Renal patients COVID-19 vaccination (RECOVAC) consortium

COVID-19 is a dangerous virus and can have fatal consequences. There are groups of people who even have an increased risk of dying from this, for example kidney patients. The chance that a kidney patient will die from the virus is 4 times greater than a person from the general population. An effective vaccine is desperately needed for this group of people, but it is known that existing vaccines generally work less well in kidney patients. Whether this is also the case for COVID-19 vaccines, why this may be the case and how this group can still be protected is what this research is about. All Dutch universities are working together on this research in a consortium called RECOVAC. Four studies have been set up within the research. Goal The goal is to protect kidney patients as best as possible against COVID-19. The 4 studies also have their own purpose: RECOVAC Immune Response study: Investigate in detail the response of the immune system to COVID-19 vaccination in kidney patients. RECOVAC Antibody study: investigating the relationship between antibody response and protection against COVID-19. RECOVAC Registration study: the occurrence and severity of COVID-19 after vaccination in kidney patients compared to the general population and to people who have not been vaccinated. RECOVAC Booster study: investigate the response of the immune system and the occurrence of COVID-19 after different booster vaccination strategies in patients who have not produced antibodies after two administrations of the Moderna vaccine. Background Why are these studies necessary? Before vaccinations are approved and vaccinations actually take place, a lot of research has been done into the operation and effect of these vaccinations. Unfortunately, there is a lack of specific research into the operation and effect of vaccinations in certain vulnerable target groups, such as kidney patients. Protection is especially important for them, because kidney patients and other patients with a compromised immune system are much more likely to become seriously ill or even die if they become infected with COVID-19. Research design RECOVAC Immune Response study The RECOVAC Immune Response study investigates the response of the immune system of kidney patients after COVID-19 vaccination. This study examines the immune system after vaccination in 175 patients with severe kidney damage, 175 dialysis patients and 300 kidney transplant patients. The results of these groups are compared with the control results of 200 people with normal kidney function. Blood is taken prior to vaccination, 28 days after the first and second vaccination, 6 and 12 months after the second vaccination. Antibodies are measured at different times, but other forms of defense are also examined. RECOVAC antibody study The second study focuses on the relationship between the level of antibodies and the (long-term) efficacy of COVID-19 vaccination. Patients with severe kidney damage, dialysis patients and kidney transplant patients are widely invited to take blood samples at home by means of a finger prick and send them 28 days and 6 months after complete vaccination. This blood is then tested for specific antibodies that are produced after vaccination. In addition, it is recorded whether someone still becomes infected with COVID-19 by means of a questionnaire that is administered 28 days, 6 months, 1 and then 2 years after complete vaccination. This will investigate a relationship between the production of antibodies after vaccination and the risk of still becoming infected with COVID-19. RECOVAC registration study This study aims to investigate the long-term efficacy of COVID-19 vaccination in dialysis patients and kidney transplant patients. It will be examined whether someone still becomes infected with COVID-19 after vaccination and to what extent and whether this differs from people in the general population or from people who have not been vaccinated. It will also be examined whether there are certain patient characteristics that could increase this risk. For this research, a large registry will be kept of all dialysis and kidney transplant patients in the Netherlands and links to existing registries will largely be used. This research will last 2 years. RECOVAC booster study This study aims to provide essential, missing information about the optimal COVID-19 booster strategy in patients for whom no antibodies are detectable after the two standard administrations of the Moderna vaccine. It is also important to investigate whether there are better methods than just repeated administration of vaccine if there are patients who produce insufficient or no antibodies even after a booster vaccination. The first results The first results will be on November 9, 2021 of the RECOVAC Immune Response study published online in Transplant Journal