Non-Covid Pipeline: Disease Definitions and Stats
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HIV/AIDS
In human clinical trials of the company's HIV vaccines, GeoVax demonstrated that VLPs are safe and eliciting both strong and durable humoral and cellular immune response. [3]
GeoVax is a clinical-stage biotechnology company which develops vaccines. GeoVax's development platform uses Modified Vaccinia Ankara (MVA) vector technology, with improvements to antigen design and manufacturing capabilities. GeoVax uses recombinant DNA or recombinant viruses to produce virus-like particles (VLPs) in the person being vaccinated.
Formed in 2001 in Atlanta, Georgia, the approach was originally based on preclinical work done by Harriet Robinson [1] [2] from 1992 to 2002. In 2002, laboratory space, equipment and personnel were acquired and work on an HIV-1 vaccine development plan began. In May 2006, human clinical trials of the drug began. The company is now working on vaccines for Marburg, Lassa Fever, Ebola, Zika and Covid-19. [ citation needed ]
In January 2020, the company announced initiation of efforts to develop a vaccine against novel coronavirus disease (COVID-19) caused by the SARS-CoV-2 coronavirus.[ citation needed ] The GeoVax program has been added to the "Draft Landscape of COVID-19 Candidate Vaccines" by the World Health Organization.[ citation needed ]
On September 25, 2020, GeoVax closed an underwritten public offering, raising gross proceeds of $12.8 million. Concurrent with the offering, GeoVax common stock began trading on The Nasdaq Capital Market under the symbol "GOVX".[ citation needed ]
Recently, the company began collaborating with Emory University on the development of a therapeutic vaccine for human papillomavirus (HPV) infection, with a specific focus on head and neck cancer (HNC).[ citation needed ]
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In human clinical trials of the company's HIV vaccines, GeoVax demonstrated that VLPs are safe and eliciting both strong and durable humoral and cellular immune response. [3]
From preclinical results (using SHIV) 96% of primates (22/23) were protected from the virus over a three and a half year period when vaccinated, while by contrast five out of six primates died within eight months after being infected when left untreated. The vaccine works with a combined DNA vaccine and MVA (modified vaccinia Ankara) vaccine both of which lead to the insertion of genes into primate DNA which leads to foreign protein expression. With the GeoVax vaccine a variety of HIV proteins (both surface and internal) are expressed from genes which include the Env, Pol and Gag genes.[ citation needed ]
GeoVax is currently conducting multiple site Phase 2 Human clinical trials for HIV/AIDS preventive vaccine products following successful completion of multiple Phase 1 human clinical trials. [4]
In 2010 GeoVax began enrolling patients in a Phase 1 therapeutic clinical trial for individuals already infected with HIV. [5] The long-term therapeutic goal is to develop a vaccine-based mechanism to treat infected individuals that either prevents or significantly slows progression to symptomatic HIV, including AIDS, by stimulating an infected individual's immune system to resist the progression of infection. The study is being completed at the AIDS Research Consortium of Atlanta. [6] [7] [8]
During 2010, the AIDS Research Consortium of Atlanta (ARCA) began patient recruitment for a Phase 1 clinical trial sponsored by GeoVax Labs, Inc., investigating GeoVax's DNA/MVA vaccine as a treatment for individuals already infected with HIV. The trial is primarily designed as a safety study, but will also collect and report data on the vaccine's ability to elicit protective immune responses and control re-emergent virus during a pause in drug treatment. As part of the trial protocol, a volunteer must have begun drug treatment in the first year of infection and have achieved 6 months of stable viral control on drug treatment before entry into the trial and receipt of the first vaccination.[ citation needed ]
GeoVax published results of Phase 1 safety and immunogenicity testing for its preventive vaccine trial on March 1, 2011. [9] Based on published results, GeoVax will be advancing two regimens forward into the Phase 2a HVTN 205 trial. Regimens selected for advancement are the DDMM combination, which produced the highest T cell response rates, and the MMM combination. The MMM regimen produced the highest antibody-induced immune response.
