Local Side Research Articles

FEM assessment of the procedures providing for a uniform crack shape in specimens for fracture toughness tested in full thickness

Acceptance tests of base metal and welded joints include the evaluation of critical CTOD values as required in product specifications. Tests have to be done in natural (full) thickness. For blanks made of pipes, quantitative criteria of satisfactory straightening and the fixture dimensions are developed. Satisfactory fatigue precrack front linearity can be attained with additional treatment. Local side compression appears efficient for the examined materials. Sequential FEM calculations of welding, side compression and specimen notching allow constructing the residual stress curves to predict fatigue crack extension. The optimum compression displacement is found. The above sequence of operations is proved to be preferable in comparison with side compression performed after notching.

SBRT in Localized Renal Carcinoma: A Review of the Literature.

Stereotactic body radiotherapy (SBRT) allows high doses of radiation to be administered in a limited number of fractions. The high doses per session might allow the theoretical radioresistance of renal carcinoma to be overcome. SBRT may be a therapeutic alternative in inoperable patients with localized renal carcinoma. This review studied the available literature on the use of SBRT in inoperable localized renal carcinoma. The review including data from English-language studies was conducted in PubMed and MEDLINE between January 2010 and December 2020. Articles were included with data from patients with renal carcinoma treated with SBRT, their indications, simulation, dose and fractionation, local control, survival and side effects, comparison with other treatments, response assessment and radioimmunotherapy. The articles included were evaluated for content and validation. The immobilization systems were variable between studies. Doses and fractions were variable from 25-26 Gy in single fractions to 21-48 Gy in 3-5 fractions, with local control being around 90% with a low rate of side-effects. We review the state of the art in SBRT for renal cell carcinoma. More research is needed to determine optimal doses and fractionation, and to develop a reliable response assessment tool. The role of radioimmunotherapy in renal carcinoma is being studied.

Characterization of a novel non-steroidal glucocorticoid receptor agonist optimized for topical treatment

Glucocorticoids (GCs) are commonly used topical treatments for skin diseases but are associated with both local and systemic side effects. In this study, we describe a selective non-steroidal glucocorticoid receptor (GR) agonist for topical use, LEO 134310, which is rapidly deactivated in the blood resulting in low systemic exposure and a higher therapeutic index in the TPA-induced skin inflammation mouse model compared with betamethasone valerate (BMV) and clobetasol propionate (CP). Selectivity of LEO 134310 for GR was confirmed within a panel of nuclear receptors, including the mineralocorticoid receptor (MR), which has been associated with induction of skin atrophy. Topical treatment with LEO 134310 in minipigs did not result in any significant reduction in epidermal thickness in contrast to significant epidermal thinning induced by treatment with BMV and CP. Thus, the profile of LEO 134310 may potentially provide an effective and safer treatment option for skin diseases compared with currently used glucocorticoids.

Safety of the BNT162b2 mRNA COVID-19 vaccine in oncologic patients undergoing numerous cancer treatment options: A retrospective single-center study.

The COVID-19 pandemic, caused by the SARS-CoV2 virus, has infected millions worldwide with cancer patients demonstrating a higher prevalence for severe disease and poorer outcomes. Recently, the BNT162b2 mRNA COVID-19 vaccine was released as the primary means to combat COVID-19. The currently reported incidence of local and systemic side effects was 27% in the general public. The safety of the BNT162b2 mRNA COVID-19 vaccine has not been studied in patients with an active cancer diagnosis who are either ongoing or plan to undergo oncologic therapy.This single center study reviewed the charts of 210 patients with active cancer diagnoses that received both doses of the BNT162b2 mRNA COVID-19 vaccine. The development of side effects from the vaccine, hospitalizations or exacerbations from various oncologic treatment were documented. Type of oncologic treatment (immunotherapy, chemotherapy, hormonal, biologic, radiation or mixed) was documented to identify if side effects were related to treatment type. The time at which the vaccine was administered in relation to treatment onset (on long term therapy, within 1 month of therapy or prior to therapy) was also documented to identify any relationships.Sixty five (31%) participants experienced side effects from the BNT162b2 mRNA COVID-19 vaccine, however most were mild to moderate. Treatment protocol was not linked to the development of vaccine related side effects (P = .202), nor was immunotherapy (P = .942). The timing of vaccine administered in relation to treatment onset was also not related to vaccine related side effects (P = .653). Six (2.9%) participants were hospitalized and 4 (2%) died.The incidence of side effects in cancer patients is similar to what has been reported for the general public (31% vs 27%). Therefore, we believe that the BNT162b2 mRNA COVID-19 vaccine is safe in oncologic patients undergoing numerous cancer treatments.

