Simplified Process Methods For Mass Vaccine Manufacture
Funder
National Health and Medical Research Council
Funding Amount
$158,393.00
Summary
The ideal way to protect against pandemic bird flu is to vaccinate all Australians as soon as possible after a dangerous strain starts to spread. Current manufacturing technology, which begins by making an infectious virus in chicken eggs, is unable to quickly deliver a mass vaccine to the entire Australian population. The existing process is slow, meaning that it will take several months before enough vaccine is available even to protect personnel working in essential services. The product from ....The ideal way to protect against pandemic bird flu is to vaccinate all Australians as soon as possible after a dangerous strain starts to spread. Current manufacturing technology, which begins by making an infectious virus in chicken eggs, is unable to quickly deliver a mass vaccine to the entire Australian population. The existing process is slow, meaning that it will take several months before enough vaccine is available even to protect personnel working in essential services. The product from chicken eggs is rendered safe after manufacture by breaking the virus structure. This make then break strategy reduces vaccine effectiveness meaning that even fewer individuals can be effectively protected per vaccine batch. Recent scientific progress has demonstrated that it is possible to make a non-infectious empty virus shell (a so-called virus-like particle) inside cells. This new product is able to provide full protection against a lethal influenza challenge, when administered nasally. However, these particles are very difficult to purify from contaminants that are packaged into the particles during manufacture in cells. These contaminants can cause an adverse reaction when the product is given to humans, meaning that although the product is effective it remains difficult to mass produce. A manufacturing problem remains. To overcome this manufacturing problem we will seek to assemble vaccine particles in vitro, building the particle from purified protein. Existing technology for manufacturing pure pharmaceutical protein is well-established and safe, and allows mass manufacture of contaminant-free product. This new make don't break manufacturing strategy is similar to that chosen by Merck to deliver a safe and effective vaccine, for cervical cancer, to mass market. Our key aim is to adapt this efficient manufacturing strategy to the manufacture of influenza vaccine. If successful, we will be able to immunize the Australian population using existing national biomanufacturing capability, within weeks of new strain identification, and without the requirement for high-level containment during manufacture.Read moreRead less
Chimeric Virus-like Particles (VLPs) Displaying H1, H3 And H5 Haemagglutinins - Construction And Immunogenicity
Funder
National Health and Medical Research Council
Funding Amount
$207,543.00
Summary
Virus-like particles (VLPs) provoke strong immune responses in the body. We have developed a novel VLP system that allows the production of VLPs containing foreign vaccine antigens of much larger size than previously possible, and have shown that these VLPs provoke strong immune responses in mice without the use of adjuvants. The capacity of these VLPs is large enough to accommodate the most important vaccine antigen of influenza, the haemagglutinin (HA) molecule. We will test whether VLPs can b ....Virus-like particles (VLPs) provoke strong immune responses in the body. We have developed a novel VLP system that allows the production of VLPs containing foreign vaccine antigens of much larger size than previously possible, and have shown that these VLPs provoke strong immune responses in mice without the use of adjuvants. The capacity of these VLPs is large enough to accommodate the most important vaccine antigen of influenza, the haemagglutinin (HA) molecule. We will test whether VLPs can be produced containing each of the three most important HA types _ H1 and H3 that are currently circulating in man, and H5 (avian) that is considered a pandemic threat. VLPs will be tested for their ability to induce neutralizing antibody and cellular immune responses in mice, and for their ability to protect ferrets from influenza infection. If successful, the HA-VLP system would provide a method for the rapid production of new influenza vaccines using large-scale fermentation technology as for hepatitis B and many other vaccines, rather than eggs or cell culture as used for current influenza vaccines.Read moreRead less