Reply to "Caution in underrepresentation of older adults in clinical trials on COVID-19 vaccines".
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ABSTRACT:
SUBMITTER: Veronese N
PROVIDER: S-EPMC8520503 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:During the COVID-19 pandemic older subjects have been disproportionately affected by the disease. Vaccination is a fundamental intervention to prevent the negative consequences of COVID-19, but it is not known if the needs and vulnerabilities of older people are adequately addressed by their inclusion in randomized clinical trials (RCTs) evaluating the efficacy of vaccines for COVID-19. Given this background, we aimed to evaluate if current and ongoing phase II-III RCTs evaluating the efficacy of COVID-19 vaccines included a representative sample of older people. A systematic literature search in PubMed and Clinicaltrials.gov was performed until May 01st, 2021. Among 474 abstracts initially retrieved, 20 RCTs (ten already published, ten ongoing) were included. In the ten studies already published, the mean age of participants was 45.2 ± 11.9 years and only 9.83% of the participants were more than 65 years, 1.66% more than 75 years and less than 1% (0.55%) more than 85 years. In the ten ongoing RCTs, many of the studies aimed at including participants older than 18 years, with one study including participants between 18 and 84 years, and two between 21 and 100 years. In conclusion, our systematic review demonstrates that in published and ongoing phase II-III randomized clinical trials evaluating the efficacy of COVID-19 vaccines only a tiny fraction of the most vulnerable group of older people was included, although they clearly were the first population that had to be vaccinated.
| S-EPMC8413602 | biostudies-literature
Project description:ObjectivesOlder patients make up the majority of patients with pancreatic cancer, with a median age of 71 years at diagnosis. However, older patients are underrepresented in clinical trials in pancreatic cancer. This study investigates trends in age distribution of patients enrolled in clinical trials for advanced pancreatic cancer over time, and examines outcomes and toxicity in older patient subgroups from two studies conducted by Eastern Cooperative Oncology Group and American College of Radiology Imaging Network (ECOG-ACRIN) in this disease.Materials and methods16,042 patients from 38 phase III clinical trials for locally advanced or metastatic pancreatic adenocarcinoma published between 1997 and 2016 were identified and included in this analysis. Outcomes and toxicity by age were examined in two of the trials, ECOG-ACRIN trials E2297 and E6201, which included a total of 1146 patients.ResultsThe median age across the trials was 62.7 years; median ages for individual trials ranged from 57 years to 66 years. Weighted linear regression showed no significant change in median age over time. Combined analysis of the two ECOG-ACRIN trials demonstrated higher rates of fatigue, thrombocytopenia, and infection in those ≥75 years compared with those <75 years, but despite this showed no difference in overall survival (OS) or progression-free survival (PFS) (OS: 5.7 vs. 5.6 months and PFS: 2.8 vs 3.5 months).ConclusionsEnrollment of older adults in phase III pancreatic cancer clinical trials has not increased over time, despite increasing number of older patients seen in clinic. Increased efforts are needed to enhance enrollment of older patients in clinical trials, and to promote trials specifically for older patients, in order to improve the evidence base for treating this patient population.
| S-EPMC6579713 | biostudies-literature
Project description:Coronavirus disease 2019 (COVID-19) has developed as a pandemic, and it created an outrageous effect on the current healthcare and economic system throughout the globe. To date, there is no appropriate therapeutics or vaccines against the disease. The entire human race is eagerly waiting for the development of new therapeutics or vaccines against severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). Efforts are being taken to develop vaccines at a rapid rate for fighting against the ongoing pandemic situation. Amongst the various vaccines under consideration, some are either in the preclinical stage or in the clinical stages of development (phase-I, -II, and -III). Even, phase-III trials are being conducted for some repurposed vaccines like Bacillus Calmette-Guérin, polio vaccine, and measles-mumps-rubella. We have highlighted the ongoing clinical trial landscape of the COVID-19 as well as repurposed vaccines. An insight into the current status of the available antigenic epitopes for SARS-CoV-2 and different types of vaccine platforms of COVID-19 vaccines has been discussed. These vaccines are highlighted throughout the world by different news agencies. Moreover, ongoing clinical trials for repurposed vaccines for COVID-19 and critical factors associated with the development of COVID-19 vaccines have also been described.
| S-EPMC7937508 | biostudies-literature
Project description:We examined the possible non-specific effects of novel mRNA- and adenovirus-vector COVID-19 vaccines by reviewing the randomized control trials (RCTs) of mRNA and adenovirus-vector COVID-19 vaccines. We calculated mortality risk ratios (RRs) for mRNA COVID-19 vaccines vs. placebo recipients and compared them with the RR for adenovirus-vector COVID-19 vaccine recipients vs. controls. The RR for overall mortality of mRNA vaccines vs. placebo was 1.03 (95% confidence interval [CI]: 0.63-1.71). In the adenovirus-vector vaccine RCTs, the RR for overall mortality was 0.37 (0.19-0.70). The two vaccine types differed significantly with respect to impact on overall mortality (p = 0.015). The RCTs of COVID-19 vaccines were unblinded rapidly, and controls were vaccinated. The results may therefore not be representative of the long-term effects. However, the data argue for performing RCTs of mRNA and adenovirus-vector vaccines head-to-head comparing long-term effects on overall mortality.
