Immunogenicity and safety of COVID-19 booster vaccination: A population-based clinical trial to identify the best vaccination strategy.

BACKGROUND: Various SARS-CoV-2 variants of concerns (VOCs) characterized by higher transmissibility and immune evasion have emerged. Despite reduced vaccine efficacy against VOCs, currently available vaccines provide protection. Population-based evidence on the humoral immune response after booster vaccination is crucial to guide future vaccination strategies and in preparation for imminent COVID-19 waves. METHODS: This multicenter, population-based cohort study included 4697 individuals ≥18 years of age who received a booster vaccination. Antibody levels against SARS-CoV-2 receptor binding domain (RBD) and neutralizing antibodies against wild-type (WT) virus and Omicron variants were assessed at baseline (day of booster vaccination) and after four weeks. Safety was evaluated daily within the first week using a participant-completed electronic diary. Antibody levels were compared across different vaccination strategies, taking into account individual host factors. RESULTS: Our main model including 3838 participants revealed that individuals who received a booster with mRNA-1273 compared to BNT162b2 vaccine had a significantly higher increase (95 %CI) in anti-RBD-antibody levels (37,707 BAU/mL [34,575-40,839] vs. 27,176 BAU/mL [26,265-28,087]), and of neutralization levels against WT (1,681 [1490-1872] vs. 1141 [1004-1278] and Omicron variant (422 [369-474] vs. 329 [284-374]). Neutralizing antibody titres highly correlated with anti-RBD antibodies, with neutralizing capacity 4.4 fold higher against WT compared to Omicron. No differences in safety were found between the two booster vaccines. CONCLUSION: Our study underlines the superiority of a booster vaccination with mRNA-1273, independent of the primary vaccination and therefore provides guidance on the vaccination strategy.

Reduced immunogenicity of BNT162b2 booster vaccination in combination with a tetravalent influenza vaccination: results of a prospective cohort study in 838 health workers.

OBJECTIVE: To investigate the immunogenicity and safety of BNT162b2 booster vaccination with and without a tetravalent influenza vaccine. METHODS: A prospective, open-label cohort study on immunogenicity and safety of COVID-19 booster vaccination with or without a tetravalent influenza vaccine was performed. Eight hundred thirty-eight health care workers were included in the following study arms: BNT162b2 booster-only, influenza-vaccine-only or combination of both. Levels of antibodies against SARS-CoV-2 spike receptor binding domain, and haemagglutinin inhibition tested for four different influenza strains (A(H1N1)pdm09, A(H3N2), B/Victoria, B/Yamagata) were measured at the time of vaccination and 4 weeks later. RESULTS: After 4 weeks, median (interquartile range) levels of antibodies against the receptor binding domain of the viral spike (S) protein and relative change from baseline were high in individuals who received BNTb162b2 booster vaccination only (absolute: 16 600 [10 980-24 360] vs. 12 630 [8198-18 750] BAU/mL [p < 0.0001]; relative increase: 49% [23.6-95.3] vs. 40% [21.9-80.6] [p 0.048]; booster-only n = 521 vs. combination-arm n = 229 respectively). Results were confirmed after matching for sex, age, body mass index, baseline antibody levels and vaccine compound received for primary immunization (absolute: 13 930 [10 610-22 760] vs. 12 520 [8710-17 940]; [p 0.031]; relative increase: 55.7% [27.8-98.5] vs. 42.2% [22.9-74.5]; p 0.045). Adverse events were almost identical in the booster-only and the combination-arm, but numerically low in the influenza arm (525/536 [97.9%] vs. 235/240 [97.9%] vs. 26/33 [78.8 %]). DISCUSSION: Although no safety concerns occurred, our study provides evidence on reduced immunogenicity of a BNT162b2 booster vaccination in combination with a tetravalent influenza vaccine. Further studies investigating new influenza variants as well as potential differences vaccine effectiveness are needed.

Performance Score (T2D)-A New Perspective in the Assessment of Six-Minute Walking Tests in Pulmonary Rehabilitation.

Because absolute changes in outcomes are difficult to interpret and the minimal clinically important difference (MCID) is not suitable to address this challenge, a novel method of classifying outcomes by relating changes to baseline values is warranted. We used the "performance score" (T2D), which reflects individual performance, enabling us to consider the functional status at the beginning of rehabilitation without dealing with the problems of mathematical coupling or regression effects, as encountered in ANCOVA. To illustrate the T2D, we retrospectively analyzed changes in the six-minute walking test (6MWT) in COPD patients undergoing outpatient pulmonary rehabilitation and compared the results with absolute differences related to a predetermined MCID. We evaluated a total of 575 COPD patients with a mean age of 61.4 ± 9.2 years. 6MWT improved significantly, with a mean change of 32.3 ± 71.2. A total of 105/311 participants who had reached the MCID were still classified as "below average" by the T2D. Conversely, 76/264 patients who had not reached the MCID were classified as "above average". This new performance measure accounts for the patient's current status and for changes over time, potentially representing a simple and user-friendly tool that can be used to quantify a patient's performance and response to rehabilitation.

Comparison of patient- and clinician-reported outcome measures in lower back rehabilitation: introducing a new integrated performance measure (t2D).

PURPOSE: Patient- and clinician-reported outcome measures (PROMs, CROMs) are used in rehabilitation to evaluate and track the patient's health status and recovery. However, controversy still exists regarding their relevance and validity when assessing a change in health status. METHODS: We retrospectively analyzed the changes in a CROM (Fingertip-To-Floor Test - FTF) and PROMs (ODI, HAQ-DI, NPRS, EQ5D) and the associations between these outcomes in 395 patients with lower back pain (57.2 ± 11.8 years, 49.1% female). We introduced a new way to measure and classify outcome performance using a distribution-based approach (t2D). Outcome measures were assessed at baseline and after 21 days of inpatient rehabilitation. RESULTS: Overall, the rehabilitation (Cohens d = 0.94) resulted in a large effect size outcome. Medium effect sizes were observed for FTF (d = 0.70) and PROMs (d > 0.50). Best performance rating was observed for pain (NPRS). We found that 13.9% of patients exhibited a deterioration in the PROMs, but only 2.3%, in the FTF. The correlation between the PROMs and FTF were low to moderate, with the highest identified for HAQ-DI (rho = 0.30-0.36); no significant correlations could be shown for changes. High consistency levels were observed among the performance scores (t2D) in 68.9% of the patients. CONCLUSIONS: Different and complementary assessment modalities of PROMs and CROMs can be used as valuable tools in the clinical setting. Results from both types of measurements and individual performance assessments in patients provide a valid basis for the meaningful interpretation of the patients' health outcomes. TRIAL REGISTRATION: This clinical study was entered retrospectively on August 14, 2020 into the German Clinical Trials Register (DRKS, registration number: DRKS00022854).

Successful application of focused extracorporeal shockwave therapy for plantar fasciitis in patients suffering from metastatic breast cancer.

PURPOSE: Focused extracorporeal shock wave therapy (fESWT) has been shown to be effective in a large number of musculoskeletal disorders. Until 2016, cancer was considered a contraindication for fESWT. The goal of this Commentary is to address the subject of fESWT in cancer patients and present a case of a successful application of fESWT in a breast cancer patient with metastatic bone disease, suffering from debilitating heel pain caused by plantar fasciitis. METHODS: The subject of fESWT application in cancer patients is discussed using the example of a 75-year-old female with breast cancer and metastatic bone disease suffering from bilateral inferior heel pain, who was referred to our clinic with a tentative diagnosis of polyneuropathy. Patient history, clinical examination, electrodiagnostic testing, and radiological findings all indicated plantar fasciitis, rather than polyneuropathy. The possibility of metastatic bone lesions in the treatment area was excluded and the patient was thereupon treated with 5 weekly applications of low-energy fESWT. RESULTS: The treatment lead to a reduction in pain of approximately 80% with no adverse events. CONCLUSION: fESWT may be a viable treatment option for plantar fasciitis even in cancer patients, provided certain conditions are met.

Effects of a structured exercise program on physical performance and function, quality of life and work ability of physically active breast cancer survivors : A retrospective data analysis.

BACKGROUND: Purpose of this retrospective data analysis was to depict the effects of a structured off-season conditioning program with breast cancer survivors competing in dragon boat paddling. METHODS: In this study 10 breast cancer survivors (mean age 52.0 ± 5.4 years) who had finished the primary cancer treatment and who were paddlers of the Vienna Pink Dragon self-help group underwent a structured 10-week exercise program as part of their routine supportive treatment. Upper extremity strength, endurance capacity, shoulder flexibility, quality of life and work ability were assessed at baseline and after completion of the exercise program. RESULTS: Out of 10 patients 8 completed more than 80% of the exercise sessions. A multivariate analysis of variance (MANOVA) of the pooled exercise effects showed a very large effect size (Η2 = 0.982); however, the change from baseline to follow-up was non-significant (p = 0.363). In the European Organisation for Research and Treatment of Cancer Quality of Life of Cancer Patients Questionnaire (EORTC QLQ-C30) the exercise program led to a significant improvement of body image (p = 0.02) and less arm symptoms in the affected arm (p = 0.04). CONCLUSION: A structured and well-planned exercise intervention program can have a large effect on the physical performance of pretrained breast cancer survivors. Moreover, it can increase the body image and decrease the arm symptoms in this population.

Can reminders improve adherence to regular physical activity and exercise recommendations in people over 60 years old? : A randomized controlled study.

PURPOSE: The purpose of the study was to investigate whether additional reminders could enhance adherence to a 12-week program consisting of regular physical activity. METHODS: The study collective consisted of pensioners insured with the Austrian Insurance Fund for Civil or Public Servants. They were made aware of our program through the public service union. The subjects were randomized to an intervention group (group A) that received reminders and to a control group (group B) that did not receive such notifications. Adherence to physical activity was assessed by the use of diaries. RESULTS: Group A performed 96 min more moderate intensity regular physical activity per week than group B (group A median 269 min, r = 0-1560 min; group B median 173 min, r = 0-2700 min). The Mann-Whitney U-test showed no significant differences (p = 0.080) between the study groups. There was no difference in muscle strengthening activity (group A: median: 2, r = 0-13 sessions; group B: median: 2, r = 0-20 sessions). CONCLUSION: The major positive observation was that both the experimental and control group participants exceeded the recommended level of physical activity. Nevertheless, there were some differences concerning the minutes of physical activity performed in favor of the intervention group.

Effects of resistance exercise in prostate cancer patients : A systematic review update as of March 2020.

PURPOSE: The aim of this systematic review is to provide an update on the effects of resistance exercise (RE) in patients with prostate cancer (PCa), with special attention to the effects on sexual health. METHODS: A systematic search of the literature was conducted in March 2020 using the databases PubMed, MEDLINE, EMBASE, SCOPUS and the Cochrane Library. Only randomized, controlled trials published after 31 December 2016 were included in this update. Additionally, articles from current and previous reviews were utilized to provide a brief summary of the effects on sexual health. RESULTS: A total of 10 articles met the inclusion criteria, of which 5 were identified as independent studies. The remaining five articles presented additional data for studies, which have already been included. The identified studies further strengthened the evidence for positive effects on muscle strength, body composition and physical function. Positive effects on bone mineral density were apparent only when RE was combined with impact training. One article reported an improvement in fatigue and health-related quality of life. Only one study examined the effects of RE in isolation and three articles indicated positive effects of exercise on sexual health. CONCLUSION: Recent evidence supports the use of RE in PCa patient rehabilitation as a countermeasure for treatment side effects. Further research is necessary to ascertain the optimal delivery methods and illuminate the effects on health-related quality of life (HRQOL), fatigue and sexual health.