scholarly journals Plant-Based COVID-19 Vaccines: Current Status, Design, and Development Strategies of Candidate Vaccines

Vaccines ◽  
2021 ◽  
Vol 9 (9) ◽  
pp. 992
Author(s):  
Puna Maya Maharjan ◽  
Sunghwa Choe
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Vaccine Development ◽  
Production Systems ◽  
Transmission Rate ◽  
Neutralizing Antibody ◽  
Current Status ◽  
Economic Losses ◽  
Phase 2 Clinical Trial ◽  
Clinical Trial Results

The prevalence of the coronavirus disease 2019 (COVID-19) pandemic in its second year has led to massive global human and economic losses. The high transmission rate and the emergence of diverse SARS-CoV-2 variants demand rapid and effective approaches to preventing the spread, diagnosing on time, and treating affected people. Several COVID-19 vaccines are being developed using different production systems, including plants, which promises the production of cheap, safe, stable, and effective vaccines. The potential of a plant-based system for rapid production at a commercial scale and for a quick response to an infectious disease outbreak has been demonstrated by the marketing of carrot-cell-produced taliglucerase alfa (Elelyso) for Gaucher disease and tobacco-produced monoclonal antibodies (ZMapp) for the 2014 Ebola outbreak. Currently, two plant-based COVID-19 vaccine candidates, coronavirus virus-like particle (CoVLP) and Kentucky Bioprocessing (KBP)-201, are in clinical trials, and many more are in the preclinical stage. Interim phase 2 clinical trial results have revealed the high safety and efficacy of the CoVLP vaccine, with 10 times more neutralizing antibody responses compared to those present in a convalescent patient’s plasma. The clinical trial of the CoVLP vaccine could be concluded by the end of 2021, and the vaccine could be available for public immunization thereafter. This review encapsulates the efforts made in plant-based COVID-19 vaccine development, the strategies and technologies implemented, and the progress accomplished in clinical trials and preclinical studies so far.

scholarly journals Current Status of HIV-1 Vaccines

Vaccines ◽  
2021 ◽  
Vol 9 (9) ◽  
pp. 1026
Author(s):  
Anna Hargrave ◽  
Abu Salim Mustafa ◽  
Asma Hanif ◽  
Javed H. Tunio ◽  
Shumaila Nida M. Hanif
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Global Health ◽  
Low Income ◽  
Vaccine Development ◽  
Low Income Countries ◽  
Current Status ◽  
Health Challenge ◽  
Hiv 1 ◽  
Global Health Challenge

HIV-1 infection and its progression to AIDS remains a significant global health challenge, particularly for low-income countries. Developing a vaccine to prevent HIV-1 infections has proven to be immensely challenging with complex biological acquisition and infection, unforeseen clinical trial disappointments, and funding issues. This paper discusses important landmarks of progress in HIV-1 vaccine development, various vaccine strategies, and clinical trials.

Repurposed Antiviral Drugs for the Treatment of COVID-19: Syntheses, Mechanism of Infection and Clinical Trials

2020 ◽  
Vol 21 ◽  
Author(s):  
Subha Sankar Paul ◽  
Goutam Biswas
Keyword(s):  
Public Health ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Small Molecule ◽  
Mode Of Action ◽  
Antiviral Drugs ◽  
Public Health Emergency ◽  
Advanced Stage ◽  
Clinical Trial Results

: COVID-19 is a public health emergency of international concern. Although, considerable knowledge has been acquired with time about the viral mechanism of infection and mode of replication, yet no specific drugs or vaccines have been discovered against SARS-CoV-2, till date. There are few small molecule antiviral drugs like Remdesivir and Favipiravir which have shown promising results in different advanced stage of clinical trials. Chloroquinine, Hydroxychloroquine, and Lopinavir-Ritonavir combination, although initially was hypothesized to be effective against SARS-CoV-2, are now discontinued from the solidarity clinical trials. This review provides a brief description of their chemical syntheses along with their mode of action and clinical trial results available in Google and different peer reviewed journals till 24th October 2020.

