COVID-19 Vaccine Race: An Overview and Update

A sudden health crisis has shut down the entire world for almost a year due to a new virus called Covid-19 and thus the WHO has declared the COVID-19 as a pandemic disease. As vaccines stimulate the immune system to fight against future infections, thereby conferring immunity, so far, vaccine development in a race throughout the world. Therefore, disseminating the overview of the vaccine development at present with their critical situation for COVID-19 is the aim of this review. The world is looking eagerly for a potential vaccine candidate that can save every life. Here, we reported the overview of the possible types of vaccines against Covid-19 as well as a glimpse of vaccine race with different phases of clinical trial data, comparison of the rate of success of phase-III clinical trials and their safety, and drawbacks with the present status. We have studied literature from clinical trial data of respective vaccine candidates published in the journals and collected data from databases dedicated to corona vaccine and the vaccine company's website to enrich our review and aiming to focus on clinical trial data stages, how consequences it faces, and how to position it belongs towards a successful vaccine candidate. Keywords: COVID-19, SARS-CoV-2, COVID-19 vaccine, Clinical trial.

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Tildrakizumab: A Review of Phase II and III Clinical Trials

Annals of Pharmacotherapy ◽

10.1177/1060028018809522 ◽

2018 ◽

Vol 53 (4) ◽

pp. 413-418 ◽

Cited By ~ 8

Author(s):

Sree S. Kolli ◽

Sarah D. Gabros ◽

Adrian Pona ◽

Abigail Cline ◽

Steven R. Feldman

Keyword(s):

Clinical Trial ◽

Phase Ii ◽

Biological Therapy ◽

Common Adverse Effect ◽

Clinical Trial Data ◽

Trial Data ◽

Severe Psoriasis ◽

Phase Iii ◽

Physician Global Assessment ◽

Phase Ii And Iii

Objective: Tildrakizumab, an inhibitor of the p19 subunit of interleukin (IL)-23, was recently Food and Drug Administration (FDA) approved for patients with moderate to severe psoriasis. This article will review the phase II and III clinical trial data of tildrakizumab. Data Sources: A PubMed search from January 2000 to September 2018 was done with the search terms tildrakizumab, guselkumab, risankizumab, p19, interleukin-23, and psoriasis. Study Selection and Data Extraction: Articles discussing phase II and III clinical trial data for tildrakizumab were selected. Data Synthesis: In phase II and phase III trials, tildrakizumab was safe and efficacious compared with placebo and etanercept. More patients achieved Psoriasis Area and Severity Index 75 receiving tildrakizumab (200 mg, 62%-74%; 100 mg, 61%-66%; 25 mg, 64%; 5 mg, 33%) compared with placebo (4%-6%, P < 0.0001) and etanercept (48%, P = 0.01). More patients achieved Physician Global Assessment (PGA) response of “clear” or “minimal” receiving tildrakizumab (200 mg, 59%; 100 mg, 55%-58%) than the placebo group (4%-7%, P < 0.0001). 59% of patients who received tildrakizumab 200 mg achieved a PGA response of “clear” or “minimal” compared with etanercept (48%, P = 0.0031). The most common adverse effect was infection. Relevance to Patient Care and Clinical Practice: Tildrakizumab is a new, FDA-approved, physician-administered biological therapy for patients with moderate to severe psoriasis. It appears to be efficacious and safe so far. Conclusion: Tildrakizumab is efficacious and safe for the treatment of patients with moderate to severe psoriasis. IL-23/p19 inhibitors are a promising class of biological therapy.

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173 Comparative effectiveness of secukinumab and golimumab in ankylosing spondylitis assessed by matching-adjusted indirect comparison using pivotal phase III clinical trial data

Rheumatology ◽

10.1093/rheumatology/key075.397 ◽

2018 ◽

Vol 57 (suppl_3) ◽

Cited By ~ 1

Author(s):

Hasan Tahir ◽

Walter Maksymowych ◽

Ernest Choy ◽

Yusuf Yazici ◽

Jessica Walsh ◽

...

