however, the risks associated with using a live attenuated vaccine in humans are too great. To circumvent this problem, GeneCure has developed a patented replication-defective HIV-1 vaccine (HIVAX™) which is capable of stimulating both cellular and antibody immune responses in mouse and primate models. HIVAX™ provides both therapeutic and protective benefits to vaccinees, and has been proven safe for use in clinical studies.

Preclinical Research

Preclinical studies have been completed on GeneCure’s replication-deficient HIV-1 vaccine (HIVAX™), and have validated HIVAX™ as a viable vaccine candidate for both a therapeutic and prophylactic HIV-1 vaccine. Results from preclinical studies performed in mouse and primate models demonstrated that HIVAX™ elicits both strong antibody and cell-mediated immune responses in vaccinate animals, and most notably provided both therapeutic and protective benefits. The safety and efficacy of HIVAX™ has been evaluated further in rhesus monkeys. Results from this preclinical study prove HIVAX™ to be a safe and effective vaccine candidate for human clinical trials. GeneCure expects to begin Phase I/II clinical trials of HIVAX™ for treatment of HIV infected individuals early 2005.

Advantages of HIVAX™

In the twenty years since HIV was identified, researchers have been unable to develop a safe and effective HIV vaccine. With the staggering numbers of HIV infected individuals worldwide, the need for an HIV vaccine is becoming desperate. By the end of 2004, over 30 clinical trials for candidate AIDS vaccine will be underway globally. Current vaccine candidates are focused on prime-boost strategies where animals are primed with viral DNA followed by boosting (re-immunizing) with viral vectors. Although these strategies have showed promise for slowing disease progression, they are faced with significant problems. Firstly, these approaches do not generally provide protective immunity in vaccinated monkeys. Secondly, vaccinated animals generally display lower but still detectable virus present in the blood. Thus, these strategies would not effectively prevent disease transmission. Thirdly, these strategies face problems due to pre-existing or vaccine-induced immunity to viral vectors such as adenovirus, poliovirus, and canarypox. This pre-existing immunity can reduce the effectiveness of the vaccine, prevent repeat immunizations, and require the use of different viral vectors for boosting and vaccinating different target subpopulations.

GeneCure’s unique design of HIVAX™ overcomes the problems associated with current prime-boost strategies. Mostly importantly, HIVAX™ elicits protective immunity in vaccinated monkeys. Secondly, when HIVAX™ vaccinated monkeys are infected with virus, they are able to control virus replication and shortly after infection become negative for virus in the blood and tissues (this was also true when HIVAX™ was administered to persistently infected monkeys as a therapeutic vaccine). Thus, HIVAX™ could delay or prevent disease progression as well as prevent transmission of HIV to uninfected individuals. Finally, GeneCure’s HIV-1 based HIVAX™ circumvents problems of pre-existing immunity to foreign viral proteins derived from the viral vector as seen with vaccines derived from adenovirus, poliovirus, and vaccinia virus. This will allow for repeated immunizations to boost the immune response.