scholarly journals The Disclosure Decision of Foreign Clinical Trials in China: Moderating Effects of Firms’ Contingencies

SAGE Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. 215824402110163
Author(s):  
Tariq H. Malik ◽  
Chunhui Huo
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Risk Taking ◽  
Academic Community ◽  
Moderating Effects ◽  
The Public ◽  
Industrial Enterprises ◽  
Unit Increase ◽  
Clinical Trial Results ◽  
Clinical Trial Activity

Result disclosure of clinical trial posts a conflicting logic between private secrecy and public interest. Despite ethical and legal requirements for disclosing clinical trial results, clinical trials’ sponsors tend to withhold the results. We explored the location, timing, and rationale behind the withheld clinical trial results. Based on the entrepreneurial orientation (EO) perspective, we propose that organizational EO contingencies moderate the disclosure decision. We used the completed clinical trial projects in China by foreign and domestic sponsors. First, we found that a unit increase in the sponsor’s experience can increase the disclosure about 1.01 times. Second, we found that industrial enterprises disclose results about 3.7 times more than universities do. Third, we found that foreign clinical trial projects in China tend to disclose 3.9 times more than domestic projects. We link these findings to two types of audience. First, we inform the academic community on the theory and empirics regarding risk-taking behavior in the biopharmaceutical industry’s clinical trial activity. Second, we address the general audiences concerned about the ethical and socioeconomic wellbeing of the public.

Efficacy of SPI-1005 for Prevention of Noise-Induced Hearing Loss: Phase 2 Clinical Trial Results

2014 ◽  
Vol 151 (1_suppl) ◽  
pp. P83-P84 ◽  
Author(s):  
Jonathan Kil ◽  
Eric D. Lynch ◽  
Scott Griffiths ◽  
Edward Lobarinas ◽  
Christopher Spankovich ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Hearing Loss ◽  
Noise Induced Hearing Loss ◽  
Phase 2 ◽  
Phase 2 Clinical Trial ◽  
Clinical Trial Results

scholarly journals Immunogenicity and Safety of Inactivated Sabin-Strain Polio Vaccine “PoliovacSin”: Clinical Trials Phase I and II

Vaccines ◽  
2021 ◽  
Vol 9 (6) ◽  
pp. 565
Author(s):  
Anastasia Piniaeva ◽  
Georgy Ignatyev ◽  
Liubov Kozlovskaya ◽  
Yury Ivin ◽  
Anastasia Kovpak ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Phase I ◽  
Safety Profile ◽  
Neutralizing Antibody ◽  
Polio Eradication ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Good Tolerability ◽  
Poliomyelitis Vaccine

Global polio eradication requires both safe and effective vaccines, and safe production processes. Sabin oral poliomyelitis vaccine (OPV) strains can evolve to virulent viruses and result in poliomyelitis outbreaks, and conventional inactivated poliomyelitis vaccine (Salk-IPV) production includes accumulation of large stocks of neurovirulent wild polioviruses. Therefore, IPV based on attenuated OPV strains seems a viable option. To increase the global supply of affordable inactivated vaccine in the still not-polio free world we developed an IPV made from the Sabin strains–PoliovacSin. Clinical trials included participants 18–60 years of age. A phase I single-center, randomized, double-blind placebo-controlled clinical trial included 60 participants, who received one dose of PoliovacSin or Placebo. A phase II multicenter, randomized, double-blind, comparative clinical trial included 200 participants, who received one dose of PoliovacSin or Imovax Polio. All vaccinations were well tolerated, and PoliovacSin had a comparable safety profile to the Placebo or the reference Imovax Polio preparations. A significant increase in neutralizing antibody levels to polioviruses types 1–3 (Sabin and wild) was observed in PoliovacSin and Imovax Polio vaccinated groups. Therefore, clinical trials confirmed good tolerability, low reactogenicity, and high safety profile of the PoliovacSin and its pronounced immunogenic properties. The preparation was approved for clinical trials involving infants.