Factors Affecting Citizen Participation in Local Development Planning in Murewa District, Zimbabwe

Local governments are the bedrock for sound public administration because of their role in promoting bottom-up socio-economic development. Although Zimbabwe has made strides in ensuring citizens’ participation in local government processes, local authorities and other stakeholders still rely on the top-down approaches, marginalising the needs of the local citizens. The purpose of this paper is to determine the factors that affect the active participation of citizens in local governance in the Murewa District in Zimbabwe. Based on a multistage sampling approach, involving purposive sampling and stratified random sampling, interviews were conducted with 30 local government officials, while a questionnaire survey was administered to 396 citizens in four wards within the district. Complementary data were collected through focus group discussions and field observations. Thematic analysis was employed on data generated from interviews, focus group discussions and field observations, while the Statistical Package for the Social Sciences (Version 16) was used to analyse quantitative data from the questionnaire survey. The results show that more than 50% of the residents in the district felt that local government leadership side lined them in development planning. Some citizens reported that officials used development planning meetings to further their political agendas. The study recommends enhancement of citizen participation through citizen empowerment programmes such as educational and political leadership training programmes that transform the marginalised communities into autonomous communities that are capable of determining their own destiny.

A COMPARATIVE STUDY OF DEXMEDETOMIDINE AND CLONIDINE AS AN ADJUVANT TO ROPIVACAINE IN SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK

Objectives: Ultrasound-guided supraclavicular brachial plexus block is the most commonly performed approach for the upper limb surgeries and perioperative pain relief. This study was conducted to compare the post-operative analgesic efficacy of dexmedetomidine and clonidine as an adjuvant to ropivacaine in supraclavicular brachial plexus block in patients undergoing upper limb surgeries. Methods: This was a prospective, randomized, and double-blinded comparative research that included 60 ASA PS I and II patients who were scheduled for the upper limb surgery. The patients were randomized into two groups, namely, Group C and Group D, with 30 patients each. The patients in Group D were given USG-guided supraclavicular brachial plexus block with 30 ml of 0.5% ropivacaine and dexmedetomidine 1 μg/kg and patients in Group C received 30 ml of 0.5% ropivacaine and clonidine 1 μg/kg. The patients were monitored for post-operative and interpreted by visual analog score and duration of analgesia. The Student’s independent t-test was employed for comparing continuous variables. Chi-square test or Fisher’s exact test, whichever is appropriate, was applied for comparing categorical variables. Results: The mean duration of analgesia was longer and the mean consumption of rescue analgesics was lower in Group D as compared to Group C. No significant post-operative complications or local side effects related to the block were noted. Conclusion: Dexmedetomidine prolongs the duration of sensory and motor block as well as the duration of post-operative analgesia as compared to clonidine when used as an adjuvant to ropivacaine in supraclavicular brachial plexus block.

Preservative free travoprost and timolol fixed combination in the initial treatment of primary glaucoma: an assessment of hypotensive efficiency and safety

