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Immunogenicity of COVID-19 Tozinameran Vaccination in Patients on Chronic Dialysis.

ABSTRACT: Patients with kidney failure have notoriously weak responses to common vaccines. Thus, immunogenicity of novel SARS-CoV-2 vaccines might be impaired in this group. To determine immunogenicity of SARS-CoV-2 vaccination in patients with chronic dialysis, we analyzed the humoral and T-cell response after two doses of mRNA vaccine Tozinameran (BNT162b2 BioNTech/Pfizer). This observational study included 43 patients on dialysis before vaccination with two doses of Tozinameran 21 days apart. Overall, 36 patients completed the observation period until three weeks after the second dose and 32 patients were further analyzed at week 10. Serum samples were analyzed by SARS-CoV-2 specific IgG and IgA antibodies ~1, ~3-4 and ~10 weeks after the second vaccination. In addition, SARS-CoV-2-specific T-cell responses were assessed at ~3-4 weeks by an interferon-gamma release assay (IGRA). Antibody and T cell outcomes at this timepoint were compared to a group of 44 elderly patients not on dialysis, after immunization with Tozinameran. Median age of patients on chronic dialysis was 74.0 years (IQR 66.0, 82.0). The proportion of males was higher (69.4%) than females. Only 20/36 patients (55.6%, 95%CI: 38.29-71.67) developed SARS-CoV-2-IgG antibodies at the first sampling, whereas 32/36 patients (88.9%, 95%CI: 73.00-96.38) demonstrated IgG detection at the second sampling. In a longitudinal follow-up at ~10 weeks after the second dose, the proportion of dialysis patients reactive for anti-SARS-CoV-2-IgG decreased to 27/32 (84.37%, 95%CI: 66.46-94.10) The proportion of anti-SARS-CoV-2 S1 IgA decreased from 33/36 (91.67%; 95%CI: 76.41-97.82) at weeks 3-4 down to 19/32 (59.38; 95%CI: 40.79-75.78). Compared to a cohort of vaccinees with similar age but not on chronic dialysis seroconversion rates and antibody titers were significantly lower. SARS-CoV-2-specific T-cell responses 3 weeks after second vaccination were detected in 21/31 vaccinated dialysis patients (67.7%, 95%CI: 48.53-82.68) compared to 42/44 (93.3%, 95%CI: 76.49-98.84) in controls of similar age. Patients on dialysis demonstrate a delayed, but robust immune response three to four weeks after the second dose, which indicates effective vaccination of this vulnerable group. However, the lower immunogenicity of Tozinameran in these patients needs further attention to develop potential countermeasures such as an additional booster vaccination.

SUBMITTER: Schrezenmeier E

PROVIDER: S-EPMC8284337 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description: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.

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Immunogenicity of COVID-19 Tozinameran Vaccination in Patients on Chronic Dialysis.

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