scholarly journals ATIM-23. ANTI-CD27 AGONIST ANTIBODY VARLILUMAB IN COMBINATION WITH NIVOLUMAB FOR RECURRENT GLIOBLASTOMA (rGBM): PHASE 2 CLINICAL TRIAL RESULTS

2018 ◽  
Vol 20 (suppl_6) ◽  
pp. vi6-vi6 ◽  
Author(s):  
David Reardon ◽  
Thomas Kaley ◽  
Fabio Iwamoto ◽  
Joachim Baehring ◽  
Deepa Subramaniam ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Recurrent Glioblastoma ◽  
Phase 2 ◽  
Phase 2 Clinical Trial ◽  
Agonist Antibody ◽  
Clinical Trial Results

scholarly journals Current status of therapeutic approaches and vaccines for SARS-CoV-2

2021 ◽  
Author(s):  
Braira Wahid ◽  
Anam Amir ◽  
Ayesha Ameen ◽  
Muhammad Idrees
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Review Article ◽  
Experimental Designs ◽  
Current Status ◽  
Therapeutic Approaches ◽  
Efficacious Treatment ◽  
Rapid Pace ◽  
Global Health Challenge

SARS-CoV-2, declared a pandemic in March 2020, is the current global health challenge. The global bioburden of this virus is increasing at a rapid pace. Many antiviral drugs and vaccines have been registered for clinical trials because of their inhibitory activity observed in vitro. Currently, five types of vaccines have successfully passed Phase IV clinical trial and are being administered in populations worldwide. A plethora of experimental designs have been proposed worldwide in order to find a safe and efficacious treatment option. Therefore, it is necessary to provide baseline data and information to clinicians and researchers so that they can review the current status of therapeutics and efficacy of already developed vaccines. This review article summarizes all therapeutic options that may help to combat SARS-CoV-2.

scholarly journals Patient Income Level and Cancer Clinical Trial Participation

2013 ◽  
Vol 31 (5) ◽  
pp. 536-542 ◽  
Author(s):  
Joseph M. Unger ◽  
Dawn L. Hershman ◽  
Kathy S. Albain ◽  
Carol M. Moinpour ◽  
Judith A. Petersen ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Universal Access ◽  
Participation Rate ◽  
Treatment Decision ◽  
Trial Participation ◽  
Lower Income ◽  
Clinical Trial Participation ◽  
Clinical Trial Results ◽  
The Impact

Purpose Studies have shown an association between socioeconomic status (SES) and quality of oncology care, but less is known about the impact of patient SES on clinical trial participation. Patients and Methods We assessed clinical trial participation patterns according to important SES (income, education) and demographic factors in a large sample of patients surveyed via an Internet-based treatment decision tool. Logistic regression, conditioning on type of cancer, was used. Attitudes toward clinical trials were assessed using prespecified items about treatment, treatment tolerability, convenience, and cost. Results From 2007 to 2011, 5,499 patients were successfully surveyed. Forty percent discussed clinical trials with their physician, 45% of discussions led to physician offers of clinical trial participation, and 51% of offers led to clinical trial participation. The overall clinical trial participation rate was 9%. In univariate models, older patients (P = .002) and patients with lower income (P = .001) and education (P = .02) were less likely to participate in clinical trials. In a multivariable model, income remained a statistically significant predictor of clinical trial participation (odds ratio, 0.73; 95% CI, 0.57 to 0.94; P = .01). Even in patients age ≥ 65 years, who have universal access to Medicare, lower income predicted lower trial participation. Cost concerns were much more evident among lower-income patients (P < .001). Conclusion Lower-income patients were less likely to participate in clinical trials, even when considering age group. A better understanding of why income is a barrier may help identify ways to make clinical trials better available to all patients and would increase the generalizability of clinical trial results across all income levels.

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