scholarly journals Severe allergic reactions after COVID-19 vaccination with the Pfizer/BioNTech vaccine in Great Britain and USA

2021 ◽  
Author(s):  
Ludger Klimek ◽  
Natalija Novak ◽  
Eckard Hamelmann ◽  
Thomas Werfel ◽  
Martin Wagenmann ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Allergic Reaction ◽  
Repeated Administration ◽  
Phase Iii ◽  
Foreign Protein ◽  
Severe Allergic Reaction ◽  
Allergic Reactions ◽  
Pivotal Phase ◽  
Other Substances ◽  
Life Threatening

SummaryTwo employees of the National Health Service (NHS) in England developed severe allergic reactions following administration of BNT162b2 vaccine against COVID-19 (coronavirus disease 2019). The British SmPC for the BNT162b2 vaccine already includes reference to a contraindication for use in individuals who have had an allergic reaction to the vaccine or any of its components. As a precautionary measure, the Medicines and Healthcare products Regulatory Agency (MHRA) has issued interim guidance to the NHS not to vaccinate in principle in “patients with severe allergies”. Allergic reactions to vaccines are very rare, but vaccine components are known to cause allergic reactions. BNT162b2 is a vaccine based on an mRNA embedded in lipid nanoparticles and blended with other substances to enable its transport into the cells. In the pivotal phase III clinical trial, the BNT162b2 vaccine was generally well tolerated, but this large clinical trial, used to support vaccine approval by the MHRA and US Food and Drug Administration, excluded individuals with a “history of a severe adverse reaction related to the vaccine and/or a severe allergic reaction (e.g., anaphylaxis) to a component of the study medication”. Vaccines are recognized as one of the most effective public health interventions. This repeated administration of a foreign protein (antigen) necessitates a careful allergological history before each application and diagnostic clarification and a risk–benefit assessment before each injection. Severe allergic reactions to vaccines are rare but can be life-threatening, and it is prudent to raise awareness of this hazard among vaccination teams and to take adequate precautions while more experience is gained with this new vaccine.

The efficacy and safety of sunitinib in patients with advanced well-differentiated pancreatic neuroendocrine tumors.

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 380-380 ◽  
Author(s):  
Eric Raymond ◽  
Matthew H. Kulke ◽  
Shukui Qin ◽  
Michael Schenker ◽  
Antonio Cubillo ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Neuroendocrine Tumors ◽  
Phase Iii ◽  
Pancreatic Neuroendocrine Tumors ◽  
Pivotal Phase ◽  
Treatment Naïve ◽  
Phase Iii Study ◽  
Previously Treated Patients ◽  
Previously Treated ◽  
Well Differentiated

380 Background: Sunitinib was approved by the FDA in 2011 for treatment of progressive, well-differentiated, advanced pancreatic neuroendocrine tumors (pNETs) based on a pivotal phase III study (NCT00428597) that showed a significant increase in progression-free survival (PFS) over placebo following early study termination. Subsequently, the FDA requested a post-approval study to support these findings. Methods: In this open-label, phase IV clinical trial (NCT01525550), patients with progressive, well-differentiated, unresectable advanced/metastatic pNETs received continuous sunitinib 37.5 mg once daily. Eligibility criteria were similar to the phase III study. Primary endpoint was investigator-assessed PFS per RECIST 1.0. This study is ongoing. Results: Sixty one treatment-naïve and 45 previously treated patients with progressive pNETs were treated with sunitinib: mean age, 54.6 years; males, 59.4%; white, 63.2%; ECOG PS 0, 65.1% or PS 1, 34.0%; and prior somatostatin analog, 48.1% (treatment-naïve, 39.3%; previously treated, 60.0%). At the data cutoff date, 82 (77%) patients discontinued treatment, mainly due to disease progression (46%). Median duration of treatment was ~11.9 months. Investigator-assessed median PFS (mPFS) was 13.2 months (95% CI, 10.9–16.7) in the overall population, with comparable mPFS in treatment-naïve and previously treated patients (13.2 vs 13.0 months). mPFS per independent radiologic review was 11.1 months (95% CI, 7.4–16.6). Objective response rate (ORR) per RECIST was 24.5%: 21.3% in treatment-naïve and 28.9% in previously treated patients. Median overall survival, although not yet mature, was 37.8 months. Treatment-emergent, all-causality adverse events (AEs) reported by ≥ 20% of all patients included neutropenia, diarrhea, leukopenia, fatigue, hand–foot syndrome, hypertension, abdominal pain, dysgeusia, and nausea. Most common grade 3/4 AEs were neutropenia (22%) and diarrhea (9%). Conclusions: The mPFS of 13.2 months and ORR of 24.5% observed in this study support the outcomes of the pivotal phase III study of sunitinib in pNETs and confirm its activity in this setting. AEs were consistent with known safety profile of sunitinib. Clinical trial information: NCT01525550.

