Master protocols and other innovative trial designs in inflammation and immunology to expedite clinical drug development
Drug Discov Today. 2024 Mar 8:103948. doi: 10.1016/j.drudis.2024.103948. Online ahead of print.ABSTRACTMaster protocol designs such as umbrella and basket studies allow multiple compounds or multiple target populations to be evaluated simultaneously within a single protocol, and THEY have been widely adopted in oncology clinical trials. These novel designs can also be applied in other therapeutic areas, where they could have several benefits over conducting traditional randomized controlled trials. Here, we detail Pfizer's recent implementations of master protocol designs in inflammation and immunology clinical studies, fo...
Source: Drug Discovery Today - March 9, 2024 Category: Drugs & Pharmacology Authors: Elena Peeva Anindita Banerjee Christopher Banfield Koshika Soma Jared Christensen Sandeep Menon Michael S Vincent Mikael Dolsten Source Type: research
Challenging Axillary Lymph Nodes on PET/CT in Cancer Patients Throughout COVID-19 Vaccination Era
CONCLUSION: The correct interpretation of images is crucial to avoid unnecessary treatments and invasive procedures in vaccinated cancer pts. A detailed anamnestic interview and the analysis of lymph nodes' CT characteristics, after performing PET/CT, may help to clear any misleading diagnosis.PMID:38454762 | DOI:10.2174/0113816128246329231016091519 (Source: Current Pharmaceutical Design)
Source: Current Pharmaceutical Design - March 8, 2024 Category: Drugs & Pharmacology Authors: Alessia Giordano Rosj Gallicchio Mariarita Milella Rebecca Storto Anna Nardelli Teresa Pellegrino Antonio Nappi Michele Di Cosola Giovanni Storto Source Type: research
Challenging Axillary Lymph Nodes on PET/CT in Cancer Patients Throughout COVID-19 Vaccination Era
CONCLUSION: The correct interpretation of images is crucial to avoid unnecessary treatments and invasive procedures in vaccinated cancer pts. A detailed anamnestic interview and the analysis of lymph nodes' CT characteristics, after performing PET/CT, may help to clear any misleading diagnosis.PMID:38454762 | DOI:10.2174/0113816128246329231016091519 (Source: Current Pharmaceutical Design)
Source: Current Pharmaceutical Design - March 8, 2024 Category: Drugs & Pharmacology Authors: Alessia Giordano Rosj Gallicchio Mariarita Milella Rebecca Storto Anna Nardelli Teresa Pellegrino Antonio Nappi Michele Di Cosola Giovanni Storto Source Type: research
Challenging Axillary Lymph Nodes on PET/CT in Cancer Patients Throughout COVID-19 Vaccination Era
CONCLUSION: The correct interpretation of images is crucial to avoid unnecessary treatments and invasive procedures in vaccinated cancer pts. A detailed anamnestic interview and the analysis of lymph nodes' CT characteristics, after performing PET/CT, may help to clear any misleading diagnosis.PMID:38454762 | DOI:10.2174/0113816128246329231016091519 (Source: Current Pharmaceutical Design)
Source: Current Pharmaceutical Design - March 8, 2024 Category: Drugs & Pharmacology Authors: Alessia Giordano Rosj Gallicchio Mariarita Milella Rebecca Storto Anna Nardelli Teresa Pellegrino Antonio Nappi Michele Di Cosola Giovanni Storto Source Type: research
Robust SARS-CoV-2 antibody and T cell immunity following three COVID-19 vaccine doses in inflammatory bowel disease patients receiving anti-TNF or alternative treatments
We read Kennedy et al1’s findings with interest, and report in-depth analyses of antibody and T cell responses in patients with inflammatory bowel disease (IBD) to COVID-19 vaccination. We prospectively recruited 100 SARS-CoV-2-uninfected patients with IBD on varying treatments at the Royal Melbourne Hospital (HREC/74403/MH-2021). Healthcare workers who did not have IBD and were not on immunosuppressive medication were enrolled as controls with approvals from Melbourne Health (HREC/68355/MH-2020) and University of Melbourne (HREC 22268, 21626). Participant characteristics are outlined in table 1. IBD medication regim...
