GeoVax Infectious Disease Programs

GeoVax was originally founded based solely upon the promise of our preventive HIV vaccine program, which is currently advancing in human clinical trials.  Since that time, we have expanded our development programs to HIV immunotherapy, Ebola, Lassa Fever, Zika, malaria, chronic Hepatitis B (therapeutic), and immuno-oncology, demonstrating the broad utility of our technology platform.

HIV/AIDS

HIV/AIDS is considered by many in the scientific and medical community to be the most lethal infectious disease in the world.  An estimated 37 million people are living with HIV worldwide, with approximately 1.8 million newly infected annually.  Since the beginning of the epidemic, more than 70 million people have been infected with the HIV virus and about 35 million have died of HIV.  The United States currently has an estimated 1.1 million HIV-infected individuals, with approximately 40,000 new infections per year.  Gay and bisexual men bear the greatest burden by risk group, representing nearly 70% of new infections in the U.S.  African-Americans also bear a disproportionate burden, representing 43% of people living with HIV, yet representing just 12% of the total population.

Preventive HIV Vaccine – Our most clinically advanced program is a prophylactic vaccine for the Clade B HIV, the subtype of HIV prevalent in the Americas, Australia, Japan and Western Europe. This program has successfully completed Phase 1 and Phase 2a human clinical trials and continues to advance toward pivotal human trials with support from the National Institute of Allergy and Infectious Diseases (NIAID).

HIV Immunotherapy (Functional Cure) – Our HIV vaccine may also prove useful as a necessary component of a combination therapy to provide a cure for HIV infection.  We have entered a collaboration with American Gene Technologies International, Inc. (AGT) to test this concept in combination with AGT’s gene therapy technology.  AGT expects to commence clinical trials in 2019. In addition, we anticipate that our HIV vaccine will participate in additional “functional cure” initiatives that are currently in the planning stage.

Ebola and Other Filoviruses

Ebola, Sudan, and Marburg viruses are the most virulent species of the Filoviridae family.  They can cause up to a 90% fatality rate in humans and are epizootic in Central and West Africa with 29 outbreaks since 1976.  The 2013-16 Ebola outbreak caused 28,616 cases and 11,310 deaths (40% fatal).

We have demonstrated 100% single-dose protection in preclinical lethal challenge models for our Ebola vaccine and are developing vaccines against Sudan and Marburg which also have pandemic potential.  Our Ebola vaccine has completed efficacy testing in non-human primates and is ready for GMP manufacture and phase 1 human trials.

Lassa Fever

Lassa fever virus, a member of the Arenaviridae family, causes severe and often fatal hemorrhagic illnesses in an overlapping region with Ebola. In contrast to the unpredictable epidemics of filoviruses, the Lassa virus is endemic in West Africa with an annual incidence of >300,000 infections, resulting in 5,000-10,000 deaths.  Data from a recent independent study suggest that the number of annual Lassa Fever cases may be much higher, reaching three million infections and 67,000 deaths, putting as many as 200 million persons at risk.

Our initial preclinical studies in rodents for our Lassa Fever vaccine candidate have shown 100% single-dose protection against a lethal challenge composed of multiple strains of Lassa delivered directly into the brain.  The study was conducted at the Institute of Human Virology at the University of Maryland School of Medicine in Baltimore. We are currently progressing with advanced preclinical testing and GMP manufacturing for our Lassa fever vaccine in preparation for human clinical trials; this work is being funded by a grant from the U.S. Department of Defense and is being performed in collaboration with USAMRIID, the Geneva Foundation, and Advanced Bioscience Laboratories (ABL).

Zika Virus

Zika disease is an emerging infectious disease caused by the Zika virus and has been linked to an increase in microcephaly in infants and Guillain-Barre syndrome (a neurodegenerative disease) in adults.  Zika is a member of the Flaviviridae family, which includes medically important pathogens such as dengue fever, yellow fever, Japanese encephalitis, tick-borne encephalitis, and West Nile viruses

We have achieved 100% protection of mice when vaccinated with a single dose of our Zika vaccine and exposed to a lethal challenge of the Zika virus injected directly into the brain. Our Zika vaccine is based on the NS1 protein of Zika which is not associated with Antibody Dependent Enhancement (ADE) of infection, a safety concern for other Zika vaccines under development.  Moreover, an NS1-based vaccine has the potential advantage of blocking transmission of Zika from humans to its mosquito vectors.  Our Zika vaccine has completed efficacy testing in non-human primates and is ready for GMP manufacture and phase 1 human trials.

Hepatitis B (immunotherapy)

An estimated 240 million people are chronically infected with the hepatitis B virus (HBV) -- 780,000 of which die each year, despite the availability of an effective prophylactic vaccine since 1982. Numerous HBV therapeutic vaccine candidates have been evaluated in clinical trials, but none have sufficiently activated both antibody and the cellular responses required for complete viral clearance, specifically, strong IgG1, IgG3 and CD4+ and CD8+ T cell responses.  Clinical data from our HIV vaccine trials demonstrated that our MVA-VLP-HIV vaccine elicited strong IgG1, IgG3 and CD4+/CD8+T cell responses, more so than shown by previous HBV therapeutic vaccine candidates. 

We have constructed vaccine candidates containing multiple protective antigens from the HBV genotype D (causing more severe disease) (MVA-VLP-HBV) which are currently undergoing preclinical testing in collaboration with Georgia State University Research Foundation.

Malaria

Globally, malaria causes 214 million infections and 438,000 deaths annually. Despite decades of vaccine research, vaccine candidates have failed to induce substantial protection (e.g. >50%). Most of these vaccines are based on truncated proteins or VLP proteins targeting a limited number of antigens derived from only one stage of the malaria parasite’s life cycle. Our MVA-VLP multi-antigen malaria vaccine candidates are designed to induce a Th1 biased immune response with durable functional antibodies (IgG1 and IgG3) and CD4+ and CD8+ T cell responses, all hallmarks of an ideal malaria vaccine.  

We are collaborating with the Burnet Institute, a leading infectious disease research institute in Australia, as well as with Leidos, Inc. (under a contract from USAID Malaria Vaccine Development Program) for the development of a vaccine to prevent both malaria infection and transmission by targeting antigens derived from multiple stages of the parasite’s life cycle. Our vaccine constructs are currently being evaluated in small animal models.
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