scholarly journals A Suspected Allergic Reaction to Boal Fish (Wallago Attu)

2020 ◽  
Vol 4 (9) ◽  
pp. CR1-CR4
Author(s):  
Ramesh Puri ◽  
Jayati Batra
Keyword(s):  
Immune System ◽  
Contact Dermatitis ◽  
Allergic Reaction ◽  
Nutritional Value ◽  
Allergic Reactions ◽  
Quick Recovery ◽  
Wallago Attu ◽  
Life Threatening

Consumption of fish has increased around the globe due to its high nutritional value and this has led to an increase in incidence of allergic reactions to fish. Reactions to fish are not only mediated by the immune system causing allergies but are often caused by proteins, metals, various toxins and parasites. Allergic reactions to fish can range from being mild and self-limiting to serious and life threatening. We report a case of an adult with suspected allergic reaction to Boal fish (Wallago Attu) who developed contact dermatitis during marinating process. Application of steroids and administration of oral antihistaminic led to a quick recovery.

scholarly journals Macrocycle Therapeutics to Treat Life-threatening Diseases

2021 ◽  
Vol 75 (6) ◽  
pp. 508-513
Author(s):  
Gokhan Batur ◽  
Philipp Ermert ◽  
Johann Zimmermann ◽  
Daniel Obrecht
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Membrane Proteins ◽  
Outer Membrane ◽  
Outer Membrane Proteins ◽  
Phase Iii ◽  
Phase Iii Clinical Trial ◽  
Life Threatening ◽  
Novel Antibiotics

Polyphor's macrocycle platform led to the discovery of novel antibiotics addressing specifically Gramnegative bacteria by targeting outer membrane proteins. Furthermore, POL6014, an inhibitor of neutrophile elastase and balixafortide, a CXCR4 inhibitor have been discovered and developed from the platform. Currently a combination of balixafortide and eribulin is in Phase III clinical trial for the treatment of patients with advanced metastatic HER2-negative breast cancer.

Clinical and immunological characteristics of sensitization to tropomyosins

2021 ◽  
Vol 18 (1) ◽  
pp. 73-78
Author(s):  
Marina A. Mokronosova ◽  
Tatiana M. Zheltikova
Keyword(s):  
Food Allergy ◽  
Allergic Reaction ◽  
Clinical Case ◽  
Oral Allergy Syndrome ◽  
Allergic Reactions ◽  
Allergenic Proteins ◽  
Primary Sensitization ◽  
Life Threatening ◽  
Reaction Severity ◽  
High Concentrations

Tropomyosins are a family of allergenic proteins found in large quantities in all invertebrates. Tropomyosins sensitization causes a life-threatening allergic reaction up to anaphylaxis after eating seafood. Identifying the source of primary sensitization is important to predict the allergic reaction severity. This article describes a clinical case of chronic recurrent urticaria in an 8-year-old boy with tropomyosins sensitization. An 8-year-old boy was diagnosed with the following: controlled atopic phenotype bronchial asthma, food allergy (oral allergy syndrome), and chronic recurrent spontaneous urticaria. Component diagnostics revealed IgE-aB to tropomyosins in high concentrations from 38.79 to 43.38 kUA/l and cat and dog uteroglobin and lipocalins in high concentrations from 7.79 to 43.38 kUA/l. It is necessary to specify the primary sensitizer to analyze the clinical significance of allergens that provoke sensitization to various groups of allergens. In this case, sensitization to tropomyosins is most likely described as caused by either a helminthic invasion or midge bites. Therefore, food allergic reactions to tropomyosins caused from crustaceans were not observed.