Source: Gut - March 7, 2024 Category: Gastroenterology Authors: Zhang, E., Nguyen, T. H. O., Allen, L. F., Kedzierski, L., Rowntree, L. C., Chang, S. Y., Zhang, W., Habel, J. R., Foo, I. J., Menon, T., Mitchell, J., Leong, R. W., Bond, K., Williamson, D. A., Kedzierska, K., Christensen, B. Tags: Gut, COVID-19 PostScript Source Type: research
Association of COVID-19 vaccination with duration of hospitalization in older adults in Hong Kong
CONCLUSION: Vaccination was associated with reduced hospital stay in breakthrough infections. Increased vaccination uptake in older adults may improve hospital bed turnover and public health outcomes especially during large community epidemics.PMID:38448323 | DOI:10.1016/j.vaccine.2024.02.074 (Source: Vaccine)
Source: Vaccine - March 6, 2024 Category: Allergy & Immunology Authors: Dongxuan Chen Benjamin J Cowling Kylie E C Ainslie Yun Lin Jessica Y Wong Eric H Y Lau Peng Wu Joshua Nealon Source Type: research
Association of COVID-19 vaccination with duration of hospitalization in older adults in Hong Kong
CONCLUSION: Vaccination was associated with reduced hospital stay in breakthrough infections. Increased vaccination uptake in older adults may improve hospital bed turnover and public health outcomes especially during large community epidemics.PMID:38448323 | DOI:10.1016/j.vaccine.2024.02.074 (Source: Vaccine)
Source: Vaccine - March 6, 2024 Category: Allergy & Immunology Authors: Dongxuan Chen Benjamin J Cowling Kylie E C Ainslie Yun Lin Jessica Y Wong Eric H Y Lau Peng Wu Joshua Nealon Source Type: research
Self-DNA driven inflammation in COVID-19 and after mRNA-based vaccination: lessons for non-COVID-19 pathologies
Front Immunol. 2024 Feb 19;14:1259879. doi: 10.3389/fimmu.2023.1259879. eCollection 2023.ABSTRACTThe coronavirus disease 2019 (COVID-19) pandemic triggered an unprecedented concentration of economic and research efforts to generate knowledge at unequalled speed on deregulated interferon type I signalling and nuclear factor kappa light chain enhancer in B-cells (NF-κB)-driven interleukin (IL)-1β, IL-6, IL-18 secretion causing cytokine storms. The translation of the knowledge on how the resulting systemic inflammation can lead to life-threatening complications into novel treatments and vaccine technologies is underway. Nev...
Source: Herpes - March 5, 2024 Category: Infectious Diseases Authors: Martin Heil Source Type: research
Questionnaire-based study of COVID-19 vaccination induced headache: evidence of clusters of adverse events
The adverse events (AEs) after a Coronavirus disease 2019 (Covid-19) Pfizer-Biotech mRNA vaccination present a medical and epidemiological issue of increasing interest. Headache is the most frequent neurologic... (Source: BMC Neurology)
Source: BMC Neurology - March 2, 2024 Category: Neurology Authors: Qiao Zhou, Thomas Eggert, Ana Zhelyazkova, Alexander Chouk ér, Kristina Adorjan and Andreas Straube Tags: Research Source Type: research
GSE250024 Impaired Innate and Adaptive Immune Responses to BNT162b2 SARS-CoV-2 Vaccination in Persons with Systemic Lupus Erythematosus [scRNA-Seq]
Series Type : Expression profiling by high throughput sequencingOrganism : Homo sapiensUnderstanding the immune responses to SARS-CoV-2 vaccination is critical to optimize vaccination strategies for individuals with autoimmune diseases, such as systemic lupus erythematosus (SLE). Here, we comprehensively analyzed innate and adaptive immune responses in 19 patients with SLE receiving a complete two-dose Pfizer-BioNTech mRNA vaccine (BNT162b2) regimen compared to a control cohort of 56 healthy control (HC) volunteers. Patients with SLE exhibited impaired neutralizing antibody production and antigen-specific CD4+ and CD8+ T-c...
Source: GEO: Gene Expression Omnibus - March 1, 2024 Category: Genetics & Stem Cells Tags: Expression profiling by high throughput sequencing Homo sapiens Source Type: research
GSE250023 Impaired Innate and Adaptive Immune Responses to BNT162b2 SARS-CoV-2 Vaccination in Persons with Systemic Lupus Erythematosus [RNA-Seq]
Series Type : Expression profiling by high throughput sequencingOrganism : Homo sapiensUnderstanding the immune responses to SARS-CoV-2 vaccination is critical to optimize vaccination strategies for individuals with autoimmune diseases, such as systemic lupus erythematosus (SLE). Here, we comprehensively analyzed innate and adaptive immune responses in 19 patients with SLE receiving a complete two-dose Pfizer-BioNTech mRNA vaccine (BNT162b2) regimen compared to a control cohort of 56 healthy control (HC) volunteers. Patients with SLE exhibited impaired neutralizing antibody production and antigen-specific CD4+ and CD8+ T-c...
Source: GEO: Gene Expression Omnibus - March 1, 2024 Category: Genetics & Stem Cells Tags: Expression profiling by high throughput sequencing Homo sapiens Source Type: research
Obstetric and Early Neonatal Outcomes Following Second and Third COVID-19 Vaccination in Pregnancy
CONCLUSIONS: Compared to the first two doses of the BNT162b2 vaccine given in pregnancy, the booster vaccination is safe and not associated with an increased rate of adverse obstetric and early neonatal outcomes.PMID:38420636 (Source: The Israel Medical Association Journal)
Source: The Israel Medical Association Journal - February 29, 2024 Category: General Medicine Authors: Ravit Peretz-Machluf Mayan Gilboa Shiran Bookstein-Peretz Omri Segal Noam Regev Raanan Meyer Gili Regev-Yochay Yoav Yinon Shlomi Toussia-Cohen Source Type: research
