scholarly journals Health Conditions in an Adult Population in Sierra Leone: Data Reported From the Sierra Leone Trial to Introduce a Vaccine Against Ebola (STRIVE)

2018 ◽  
Vol 217 (suppl_1) ◽  
pp. S75-S80 ◽  
Author(s):  
Augustin E Fombah ◽  
Susan T Goldstein ◽  
Olamide D Jarrett ◽  
Mohamed I Jalloh ◽  
Jill El-Khorazaty ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Sierra Leone ◽  
Ebola Virus ◽  
Medical Condition ◽  
Drug Hypersensitivity ◽  
Adult Population ◽  
Health Conditions ◽  
Ulcer Disease ◽  
Sierra Leonean ◽  
Clinical Trials Registry

Abstract The Sierra Leone Trial to Introduce a Vaccine Against Ebola (STRIVE), a clinical trial of the investigational recombinant vesicular stomatitis virus–based Ebola virus vaccine (rVSV∆ZEBOV-GP; Merck), provided an opportunity to assess health conditions in a cohort of healthy Sierra Leonean adults before vaccination. Of the 8793 healthcare and frontline Ebola response workers screened for study enrollment, 7 (0.1%) self-reported human immunodeficiency virus infection or another significant immunodeficiency disorder and 11 of 3190 (0.3%) women 18–49 years old had a positive urine pregnancy test. Of the 440 participants included in a safety substudy, 124 (28.2%) reported at least 1 medical condition at baseline, most commonly drug hypersensitivity (11.6%), arthralgia (3.9%), arthropathy (2.7%), or gastric (3.0%) or peptic (2.7%) ulcer disease. We calculated the incidence per 100 person-years (PY) and 95% confidence intervals (CIs) of new medical conditions among the 4297 participants followed for 18–24 weeks from enrollment to scheduled vaccination. The most commonly reported conditions were headache (32.4 PY [95% CI, 29.7–35.3 PY]), pain (unspecified) (17.3 PY [95% CI, 15.4–19.4 PY]), arthralgia (9.3 PY [95% CI, 7.9–10.8 PY]), and abdominal pain (9.1 PY [95% CI, 7.7–10.7 PY]). Nasopharyngitis (7.0 PY [95% CI, 5.8–8.4 PY]) and malaria (1.9 PY [95% CI, 1.3–2.7 PY]) were the most commonly reported infectious conditions. Several cases of hypertension, diabetes mellitus, and cancer were also reported. Clinical Trials Registration ClinicalTrials.gov [NCT02378753] and Pan African Clinical Trials Registry [PACTR201502001037220].

scholarly journals VP196 Impact Of Trial Registry Search Features On Searches In CT.gov/ICTRP

2017 ◽  
Vol 33 (S1) ◽  
pp. 240-241
Author(s):  
Elke Hausner ◽  
Marco Knelangen ◽  
Siw Waffenschmidt
Keyword(s):  
Clinical Trials ◽  
New Drugs ◽  
Health Conditions ◽  
Bibliographic Databases ◽  
Trial Registry ◽  
Search Queries ◽  
Search Terms ◽  
Advanced Search ◽  
Approved Drugs ◽  
Clinical Trials Registry

