scholarly journals Safety and efficacy of the Novavax vaccine—a narrative review

2021 ◽  
Vol 3 (4) ◽  
pp. 102-106
Author(s):  
Sanny Zi Lung Choo ◽  
◽  
Shyh Poh Teo
Keyword(s):  
Vaccine Efficacy ◽  
Animal Studies ◽  
Phase 1 ◽  
Efficacy Rate ◽  
Phase 3 ◽  
Symptomatic Infection ◽  
Safety And Efficacy ◽  
Vaccination Programs ◽  
Olive Baboons ◽  
Cell Mediated Immune Response

Mass vaccination programs are a public health priority for managing the global coronavirus disease (COVID-19) pandemic. The NVX-CoV2373 vaccine is being developed by Novavax. It consists of a SARS-CoV-2 spike glycoprotein subunit (NVX-CoV2373), which has been shown to have structural stability with pH and temperature perturbations, and the saponin-based Matrix-M adjuvant, which is added to enhance the B- and T-cell-mediated immune response. Animal studies in mice, olive baboons, and cynomolgus macaques demonstrated the potential of this vaccine in protecting the respiratory tract against COVID-19. Subsequent phase 1 and 2 trials then confirmed its safety and the dose-sparing potential of Matrix-M. The results led to the use of a low dose (5 μg) of NVX-CoV2373 in phase 3 trials. In a phase 3 trial involving 14,039 participants, the vaccine efficacy rate was 89.7% (prevention of symptomatic infection). Local and systemic adverse events were mild and self-limiting; commonly reported symptoms included injection-site pain and tenderness, headache, myalgia, and fatigue. A subgroup study confirmed the safety and efficacy of co-administering the NVX-CoV2373 vaccine and the seasonal influenza vaccine. Overall, the vaccine has been found to be safe and effective, meeting the minimum vaccine efficacy rate of 50% to be considered for COVID-19 vaccine emergency use listing approval. Keywords: Clinical trials, COVID-19, COVID-19 vaccine, immunology

Ezogabine: An Evaluation of Its Efficacy and Safety as Adjunctive Therapy for Partial-Onset Seizures in Adults

2012 ◽  
Vol 46 (10) ◽  
pp. 1358-1367 ◽  
Author(s):  
Mikiko Yamada ◽  
Timothy E Welty
Keyword(s):  
Clinical Trials ◽  
Clinical Studies ◽  
English Language ◽  
De Novo ◽  
Phase 1 ◽  
Published Data ◽  
Partial Seizures ◽  
Phase 3 ◽  
Safety And Efficacy

Objective: To evaluate the safety, efficacy, pharmacokinetics, pharmacodynamic properties, and clinical application of ezogabine (retigabine. INN), an antiepileptic drug approved in 2011. Data Sources: Published data from in vitro, animal, and clinical studies were obtained from PubMed and CINAHL searches, from January 1980 to March 31, 2012. Other relevant data regarding the safety and efficacy of ezogabine were obtained from the Food and Drug Administration and the European Medication Agency Web sites. Study Selection and Data Extraction: Selected articles were prospective in vitro, animal, and controlled clinical studies of ezogabine. Non-English-language articles were excluded. Data Synthesis: In vitro and animal studies show that ezogabine activates voltage-gated potassium channels, leading to reduction of seizure frequency by inhibiting hyperexcitability activity in the central nervous system. Additionally, ezogabine enhances γ-aminobutyric acid (GABA) activity and de novo GABA synthesis. Eight clinical studies of ezogabine have been published, 5 being Phase 1 clinical trials in healthy subjects and 3 being Phase 3 clinical trials in patients with pharmacoresistant partial-onset seizures. Phase 3 clinical trials demonstrated the safety and efficacy of ezogabine in patients with partial-onset seizures. Conclusions: Clinical trials have shown that ezogabine is efficacious as an adjunctive agent in patients with pharmacoresistant partial seizures. Careful monitoring of drug interactions and adverse reactions is necessary. While ezogabine is efficacious (or partial seizures, its precise role in the management of patients with epilepsy is yet to be determined.

PENERAPAN MODEL QUANTUM LEARNING UNTUK MENINGKATKAN HASIL BELAJAR AUTOCAD SISWA KELAS X TEKNIK PEMESINAN SMK NEGERI 1 STABAT

2013 ◽  
Vol 5 (1) ◽  
Author(s):  
Abdul Hasan Saragih
Keyword(s):  
Positive Response ◽  
Phase 1 ◽  
First Grade ◽  
Learning Model ◽  
Second Phase ◽  
Phase 2 ◽  
Phase 3 ◽  
The Third ◽  
Third Phase ◽  
Quantum Learning

This classroom research was conducted on the autocad instructions to the first grade of mechinary class of SMK Negeri 1 Stabat aiming at : (1) improving the student’ archievementon autocad instructional to the student of mechinary architecture class of SMK Negeri 1 Stabat, (2) applying Quantum Learning Model to the students of mechinary class of SMK Negeri 1 Stabat, arising the positive response to autocad subject by applying Quantum Learning Model of the students of mechinary class of SMK Negeri 1 Stabat. The result shows that (1) by applying quantum learning model, the students’ achievement improves significantly. The improvement ofthe achievement of the 34 students is very satisfactory; on the first phase, 27 students passed (70.59%), 10 students failed (29.41%). On the second phase 27 students (79.41%) passed and 7 students (20.59%) failed. On the third phase 30 students (88.24%) passed and 4 students (11.76%) failed. The application of quantum learning model in SMK Negeri 1 Stabat proved satisfying. This was visible from the activeness of the students from phase 1 to 3. The activeness average of the students was 74.31% on phase 1,81.35% on phase 2, and 83.63% on phase 3. (3) The application of the quantum learning model on teaching autocad was very positively welcome by the students of mechinary class of SMK Negeri 1 Stabat. On phase 1 the improvement was 81.53% . It improved to 86.15% on phase 3. Therefore, The improvement ofstudent’ response can be categorized good.

