scholarly journals A Decade in Review: A Systematic Review of Universal Influenza Vaccines in Clinical Trials during the 2010 Decade

Viruses ◽  
2020 ◽  
Vol 12 (10) ◽  
pp. 1186
Author(s):  
Brigette N. Corder ◽  
Brianna L. Bullard ◽  
Gregory A. Poland ◽  
Eric A. Weaver
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Influenza Vaccine ◽  
Seasonal Influenza ◽  
Influenza Vaccines ◽  
Phase Iii ◽  
Virus Infections ◽  
Vaccine Platform ◽  
Phase Iii Clinical Trials ◽  
Universal Influenza Vaccine

On average, there are 3–5 million severe cases of influenza virus infections globally each year. Seasonal influenza vaccines provide limited protection against divergent influenza strains. Therefore, the development of a universal influenza vaccine is a top priority for the NIH. Here, we report a comprehensive summary of all universal influenza vaccines that were tested in clinical trials during the 2010–2019 decade. Of the 1597 studies found, 69 eligible clinical trials, which investigated 27 vaccines, were included in this review. Information from each trial was compiled for vaccine target, vaccine platform, adjuvant inclusion, clinical trial phase, and results. As we look forward, there are currently three vaccines in phase III clinical trials which could provide significant improvement over seasonal influenza vaccines. This systematic review of universal influenza vaccine clinical trials during the 2010–2019 decade provides an update on the progress towards an improved influenza vaccine.

scholarly journals Is a universal influenza vaccine feasible?

2019 ◽  
Vol 7 ◽  
pp. 251513551988554
Author(s):  
Joshua E. Phillipson ◽  
Ron Babecoff ◽  
Tamar Ben-Yedidia
Keyword(s):  
Clinical Trials ◽  
Influenza Vaccine ◽  
Influenza Vaccines ◽  
Phase Iii ◽  
Private Funding ◽  
Public And Private ◽  
Phase Iii Trial ◽  
Pandemic Threat ◽  
Universal Influenza Vaccine ◽  
Funding Research

The influenza virus causes significant human morbidity and mortality annually and poses a pandemic threat. In addition, the virus frequently mutates, contributing to thousands of identified strains. Current influenza vaccine solutions are strain specific, target existing strains, and achieve only approximately 40% vaccine effectiveness (VE). The need for broadly protective Universal Influenza Vaccines (UIVs) is clear. UIV research and development efforts focus on widely conserved (i.e. not strain specific) influenza epitopes. The most clinically advanced UIV candidate, the Multimeric-001 (M-001), is currently undergoing a pivotal, clinical efficacy, phase III trial. Completed clinical trials indicate M-001 is safe, well tolerated, and immunogenic to a broad range of influenza strains. Additional candidates are also under development, supported by public and private funding. Research results suggest that it is only a matter of time until a broadly protective influenza vaccine is approved for licensure.

Reno-vascular toxicities associated with carfilzomib: Systematic review and meta-analysis.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e21622-e21622
Author(s):  
Chintan Shah ◽  
Harini Bejjanki ◽  
Rohit Bishnoi ◽  
Ankur Jain ◽  
Subhankar Samal ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Phase I ◽  
Meta Analysis ◽  
Random Effect ◽  
Random Effect Model ◽  
Dose Effect ◽  
Phase Iii ◽  
Control Group ◽  
Phase Iii Clinical Trials

e21622 Background: Carfilzomib (Carf) is a novel proteasome inhibitor that is approved for patients with relapsed multiple myeloma (RMM) who have failed ≥ 1 prior lines of therapy. The incidence and seriousness of Carf associated reno-vascular toxicities (RVT) is not well known. We performed systematic review of Carf literature with meta-analysis to determine its incidence and overall risk. Methods: Initial search of literature led to a total of 175 Carf related articles. However, we used a total of 29 publications; phase I/II, phase II and phase III clinical trials (n = 3) which used Carf as monotherapy or in combination. We excluded phase I studies. Incidence rates and odds ratios (OR) were calculated with either fixed effect or random effect model based on the heterogeneity of included studies. Toxicity such as hypertension (HTN), renal failure (RF) and venous thromboembolism (VTE) were reported according to CTCAE v4.0. Results: A total of 4560 patients with various hematological and solid malignancies were included. Incidences of toxicities were: 15.9% and 4.7 % for HTN, 11.2% and 3.44% for RF, 6.47% and 2.22% for VTE, respectively for all grades and high grades in each category. When compared to control group taken from phase III clinical trials, the risk of HTN and RF due to Carf was significantly higher [OR = 2.91 and 3.32 in HTN (P < 0.001)], [OR = 1.71 and 1.79 (P < 0.05) for RF], respectively for all grade and high grade in each category. Moreover, incidence of HTN with higher than standard dose of carf (27 mg/m2 twice weekly) was significantly higher (P < 0.001). RF and VTE did not have the dose effect. Concomitant use of immunomodulator (IMiD) significantly increased, as expected, the incidence of VTE (P < 0.001). There was no variation in the incidence of RVT among newly diagnosed versus RMM (P = 0.4). Conclusions: Overall incidence and risk of hypertension and renal toxicities seems to be high when using Carf. Higher doses of Carf seem to lead to higher incidence of HTN, while the risk of VTE is higher with concomitant IMiD use. The pathophysiology for these complications is poorly understood, however it could be secondary to endothelial effect of carf. Physician should be vigilant about these effects as it can lead to poor overall outcomes.

scholarly journals Development and testing of the Australian pandemic influenza vaccine – a timely response