INTRODUCTION:In contrast to bibliographic databases, trial registries do not offer the option of formulating complex search queries, thus making targeted searches more difficult. However, ClinicalTrials.gov (CT.gov) and the International Clinical Trials Registry Platform (ICTRP) offer different search features that may help compensate this limitation. Our aim was to determine the importance of search features (for example, searches using synonyms or, additionally in CT.gov, automatic inclusion of further search fields) for trial registry searches.METHODS:We conducted a project called “Trial registry searches for studies of newly approved drugs” (1). One analysis investigated the question as to whether searches for different health conditions and interventions (new drugs) directly identified registry entries with the search terms entered or whether certain search features were responsible for this. We searched CT.gov and ICTRP for different conditions and interventions using the advanced search interface. For each search, we documented the synonyms listed in the two registries. We imported the registry entries into EndNote and evaluated whether the search terms used were available in the corresponding search fields (condition; intervention).RESULTS:For CT.gov, 96 registry entries on 18 interventions and 190 entries on 12 conditions were analysed. Of these, twenty-three (24 percent) entries for interventions and thirty-eight (20 percent) for conditions were identified by search features, not by search terms. For ICTRP, 32 entries on 10 interventions and 100 entries on 9 conditions were analysed. Of these, five (16 percent) entries for interventions and eight (8 percent) for conditions were identified by search features.CONCLUSIONS:Trial registry search features have an important impact on the sensitivity of searches. Many studies are not identified by the search terms entered, but by searches using synonyms and, additionally in CT.gov, by automatic inclusion of further search fields. Moreover, search features in CT.gov are more effective than in ICTRP – even though the same search terms are used, they consistently yield higher sensitivities.

scholarly journals Operationalizing International Regulatory Standards in a Limited-Resource Setting During an Epidemic: The Sierra Leone Trial to Introduce a Vaccine Against Ebola (STRIVE) Experience

2018 ◽  
Vol 217 (suppl_1) ◽  
pp. S56-S59 ◽  
Author(s):  
Abdul Karim Kabineh ◽  
Wendy Carr ◽  
Mahnaz Motevalli ◽  
Jennifer Legardy-Williams ◽  
Willietta Vincent ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Sierra Leone ◽  
Human Subjects ◽  
Limited Resource ◽  
Scientific Integrity ◽  
Pan African ◽  
Resource Setting ◽  
Regulatory Standards ◽  
Clinical Trials Registry ◽  
Regulatory Sites

Abstract International regulatory standards ensure human subjects protection, data quality, and scientific integrity of clinical trials. Operationalizing regulatory standards during a large vaccine clinical trial—the Sierra Leone Trial to Introduce a Vaccine Against Ebola—in a resource-constrained setting during an epidemic required flexibility and creativity. We highlight areas that required special attention, such as developing standard operating procedures appropriate for the setting, obtaining space and supplies for the regulatory office, and creating a strategy to maintain both a dedicated central regulatory office and satellite regulatory sites for this trial with paper-based records. Clinical Trials Registration ClinicalTrials.gov [NCT02378753] and Pan African Clinical Trials Registry [PACTR201502001037220].

scholarly journals Rapid Establishment of a Cold Chain Capacity of –60°C or Colder for the STRIVE Ebola Vaccine Trial During the Ebola Outbreak in Sierra Leone

2018 ◽  
Vol 217 (suppl_1) ◽  
pp. S48-S55 ◽  
Author(s):  
Morrison O Jusu ◽  
Geoffrey Glauser ◽  
Jane F Seward ◽  
Mohamed Bawoh ◽  
Judith Tempel ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Supply Chain ◽  
Sierra Leone ◽  
Ebola Virus ◽  
Virus Disease ◽  
Vaccine Trial ◽  
Cold Chain ◽  
Clinical Practices ◽  
Virus Envelope ◽  
Power Sources

Abstract In response to the 2014‒2015 Ebola virus disease (Ebola) epidemic in West Africa, researchers accelerated the development of Ebola vaccines. The Centers for Disease Control and Prevention, in collaboration with local partners, sponsored a phase 2/3 trial in Sierra Leone of a single dose (2 × 107 plaque-forming units/mL) of a candidate replication-competent recombinant vesicular stomatitis virus–Zaire Ebola virus envelope glycoprotein vaccine (rVSVΔG-ZEBOV-GP). Because of its early development status and limited, critical stability data, the vaccine had to be stored at –60°C or colder. Planning for the trial began in late 2014 on an accelerated timeline with significant challenges, including the lack of –60°C or colder vaccine storage, handling, and transport capability in a country with high year-round ambient temperatures. The supply chain needs for vaccine handling from storage through transport, up to the time of administration, were carefully evaluated, and then the supply chain was designed. Critical equipment that was procured, shipped, installed, and qualified to meet an aggressive timeline for launching the trial included ultracold freezers, custom-developed Arktek DF containers for storage at –60°C or colder, insulated containers for storage at 2°C–8°C, and multiple backup power sources at vaccine storage sites. Local personnel were trained in good clinical practices and trial documentation. During 9 April–12 December 2015, the trial staff vaccinated approximately 8000 participants. Five temperature excursions occurred, but the vaccine manufacturer assessed that vaccine quality was not impaired because of improper storage or transport temperatures. Both the infrastructure and the human capacity developed for the cold chain during the trial will continue to be useful as the country maintains preparedness for ring vaccination responses and future clinical research. Clinical Trials Registration ClinicalTrials.gov [NCT02378753] and Pan African Clinical Trials Registry [PACTR201502001037220].

