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

Since the discovery of the human immunodeficiency virus (HIV) as the agent responsible for AIDS (acquired immunodeficiency syndrome), HIV/AIDS has become a serious global epidemic. Approximately 38 million people globally are living with HIV/AIDS and 32 million people have died from AIDS-related illnesses.

Current HIV treatment relies on the lifelong use of antiviral drugs since viral load will soon rebound to pre-treatment levels if they are stopped. Although antiviral drugs have dramatically improved the lives of HIV infected patients, they are still associated with many issues such as drug toxicity, medication non-compliance, drug resistance, and high costs. Even after more than thirty 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 most promising protective immunity generated against HIV has been demonstrated by live attenuated (weakened) virus vaccines. However, the risks associated with using a live attenuated vaccine in humans are far too great.

To circumvent this issue, 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 studies 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. 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.

A randomized, placebo-controlled clinical trial was conducted to evaluate the safety and the immunogenicity of a replication defective HIV-1 vaccine (HIVAX) given as a subcutaneous injection to HIV-1 infected participants who were receiving antiviral drugs. HIVAX was considered to be generally safe and elicited strong anti-HIV-1 immune responses. Furthermore, HIVAX significantly reduced viral load after stopping antiviral drug treatment.

References:

1. Tung, Frank Y., et al. "A therapeutic HIV-1 vaccine enhances anti-HIV-1 immune responses in patients under highly active antiretroviral therapy." Vaccine 34.19 (2016): 2225-2232. PMID: 27002500.

2. Pallikkuth, Suresh, et al. "A therapeutic HIV-1 vaccine reduces markers of systemic immune activation and latent infection in patients under highly active antiretroviral therapy." Vaccine (2020). PMID: 32387010.

After over thirty years since HIV was identified, researchers have not 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 monumental.

By the end of 2019, over 40 clinical trials for candidate HIV vaccine are underway globally. Current vaccine candidates are focused on prime-boost strategies where subjects are primed with a DNA vaccine followed by boosting (re-immunizing) with a viral vector vaccine. 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 specific 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 become negative for virus in the blood and tissues shortly after infection. This effect was also seem 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 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 poxvirus. This advantage will allow for repeated immunizations to boost the immune response if necessary.