Randomised trial optimising COVID-19 vaccination in patients with chronic health conditions and a poor response to standard vaccination

ABSTRACT: Background and study aims COVID-19 is a condition caused by the coronavirus (called SARS-CoV-2) that was first identified in late 2019. This virus can infect the respiratory (breathing) system. Some people do not have symptoms but can carry the virus and pass it on to others. People who have developed the condition may develop a fever and/or a continuous cough among other symptoms. This can develop into pneumonia. Pneumonia is a chest infection where the small air pockets of the lungs, called alveoli, fill with liquid and make it more difficult to breathe. Nearly 32 million people in the UK have received two doses of the COVID-19 vaccine. Research shows that this prevents infection in over 90% of people. However, these vaccines were tested in healthy people. Recent research in individuals with chronic health problems or cancer suggests that 30% are generating low antibody or T-cells (a type of white blood cell which fights infection) levels after two doses of the Pfizer or AstraZeneca COVID-19 vaccines. This raises the question of the potential benefit of a third dose (re-boost) of the vaccine in these vulnerable patients. A re-boost strategy has been successfully used for other vaccines but the limited research performed to date for COVID-19 has given variable results, so additional research is needed. This study aims to find out whether a re-boost vaccine strategy can induce an immune response in clinically vulnerable patients who have not produced an adequate antibody response after two doses of the COVID-19 vaccine. Who can participate? Patients aged 18 and over who have not produced an adequate antibody response after two doses of COVID-19 vaccine and have one of the following diseases: 1. Breast or lung cancer 2. Certain types of blood cancer 3. Immune-mediated rheumatic diseases (e.g. rheumatoid arthritis) 4. Chronic kidney disease 5. Chronic liver disease 6. Inflammatory bowel disease on immune suppressive therapy 7. Stem cell transplant 8. Primary immunodeficiency (a group of disorders characterized by poor or absent immune function) What does the study involve? Participants will be randomly allocated to receive an additional dose of Pfizer or Moderna COVID-19 vaccine (the main study) or, for a sub-set of patients with blood cancer, the Pfizer or Moderna or Novavax vaccine. Blood samples will be collected before and 21 days after the re-boost vaccine and the level of antibodies and T-cells determined. Patients will be followed up for 3 months to see if they go on to develop COVID-19.

DISEASE(S): 7) Haematopoietic Stem Cell Transplant,3) Immune-mediated Rheumatic Diseases,2) Lymphoid Malignancies,6) Inflammatory Bowel Disease On Immune Suppressive Therapy,8) Primary Immunodeficiency Who Have Received Two Doses Of Sars-cov-2 Vaccine But Have Proven Inadequate Response To The Sars-cov-2 Vaccine,4) End Stage Kidney Disease,5) Liver Disease,Patients With 1) Solid Cancer

PROVIDER: 2411337 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR