Immune response after two doses of the BNT162b2 COVID-19 vaccine and risk of SARS-CoV-2 breakthrough infection in Tyrol, Austria: an open-label, observational phase 4 trial.

BACKGROUND: Correlates of protection could help to assess the extent to which a person is protected from SARS-CoV-2 infection after vaccination (so-called breakthrough infection). We aimed to clarify associations of antibody and T-cell responses after vaccination against COVID-19 with risk of a SARS-CoV-2 breakthrough infection and whether measurement of these responses enhances risk prediction. METHODS: We did an open-label, phase 4 trial in two community centres in the Schwaz district of the Federal State of Tyrol, Austria, before the emergence of the omicron (B.1.1.529) variant of SARS-CoV-2. We included individuals (aged ≥16 years) a mean of 35 days (range 27-43) after they had received a second dose of the BNT162b2 (Pfizer-BioNTech) COVID-19 vaccine. We quantified associations between immunological parameters and breakthrough infection and assessed whether information on these parameters improves risk discrimination. The study is registered with the European Union Drug Regulating Authorities Clinical Trials Database, 2021-002030-16. FINDINGS: 2760 individuals (1682 [60·9%] female, 1078 [39·1%] male, mean age 47·4 years [SD 14·5]) were enrolled into this study between May 15 and May 21, 2021, 712 (25·8%) of whom had a previous SARS-CoV-2 infection. Over a median follow-up of 5·9 months, 68 (2·5%) participants had a breakthrough infection. In models adjusted for age, sex, and previous infection, hazard ratios for breakthrough infection for having twice the immunological parameter level at baseline were 0·72 (95% CI 0·60-0·86) for anti-spike IgG, 0·80 (0·70-0·92) for neutralising antibodies in a surrogate virus neutralisation assay, 0·84 (0·58-1·21) for T-cell response after stimulation with a CD4 peptide pool, and 0·77 (0·54-1·08) for T-cell response after stimulation with a combined CD4 and CD8 peptide pool. For neutralising antibodies measured in a nested case-control sample using a pseudotyped virus neutralisation assay, the corresponding odds ratio was 0·78 (0·62-1·00). Among participants with previous infection, the corresponding hazard ratio was 0·73 (0·61-0·88) for anti-nucleocapsid Ig. Addition of anti-spike IgG information to a model containing information on age and sex improved the C-index by 0·085 (0·027-0·143). INTERPRETATION: In contrast to T-cell response, higher levels of binding and neutralising antibodies were associated with a reduced risk of breakthrough SARS-CoV-2 infection. The assessment of anti-spike IgG enhances the prediction of incident breakthrough SARS-CoV-2 infection and could therefore be a suitable correlate of protection in practice. Our phase 4 trial measured both humoral and cellular immunity and had a 6-month follow-up period; however, the longer-term protection against emerging variants of SARS-CoV-2 remains unclear. FUNDING: None.

Seroprevalence of SARS-CoV-2 infection in the Tyrolean district of Schwaz at the time of the rapid mass vaccination in March 2021 following B.1.351-variant outbreak.

In order to curb the rapid dissemination of the B.1.351 variant of SARS-CoV-2 in the district of Schwaz and beyond, the EU allocated additional vaccine doses at the beginning of March 2021 to implement a rapid mass vaccination of the population (16+). The aim of our study was to determine the seroprevalence of SARS-CoV-2 among the adult population in the district of Schwaz at the time of the implementation. Data on previous history of infections, symptoms and immunization status were collected using a structured questionnaire. Blood samples were used to determine SARS-CoV-2 specific anti-spike, anti-nucleocapsid and neutralizing antibodies. We recruited 2,474 individuals with a median age (IQR) of 42 (31-54) years. Using the official data on distribution of age and sex, we found a standardized prevalence of undocumented infections at 15.0% (95% CI: 13.2-16.7). Taken together with the officially documented infections, we estimated that 24.0% (95% CI: 22.5-25.6) of the adult population had prior SARS-CoV-2 infection. Hence, the proportion of undocumented infections identified by our study was 55.8% (95% CI: 52.7-58.5). With a vaccination coverage of 10% among the adults population at that time, we imply that a minimum of two-thirds of the target popuation was susceptible to the circulating threat when this unique campaign started.

Variation in patterns and volumes of injuries admitted to a level one trauma center during lockdown for COVID-19.

INTRODUCTION: Due to the global COVID-19 pandemic, a ban on sports outside one's home and a prohibition on travel between communities were imposed in spring 2020 in Tyrol, Austria. The aim of this study was to evaluate the impact of these restrictions on a level one trauma center. The objective was to identify the most common injury patterns to ensure targeted prevention in times of an ongoing pandemic. MATERIAL AND METHODS: Patients who presented themselves to our trauma center between weeks 7 and 22 in 2020 were retrospectively compared to a mean of the patients of the three previous years (2017-2019). The evaluated variables were the number of patients, age, gender, country of residence, place of accident, time of treatment, injured body region and anatomical structure, number of surgical intervention and severely injured patients. RESULTS: Comparing the mean count of treated patients per week in 2020 of the pre-lockdown period (n = 804.6) with the lockdown period (n = 201.8) a decrease in admissions by 69.7% could be observed. The admission incidence was 9.9 times higher in previous years than in 2020 during the lockdown period. Among the injuries treated during the lockdown the largest increase in relative numbers was in home injuries, head or face injuries and superficial or penetrating injuries. There was a decrease of seriously injured patients as well as patients that needed surgery during the lockdown compared to previous years. CONCLUSIONS: We observed a significant change in the pattern and volume of injuries during a strict lockdown. Intervention programs to reduce the risk of home injuries should be introduced. Furthermore, in order to save resources during a pandemic, specific guidelines on patient management and treatment should be established for the respective medical specialties. TRIAL REGISTRATION: 1157/2020, 10.12.2020.

