Severe Acute Respiratory Coronavirus-2 Antibody and T cell response after a third vaccine dose in hemodialysis patients compared with healthy controls (preprint)

1. Abstract Hemodialysis patients (HD patients) have a high health risk from Severe Acute Respiratory Coronavirus-2 (SARS CoV 2) infection. In this study, we assess the impact of a third vaccine dose (3D) on antibody levels and T cell response in HD patients and compare the results to those of a healthy control group. We conducted a prospective cohort study consisting of 60 HD patients and 65 healthy controls. All of them received two doses of the Comirnaty mRNA vaccine and a third mRNA vaccine dose (Spikevax or Comirnaty). The SARS CoV 2 S antibody response in all participants was measured 6 months after the second vaccine dose and 6 to 8 weeks after administration of the 3D. We also assessed INF-{gamma} secretion 6 to 8 weeks after the 3D in 24 healthy controls, 17 HD patients with a normal and 20 HD patients with a low or no antibody response after the second dose. The groups were compared using univariate quantile regressions and multiple analyses. The adverse effects of vaccines were assessed via a questionnaire. After the 3D, the SARS CoV 2-specific antibody and INF-{gamma} titers of most HD patients were comparable to those of healthy controls. A subgroup of HD patients who had shown a diminished antibody response after the first two vaccine doses developed a significantly lower antibody and INF-{gamma} response compared to responder HD patients and controls, even after the 3D. A new strategy is needed to protect this patient group from severe COVID 19 infection.

Symptoms and risk factors for hospitalization of COVID-19 presented in primary care (preprint)

ObjectiveTo extend knowledge of early symptoms as a precondition of early identification, and to gain understanding of associations between early symptoms and the development of a severe course of the disease. DesignRetrospective observational study SettingAustrian GP practices in the year 2020, patients above 18 years were included. ParticipantsWe recruited 22 practices who included altogether 295 participants with a positive SARS-CoV-2 test. Main outcome measuresData collection comprised basic demographic data, risk factors and the recording of symptoms at several points in time in the course of the illness. Descriptive analyses for possible associations between demographics and symptoms were conducted by means of cross table. Group differences (hospitalized yes/no) were assessed using Fishers exact test. The significance level was set to 0.05; due to the observational character of the study, no adjustment for multiplicity was performed. ResultsLittle more than one third of patients report symptoms generally understood to be typical for Covid-19. Most patients present with a variety of unspecific complaints. We found symptoms indicating complicated disease, depending on when they appear. The number of symptoms is likely to be a predictor for the need of hospital care. More than 50% of patients still experience symptoms 14 days after onset. ConclusionsUnderrating unspecific symptoms as possible indicators for SARS-CoV-2 infection harbours the danger of overlooking early disease. Monitoring patients during their illness using the indicators for severe disease we identified may help to identify patients who are likely to profit from early intervention. Data availability statementAll data referred to in the manuscript are available from: Department of General Medicine and Family Practice, Karl Landsteiner Privatuniversitaet, Krems, Austria Article SummaryO_ST_ABSStrengths and limitationsC_ST_ABSO_LIThis study investigates data on the course of COVID-19 collected exclusively from patients in primary care and explores a wide range of symptoms. C_LIO_LIGPs were free to make their own testing decision according to their clinical judgement, and they followed each patient individually from day 1 to day 10 or 14. C_LIO_LILimitations of our study concern the limited number of patients, due to the increased workload under difficult working conditions during the pandemic as well as the effort not being remunerated. However, the number of cases needed to identify group differences was calculated in advance, and this number has been reached. Our overall results are in accordance with our preliminary result analyses. C_LI

Hemodialysis Patients Show a Highly Diminished Antibody Response after COVID-19 mRNA Vaccination Compared to Healthy Controls (preprint)

1.1.1 Background and ObjectivesHemodialysis patients are prone to infection with SARS-COV2 and show a high probability of a severe course of disease and high mortality when infected. In many countries hemodialysis patients are prioritised in vaccination programs to protect this vulnerable community. However, no hemodialysis patients were included in efficacy trials of SARS CoV-2 vaccines and therefore efficacy and safety data for this patient group are lacking. These data would be critical, since hemodialysis patients showed decreased responses against various other vaccines and this could mean decreased response to SARS CoV-2 vaccines. 1.2 Design, setting, participants, and measurementsWe conducted a prospective cohort study consisting of a group of 81 hemodialysis patients and 80 healthy controls who were vaccinated with mRNA vaccine BNT162b2 (BionTech/Pfizer, 2 doses with an interval of 21 days). Anti-SARS-COV-2 S antibody response in all participants was measured 21 days after the second dose. The groups were compared with univariate quantile regressions and a multiple analysis. Adverse events (AEs) of the vaccination were assessed with a standardized questionnaire. We also performed a correlation of HBs-Antibody response with the SARS-COV-2 antibody response in the hemodialysis patients. 1.3 ResultsDialysis patients had significantly lower Anti-SARS-COV-2 S antibody titres than healthy control patients 21 days after vaccination with BNT162b2 (median dialysis Patients 171 U/ml versus median controls 2500 U/ml). Age also had a significant but less pronounced influence on antibody titres. Dialysis patients showed less AEs than the control group. No significant correlation was found for Hepatitis B vaccine antibody response and SARS CoV-2 vaccine antibody response. 1.4 ConclusionsHemodialysis patients exhibit highly diminished SARS-COV-2 S antibody titres compared to a cohort of controls. Therefore these patients could be much less protected by SARS CoV-2 mRNA vaccination than expected. Alternative vaccination schemes must be considered and preventive measures must be maintained after vaccination.