scholarly journals Trust, fear, stigma and disruptions: community perceptions and experiences during periods of low but ongoing transmission of Ebola virus disease in Sierra Leone, 2015

2018 ◽  
Vol 3 (2) ◽  
pp. e000410 ◽  
Author(s):  
Azizeh Nuriddin ◽  
Mohamed F Jalloh ◽  
Erika Meyer ◽  
Rebecca Bunnell ◽  
Franklin A Bio ◽  
...  
Keyword(s):  
Risk Communication ◽  
Sierra Leone ◽  
Healthcare System ◽  
Ebola Virus ◽  
Virus Disease ◽  
Community Members ◽  
Public Health Emergencies ◽  
Sierra Leonean ◽  
Quantitative Studies ◽  
Social Mobilisation

Social mobilisation and risk communication were essential to the 2014–2015 West African Ebola response. By March 2015, >8500 Ebola cases and 3370 Ebola deaths were confirmed in Sierra Leone. Response efforts were focused on ‘getting to zero and staying at zero’. A critical component of this plan was to deepen and sustain community engagement. Several national quantitative studies conducted during this time revealed Ebola knowledge, personal prevention practices and traditional burial procedures improved as the outbreak waned, but healthcare system challenges were also noted. Few qualitative studies have examined these combined factors, along with survivor stigma during periods of ongoing transmission. To obtain an in-depth understanding of people’s perceptions, attitudes and behaviours associated with Ebola transmission risks, 27 focus groups were conducted between April and May 2015 with adult Sierra Leonean community members on: trust in the healthcare system, interactions with Ebola survivors, impact of Ebola on lives and livelihood, and barriers and facilitators to ending the outbreak. Participants perceived that as healthcare practices and facilities improved, so did community trust. Resource management remained a noted concern. Perceptions of survivors ranged from sympathy and empathy to fear and stigmatisation. Barriers included persistent denial of ongoing Ebola transmission, secret burials and movement across porous borders. Facilitators included personal protective actions, consistent messaging and the inclusion of women and survivors in the response. Understanding community experiences during the devastating Ebola epidemic provides practical lessons for engaging similar communities in risk communication and social mobilisation during future outbreaks and public health emergencies.

scholarly journals ”For this one, let me take the risk”: why surgical staff continued to perform caesarean sections during the 2014–2016 Ebola epidemic in Sierra Leone

2019 ◽  
Vol 4 (4) ◽  
pp. e001361 ◽  
Author(s):  
Gustaf Drevin ◽  
Helle Mölsted Alvesson ◽  
Alex van Duinen ◽  
Håkon A Bolkan ◽  
Alimamy P Koroma ◽  
...  
Keyword(s):  
Sierra Leone ◽  
Ebola Virus ◽  
Virus Disease ◽  
Moral Dilemmas ◽  
Public Hospitals ◽  
Infection Prevention And Control ◽  
Protective Equipment ◽  
Framework Analysis ◽  
Health Service Provision ◽  
Sierra Leonean