Purpose. To evaluate the efficacy and safety of Travapress Duo with respect to hypotensive results, changes in functional parameters, and adverse reactions. Material and methods. 30 patients aged 65–75 (averagely 71.3 ± 3.2 years) with a newly diagnosed primary open-angle glaucoma (POAG) received Travapress Duo in the evening, once a day. Goldman tonometry was performed during the screening, then 1 week, 1 month and 3 months from the treatment start. Static perimetry and optical coherence tomography (OCT) were performed before treatment and at the end of the 3rd month since the treatment start. Adverse events were recorded at each stage of the study.Results. As a result of a 3 month long therapy with Travapress Duo, a significant decrease in IOP was noted starting from the 1st week of instillations (by 34 %), after 1 month, by 35 % and after 3 months of observation by 36 %. By the end of the 3rd month of treatment, we noted an insignificant increase in visual acuity, a positive dynamic of the standard deviation and the standard deviation pattern, as well as OCT indicators, such as average thickness of the layer of retinal nerve fibers and the layer of retinal ganglion cells in the macula, stabilization of the thickness of the retinal ganglion cell complex layer and the size of the inner plexiform layer. One patient complained of discomfort and hyperemia by the end of the 1st week of drug instillation. No systemic side effects were noted during the follow-up, and in no case drug withdrawal was require. Conclusion. The preservative-free Travapress Duo drug displayed a high hypotensive efficacy, reducing the IOP to 36% of the initial value. The hypotensive effect was accompanied by indirect neuroprotection, which manifested itself in the positive changes observable in the results of functional studies with varying degrees of reliability. Travapress Duo is characterized by a low level of local side effects and can be recommended for both for the initial and long-term therapy of primary glaucoma of developed and advanced stages.

Subconjunctival use of allogeneic mesenchymal stem cells to treat chronic superficial keratitis in German shepherd dogs: Pilot study.

Chronic superficial keratitis (CSK) is an ocular condition in dogs characterized by corneal opacification leading to visual function impairment. Control of this chronic condition requires the use of topical immunomodulators or corticosteroids daily. Regenerative medicine has shown promising results in several fields of medicine. The aim of this study was to evaluate the clinical effect of allogeneic mesenchymal stem cells (MSCs) of adipose tissue applied via subconjunctival in dogs with CSK. A series of cases of eight dogs diagnosed with CSK were divided into two groups, four dogs each; the conventional treatment group received prednisolone 1% as topical eye drops and the experimental group (EG) received allogeneic MSCs transplantation. The dogs had not previously been treated for CSK. Systemic and ophthalmologic examinations were performed to exclude other abnormalities. An administered amount of MSC (1 × 106 cells each time) was injected via subconjunctival in the peri-limbal region at 0 and 30 days. The animals were followed for 110 days for clinical evaluation, and, at the same time, the images of the corneal abnormalities were obtained and analyzed in the ImageJ software. The statistical analysis was performed in the GrandPrism 7.0 software. Initial and final images revealed that areas with neovascularization, inflammatory infiltrate, and opacity regressed in most eyes in both groups (7/8 eyes in each group) at the end of the 110 days, p = 0.0391 and p = 0.0078 respectively, but this response was minor in the EG comparing to conventional group (CG) (p = 0.026). No local or systemic side effects were observed. Despite the small melioration, MSCs treatment suggests clinical improvement in patients with CSK after 110 days without any local or systemic side effects. However, the improvement achieved was significantly less than the observed within CG. Further studies still are needed to evaluate the use and benefits of stem cells as an adjunct treatment for CSK.

Reported Side Effects of COVID-19 Vaccination among Adults in Saudi Arabia: A Cross-Sectional Study.

BackgroundThe coronavirus disease 2019 (COVID-19) pandemic, caused by the severe acute respiratory syndrome coronavirus 2, is a major international crisis. Although vaccination is the only hope to end this pandemic, adverse effects attributable to vaccines are still being reported. Active surveillance is critical for generating near-real-time, high-quality evidence for potential safety hazards, allowing us to respond quickly to vaccinationPurposeTo investigate the prevalence of side effects following COVID-19 vaccination with Oxford–AstraZeneca among adults in northwestern Riyadh Province, Saudi Arabia.MethodsThis is a cross-sectional and community-based study performed among individuals who had received any type of COVID-19 vaccination. A convenience sampling method was used to collect data using an online survey.ResultsA total of 222 individuals responded to the survey, and the majority frequently reported both localized and systemic side effects after vaccination. The most reported side effects include pain at the site of injection, myalgia, headache, and fever. Some demographic factors were significantly associated with the reported post-vaccination side effects.ConclusionThe most prevalent side effects experienced by individuals after receiving the COVID-19 vaccine were determined in this study. Prior to the administration of a vaccination, counseling programs should be established to help people understand and deal with the possible side effects, with a special focus on demographic differences.

Prof M. Murugappan Poster Award

Aim:Somatic Symptom Disorder with predominant pain (SSD-P) is a common disorder with unsatisfactory treatment options. Non-invasive brain stimulation such as tDCS is useful in various chronic painful conditions. The aim of the study was to assess the effect and safety of 2 sessions of HD-tDCS over left motor cortex on pain and other associated variables in SSD-P on appropriate rating scales.Methodology:Institute Ethics Committee approval was sought and registered in the Clinical Trials Registry of India. Single-blind, sham controlled, cross-over study design was employed. Thirty right handed patients with DSM-5 diagnosis of SSD-P, aged 18-60 years, receiving stable treatment were enrolled by consecutive sampling. After block randomization, a novel protocol (2 short interval repeated sessions) of either active or sham HD-tDCS was administered followed by a wash out period of 7 days and cross over. Assessments were done at baseline, week 1 and 2.Results:Participants were comparable on all baseline parameters. ANCOVA showed no order×group interaction. On RM-ANOVA all participants irrespective of entering active or sham arm showed statistically significant difference (with good effect size, Cohen’s d >0.8) in pain and associated parameters like depression, anxiety, pain related interference, burden and disability at week 2. But at week 1, this was observed only in active arm. Transient mild local side effects like burning, pain and itching were noted. No cognitive side effects were observed.Discussion:This was the first study of HD-tDCS on SSD-P. Bias due to randomization, order of stimulation and blinding was ruled out. Single session repeated protocol can be effective in pain reduction and other parameters. Effects were sustained over a week.Conclusion:2 sessions of active HD-tDCS is safe and effective in reduction of pain and other associated variables like interference, burden and disability in SSD-P. Trial of short protocols is further required.

A Comprehensive Review on Various Aspects of SARS-CoV-2 (COVID-19) Vaccines.

This is a comprehensive review based on the published papers in the field of COVID-19 vaccines and vaccination. Many efforts have been made to develop vaccines to combat this pandemic. Since December 2020, more than 200 vaccines have been tested in various research stages and in clinical trials on humans, of which eight vaccines reached phase four clinical trials in humans and approved by FDA and EUA. After the Pfizer-BioNTech vaccine that had the highest efficacy (95%), the efficacy of the other vaccines are as follows: Moderna 94.5%, Sputnik V 91%, Novavax 89.7%, Sinopharm 79.3%, Oxford/AstraZenaca 70.4%, Johnson and Johnson 66.9%, and Sinovac 50.7%. At present, protein-based vaccines, with 35% of all available COVID-19 vaccines, are the most common technique in the vaccine production, and then there are vaccines of non-replicating viral vector (13.3%), mRNA1 (12.1%), DNA (10.2%), replicating viral vector (9.8%), and inactivated vaccines (8.2%). The most frequently recognized adverse effects within 7 days of each vaccine dose involved fever, fatigue, headache, chill, and myalgia. The mRNA-based vaccines were associated with a higher occurrence of local side effects (78.3 vs. 70.4%; Sig. = 0.064), whereas the viral vector-based vaccine was associated with a higher prevalence of systemic side effects (87.2 vs. 61%; Sig. < 0.001). Based on the evidence and articles in the field of vaccination, AstraZeneca-Oxford and Sinopharm vaccines reported the highest and lowest side effects, respectively. Because of being emerging, pathogenicity, and high infectivity of COVID-19, vaccination against the disease to prevent its incident rate and decrease the prevalence rate is recommended immediately. Being informed of various aspects of the existing vaccines such as efficacy, effectiveness, safety, etc.can accelerate to make effective and useful choices and consequently have a vaccinated community against the epidemic.

Monotherapy of Biofiller for Atrophic Acne Scars: A Prospective Nonrandomized Study.

Atrophic acne scarring is an unpleasant and often permanent complication and a therapeutic challenge for dermatologists. Platelet-poor plasma (PPP) gel injections are derived from the patient's own blood and used as a "biofiller" for skin rejuvenation. The objective was to study the efficacy and safety profile of PPP gel in atrophic acne scars. Thirty patients with atrophic acne scars were included in the study. Topical anesthesia was applied on the area of interest 45 min prior to the procedure. 20 mL of blood was collected in eight sodium citrate bulbs and centrifuged to get PPP that is coagulated with heat to form gel. This gel (biofiller) was injected in the scarred areas monthly for 6 months. Patients were evaluated using Goodman and Baron Scar (GBS) scale (quantitative and qualitative), Physician Global Assessment, and Visual Analogue Scale (VAS) at each visit. The final visit was after 3 months of the last procedure. The mean value of GBS at the first visit was 28, which reduced to 8.2 at the final visit. The analysis of variance test was applied to the quantitative scale from the baseline visit to the final visit. The F value was 462.55 with a P value < 0.0001. The paired t-test was applied for the GBS quantitative scale, which showed a value of 22.86 with a P value of <0.001. Transient local side effects were noted. Biofiller is efficacious in improving atrophic acne scars. It is a simple, minimally invasive, cost-effective procedure with no risk of immunogenic reaction.

Обзор местных побочных эффектов при применении аналогов простагландинов у пациентов с первичной открытоугольной глаукомой

A brief review of the hypotensive effect of prostaglandin analogs is presented. The history of the appearance of the molecule of the first of prostaglandin analogues, latanoprost, is touched upon. All groups of prostaglandin analogs presented on the Russian market, their mechanisms of action and positive effects are considered. Possible local side effects having a pronounced negative impact on compliance, as well as possible cosmetic defects, including issues affecting the duration and effectiveness of surgical treatment, are described in more detail.

Safety of allergen-specific immunotherapy in children.

Allergic respiratory diseases, such as asthma and allergic rhinitis, are global health issues and have had an increasing prevalence in the last decades. Allergen‐specific immunotherapy (AIT) is the only curative treatment for allergic rhinitis and asthma, as it has a disease‐modifying effect. AIT is generally administered by two routes: subcutaneous (SCIT) and sublingual immunotherapy (SLIT). Local side effects are common, but usually well‐tolerated and self‐limited. However, systemic side effects are rare, and associated with uncontrolled asthma and bronchial obstruction, or related to errors in administration. Physicians should constantly assess potential risk factors for not only reporting systemic reactions and fatalities but also implementing other therapies to improve AIT safety. This paper highlights recent evidence on local and systemic reactions related to SCIT and SLIT in children.

Prevalence of Oral Candidiasis in Asthma and COPD Patients Using Inhaled Corticosteroids in the Philippine General Hospital Department of Out-patient Services.

Oral candidiasis (OC) is a well-known local side effect of inhaled corticosteroid (ICS) therapy in patients with asthma and chronic obstructive pulmonary disease (COPD). This study aimed to determine the prevalence of OC and its association with ICS-related factors in out-patient asthma and COPD patients of the Departments of Pulmonology and Pediatric Pulmonology of the Philippine General Hospital (PGH). This is a cross-sectional study conducted from October 2019 to January 2020. Data was collected through a two-part questionnaire accomplished by doctors and patients with asthma or COPD. A total of 67 patients were included in the study. Oral candidiasis was observed in 4 (5.97%) ICS users, and the prevalence was 1.65% to 14.59% (95% CI, SE: 0.028946). This study determined the prevalence of oral candidiasis in asthma and COPD patients and its association with ICS-related factors, including the dosage, medication, device, and duration of therapy. The prevalence of OC in ICS users in PGH cannot be interpreted as high or low due to the small number of respondents, but is consistent with OC prevalence found in related literature. Increased prevalence was observed in adult females with asthma under low dose ICS therapy with Fluticasone/Salmeterol DPI for more than a year. There was no statistically significant correlation among OC prevalence, age, sex, and components of ICS-therapy including dosage, medication, device, frequency, and duration of therapy. A large-scale study is recommended for more accurate assessment of OC prevalence in the population and to determine statistically significant associations among the factors. It is also recommended to quantifiably measure patient compliance, inhalation technique and instruction, and its association to OC prevalence. Findings may be used to strengthen patient education, preventive measures, and disease management to facilitate improved compliance and effective treatment outcomes.

Vaccination Against COVID-19 Disease During Pregnancy.