Estimating seroprevalence of SARS-CoV-2 antibodies using three self-reported symptoms: development of a prediction model based on data from Ischgl, Austria.

We report the development of a regression model to predict the prevalence of severe acute respiratory syndrome coronavirus (SARS-CoV-2) antibodies on a population level based on self-reported symptoms. We assessed participant-reported symptoms in the past 12 weeks, as well as the presence of SARS-CoV-2 antibodies during a study conducted in April 2020 in Ischgl, Austria. We conducted multivariate binary logistic regression to predict seroprevalence in the sample. Participants (n = 451) were on average 47.4 years old (s.d. 16.8) and 52.5% female. SARS-CoV-2 antibodies were found in n = 197 (43.7%) participants. In the multivariate analysis, three significant predictors were included and the odds ratios (OR) for the most predictive categories were cough (OR 3.34, CI 1.70-6.58), gustatory/olfactory alterations (OR 13.78, CI 5.90-32.17) and limb pain (OR 2.55, CI 1.20-6.50). The area under the receiver operating characteristic curve was 0.773 (95% CI 0.727-0.820). Our regression model may be used to estimate the seroprevalence on a population level and a web application is being developed to facilitate the use of the model.

Viewing an alpine environment positively affects emotional analytics in patients with somatoform, depressive and anxiety disorders as well as in healthy controls.

BACKGROUND: Patients with somatoform, depressive or anxiety disorders often don't respond well to medical treatment and experience many side effects. It is thus of clinical relevance to identify alternative, scientifically based, treatments. Our approach is based on the recent evidence that urbanicity has been shown to be associated with an increased risk for mental disorders. Conversely, green and blue environments show a dose-dependent beneficial impact on mental health. METHODS: Here we evaluate the effect of viewing stimuli of individuals in an alpine environment on emotional analytics in 183 patients with psychiatric disorders (mostly somatoform, depressive and anxiety disorders) and 315 healthy controls (HC). Emotional analytics (valence: unhappy vs happy, arousal: calm vs excited, dominance: controlled vs in control) were assessed using the Self-Assessment Manikin. Further parameters related to mental health and physical activity were recorded. RESULTS: Emotional analytics of patients indicated that they felt less happy, less in control and had higher levels of arousal than HC when viewing neutral stimuli. The comparison alpine>neutral stimuli showed a significant positive effect of alpine stimuli on emotional analytics in both groups. Patients and HC both felt attracted to the scenes displayed in the alpine stimuli. Emotional analytics correlated positively with resilience and inversely with perceived stress. CONCLUSIONS: Preventive and therapeutic programs for patients with somatoform, depressive and anxiety disorders should consider taking the benefits of natural outdoor environments, such as alpine environments, into account. Organizational barriers which are preventing the implementation of such programs in clinical practice need to be identified and addressed.

The effect of physical activity in an alpine environment on quality of life is mediated by resilience in patients with psychosomatic disorders and healthy controls.

OBJECTIVE: Physical activity (PA) in an outdoor environment has been shown to exert positive effects on mental well-being beyond those found for PA indoors. The specific effect of an alpine environment has not been investigated so far. Here we evaluate the association of PA in an alpine environment with resilience and quality of life (QOL) in patients with psychosomatic disorders and controls. METHODS: 194 patients with psychosomatic disorders (mostly somatoform disorder and major depressive syndrome) and 326 healthy controls were included in this web-based cross-sectional study. PA was scored using an adapted version of the Global Physical Activity Questionnaire including the environmental aspect (indoor, outdoor, alpine environment). Resilience was assessed using the Resilience Scale-13, QOL using the WHOQOL-BREF. Group comparisons, correlation and mediation analyses were performed. RESULTS: Patients showed significantly lower levels of resilience (p < 0.001) and QOL (p < 0.001) compared to controls. PA in an alpine environment was associated with resilience (patients: r = 0.35, p < 0.001; controls r = 0.18, p < 0.001). There were no significant associations between PA in other environments (outdoor or indoor) and resilience. PA in all three environments correlated with subcategories of QOL. The effect of PA in an alpine environment on QOL was partly mediated by resilience in patients (68% of total effect mediated, p < 0.001) and controls (49% mediated, p = 0.006). CONCLUSION: There is a positive effect of PA in an alpine environment on mental health beyond that of physical activity itself. Preventive and therapeutic programs should thus include physical activity, but also take additional benefits of natural environments into account.