ABSTRACT
Background and Aims: SARS-CoV-2 mRNA vaccines have been approved to prevent COVID-19. We assessed immunogenicity, effectiveness and safety of vaccines in patients with compensated and decompesated cirrhosis. Method: This is a prospective single center study assessing humoral and cellular responses in cirrhotics compared to healthy controls, incidence post-vaccination SARS-CoV-2 infections and adverse events (AEs). Antibodies against the spike- and nucleocapside-protein (anti-S and anti-N) were tested at baseline, 21 days after the first and second doses and during follow-up. Spike-specific T-cells quantity assessment was longitudinally conducted by the stimulation of whole blood with peptides covering the SARS-CoV-2 spike protein, followed by IFN-γ and IL-2 measurement. Results: 182 cirrhotics (61 years, 75% males, 45% viral-related, 74% Child-Pugh A, 31% HCC, 85% COVID-19 naïve) and 38 healthy subjects were enrolled. Previous SARS-CoV-2 infection predicted higher anti-S titres at all time points after vaccination, in both groups. COVID-19 naïve cirrhotics showed significantly lower anti-S titres compared to controls [998.5 (0.4-12,500) vs 1,520 (259-12,500) U/mL, p=0.048], anti-S titres significantly decreased after a median of 133 (70-182) days [536 (0.4-8,777) U/mL, p<0.0001] and were lower in decompensated vs compensated cirrhosis [632 (0.4-12,500) vs 1,377 (0.4-12,500) U/mL, p=0.028]. By multivariable analysis in COVID-19 naïve cirrhotics, independent predictors of lower anti-S were active HCC, immunocompromised conditions, BNT162b2 and lower anti-S after first dose. The spike-specific T-cell response was evaluated in 14 cirrhotics, showing a heterogeneous magnitude of response, but on average the quantity and kinetics of decline of the spike-specific cellular responses diverged in cirrhotics compared to controls, with lower concentrations of both IFN-γ and IL-2. During follow-up, 4/133 (3%) COVID-19 naïve cirrhotics tested positive for anti-N, all asymptomatic. Neither unexpected nor severe AEs emerged. Conclusion: Humoral and cellular responses to SARS-CoV-2 mRNA vaccines appeared suboptimal in patients with cirrhosis, however the rate of post-vaccination infection seems low.
ABSTRACT
Background and aim: COVID-19 vaccination campaign represents the most relevant way to overcome the pandemic. COVID-19 vac-cines have been developed at the fastest known pace yet;such a fast production has led to concerns among general population wor-ldwide about safety and efficacy of COVID-19 vaccines. Specifically, patients affected by chronic illnesses, such as Celiac Disease (CeD), may have greater apprehension. The immune status of CeD patients has been studied in literature, however the actual risk of infections is not clear, depending on various factors such as suboptimal nutri-tional status. Information on vaccine hesitancy plays a pivotal role in the development of an efficient vaccine campaign. In our study, we aimed at evaluating COVID-19 vaccine hesitancy among CeD patients, its reasons and determinants. Materials and methods: An anonymous validated questionnaire formulated on the EUSurvey web platform was sent to a mailing list of CeD patients followed at our “Celiac Center” of Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico of Milan. The questions focused on socio-demographic data, disease-related and lifestyle data, attitude to vaccinations in general and predisposition to the COVID-19 vaccine. Hesitancy was defined by a negative answer to the question “Would You accept to get vaccinated tomorrow against COVID-19?”. Among the hesitant, COVID-19 vaccine refusing patients were defined as those who answered negatively to the fol-lowing question: “Would You eventually accept it in the future when more data is available?”. We evaluated the reasons and the factors associated (determinants) to hesitancy, by calculating Adjusted Odds Ratio (AdjOR) with 95% confidence intervals (CI). Results: The questionnaire was sent to 346 patients with a response rate of 29.8% (103). Among the respondents, 25.2% of patients were hesitant, with a total refusal rate of 4.8%. The main reason was the fear of adverse events (68.2%). Among the hesitant patients, 23% declared that their opinion was influenced by CeD. A positive atti-tude towards general vaccinations, a perceived good knowledge about COVID-19 and related vaccines and the adherence to GFD were determinants significantly associated to vaccine willingness (respective AdjOR of 16.48, 95% C.I. 3.34–81.31;6.50, 95% C.I. 1.44–29.22;12.71, 95% C.I. 1.82–88.58).(figure presented) Conclusions: Most CeD patients would accept COVID-19 vaccines. Data on the reasons and the determinants of vaccine hesitancy plays a pivotal role in the development of an efficient vaccine campaign