.Background.The effect of COVID-19 disease during pregnancy is still under investigation, however scientific studies have shown that pregnant women with COVID-19 infection are at increased risk for severe illness or complications [1]. Risk factors for severe disease and death in pregnancy include maternal age (especially ≥35 years), obesity, preexisting medical comorbidities (particularly hypertension and diabetes or more than one comorbidity), and being unvaccinated [2]. Many societies of obstetricians and gynecologists recommend that all pregnant patients undergo COVID-19 vaccination [1]. The aim of this study is to observe demographic characteristics, including education, place of residence and type of employment of women who chose to be vaccinated against COVID-19 in Lithuania, as well as to investigate any adverse reactions following the COVID-19 vaccine during pregnancy and compare the results to published scientific data.Materials and methods.An online questionnaire for pregnant women primarily located in Lithuania who received at least one dose of COVID-19 vaccine before giving birth has been launched in July, 2021. Data were entered via Google Forms and analyzed using Microsoft Excel and IBM SPSS Statistics. Literature review was performed on PubMed and Google Scholar search engines on inclusion criteria: publication date 2019–2021, used keywords pregnancy, COVID-19, vaccination, side effects.Results.Data were collected from 227 women vaccinated against COVID-19 during pregnancy. It was observed that the most chosen vaccine was Pfizer-BioNTech BNT162b2 (196 out of 227 individuals (86%)). More pregnant women confirmed having fever after the second dose compared to the first dose (p=0.006). In addition, injection site pain was the most common local side effect after both doses (98%) and more common after the first dose compared to the second (p=0.002). Regarding systemic reactogenicity more women experienced fatigue after the second dose comparing to the first dose (p=0.01). Furthermore, more women were unable to engage in daily activities after the second dose (p=0.03). All other symptoms did not differ after doses 1 and 2.Conclusions.Overall findings of this study did not suggest any obvious safety signals among pregnant individuals who received COVID-19 vaccine and all the side effects were comparable to the general population. Completed literature review indicates that pregnant women vaccinated against COVID-19 experience the same side effects as individuals in general population and no specific postvaccination reactions among pregnant individuals are observed.

Safety of SARS-CoV-2 vaccines in patients with chronic myeloid leukemia: a multicenter survey in China.

Safety of SARS-CoV-2 vaccines in patients with chronic myeloid leukemia: a multicenter survey in China.

Standardized Quantitative Evaluation of Clinical Effectiveness and Side Effect Profile of Subcutaneous and Sublingual Allergen-Specific Immunotherapy in Children: A 5-Year Single Center Experience

Objective: Allergen-specific immunotherapy (allergen-SIT) is a treatment method with variable efficacy in allergic diseases. This study aimed to investigate the effectiveness of allergen immunotherapy, frequency of LRs and SRs and variables affecting these parameters in patients who underwent allergen-SIT. Materials and Methods: In this study, the recorded data of 81 patients, who received subcutaneous (SCIT) or sublingual (SLIT) allergen immunotherapy for respiratory allergic diseases between 2014 and 2019, were analyzed. In asthma and/or allergic rhinoconjunctivitis (ARC) patients, the effectiveness of treatment was evaluated by analysing the change rates in disease symptom, medication and combined scores (symptom + medication) and visual analog score (VAS). Treatment success was defined by the degree of decrease in scores as; high response above 50%; low response between 20-50%; and failure &lt;20%.Results: The mean age of allergen-SIT initiation was 11.4± 3.1 years. Diagnostic distributions of the patients were asthma (± ARC) in 64.2%, and ARC (without asthma) in 35.8%. The mode of allergen-SIT was SCIT in 77.8% (65% asthma and 35% ARC) and SLIT in 22.2% (61.1% asthma and 38.9% ARC). The main allergens used in allergen-SIT were mite (79%), grass-grain pollen (33.3%), alternaria (9.9%) and olea (8.6%). There was a significant decrease in symptoms, medication, combined and VAS scores in the asthma and ARC groups (p &lt;0.0001), when end-SCIT values were compared to baseline. SLIT also resulted in significant decreases in these scores except asthma medication score. Among the asthma patients the rate of high-responders was 88.8% by SCIT and 50% by SLIT, according to combined asthma score. Among the ARC (without asthma) patients the rate of high-responders was 100% for both SCIT and SLIT. SCIT resulted in local (LR) and systemic side effects (SR) in 18% and 0.6% (all Grade I and Grade II) of the total injections performed. A high number of total injections was significantly associated with higher LR and SR rates. While LR was observed in 16.6% of the patients who underwent SLIT, no systemic reaction was found in any of the patients. Conclusion: SCIT was highly successful in the treatment of asthma and ARC in terms of the degree of therapeutic response. SLIT resulted in a high rate of good response in ARC patients, but a lower response degree in asthmatic patients. Systemic side effects were very low as a result of close risk monitoring and the dose adjustments performed. Keywords: Allergen-specific immunotherapy, SCIT, SLIT, efficacy, symptom score, medication score, visual analog score, side effects