2011 ◽  
Vol 32 (1) ◽  
pp. 11 ◽  
Author(s):  
Steven Rockman ◽  
Peter Schoofs ◽  
Michael Greenberg
Keyword(s):  
Clinical Trials ◽  
Influenza Vaccine ◽  
Seasonal Influenza ◽  
Influenza Pandemic ◽  
Lessons Learned ◽  
Influenza Vaccines ◽  
Timely Response ◽  
Novel Virus ◽  
Pandemic Response ◽  
Pandemic Vaccine

In April 2009 a novel virus strain appeared which would cause the first influenza pandemic of the 21st century. This pandemic was the first to occur in an era where bioinformatic technologies contributed to the response to this virus; still, the creation of a vaccine relied largely on existing egg-based technology. The ongoing threat of a H5N1 pandemic spurred the development of strategies to rapidly produce a pandemic vaccine. These plans were implemented and allowed CSL and Australia to conduct the first clinical trials and produce one of the first 2009 pandemic vaccines. However, new candidate influenza vaccine viruses often present challenges to manufacturing a new vaccine. This pandemic virus was no exception. Being in the post-pandemic phase, it is important to review lessons learned to improve our response to future pandemics. In hindsight, the production of a pandemic vaccine is similar to that of seasonal influenza vaccines, yet the urgency of the pandemic response compresses timelines. This report explores those timelines and implications for producing a pandemic vaccine for Australia.

scholarly journals Subgroup analysis in Haematologic Malignancies Phase III Clinical Trials: A systematic review

2020 ◽  
Author(s):  
Nerea B ez Guti rrez ◽  
H ctor Rodr guez Ramallo ◽  
Laila Abdel kader Mart n ◽  
Sandra Flores Moreno
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Subgroup Analysis ◽  
Phase Iii ◽  
Phase Iii Clinical Trials ◽  
Haematologic Malignancies

scholarly journals Influenza Vaccines toward Universality through Nanoplatforms and Given by Microneedle Patches

Viruses ◽  
2020 ◽  
Vol 12 (11) ◽  
pp. 1212
Author(s):  
Sijia Tang ◽  
Wandi Zhu ◽  
Bao-Zhong Wang
Keyword(s):  
Public Health ◽  
Influenza Vaccine ◽  
Seasonal Influenza ◽  
Surface Antigens ◽  
Influenza Viruses ◽  
Influenza Vaccines ◽  
Vaccine Strategy ◽  
Influenza Pandemics ◽  
Major Surface ◽  
Universal Influenza Vaccine

Influenza is one of the top threats to public health. The best strategy to prevent influenza is vaccination. Because of the antigenic changes in the major surface antigens of influenza viruses, current seasonal influenza vaccines need to be updated every year to match the circulating strains and are suboptimal for protection. Furthermore, seasonal vaccines do not protect against potential influenza pandemics. A universal influenza vaccine will eliminate the threat of both influenza epidemics and pandemics. Due to the massive challenge in realizing influenza vaccine universality, a single vaccine strategy cannot meet the need. A comprehensive approach that integrates advances in immunogen designs, vaccine and adjuvant nanoplatforms, and vaccine delivery and controlled release has the potential to achieve an effective universal influenza vaccine. This review will summarize the advances in the research and development of an affordable universal influenza vaccine.

scholarly journals Adenoviral Vector-Based Vaccine Platforms for Developing the Next Generation of Influenza Vaccines

Vaccines ◽  
2020 ◽  
Vol 8 (4) ◽  
pp. 574 ◽  
Author(s):  
Ekramy E. Sayedahmed ◽  
Ahmed Elkashif ◽  
Marwa Alhashimi ◽  
Suryaprakash Sambhara ◽  
Suresh K. Mittal
Keyword(s):  
Large Scale ◽  
Seasonal Influenza ◽  
Influenza Pandemic ◽  
Influenza Viruses ◽  
Influenza Vaccines ◽  
Vaccine Platform ◽  
Large Numbers ◽  
Universal Influenza Vaccine ◽  
Short Time ◽  
New Strategies

Ever since the discovery of vaccines, many deadly diseases have been contained worldwide, ultimately culminating in the eradication of smallpox and polio, which represented significant medical achievements in human health. However, this does not account for the threat influenza poses on public health. The currently licensed seasonal influenza vaccines primarily confer excellent strain-specific protection. In addition to the seasonal influenza viruses, the emergence and spread of avian influenza pandemic viruses such as H5N1, H7N9, H7N7, and H9N2 to humans have highlighted the urgent need to adopt a new global preparedness for an influenza pandemic. It is vital to explore new strategies for the development of effective vaccines for pandemic and seasonal influenza viruses. The new vaccine approaches should provide durable and broad protection with the capability of large-scale vaccine production within a short time. The adenoviral (Ad) vector-based vaccine platform offers a robust egg-independent production system for manufacturing large numbers of influenza vaccines inexpensively in a short timeframe. In this review, we discuss the progress in the development of Ad vector-based influenza vaccines and their potential in designing a universal influenza vaccine.

Subgroup analysis in haematologic malignancies phase III clinical trials: A systematic review

2020 ◽  
Author(s):  
Nerea Báez‐Gutiérrez ◽  
Héctor Rodríguez‐Ramallo ◽  
Sandra Flores‐Moreno ◽  
Laila Abdel‐kader Martín
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Subgroup Analysis ◽  
Phase Iii ◽  
Phase Iii Clinical Trials ◽  
Haematologic Malignancies
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