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GeoVax HIV Clinical Trials Update
Participant Enrollment Completed for HVTN 114 Trial
GeoVax Labs, Inc. (OTCQB: GOVX), a biotechnology company developing human vaccines, today announced that the HIV Vaccine Trials Network (HVTN) has closed enrollment for the phase 1 human clinical trial evaluating late boosts of GeoVax’s preventive vaccine (GOVX-B11) for clade B HIV. The trial, designated HVTN 114, is being conducted by the HVTN and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
HVTN 114 began in January 2017, enrolling individuals who previously participated in the HVTN 205 Phase 2a trial of the GOVX-B11 vaccine, which concluded in 2012. HVTN 114 tests the ability of late boosts (additional vaccinations) to increase the antibody responses elicited by the GeoVax vaccine regimen. These “late boosts” consist of the GeoVax MVA62B vaccine with or without a gp120 protein vaccine. The gp120 protein, AIDSVAX® B/E, is the same protein used to boost immune responses in the partially protective RV144 trial in Thailand, and is being used in HVTN 114 to assess the effect of adding a protein vaccine to GOVX-B11. Participants in
HVTN 114 receive either (a) another MVA62B boost, (b) a combined boost of MVA62B and AIDSVAX® B/E, or (c) AIDSVAX® B/E alone. Meanwhile, newer proteins are being manufactured using current Good Manufacturing Practices (cGMP) for use with GOVX-B11 in future clinical trials.
Harriet L. Robinson, Ph.D., director of GeoVax’s HIV vaccine program, commented, “We are pleased with the progress HVTN has made in the conduct of HVTN 114 and look forward to completion of the immunizations and analysis of the results. Information from this trial will contribute to the design of clinical trials testing GOVX-B11 in combination with the new gp120 proteins that are currently being prepared.”
GeoVax has designed GOVX-B11 for use against the clade B subtype of HIV prevalent in the Americas, Australia, Japan and Western Europe. GOVX-B11 consists of two vaccine components – a recombinant DNA vaccine (pGA2/JS7) and a recombinant live MVA (modified vaccinia Ankara) virus vaccine (MVA/HIV62B), both expressing Gag, protease, reverse transcriptase and Env (gp120/gp41) proteins from HIV-1. The DNA vaccine is intended to prime a person’s immune response, and the MVA/HIV62B to boost the primed response. Both the DNA and MVA vaccines produce non-infectious virus-like particles in the cells of the vaccinated person. The HVTN has tested various doses and regimens of GOVX-B11 in trials involving a total of approximately 500 participants where it has been shown to be safe and well-tolerated. AIDSVAX® B/E is supplied by Global Solutions for Infectious Diseases (GSID).
The HVTN is the world’s largest publicly funded multi-disciplinary international collaboration facilitating the development of vaccines to prevent HIV/AIDS. The HVTN conducts all phases of clinical trials, from evaluating experimental vaccines for safety and immunogenicity to testing vaccine efficacy. Primary funding for the HVTN is provided by the NIAID. HVTN trial sites are located at leading research institutions in 27 cities on four continents. The Network’s headquarters are at the Fred Hutchinson Cancer Research Center in Seattle, Washington. For more information, go to www.hvtn.org.
GeoVax Labs, Inc., is a clinical-stage biotechnology company developing human vaccines against infectious diseases using its MVA-VLP vaccine platforms. The Company’s HIV vaccine for the clade B epidemic in the Americas, Australia, Japan and Europe is advancing in human trials conducted by the HVTN. Preclinical programs are focused on preventive vaccines for Zika virus, hemorrhagic fever viruses (Ebola, Sudan, Marburg, and Lassa), and malaria, as well as therapeutic vaccines for HIV, chronic Hepatitis B infections and cancers. GeoVax’s vaccine platform supports in vivo production of non-infectious VLPs from the cells of the very person receiving the vaccine, mimicking a natural infection and effectively stimulating both the humoral and cellular arms of the immune system to recognize, prevent, and control the target infection. For more information, visit www.geovax.com.
Certain statements in this document are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act. These statements are based on management's current expectations and are subject to uncertainty and changes in circumstances. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax can develop and manufacture its vaccines with the desired characteristics in a timely manner, GeoVax's vaccines will be safe for human use, GeoVax's vaccines will effectively prevent targeted infections in humans, GeoVax’s vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete vaccine development, there is development of competitive products that may be more effective or easier to use than GeoVax's products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control. GeoVax assumes no obligation to update these forward-looking statements, and does not intend to do so. More information about these factors is contained in GeoVax's filings with the Securities and Exchange Commission including those set forth at "Risk Factors" in GeoVax's Form 10-K.