IntroductionRoutine health service provision decreased during the 2014–2016 Ebola virus disease (EVD) outbreak in Sierra Leone, while caesarean section (CS) rates at public hospitals did not. It is unknown what made staff provide CS despite the risks of contracting EVD. This study explores Sierra Leonean health worker perspectives of why they continued to provide CS.MethodsThis qualitative study documents the experiences of 15 CS providers who worked during the EVD outbreak. We interviewed surgical and non-surgical CS providers who worked at public hospitals that either increased or decreased CS volumes during the outbreak. Hospitals in all four administrative areas of Sierra Leone were included. Semistructured interviews averaged 97 min and healthcare experience 21 years. Transcripts were analysed by modified framework analysis in the NVivo V.11.4.1 software.ResultsWe identified two themes that may explain why providers performed CS despite EVD risks: (1) clinical adaptability and (2) overcoming the moral dilemmas. CS providers reported being overworked and exposed to infection hazards. However, they developed clinical workarounds to the lack of surgical materials, protective equipment and standard operating procedures until the broader international response introduced formal personal protective equipment and infection prevention and control practices. CS providers reported that dutifulness and sense of responsibility for one’s community increased during EVD, which helped them justify taking the risk of being infected. Although most surgical activities were reduced to minimise staff exposure to EVD, staff at public hospitals tended to prioritise performing CS surgery for women with acute obstetric complications.ConclusionThis study found that CS surgery during EVD in Sierra Leone may be explained by remarkable decisions by individual CS providers at public hospitals. They adapted practically to material limitations exacerbated by the outbreak and overcame the moral dilemmas of performing CS despite the risk of being infected with EVD.

scholarly journals Characterisation of the T-cell response to Ebola virus glycoprotein amongst survivors of the 2013–16 West Africa epidemic

2021 ◽  
Vol 12 (1) ◽  
Author(s):  
T. R. W. Tipton ◽  
Y. Hall ◽  
J. A. Bore ◽  
A. White ◽  
L. S. Sibley ◽  
...  
Keyword(s):  
T Cell ◽  
West Africa ◽  
Cell Response ◽  
Ebola Virus ◽  
Medical Condition ◽  
Virus Disease ◽  
T Cell Response ◽  
Ebola Virus Disease ◽  
Cell Phenotype ◽  
T Cell Epitopes

AbstractZaireebolavirus (EBOV) is a highly pathogenic filovirus which can result in Ebola virus disease (EVD); a serious medical condition that presents as flu like symptoms but then often leads to more serious or fatal outcomes. The 2013–16 West Africa epidemic saw an unparalleled number of cases. Here we show characterisation and identification of T cell epitopes in surviving patients from Guinea to the EBOV glycoprotein. We perform interferon gamma (IFNγ) ELISpot using a glycoprotein peptide library to identify T cell epitopes and determine the CD4+ or CD8+ T cell component response. Additionally, we generate data on the T cell phenotype and measure polyfunctional cytokine secretion by these antigen specific cells. We show candidate peptides able to elicit a T cell response in EBOV survivors and provide inferred human leukocyte antigen (HLA) allele restriction. This data informs on the long-term T cell response to Ebola virus disease and highlights potentially important immunodominant peptides.

scholarly journals Clinical trial registries as Scientometric data: A novel solution for linking and deduplicating clinical trials from multiple registries

2021 ◽  
Author(s):  
Christian Thiele ◽  
Gerrit Hirschfeld ◽  
Ruth von Brachel
Keyword(s):  
Clinical Trials ◽  
Random Forest ◽  
Random Forest Model ◽  
Scientometric Analysis ◽  
Data Set ◽  
The Public ◽  
Forest Model ◽  
Clinical Trial Registries ◽  
Multiple Primary ◽  
Clinical Trials Registry

