GeoVax Announces Initiation of HIV Human Clinical Trial
January 23, 2017 at 02:00 pm
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GeoVax Labs, Inc. announced the initiation of the next human clinical trial of GeoVax's preventive HIV vaccine, GOVX-B11. The Phase 1 trial (designated HVTN 114) is being conducted by the HIV Vaccine Trials Network (HVTN) and is funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). HVTN 114 will enroll up to 100 individuals who participated in the HVTN 205 Phase 2a trial of the GOVX-B11 vaccine (concluded in 2012) and will test the ability of late boosts (additional vaccinations) to increase the antibody responses elicited by the GeoVax vaccine. These "late boosts" will consist of the GeoVax MVA62B vaccine with or without a gp120 protein vaccine. The gp120 protein, AIDSVAX® B/E, supplied by Global Solutions for Infectious Diseases (GSID), is the same protein used to boost immune responses in the partially protective RV144 trial in Thailand, and is being used here to assess the effect of late boosts of GOVX-B11 while newer proteins are cGMP manufactured and safety tested for use with GOVX-B11 in future clinical trials. Eligible participants in HVTN 114 will receive either (a) another MVA62B boost, (b) a combined boost of MVA62B and AIDSVAX® B/E, or (c) AIDSVAX® B/E alone. GOVX-B11 is being developed for use against the clade B subtype of HIV prevalent in the Americas and Western Europe. Despite advancements in drug treatment, data from the U.S. Centers for Disease Control and Prevention (CDC) indicate that only a minority (30%) of HIV-infected Americans successfully control their infections with drugs. HIV diagnosis rates are increasing in American youth faster than in other age groups. In those aged 13 to 24, the incidence of HIV increased at an estimated average annual rate of 10.5% between 2002 and 2011. With the increasing burden of the epidemic, healthcare costs are also growing. The development of an effective HIV vaccine is critical to bringing an end to the HIV/AIDS pandemic. GOVX-B11 consists of two vaccine components -- a recombinant DNA vaccine to prime a person's immune response and a recombinant MVA (modified vaccinia Ankara) vaccine to boost the primed response. Both the DNA and MVA vaccines produce non-infectious virus-like particles in the cells of the vaccinated person. With NIAID's support, GOVX-B11 has been tested at various doses and regimens by the HVTN in trials involving approximately 500 participants where it has shown excellent safety and reproducible immunogenicity. In August 2016, NIAID awarded GeoVax a Staged Vaccine Development contract of approximately $200,000 with additional development options of up to $7.6 million to manufacture the DNA component of GOVX-B11 for use in future clinical trials.
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing human vaccines and immunotherapies against infectious diseases and solid tumor cancers using proprietary platforms. Its product pipeline includes ongoing human clinical trials for a Covid-19 vaccine and a gene-directed therapy against advanced head and neck cancers. Its additional research and development programs include preventive vaccines against Mpox and smallpox, hemorrhagic fever viruses (Ebola Zaire, Ebola Sudan and Marburg), Zika virus and malaria, as well as immunotherapies for multiple solid tumors. The Companyâs portfolio of wholly owned, co-owned, and in-licensed intellectual property, stands at over 155 granted or pending patent applications spread over 24 patent families. Its product candidate includes GEO-CM04S1, GEO-CM02, Gedeptin, MVA-VLP-MUC1, GEO-ZM02 and others. Its lead infectious disease candidate is GEO-CM04S1, a COVID-19 vaccine targeting high-risk immunocompromised patient populations.
GEOVAX LABS, INC. 
