Purpose: A phase I clinical trial was conducted to evaluate the immunogenicity and safety of newly developed egg-cultivated trivalent inactivated split influenza vaccine (TIV) in Korea.
Materials And Methods: The TIV was administered to 43 healthy male adults. Subjects with high pre-existing titers were excluded in a screening step. Immune response was measured by a hemagglutination inhibition (HI) assay.
Results: The seroprotection rates against A/California/7/2009 (H1N1), A/Perth/16/2009 (H3N2) and B/Brisbane/60/2009 were 74.42% [95% confidence interval (CI): 61.38-87.46], 72.09% (95% CI: 58.69-85.50), and 86.05% (95% CI: 75.69-96.40), respectively. Calculated seroconversion rates were 74.42% (95% CI: 61.38-87.46), 74.42% (95% CI: 61.38-87.46), and 79.07% (95% CI: 66.91-91.23), respectively. There were 25 episodes of solicited local adverse events in 21 subjects (47.73%), 21 episodes of solicited general adverse events in 16 subjects (36.36%) and 5 episodes of unsolicited adverse events in 5 subjects (11.36%). All adverse events were grade 1 or 2 and disappeared within three days.
Conclusion: The immunogenicity and safety of TIV established in this phase I trial are sufficient to plan a larger scale clinical trial.
Download full-text PDF |
Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5011266 | PMC |
| http://dx.doi.org/10.3349/ymj.2016.57.6.1354 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Swab Testing to Optimize Pneumonia treatment with empiric Vancomycin (STOP-Vanc): study protocol for a randomized controlled trial.
Trials
December 2024
Division of Infectious Diseases, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.
Background: Vancomycin, an antibiotic with activity against methicillin-resistant Staphylococcus aureus (MRSA), is frequently included in empiric treatment for community-acquired pneumonia (CAP) despite the fact that MRSA is rarely implicated in CAP. Conducting polymerase chain reaction (PCR) testing on nasal swabs to identify the presence of MRSA colonization has been proposed as an antimicrobial stewardship intervention to reduce the use of vancomycin. Observational studies have shown reductions in vancomycin use after implementation of MRSA colonization testing, and this approach has been adopted by CAP guidelines.
View Article and Find Full Text PDFComparison of different puncture needles used for endoscopic ultrasound-guided fine-needle biopsy of Gastrointestinal subepithelial lesions (≤ 2 cm) with respect to the adequacy of specimen collection: study protocol for a multicenter randomized prospective trial.
Trials
December 2024
Second Department of Internal Medicine, Wakayama Medical University, 811-1, Kimiidera, Wakayama City, 641-0012, Japan.
Background: Gastrointestinal subepithelial lesions (SELs) range from benign to malignant. Endoscopic ultrasound (EUS)-guided fine-needle biopsy (EUS-FNB) is used widely for pathological diagnosis of SELs. Early diagnosis and treatment are important because all Gastrointestinal stromal tumors (GISTs) have some degree of malignant potential.
View Article and Find Full Text PDFStress hyperglycaemia ratio is an independent predictor of in-hospital heart failure among patients with anterior ST-segment elevation myocardial infarction.
BMC Cardiovasc Disord
December 2024
Prince Faisal bin Khalid Cardiac Centre, Abha, Saudi Arabia.
Background: Stress hyperglycaemia ratio (SHR) has been reported to be independently and significantly associated with various adverse cardiovascular events as well as mortality. Moreover, in-hospital heart failure following acute myocardial infarction has been demonstrated to account for majority of all heart failure (HF) cases with anterior myocardial infarction showing higher rates of HF. However, the association between SHR and in-hospital HF following an anterior ST-elevation myocardial infarction (STEMI) has not been reported earlier.
View Article and Find Full Text PDFTargeting molecular pathways to control immune checkpoint inhibitor toxicities.
Trends Immunol
December 2024
Heidelberg University, Medical Faculty Heidelberg, Department of Dermatology and National Center for Tumor Diseases (NCT), NCT Heidelberg, a partnership between DKFZ and University Hospital Heidelberg, Heidelberg, Germany; German Cancer Consortium (DKTK), German Cancer Research Center (DKFZ) Core Center Heidelberg, 69120 Heidelberg, Germany. Electronic address:
Immune checkpoint inhibitors (ICIs) have transformed cancer treatment but are frequently associated with immune-related adverse events (irAEs). This article offers a novel synthesis of findings from both preclinical and clinical studies, focusing on the molecular mechanisms driving irAEs across diverse organ systems. It examines key immune cells, such as T cell subsets and myeloid cells, which are instrumental in irAE pathogenesis, alongside an in-depth analysis of cytokine signaling [interleukin (IL)-6, IL-17, IL-4), interferon γ (IFN-γ), IL-1β, tumor necrosis factor α (TNF-α)], integrin-mediated interactions [integrin subunits αITGA)4 and ITGB7], and microbiome-related factors that contribute to irAE pathology.
View Article and Find Full Text PDFChanging the culture: increasing captured intraoperative anaesthesia-related safety events through targeted interventions.
BMJ Open Qual
December 2024
Anesthesiology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.
Background: There is an under-reporting of anaesthesia-related safety events. Incident-capturing systems (ICSs) are essential for patient safety monitoring, identifying risks and ongoing opportunities for improvement. After a literature review and assessment of our current ICSs, we concluded that our institution lacked a reliable anaesthesia-specific ICS system, leading to under-reporting of anaesthesia-related safety events.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!