FAQ

• What is a Vaccine and how does a Vaccine work? A vaccine is a biological substance introduced into the body to build-up immunity against an invading germ like bacteria or viruses. A vaccine works by stimulating the production of antibodies against the invading micro-organism, stimulating the production of certain special "military" cells called CTL (Cytotoxic T Lymphocytes) that search and destroy body-cells that contain the invading organism, or a combination of both of the actions. The first method is useful primarily against bacteria and the second primarily against viruses.
• What is a "Therapeutic" Vaccine?Specifically, a therapeutic vaccine is one that is given to a patient AFTER being exposed to an invading micro-organism. In contrast, a "prophylactic" vaccine is given BEFORE exposure to prevent the micro-organism from invading in the first place. One example of a therapeutic vaccine is the one currently used for the treatment of rabies. Therapeutic vaccines are useful only when the incubation period (the time between being infected and the onset of symptoms) of the illness is long enough that defense mechanisms can be established before death occurs. In HIV, the incubation period is 10 or more years allowing enough time for the immune system to be strengthened by the vaccine before death. This "therapeutic" use is different from the more common preventive (prophylactic) use of vaccines in childhood immunizations for diseases such as diphtheria, whooping cough, and measles.
• What is a "Live" Vaccine?A live vaccine contains a weakened version of a live micro-organism (bacteria or virus) against which one desires to build-up protective immunity. The oral vaccine against polio (Sabin) or the rabies vaccine belong to this category. Other vaccines use only a portion of the invading micro-organism's proteins or dead micro-organisms as in the Salk vaccine. Live vaccines build-up "military cells" (CTL) that, once activated, go on search-and-destroy missions killing the invading micro-organisms. Dead vaccines usually only produce antibodies against the invading micro-organism but are unable to form "military cells". Your body is capable of making antibodies against a portion of a foreign virus or bacterium without actually being infected.
• What is a Recombinant Vaccine?A recombinant vaccine is created by genetically altering the invading virus. The purpose of genetically altering the virus is to weaken it so that it can boost immunity without causing death and disease. In the case of recombinant HIV, the vaccine contains everything from a live HIV strain except the nef gene. Previously, other methods were used to make vaccines in which the micro-organisms were weakened by methods such as heat, radiation and chemicals. These methods are not useful in making a live anti-HIV vaccine because the virus is extremely fragile and dies when conventional weakening methods are used.
• How is IMTV014 Vaccine Made?Immgenuity's acquired technology constructs IMTV014 by genetically altering HIV's nef gene (the cloaking or blocking gene) thus making a new, weakened version of the virus. This version of the virus is unable to stop the production, recruitment and attack of the cytotoxic T lymphocytes (CTLs).
• How does IMTV014 work?IMTV014, which is essentially a live but weakened HIV virus, is administered to a patient suffering from HIV infection. IMTV014 invades the patient's body just as real HIV does. However, unlike the real HIV, IMTV014 will not interfere with production, recruitment and attack of cytotoxic T-lymphocytes (CTLs). The CTLs will now do their designated job and start "search and destroy" missions throughout the body to kill any cell harboring HIV. This is particularly useful in areas where antiretroviral drugs cannot achieve a high concentration such as in the brain. Since there is no difference between IMTV014 and the wild-type HIV in terms of the proteins seen on the surface of the host cell, activated CTLs cannot tell the difference between host cells containing IMTV014 and host cells containing the wild-type HIV, thus killing them all.
• What is involved in the treatment?The current research protocol consists of two injections of IMTV014- a month apart. Further research may require modification of this protocol.
• How long does it take to show benefit?Most patients are expected to show substantial improvement in their immune system within 14-16 weeks after the first injection. This period will be better defined after the first larger scale clinical trial.
• Will IMTV014 be made ineffective by mutations of the HIV?The proteins that the CTLs see on the surface of the infected cells are from a "conserved" i.e., non-changing part of the virus called Gag proteins. Since these proteins do not change frequently like the Env (envelope) proteins, IMTV014 should maintain its effectiveness for a long time and across almost the entire spectrum of mutant strains.
• How is IMTV014 different from antiretroviral drugs?The drugs used in the treatment of HIV do not kill the "blue-prints" of HIV (pro-viral DNA). They only stop production of the virus from these "blue-prints". Given over a period of time, the cells containing the "blue-prints" die and are replaced with healthy cells. For example, the blood cells, mucosal and lymphoid cells are replaced in about a year and eliminate the virus "blue-prints" harboring within them. HOWEVER, the "blue-prints" also exist in some brain cells called "microglia" and other "sanctuary areas" and these cells are in the body for life. They do not die out. These "blue-prints" present in the brain are fully capable of generating large quantities of the virus and re-invading the whole body as soon as the drugs are stopped or as soon as the virus becomes resistant to the effect of the drugs.
• Can IMTV014 be used as a preventive vaccine?This is a possibility. IMTV014 can indeed be used as a "prophylactic" vaccine to immunize the body before the infection. However, the use of such a vaccine in healthy subjects raises serious ethical questions and thus it would be impossible to do such a research. Furthermore, since HIV can be more easily prevented by avoiding high-risk behavior known to be associated with the transmission of HIV, abstaining from such behavior continues to be the best means of prevention. IMTV014 may eventually have application as a prophylactic vaccine for high-risk individuals such as chronic recipients of blood products, prison populations, for commercial sex workers or habitual IV drug abusers.
• Is IMTV014 patented?Immgenuity has patent rights in the United States, Canada, Japan, Brazil, all countries in Europe and several more countries, such as Canada, Australia and Japan. Several dozen new patents will be applied for once clinical trials are complete.