The DDMM regimen consists of priming with two doses of the pGA2/JS7 recombinant DNA vaccine and boosting with two doses of VA/HIV62B recombinant MVA vaccine. The MMM regimen consists of priming and boosting with a total of three doses of the recombinant MVA vaccine. [10]
HVTN 205 Study—In early 2009, the HVTN began enrolling patients in a preventive Phase 2 clinical trial sponsored by GeoVax Labs, Inc. This study is investigating a prime-boost approach using GeoVax's combination DNA/MVA vaccine. During 2010, the study was expanded from 225 to 300 participants to include an arm gathering additional data on three MVA injections, without the use of the DNA component, which is an addition to the original arm testing two DNA priming and two MVA boosting injections. Preliminary results were announced by the company on December 9, 2010. Preliminary results indicate an excellent safety profile and highly reproducible immunogenicity subsequently confirmed by the official publication above in The Journal of Infectious Diseases. [11]
In April 2011, GeoVax Labs, Inc. in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH) and the HIV Vaccine Trials Network (HVTN) announced an expansion of the current Phase 2a clinical trial to include a new component. The new trial is HVTN 094 and will be conducted by the HIV Vaccine Trials Network. "Specifically, the HVTN plans to clinically test a novel vaccine product developed by GeoVax scientists that expresses human granulocyte-macrophage colony stimulating factor (GM-CSF) in combination with inactivated HIV proteins. The novel vaccine consists of a recombinant DNA vaccine co-expressing human GM-CSF and non-infectious HIV virus-likeparticles. The DNA vaccine is used to prime immune responses that are subsequently boosted by vaccination with a recombinant modified vaccinia Ankara (MVA) vectored vaccine. The MVA expresses the HIV virus-like-particles, but does not express GM-CSF. The regimen builds on the GeoVax DNA/MVA vaccine that is currently in Phase 2a clinical testing through the HVTN." [12] [13]
An HIV vaccine is a potential vaccine that could be either a preventive vaccine or a therapeutic vaccine, which means it would either protect individuals from being infected with HIV or treat HIV-infected individuals.
This is a list of AIDS-related topics, many of which were originally taken from the public domain U.S. Department of Health Glossary of HIV/AIDS-Related Terms, 4th Edition.
Modified vaccinia Ankara (MVA) is an attenuated (weakened) strain of the vaccinia virus. It is being used as a vaccine against smallpox and mpox, having fewer side effects than smallpox vaccines derived from other poxviruses.
The Division of Acquired Immunodeficiency Syndrome (DAIDS) is a division of the National Institute of Allergy and Infectious Diseases, which is part of the National Institutes of Health. It was formed in 1986 as a part of the initiative to address the national research needs created by the advent and spread of the HIV/AIDS epidemic. Specifically, the Division's mission is to increase basic knowledge of the pathogenesis, natural history, and transmission of HIV disease and to support research that promotes progress in its detection, treatment, and prevention. DAIDS accomplishes this through planning, implementing, managing, and evaluating programs in (1) fundamental basic research, (2) discovery and development of therapies for HIV infection and its complications, and (3) discovery and development of vaccines and other prevention strategies.
The HIV Vaccine Trials Network (HVTN) is a non-profit organization which connects physicians and scientists with activists and community educators for the purpose of conducting clinical trials seeking a safe and effective HIV vaccine. Collaboratively, researchers and laypeople review potential vaccines for safety, immune response, and efficacy. The HVTN is a network for testing vaccines, and while its members may also work in vaccine development for other entities, the mission of the HVTN does not include vaccine design.
AIDSVAX is an experimental HIV vaccine that was developed originally at Genentech in San Francisco, California, and later tested by the VaxGen company, a Genentech offshoot. The development and trials of the vaccine received significant coverage in the international media, but American trials proved inconclusive. The vaccine was then tested on a group of at-risk individuals in Thailand.
As of 2021, a vaccine against Epstein–Barr virus was not yet available. The virus establishes latent infection and causes infectious mononucleosis. There is also increasingly more evidence that EBV may be a trigger of multiple sclerosis. It is a dual-tropic virus, meaning that it infects two different host cell types — in this case, both B cells and epithelial cells. One challenge is that the Epstein–Barr virus expresses very different proteins during its lytic and its latent phases. Antiviral agents act by inhibiting viral DNA replication, but as of 2016, there was little evidence that they are effective against Epstein–Barr virus, they are expensive, they risk causing resistance to antiviral agents, and can cause unpleasant side effects.
