Antibody – A Y-shaped protein found in blood or other bodily fluids that is used by the immune system to identify and neutralize a foreign antigen or object such as a bacteria or virus by binding specifically to it.
Antigen – A protein the immune system recognizes as “foreign”; this can be a substance such as a bacteria or toxin from an infectious disease or enzyme that stimulates an immune response, especially the production of antibodies; also called allergen, immunogen.
Assay – To subject (a drug) to an analysis for the determination of its potency or composition
Bacteria – One-celled organisms, not able to be seen except under a microscope, found in rotting matter, in air, in soil and in living bodies, some being the germs of disease
Cellular immune response – Immune response produced when sensitized T-cells (T lympocytes) directly attack foreign antigens and also stimulate initiation of the body’s humoral immune response. Also known as cell–mediated immune response.
Clinical trial – A study (experiment) in humans that evaluates a diagnostic or therapeutic product. Typically clinical studies go through Phase I (safety), Phase II (initial efficacy and dosing), and Phase III (large scale studies assessing both safety and efficacy and may represent a pivotal study that provides the evidence to file a New Drug Application for drug approval).
Cytokine – Any of several regulatory proteins, such as interleukins and lymphokines, that are released by cells of the immune system and act as intercellular mediators in the generation of an immune response.
DNA – Main component of chromosomes that is the material that transfers genetic characteristics in all life forms
DNA delivery – A method for delivering DNA- or gene-based treatments, typically into cells of the targeted tissue
DNA vaccine – A next-generation vaccine technology that uses a DNA fragment that is coded to produce a unique antigenic (foreign) protein associated with a targeted disease, rather than using a live or weakened version of the targeted disease to present these same proteins to the body
Efficacy – The power or ability to produce an effect.
Electroporation – The application of electric current to a living surface (as the skin or plasma membrane of a cell) in order to open pores or channels through which a biologic material may pass (as a drug or DNA).
Electroporation-based DNA delivery – A method of DNA delivery using electroporation as the enabling mechanism.
Ex vivo – Outside the body.
FDA or Food & Drug Administration – A US federal agency established to regulate the release of new foods and health-related products.
Gene – A hereditary unit consisting of a sequence of DNA that occupies a specific location on a chromosome and determines a particular characteristic in an organism.
Gene delivery – See DNA
Gene gun – A method of gene delivery, also known as a biolistic gun, that uses high-pressure helium gas to blast microscopic particles of gold coated with the material of interest into skin tissue; a method used to deliver DNA vaccines
Gene expression – Process by which the inheritable information in a gene, such as the DNA sequence, is made into a functional gene product, such as protein or RNA.
Gene therapy – A technique for the treatment of genetic disease in which a gene that is absent or defective is replaced by a healthy gene.
Genomics – The branch of molecular genetics concerned with the study of genomes, specifically the identification and sequencing of their constituent genes and the application of this knowledge in medicine, pharmacy, agriculture, etc
Humoral immune response – The aspect of immunity that is mediated by secreted antibodies (as opposed to cell-mediated immunity which involves T lymphocytes) produced B cells.
Immune system – A collection of mechanisms within an organism that protects against disease by identifying and killing pathogens and tumor cells.
Immune response – How your body recognizes and defends itself against bacteria, viruses, and substances that appear foreign and harmful to the body.
Immunogenicity – Causing or capable of producing an immune response.
Immunotherapy – Treatment designed to produce immunity to a disease or enhance the resistance of the immune system to an active disease process, e.g. an infection or cancer.
IND – An Investigation New Drug application containing laboratory (pre-clinical) study results of a drug candidate is submitted to the FDA to request permission to conduct studies in humans.
In vitro – In a test tube.
In vivo – Inside the body.
Indication – The medical use of a product (e.g. aspirin is used to treat a headache).
Intracellular – Inside a cell.
Intradermal – Inside dermis, or skin.
Intramuscular – Inside muscle.
Intratumoral – Inside a tumor.
Investigational New Drug – See IND.
Lipid – Essential structural component of living cells, along with proteins and carbohydrates
Lipid vector – A lipid modified to act as a carrier or transporter, such as for a DNA vaccine, into a host cell.
Metabolism – The chemical processes occurring within a living cell or organism that are necessary for the maintenance of life. In metabolism some substances are broken down to yield energy for vital processes while other substances, necessary for life, are synthesized.
Metaboliz –e To subject (a substance) to metabolism.
Mucosal – Of or relating to mucous membranes, which line passages and cavities of the body that are exposed to the exterior, as well as ducts and receptacles of secretion, and habitually secreting mucus.
Mutagenesis – Formation or development of a mutation.
Mutation – A sudden departure from the parent type in one or more heritable characteristics, caused by a change in a gene or a chromosome.
NDA – New Drug Application, submitted to the FDA for approval to market a drug in the U.S.
New Drug Application – See NDA.
Oncogenicity – The capability of inducing tumor formation.
Pathogen – Any disease-producing agent, especially a virus, bacterium, or other microorganism.
Phase I clinical trial – The initial set of drug studies in humans, which are generally designed to evaluate the safety of a new drug in a small number of patients or normal volunteers.
Phase II clinical trial – Small–scale drug studies in patients that are designed to characterize a drug’s effects on a particular disease. These studies usually evaluate more than one drug dose and generally compare the new drug to therapy that is already known to be effective.
Phase III clinical trial – These studies are the definitive trials conducted to demonstrate the safety and effectiveness of a new drug for the diagnosis or treatment of a disease.
Plasmid – A circular bacterial DNA, sometimes used as a vector for gene insertion or genetic engineering.
Preclinical – The testing of an experimental drug in a test tube or animals before clinical trials in humans may be carried out.
Protein – are large organic compounds made of amino acids arranged in a linear chain and joined together by peptide bonds between the carboxyl and amino groups of adjacent amino acid residues.
Protocol – The plan or set of instructions that tells an investigator (generally a physician) how to conduct a clinical trial.
Synthetic vaccine – A vaccine consisting mainly of synthetic peptides, carbohydrates, or antigens. They are usually considered to be safer than vaccines from bacterial cultures.
T-cells – Belong to a group of white blood cells known as lymphocytes, and play a central role in cell-mediated immunity.
Transdermal – Through the skin. Referring to absorption of drugs that are either placed directly on the skin, such as creams and ointments, or applied in time-release forms, such as skin patches.
Transfection – Describes the introduction of foreign material into cells using a means of transfer.
Transgene – A gene or genetic material that has been transferred by any of a number of genetic engineering techniques from one organism to another.
Vaccine – An immunity booster to a specified disease.
Vector – Any agent that acts as a carrier or transporter, such as a virus or plasmid that conveys a genetically engineered DNA segment into a host cell.
Viral vector – A genetically modified virus used to deliver genetic material such as a DNA vaccine into cells.
Virus – A sub-microscopic infectious agent that is unable to grow or reproduce outside a host cell.