Keyword(s):

Clinical Trial ◽

Ankylosing Spondylitis ◽

Comparative Effectiveness ◽

Indirect Comparison ◽

Clinical Trial Data ◽

Trial Data ◽

Phase Iii ◽

Pivotal Phase ◽

Phase Iii Clinical Trial ◽

Adjusted Indirect Comparison

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The Development of Tumor Neoantigen Vaccine Immunotherapy

E3S Web of Conferences ◽

10.1051/e3sconf/20197801005 ◽

2019 ◽

Vol 78 ◽

pp. 01005

Author(s):

Wanqiu Wang

Keyword(s):

Clinical Trial ◽

Tumor Immunology ◽

Somatic Mutations ◽

Clinical Trial Data ◽

Trial Data ◽

Normal Cells ◽

The Core ◽

The World ◽

Recent Clinical Trial ◽

Future Direction

Activating the immune system to fight against cancers has long been a goal in immunology and oncology studies. Recent clinical-trial data proved that boosting the activity of endogenous T cells to destroy cancer cells has great potential in controlling the progression of a variety of human malignancies. In essence, neoantigen is at the core of tumor immunology. Autologous T lymphocytes could distinguish tumor cells from normal cells by recognizing neoantigens, which are tumor specific. Neoantigens are derived from genome somatic mutations of tumors, and there are different approaches to predict and identify them with increasing accuracy. Neoantigens are tumor specific, which are ideal and attractive targets for tumor immunotherapies; many neoantigen-based clinical trials are being carried out around the world. In this review, we will discuss the recent advances of tumor neoantigen vaccine immunotherapy, and present the potential obstacle and future direction of this approach.

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Perampanel, a Selective, Non-Competitive AMPA Receptor Antagonist, Prolongs Time to Seizure Recurrence in Patients with Epilepsy: Results of Pooled Phase III Clinical Trial Data (S56.005)

Neurology ◽

10.1212/wnl.78.1_meetingabstracts.s56.005 ◽

2012 ◽

Vol 78 (Meeting Abstracts 1) ◽

pp. S56.005-S56.005 ◽

Cited By ~ 1

Author(s):

A. Laurenza ◽

J. French ◽

A. Gil-Nagel ◽

R. Guerrini ◽

D. Squillacote ◽

...

Keyword(s):

Clinical Trial ◽

Receptor Antagonist ◽

Ampa Receptor ◽

Clinical Trial Data ◽

Trial Data ◽

Phase Iii ◽

Seizure Recurrence ◽

Phase Iii Clinical Trial ◽

Ampa Receptor Antagonist ◽

Patients With Epilepsy

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Transparency in clinical trials

10.24075/medet.2021.014 ◽

2021 ◽

Author(s):

ChS Pavlov ◽

DL Varganova ◽

AA Svistunov ◽

C Gluud

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Technology Development ◽

Personal Data ◽

Clinical Trial Data ◽

Trial Data ◽

Positive Effects ◽

The World ◽

Information Technology Development ◽

Meta Analyses

In the age of information technology development, healthcare professionals around the world have the opportunity to simultaneously access advanced scientific developments, modern achievements, and the results of new clinical trials. The clinical guidelines of the international medical communities are based on the results of meta-analyses of clinical trial data. As new medical challenges emerge, clinical trial data are reviewed and re-analyzed. Unfortunately, to date, the results of not all studies are made public, or are presented selectively, indicating the positive effects of a particular technology (intervention), which makes it difficult to critically evaluate the results of work and makes the task of assessing the true effectiveness of the intervention more difficult. The problem of transparency of research data with the preservation of personal data of participants remains relevant for decades. This article is focused on possible ways of solving this problem and the analysis of the current situation in the world.

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Perampanel, a Selective, Non-Competitive AMPA Receptor Antagonist, Prolongs Time to Seizure Recurrence in Patients with Epilepsy: Results of Pooled Phase III Clinical Trial Data (IN5-1.004)

Neurology ◽

10.1212/wnl.78.1_meetingabstracts.in5-1.004 ◽

2012 ◽

Vol 78 (Meeting Abstracts 1) ◽

pp. IN5-1.004-IN5-1.004

Author(s):

A. Laurenza ◽

J. French ◽

A. Gil-Nagel ◽

R. Guerrini ◽

D. Squillacote ◽

...