scholarly journals Myths, facts and controversies in the diagnosis and management of anaphylaxis

2018 ◽  
Vol 104 (1) ◽  
pp. 83-90 ◽  
Author(s):  
Katherine Anagnostou ◽  
Paul J Turner
Keyword(s):  
Allergic Reaction ◽  
Healthcare Professionals ◽  
Allergic Reactions ◽  
International Guidelines ◽  
Diagnosis And Management ◽  
Systemic Allergic Reaction ◽  
Consensus Statements ◽  
Life Threatening ◽  
Optimal Approach ◽  
Common Misconceptions

Anaphylaxis is a serious systemic allergic reaction that is rapid in onset and may cause death. Despite numerous national and international guidelines and consensus statements, common misconceptions still persist in terms of diagnosis and appropriate management, both among healthcare professionals and patient/carers. We address some of these misconceptions and highlight the optimal approach for patients who experience potentially life-threatening allergic reactions.

Anaphylaxis: Triggers and symptoms

2020 ◽  
Vol 1 (3) ◽  
pp. 120-123
Author(s):  
Deborah Louise Duncan
Keyword(s):  
Allergic Reaction ◽  
Health Professionals ◽  
Severe Allergic Reaction ◽  
Life Threatening ◽  
The Common ◽  
Assessment And Diagnosis

Anaphylaxis is a severe allergic reaction, which is potentially life-threatening. It is therefore important that health professionals have a good understanding of its triggers, presentation and management. This first article of a two-part series, focuses on the common triggers and symptoms of anaphylaxis, and explores some of the literature around assessment and diagnosis.

Abstract P151: Remote Enrollment Practices for Acute Stroke Clinical Research Trials During a Pandemic

Stroke ◽  
2021 ◽  
Vol 52 (Suppl_1) ◽  
Author(s):  
Christopher D Streib ◽  
Megan Tessmer ◽  
Abbey Staugaitis ◽  
Denise Gaffney ◽  
Navdeep S Sangha
Keyword(s):  
Clinical Trial ◽  
Clinical Research ◽  
Acute Stroke ◽  
Phase Iii ◽  
Successful Completion ◽  
Pivotal Phase ◽  
Exact Test ◽  
Fisher's Exact Test ◽  
Clinical Stroke Trial ◽  
Fisher’S Exact Test

Introduction: Many clinical trials have suffered poor enrollment or have been placed on hold due to the COVID-19 pandemic. Limitations on in-person interaction with patients, legally authorized representatives, coordinators, and physician investigators disrupt research processes including screening, consent, randomization, and study interventions. Remote enrollment practices incorporating telemedicine and electronic consent may address these enrollment limitations. Methods: We retrospectively reviewed clinical trial enrollments in two pivotal phase-III acute stroke trials (NCT03735979, NCT03785678) at two high-volume stroke centers that routinely use remote enrollments in clinical research. Individual elements of acute clinical stroke trial enrollment, including: screening, consent, randomization, and intervention were reviewed. For each research phase, we compared the rate of successful completion and research protocol violations for in-person vs remote research via Fisher’s exact test. Results: Forty patients were reviewed (median age 72 [IQR 63-84], 50% female, median NIHSS 13 [IQR 7.5-19.5]; 35 patient were enrolled and 5 were screened and consented, but found ineligible on qualifying imaging. All research phases were completed successfully with the exception of one in-person study intervention. Fisher’s exact test revealed no differences in protocol violations between research elements conducted remotely (predominantly via telemedicine) versus in-person (see Table). Conclusion: Our study revealed no difference in successful completion of acute clinical trial research elements when conducted remotely or in-person. Incorporation of remote research, especially telemedicine, may enable stroke clinical trial enrollments both during the COVID 19 pandemic and beyond.

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