Pandemic Influenza Vaccine in Organ Transplantation (PIVOT Trial): SAFETY AND IMMUNOGENICITY OF PANDEMIC INFLUENZA VACCINE IN KIDNEY TRANSPLANT RECIPIENTS

Influenza, the cause of the "flu", is an important virus in patients who have had an organ transplant, including kidney transplant patients. This is because they have weakened immune systems related to the anti-rejection medications they take each day, leaving them vulnerable to infection and becoming very unwell, including need for hospitalization, breathing support and even death. The current widespread outbreak of highly disease causing avian influenza (a strain of bird flu) in livestock, known as H5N1, and the recording of a number of human cases of infection suggest that the next influenza pandemic, meaning worldwide spread of disease, may be soon approaching. Transplant patients, due to having weakened immune systems, as well as living in regional or rural areas, and potentially from their occupation, may be more susceptible to serious infection with the bird flu virus. We describe a number of important reasons to evaluate prevention strategies including vaccination in this highly vulnerable population. Currently, the immunity and protection against the bird flu virus after receiving the H5N8 influenza vaccine is not known in transplant patients. We plan to study the safety and immunity after receiving two doses of the pandemic influenza H5N8 vaccine and compare this with two doses of placebo vaccine (salty water, no immunity expected) in kidney transplant patients. We will also include healthy participants who will receive two doses of the H5N8 vaccine so we know what an expected immune response is in those who are not immune suppressed.