| S-EPMC10125209 | biostudies-literature
Project description:The uncertainty related to prevention and treatment of Coronavirus disease 2019 due to lack of effective vaccine candidates or drug molecules has resulted in extensive spread of infection and mortality worldwide. Although the asymptomatic or mild patients are becoming healthy with regular over-the-counter medicines and proper rest and care, for the severe patients, in the absence of definite cure, different drug combinations are being used to treat on trial basis without the assurance of efficacy and safety. This scenario has however changed now with some medicines including antiviral Remdesivir and Favipiravir and anti-inflammatory drugs like dexamethasone and tocilizumab which have shown some positive results in trials such as decreasing need of mechanical or non-invasive ventilation or mortality. Further, a number of vaccine candidates are currently in pipeline and in advance stages of clinical trials, which will enhance their prospects in determining how the disease will be controlled in the times to come. In this article, an account of the under-trial potential drugs and vaccine candidates has been provided, and their future prospects have been discussed.
| S-EPMC7984501 | biostudies-literature
Project description:COVID-19, the greatest public health emergency of the 21st century, has affected 215 countries and territories around the world resulting in 15,151,738 confirmed cases and 621,121 deaths. The outbreak has continued at breakneck pace despite stringent public health measures, ravaging the global economy and causing profound human casualties. Vaccination is currently the best bet for the prevention of COVID-19. Still, in its absence, there has been considerable interest in repurposing existing therapeutic agents to reduce the severity of the illness and ease the burden on the already strained healthcare systems. This review outlines the current evidence regarding proposed treatments- experimental or repurposed, for COVID-19, and gives an insight into the clinical trial landscape for drugs as well as vaccines.
| S-EPMC7392210 | biostudies-literature
Project description:We conducted a matched retrospective cohort study of two cohorts to estimate inactivated vaccine effectiveness (VE) and its comparative effectiveness of booster dose among older people in Shanghai. Cohort 1 consisted of a vaccinated group (≥1 dose) and an unvaccinated group (3,317,475 pairs), and cohort 2 consisted of a booster vaccinated group and a fully vaccinated group (2,084,721 pairs). The Kaplan-Meier method and Cox regression models were used to estimate risk and hazard ratios (HRs) study outcomes. For cohort 1, the overall estimated VEs of ≥1 dose of inactivated vaccine against SARS-CoV-2 infection, severe/critical Covid-19, and Covid-19 related death were 24.7% (95%CI 23.7%-25.7%), 86.6% (83.1%-89.4%), and 93.2% (88.0%-96.1%), respectively. Subset analysis showed that the booster vaccination provided greatest protection. For cohort 2, compared with full vaccination, relative VEs of booster dose against corresponding outcome were 16.3% (14.4%-17.9%), 60.5% (37.8%-74.9%), and 81.7% (17.5%-95.9%). Here we show, although under the scenario of persistent dynamic zero-Covid policy and non-pharmaceutical interventions, promoting high uptake of the full vaccination series and booster dose among older adults is critically important. Timely vaccination with the booster dose provided effective protection against Covid-19 outcomes.
| S-EPMC10086022 | biostudies-literature
Project description:Various strategies have been designed to contain the COVID-19 pandemic. Among them, vaccine development is high on the agenda in spite of the unknown duration of the protection time. Various vaccines have been under clinical trials with promising results in different countries. The protective efficacy and the short-term and long-term side effects of the vaccines are of major concern. Therefore, comparing the protective efficacy and risks of vaccination is essential for the global control of COVID-19 through herd immunity. This study reviews the most recent data of 12 vaccines to evaluate their efficacy, safety profile and usage in various populations.
| S-EPMC8144958 | biostudies-literature
Project description:Purpose: This study aims to characterize the early innate and adaptive responses induced by SARS-CoV-2 infection in children and adults over time up to 8 weeks post symptoms onset (POS). We report the gene signature of COVID-19 over the course of the disease in both age groups. The kinetic of infection was divided in 5-time intervals according to the calculated days POS: interval 1 (0-5), interval 2 (6-14), interval 3 (15-22), interval 4 (23-35), and interval 5 (36-81). Methods: RNA extraction was performed automatically via the PAXgene Blood miRNA Kit and the QIAcube instrument (Qiagen) following the manufacturer’s protocol. RNA concentration and quality were assessed by using the Qubit instrument (Invitrogen) and the Agilent 2100 Bioanalyzer, respectively. The Stranded Total RNA Ribo-Zero Plus kit from Illumina was used for the library preparation with 100 ng of total RNA as input. Library molarity and quality were assessed with the Qubit and Tapestation using a DNA High sensitivity chip (Agilent Technologies). Libraries were pooled at 2 nM for clustering and sequenced on an Illumina HiSeq 4000 sequencer for a minimum of 30 million single-end 100 reads per sample. Main results: (I) we observed an antiviral-IFN-signature and innate-cell-activation within the first 5 days post symptoms onset (POS), while genes associated with CD4 T-cell responses, plasma cells and immunoglobulin were upregulated in both age groups during the first two weeks POS, indicative of SARS-CoV-2-specific adaptive immune responses; (II) in adults, genes associated with IFN antiviral responses and activated dendritic cells were maintained during the second week of disease, and subsided only after 14 days. By contrast, those transcriptome changes subsided already after 5 days in children.
2021-09-22 | GSE166190 | GEO
Project description: Not available
| S-EPMC8102034 | biostudies-literature