Keyword(s):

Clinical Trial ◽

Receptor Antagonist ◽

Ampa Receptor ◽

Clinical Trial Data ◽

Trial Data ◽

Phase Iii ◽

Seizure Recurrence ◽

Phase Iii Clinical Trial ◽

Ampa Receptor Antagonist ◽

Patients With Epilepsy

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Should positive phase III clinical trial data be required before proton beam therapy is more widely adopted? No

Yearbook of Oncology ◽

10.1016/s1040-1741(09)79303-0 ◽

2009 ◽

Vol 2009 ◽

pp. 193-194

Author(s):

C.A. Lawton

Keyword(s):

Clinical Trial ◽

Proton Beam ◽

Clinical Trial Data ◽

Proton Beam Therapy ◽

Trial Data ◽

Phase Iii ◽

Positive Phase ◽

Phase Iii Clinical Trial

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Recent Updates in Experimental Research and Clinical Evaluation on Drugs for COVID-19 Treatment

Frontiers in Pharmacology ◽

10.3389/fphar.2021.732403 ◽

2021 ◽

Vol 12 ◽

Author(s):

Houwen Zou ◽

Yuqi Yang ◽

Huiqiang Dai ◽

Yunchuang Xiong ◽

Jing-Quan Wang ◽

...

Keyword(s):

Public Health ◽

Clinical Trial ◽

Experimental Research ◽

Clinical Evaluation ◽

Clinical Studies ◽

Virus Disease ◽

Clinical Trial Data ◽

Trial Data ◽

Global Public Health ◽

The World

Since the outbreak of corona virus disease 2019 (COVID-19) in Wuhan (China) in December 2019, the epidemic has rapidly spread to many countries around the world, posing a huge threat to global public health. In response to the pandemic, a number of clinical studies have been initiated to evaluate the effect of various treatments against COVID-19, combining medical strategies and clinical trial data from around the globe. Herein, we summarize the clinical evaluation about the drugs mentioned in this review for COVID-19 treatment. This review discusses the recent data regarding the efficacy of various treatments in COVID-19 patients, to control and prevent the outbreak.

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A review of oncologic therapeutic phase III clinical trial literature: Exploring the reporting of clinical trial data of older patients with cancer.

Journal of Clinical Oncology ◽

10.1200/jco.2018.36.30_suppl.70 ◽

2018 ◽

Vol 36 (30_suppl) ◽

pp. 70-70 ◽

Cited By ~ 1

Author(s):

Karlynn BrintzenhofeSzoc ◽

Armin Shahrokni ◽

Beverly E. Canin ◽

Ira Russell Parker ◽

Jessica L. Krok-Schoen ◽

...

Keyword(s):

Older Adults ◽

Clinical Trial ◽

Clinical Oncology ◽

Keyword Search ◽

Clinical Trial Data ◽

Trial Data ◽

Phase Iii ◽

Exclusion Criteria ◽

Phase 3 ◽

Journal Editors

70 Background: With demographic shifts leading to an aging cancer population, the American Society of Clinical Oncology (ASCO) has recommended that journal editors improve the reporting of clinical trial data specific to older adults. This study aimed to assess the current reporting status of clinical trial data regarding older adults with cancer. Methods: This was a review of oncologic therapeutic phase-3 clinical trial data published from 07/01/2016-06/30/2017. Based on a keyword search of EMBASE and PubMed, 929 manuscripts were identified. Removing duplicates (n = 116) and articles that did not meet this study’s cancer inclusion criteria (n = 589), a total of 224 were identified. In the pilot phase there was 85% agreement among the reviewers. Results: Thus far, 197 papers (88%), have been independently reviewed with 118 evaluated by more than one reviewer. Reviewed papers were published in 57 journals including Journal of Clinical Oncology (28, 14.2%), Lancet Oncology (25, 12.7%), and NEJM (20, 10.2%). Much of the literature focused upon the following cancer sites: Breast (33, 16.7%), Lung (27, 13.7%), Colorectal (18, 9.1%), and Prostate (12, 6.1%). 175 articles included inclusion/exclusion criteria, 32 (16.2%) had upper age exclusion criteria. Age was presented in 184 articles and data was stratified by age in 84 (42.6%). Age stratification of effectiveness and toxicity were presented in the results section in 65 (38.2%) and 21 (14.4%). Effectiveness by age was in the discussion section in 37 (18.8%) and toxicity by age in 16 (8.1%). Reviewers could not determine the proportion of study participants who were older adults in 111 articles (56.2%). In the remainder of the articles, the proportion ranged from 0% to 81%, except one in which all participants were older adults. Conclusions: A slim minority of phase-3 oncologic clinical trials included and discussed age-referenced results regarding the effectiveness and toxicity of treatments in older adults. Clinical investigators and journal editors should consider the ASCO recommendation and increase the reporting of oncologic clinical trial data specific to older adults.

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