RV 144, or the Thai trial, was an HIV vaccine clinical trial that was conducted in Thailand between 2003 and 2006. It used a combination of two HIV vaccines that had each failed in earlier trials. Participants were vaccinated over the course of 24 weeks beginning in October 2003 and were then tested for HIV until July 2006. The results of the study were publicized in September 2009. The initial report showed that the rate of HIV infection among volunteers who received the experimental vaccine was 31% lower than the rate of HIV infection in volunteers who received the placebo. This reduction was not large enough for the Ministry of Public Health in Thailand to support approving the vaccine; it would have licensed it if the reduction had been 50% or more.
The United States Military HIV Research Program was initiated by the United States Congress in 1986, in reaction to the threat of lost effectiveness of U.S./Allied troops due to HIV infection. The mission of MHRP is to develop an HIV-1 vaccine, provide prevention, care, and treatment, and conduct meaningful HIV/AIDS research for the global community through the President's Emergency Plan for AIDS Relief (PEPFAR). It is centered at the Walter Reed Army Institute of Research (WRAIR), and has established five international research sites in Africa and Asia. MHRP also partners with the Armed Forces Research Institute of Medical Sciences (AFRIMS) in Thailand. MHRP works closely with The Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF), most notably in the development of the RV144 HIV vaccine in Thailand. MHRP is the largest research program supported by the HJF.
HVTN 505 is a clinical trial testing an HIV vaccine regimen on research participants. The trial is conducted by the HIV Vaccine Trials Network and sponsored by the National Institute of Allergy and Infectious Diseases. Vaccinations were stopped in April 2013 due to initial results showing that the vaccine was ineffective in preventing HIV infections and lowering viral load among those participants who had become infected with HIV. All study participants will continue to be monitored for safety and any long-term effects.
MVA-B, or Modified Vaccinia Ankara B, is an HIV vaccine created to give immune resistance to infection by the human immunodeficiency virus. It was developed by a team of Spanish researchers at the Spanish National Research Council's Biotechnology National Centre headed by Dr. Mariano Esteban. The vaccine is based on the Modified vaccinia Ankara (MVA) virus used during the 1970s to help eradicate the smallpox virus. The B in the name "refers to HIV-B, the most common HIV subtype in Europe". It has been stated by Dr. Esteban that, in the future, the vaccine could potentially reduce the virulence of HIV to a "minor chronic infection akin to herpes".
SAV001-H is the first candidate preventive HIV vaccine using a killed or "dead" version of the HIV-1 virus.
HIV/AIDS research includes all medical research that attempts to prevent, treat, or cure HIV/AIDS, as well as fundamental research about the nature of HIV as an infectious agent and AIDS as the disease caused by HIV.
Ebola vaccines are vaccines either approved or in development to prevent Ebola. As of 2022, there are only vaccines against the Zaire ebolavirus. The first vaccine to be approved in the United States was rVSV-ZEBOV in December 2019. It had been used extensively in the Kivu Ebola epidemic under a compassionate use protocol. During the early 21st century, several vaccine candidates displayed efficacy to protect nonhuman primates against lethal infection.
Anna-Lise WilliamsonMASSAf is a Professor of Virology at the University of Cape Town. Williamson obtained her PhD from the University of the Witwatersrand in 1985. Her area of expertise is human papillomavirus, but is also known on an international level for her work in developing vaccines for HIV. These vaccines have been introduce in phase 1 of clinical trial. Williamson has published more than 120 papers.
M. Juliana “Julie” McElrath is a senior vice president and director of the vaccine and infection disease division at Fred Hutchinson Cancer Research Center and the principal investigator of the HIV Vaccine Trials Network Laboratory Center in Seattle, Washington. She is also a professor at the University of Washington.
Pontiano Kaleebu is a Ugandan physician, clinical immunologist, HIV/AIDS researcher, academic and medical administrator, who is the executive director of the Uganda Virus Research Institute.
A viral vector vaccine is a vaccine that uses a viral vector to deliver genetic material (DNA) that can be transcribed by the recipient's host cells as mRNA coding for a desired protein, or antigen, to elicit an immune response. As of April 2021, six viral vector vaccines, four COVID-19 vaccines and two Ebola vaccines, have been authorized for use in humans.
Harriet Latham Robinson is an American vaccine researcher who is founder and Chief Scientific Officer Emeritus at GeoVax. She is the former Chief of Microbiology and Immunology at the Yerkes National Primate Research Center and Asa Griggs Candler Professor of Microbiology at Emory University. Her research considered HIV vaccine development. She is a Fellow of the American Association for the Advancement of Science.