Antibody Response and Safety After mRNA-1273 SARS-CoV-2 Vaccination in Peritoneal Dialysis Patients - the Vienna Cohort.

BackgroundDialysis patients are at high risk for a severe clinical course after infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Safety and early immune responses after mRNA-based vaccination have been reported mostly in patients on hemodialysis (HD), whereas reports of peritoneal dialysis (PD) patients remain rare.MethodsIn this retrospective observational study, 39 PD patients had received two doses of the mRNA-1273 Moderna® vaccine. We analyzed SARS-CoV-2 Spike (S) antibody titers 4 weeks after each dose of mRNA-1273 and report local and systemic side effects in PD patients that occurred within one week after each mRNA-1273 dose. Using a quantile regression model we examined factors that might influence SARS-CoV-2 S antibody levels in PD patients.ResultsFour weeks after the first dose of mRNA-1273 vaccine 33 of 39 (84.6%) PD patients seroconverted and presented with 6.62 U/mL (median; IQR 1.57-22.5) anti-SARS-CoV-2 S antibody titers. After the second dose, 38 of 39 (97.4%) PD patients developed anti-SARS-CoV-2 S antibodies and titers increased significantly (median 968 U/mL; IQR 422.5-2500). Pain at the injection site was the most common local adverse event (AE) (71%). Systemic AEs occurring after the first dose were mostly fatigue (33%) and headache (20%). No severe systemic AEs were reported after the first injection. After the second dose the incidence and the severity of the systemic AEs increased. The most common systemic AEs were: fatigue (40.5%), headache (22.5%), joint pain (20%), myalgia (17.5%) and fever (13%). Lower Davies Comorbidity Score (p=0.04) and shorter dialysis vintage (p=0.017) were associated with higher antibody titers after the first dose. Patients with higher antibody titers after the first dose tended to have higher antibody titers after the second dose (p=1.53x10-05).ConclusionsPeritoneal dialysis patients in this cohort had a high seroconversion rate of 97.4%, showed high antibody titers after full vaccination and tolerated the anti-SARS-CoV-2 mRNA-1273 vaccine well without serious adverse events.

Cellular and humoral immune response after mRNA-1273 SARS-CoV-2 vaccine in liver and heart transplant recipients

Recently published studies have found an impaired immune response after SARS-CoV-2 vaccination in solid organ recipients. However, most of these studies have not assessed immune cellular responses in liver and heart transplant recipients. We prospectively studied heart and liver transplant recipients eligible for SARS-CoV-2 vaccination. Patients with past history of SARS-CoV-2 infection or SARS-CoV-2 detectable antibodies (IgM or IgG) were excluded. We assessed IgM/IgG antibodies and ELISpot against the S protein 4weeks after receiving the second dose of the mRNA-1273 (Moderna) vaccine. Side effects, troponin I, liver tests and anti-HLA donor-specific antibodies (DSA) were also assessed. A total of 58liver and 46heart recipients received two doses of mRNA-1273 vaccine. Median time from transplantation to vaccination was 5.4years (IQR 0.3-27). Sixty-four percent of the patients developed SARS-CoV-2 IgM/IgG antibodies and 79% S-ELISpot positivity. Ninety percent of recipients developed either humoral or cellular response (87% in heart recipients and 93% in liver recipients). Factors associated with vaccine unresponsiveness were hypogammaglobulinemia and vaccination during the first year after transplantation. Local and systemic side effects were mild or moderate, and none presented DSA or graft dysfunction after vaccination. Ninety percent of our patients did develop humoral or cellular responses to mRNA-1273 vaccine. Factors associated with vaccine unresponsiveness were hypogammaglobulinemia and vaccination during the first year after transplantation, highlighting the need to further protect these patients.