AIDS (Acquired Immunodeficiency Syndrome): AIDS occurs in individuals who have suffered long term infections with the human immunodeficiency virus (HIV) and have compromised immune systems. People with AIDS suffer life threatening diseases from ubiquitous environmental organisms which have limited virulence in normal humans.
Chicken Embryo Fibroblast (CEF): MVA is propagated on primary chicken embryo fibroblast cells prepared from embryonated eggs. A fibroblast is a cell that makes the structural fibers and ground substance of connective tissue. It has a branched cytoplasm surrounding an elliptical, speckled nucleus having 1 or 2 nucleoli.
DNA (Deoxyribonucleic Acid): DNA is the genetic code for all living matter. DNA vaccines use purified DNA for vaccination. The GeoVax DNA vaccine expresses non-infectious forms of the three major proteins of HIV: Gag, Pol, and Env. It is used as a prime for the GeoVax MVA boost.
DNA Immunization: DNA vaccination is an experimental technique for protecting an organism against disease by injecting it with naked DNA to produce an immunological response.
FDA (Food and Drug Administration): The US FDA has oversight of all new vaccines that enter testing in humans.
HIV (Human Immunodeficiency Virus): HIV, a retrovirus, infects and kills the CD4+ T cells of the human immune system. As CD4+ cells are destroyed, the immune system fails, leading to AIDS.
HIV Envelope (Gp120): An HIV envelope glycoprotein that is anchored to the membrane through non-covalent bonds along with gp41, both coming from a cleaved protein, gp160. Gp120 has a pseudorecognision site for CD4 receptors which is inherent to T-cells. This binding thereafter begins the infection of cells. A theory gives it that this protein is being shed from the virus' surface and captured by T-cells. Gp120 may shed normally from the virus' surface.
HIV Gag. (Group-specific Antigen): codes for p24, the viral capsid; p6 and p7, the nucleocapsid proteins; and p17, a matrix protein.
HIV Pol: Codes for viral enzymes, the most important of which are reverse transcriptase, integrase, and protease which cleaves the proteins derived from gag and pol into functional proteins.
HVTN: US HIV Vaccine Trials Network
IND (Investigational New Drug application): INDs are filed for FDA approval prior to the initiation of trials in humans.
MVA (Modified Vaccinia Ankara): MVA was developed to be a safe smallpox vaccine by further attenuating the standard smallpox vaccine during serial passage in chicken embryos. The MVA component of the GeoVax vaccine is used to deliver genes expressing non-infectious forms of the three major proteins of HIV: Gag, Pol, and Env. This vaccine has been used as a single component vaccine with MVA priming and boosting, or as a two component vaccine with DNA priming and MVA boosting, to protect monkeys against AIDS. The GeoVax MVA vaccine also protects monkeys against smallpox (monkeypox). Thus, it could be a dual-purpose vaccine for both HIV and smallpox. MVA has been used safely in over 120,000 humans including immunocompromised individuals .
NIH: US National Institutes of Health
Phase I Trial: Phase I trials test the safety and tolerability of new products in small numbers of healthy volunteers who are not at risk for disease. Studies are initiated with low doses and, if these are safe, proceed to test higher doses.
Phase II Trial: Once the initial safety of the therapy has been confirmed in Phase I trials, Phase II trials are performed on larger groups (100-300) and are designed to assess clinical efficacy of the therapy; as well as to continue Phase I assessments in a larger group of volunteers and patients.
Phase III Trials: Phase III studies are large double-blind randomized controlled trials on large patient groups (1000-3000 or more) and are aimed at being the definitive assessment of the efficacy of the new therapy, especially in comparison with currently available alternatives.
Vaccination: Vaccination is the deliberate induction of protective immunity to a pathogen by administration of non-pathogenic forms of the pathogen or its antigens to induce a memory immune response.
Vaccine: A vaccine is an antigenic preparation used to produce active immunity to a disease, in order to prevent or ameliorate the effects of infection by any natural or 'wild' strain of the organism.
Vaccinia virus (VV): Vaccinia virus is closely related to the virus that causes cowpox. It is in the pox family of viruses, which also includes smallpox. Vaccinia is so mild that it is typically asymptomatic in healthy individuals, but may causes a mild rash and fever, with an extremely low rate of fatality.
Vector DNA: A Vector DNA is a small piece of DNA containing regulatory and coding sequences of interest. A vector is a DNA molecule into which foreign fragments of DNA may be inserted. A vector functions like a "molecular carrier", which will carry fragments of DNA into a host cell. Vectors are usually derived from plasmids, which are small, circular, double-stranded DNA molecules occurring naturally in the cytoplasm of bacteria.