AbstractRegistries of clinical trials are a potential source for scientometric analysis of medical research and serve important functions for the research community and the public at large. Clinical trials that recruit patients in Germany are usually registered in the German Clinical Trials Register (DRKS) or in international registries such as ClinicalTrials.gov. Furthermore, the International Clinical Trials Registry Platform (ICTRP) aggregates trials from multiple primary registries. We queried the DRKS, ClinicalTrials.gov, and the ICTRP for trials with a recruiting location in Germany. Trials that were registered in multiple registries were linked using the primary and secondary identifiers and a Random Forest model based on various similarity metrics. We identified 35,912 trials that were conducted in Germany. The majority of the trials was registered in multiple databases. 32,106 trials were linked using primary IDs, 26 were linked using a Random Forest model, and 10,537 internal duplicates on ICTRP were identified using the Random Forest model after finding pairs with matching primary or secondary IDs. In cross-validation, the Random Forest increased the F1-score from 96.4% to 97.1% compared to a linkage based solely on secondary IDs on a manually labelled data set. 28% of all trials were registered in the German DRKS. 54% of the trials on ClinicalTrials.gov, 43% of the trials on the DRKS and 56% of the trials on the ICTRP were pre-registered. The ratio of pre-registered studies and the ratio of studies that are registered in the DRKS increased over time.

scholarly journals Vitamin C in the Treatment of COVID-19

Nutrients ◽  
2021 ◽  
Vol 13 (4) ◽  
pp. 1172
Author(s):  
Gregorio Paolo Milani ◽  
Marina Macchi ◽  
Anat Guz-Mark
Keyword(s):  
Clinical Trials ◽  
Vitamin C ◽  
Respiratory Infections ◽  
Medical Condition ◽  
Case Reports ◽  
Case Series ◽  
Theoretical Background ◽  
Current Evidence ◽  
Vitamin C Supplementation ◽  
Essential Nutrient

Vitamin C is an essential nutrient that serves as antioxidant and plays a major role as co-factor and modulator of various pathways of the immune system. Its therapeutic effect during infections has been a matter of debate, with conflicting results in studies of respiratory infections and in critically ill patients. This comprehensive review aimed to summarize the current evidence regarding the use of vitamin C in the prevention or treatment of patients with SARS-CoV2 infection, based on available publications between January 2020 and February 2021. Overall, 21 publications were included in this review, consisting of case-reports and case-series, observational studies, and some clinical trials. In many of the publications, data were incomplete, and in most clinical trials the results are still pending. No studies regarding prevention of COVID-19 with vitamin C supplementation were found. Although some clinical observations reported improved medical condition of patients with COVID-19 treated with vitamin C, available data from controlled studies are scarce and inconclusive. Based on the theoretical background presented in this article, and some preliminary encouraging studies, the role of vitamin C in the treatment of patients with SARS-CoV-2 infection should be further investigated.

scholarly journals Effects of open-label placebos in clinical trials: a systematic review and meta-analysis

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Melina von Wernsdorff ◽  
Martin Loef ◽  
Brunna Tuschen-Caffier ◽  
Stefan Schmidt
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Medical Condition ◽  
Data Extraction ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Open Label ◽  
Cancer Related Fatigue ◽  
Promising Treatment ◽  
Irritable Bowel

AbstractOpen-label placebos (OLPs) are placebos without deception in the sense that patients know that they are receiving a placebo. The objective of our study is to systematically review and analyze the effect of OLPs in comparison to no treatment in clinical trials. A systematic literature search was carried out in February 2020. Randomized controlled trials of any medical condition or mental disorder comparing OLPs to no treatment were included. Data extraction and risk of bias rating were independently assessed. 1246 records were screened and thirteen studies were included into the systematic review. Eleven trials were eligible for meta-analysis. These trials assessed effects of OLPs on back pain, cancer-related fatigue, attention deficit hyperactivity disorder, allergic rhinitis, major depression, irritable bowel syndrome and menopausal hot flushes. Risk of bias was moderate among all studies. We found a significant overall effect (standardized mean difference = 0.72, 95% Cl 0.39–1.05, p < 0.0001, I2 = 76%) of OLP. Thus, OLPs appear to be a promising treatment in different conditions but the respective research is in its infancy. More research is needed, especially with respect to different medical and mental disorders and instructions accompanying the OLP administration as well as the role of expectations and mindsets.

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