Clinical Drug Development for the Treatment of Pulmonary Arterial Hypertension: Collaboration With the Pharmaceutical Industry and Regulatory Agencies

2010 ◽  
Vol 9 (4) ◽  
pp. 214-219
Author(s):  
Robyn J. Barst
Keyword(s):  
Clinical Trials ◽  
Pulmonary Arterial Hypertension ◽  
Drug Development ◽  
Phase 1 ◽  
Preclinical Studies ◽  
Phase 2 ◽  
Phase 3 ◽  
Preclinical Testing ◽  
New Drug ◽  
Pulmonary Arterial

Drug development is the entire process of introducing a new drug to the market. It involves drug discovery, screening, preclinical testing, an Investigational New Drug (IND) application in the US or a Clinical Trial Application (CTA) in the EU, phase 1–3 clinical trials, a New Drug Application (NDA), Food and Drug Administration (FDA) review and approval, and postapproval studies required for continuing safety evaluation. Preclinical testing assesses safety and biologic activity, phase 1 determines safety and dosage, phase 2 evaluates efficacy and side effects, and phase 3 confirms efficacy and monitors adverse effects in a larger number of patients. Postapproval studies provide additional postmarketing data. On average, it takes 15 years from preclinical studies to regulatory approval by the FDA: about 3.5–6.5 years for preclinical, 1–1.5 years for phase 1, 2 years for phase 2, 3–3.5 years for phase 3, and 1.5–2.5 years for filing the NDA and completing the FDA review process. Of approximately 5000 compounds evaluated in preclinical studies, about 5 compounds enter clinical trials, and 1 compound is approved (Tufts Center for the Study of Drug Development, 2011). Most drug development programs include approximately 35–40 phase 1 studies, 15 phase 2 studies, and 3–5 pivotal trials with more than 5000 patients enrolled. Thus, to produce safe and effective drugs in a regulated environment is a highly complex process. Against this backdrop, what is the best way to develop drugs for pulmonary arterial hypertension (PAH), an orphan disease often rapidly fatal within several years of diagnosis and in which spontaneous regression does not occur?

scholarly journals A phase 1 and randomized controlled phase 2 trial of the safety and efficacy of the combination of gemcitabine and docetaxel with ontuxizumab (MORAb‐004) in metastatic soft‐tissue sarcomas

Cancer ◽  
2019 ◽  
Vol 125 (14) ◽  
pp. 2445-2454 ◽  
Author(s):  
Robin L. Jones ◽  
Sant P. Chawla ◽  
Steven Attia ◽  
Patrick Schöffski ◽  
Hans Gelderblom ◽  
...  
Keyword(s):  
Soft Tissue ◽  
Phase 1 ◽  
Soft Tissue Sarcomas ◽  
Phase 2 ◽  
Safety And Efficacy ◽  
Randomized Controlled ◽  
Phase 2 Trial

scholarly journals How to improve emergency care to adults discharged within 24 hours? Acute Care planning in Emergency departments (The ACE study): a protocol of a participatory design study

BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e041743
Author(s):  
Christina Østervang ◽  
Annmarie Touborg Lassen ◽  
Charlotte Myhre Jensen ◽  
Elisabeth Coyne ◽  
Karin Brochstedt Dieperink
Keyword(s):  
Patient Outcomes ◽  
Participatory Design ◽  
Hospital Admissions ◽  
Phase 1 ◽  
Family Needs ◽  
Focus Group Interviews ◽  
Phase 3 ◽  
Ace Study ◽  
Group Interviews ◽  
Improve Patient

IntroductionThe development of acute symptoms or changes in diseases led to feelings of fear and vulnerability and the need for health professional support. Therefore, the care provided in the acute medical and surgical areas of the emergency department (ED) is highly important as it influences the confidence of patients and families in managing everyday life after discharge. There is an increase in short-episode (<24 hours) hospital admissions, related to demographic changes and a focus on outpatient care. Clear discharge information and inclusion in treatment decisions increase the patient’s and family’s ability to understand and manage health needs after discharge, reduces the risk of readmission. This study aims to identify the needs for ED care and develop a solution to improve outcomes of patients discharged within 24 hours of admission.Methods and analysisThe study comprises the three phases of a participatory design (PD). Phase 1 aims to understand and identify patient and family needs when discharged within 24 hours of admission. A qualitative observational study will be conducted in two different EDs, followed by 20 joint interviews with patients and their families. Four focus group interviews with healthcare professionals will provide understanding of the short pathways. Findings from phase 1 will inform phase 2, which aims to develop a solution to improve patient outcomes. Three workshops gathering relevant stakeholders are arranged in the design plus development of a solution with specific outcomes. The solution will be implemented and tested in phase 3. Here we report the study protocol of phase 1 and 2.Ethics and disseminationThe study is registered with the Danish Data Protection Agency (19/22672). Approval of the project has been granted by the Regional Committees on Health Research Ethics for Southern Denmark (S-20192000–111). Findings will be published in suitable international journals and disseminated through conferences.

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