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Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments and known interventions that warrant further study and comparison. Clinical trials generate data on dosage, safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial—their approval does not mean the therapy is 'safe' or effective, only that the trial may be conducted.
Ebola, also known as Ebola virus disease (EVD) and Ebola hemorrhagic fever (EHF), is a viral hemorrhagic fever in humans and other primates, caused by ebolaviruses. Symptoms typically start anywhere between two days and three weeks after infection. The first symptoms are usually fever, sore throat, muscle pain, and headaches. These are usually followed by vomiting, diarrhoea, rash and decreased liver and kidney function, at which point some people begin to bleed both internally and externally. It kills between 25% and 90% of those infected – about 50% on average. Death is often due to shock from fluid loss, and typically occurs between six and 16 days after the first symptoms appear. Early treatment of symptoms increases the survival rate considerably compared to late start. An Ebola vaccine was approved by the US FDA in December 2019.
Brincidofovir, sold under the brand name Tembexa, is an antiviral drug used to treat smallpox. Brincidofovir is a prodrug of cidofovir. Conjugated to a lipid, the compound is designed to release cidofovir intracellularly, allowing for higher intracellular and lower plasma concentrations of cidofovir, effectively increasing its activity against dsDNA viruses, as well as oral bioavailability.
The 2013–2016 epidemic of Ebola virus disease, centered in Western Africa, was the most widespread outbreak of the disease in history. It caused major loss of life and socioeconomic disruption in the region, mainly in Guinea, Liberia and Sierra Leone. The first cases were recorded in Guinea in December 2013; later, the disease spread to neighbouring Liberia and Sierra Leone, with minor outbreaks occurring in Nigeria and Mali. Secondary infections of medical workers occurred in the United States and Spain. In addition, isolated cases were recorded in Senegal, the United Kingdom and Italy. The number of cases peaked in October 2014 and then began to decline gradually, following the commitment of substantial international resources.
A public health emergency of international concern is a formal declaration by the World Health Organization (WHO) of "an extraordinary event which is determined to constitute a public health risk to other States through the international spread of disease and to potentially require a coordinated international response", formulated when a situation arises that is "serious, sudden, unusual, or unexpected", which "carries implications for public health beyond the affected state's national border" and "may require immediate international action". Under the 2005 International Health Regulations (IHR), states have a legal duty to respond promptly to a PHEIC. The declaration is publicized by an IHR Emergency Committee (EC) of international experts, which was developed following the 2002–2004 SARS outbreak.
ZMapp is an experimental biopharmaceutical drug comprising three chimeric monoclonal antibodies under development as a treatment for Ebola virus disease. Two of the three components were originally developed at the Public Health Agency of Canada's National Microbiology Laboratory (NML), and the third at the U.S. Army Medical Research Institute of Infectious Diseases; the cocktail was optimized by Gary Kobinger, a research scientist at the NML and underwent further development under license by Mapp Biopharmaceutical. ZMapp was first used on humans during the Western African Ebola virus epidemic, having only been previously tested on animals and not yet subjected to a randomized controlled trial. The National Institutes of Health (NIH) ran a clinical trial starting in January 2015 with subjects from Sierra Leone, Guinea, and Liberia aiming to enroll 200 people, but the epidemic waned and the trial closed early, leaving it too statistically underpowered to give a meaningful result about whether ZMapp worked.
Recombinant vesicular stomatitis virus–Zaire Ebola virus (rVSV-ZEBOV), also known as Ebola Zaire vaccine live and sold under the brand name Ervebo, is an Ebola vaccine for adults that prevents Ebola caused by the Zaire ebolavirus. When used in ring vaccination, rVSV-ZEBOV has shown a high level of protection. Around half the people given the vaccine have mild to moderate adverse effects that include headache, fatigue, and muscle pain.
Ebola vaccines are vaccines either approved or in development to prevent Ebola. As of 2022, there are only vaccines against the Zaire ebolavirus. The first vaccine to be approved in the United States was rVSV-ZEBOV in December 2019. It had been used extensively in the Kivu Ebola epidemic under a compassionate use protocol. During the early 21st century, several vaccine candidates displayed efficacy to protect nonhuman primates against lethal infection.
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Rüdiger Krech is a German public health expert who currently works as a senior official at the World Health Organization (WHO). An advocate for universal health coverage, social determinants of health, Health in All Policies and social protection, he is the Director of Health Promotion at WHO.
The Democratic Republic of the Congo (DRC) was identified by the World Health Organization (WHO) on 11 May 2017 as having one Ebola-related death.
The 2018 Équateur province Ebola outbreak occurred in the north-west of the Democratic Republic of the Congo (DRC) from May to July 2018. It was contained entirely within Équateur province, and was the first time that vaccination with the rVSV-ZEBOV Ebola vaccine had been attempted in the early stages of an Ebola outbreak, with a total of 3,481 people vaccinated. It was the ninth recorded Ebola outbreak in the DRC.
The Kivu Ebola epidemic was an outbreak of Ebola virus disease (EVD) mainly in eastern Democratic Republic of the Congo (DRC), and in other parts of Central Africa, from 2018 to 2020. Between 1 August 2018 and 25 June 2020 it resulted in 3,470 reported cases. The Kivu outbreak also affected Ituri Province, whose first case was confirmed on 13 August 2018. In November 2018, the outbreak became the biggest Ebola outbreak in the DRC's history, and had become the second-largest Ebola outbreak in recorded history worldwide, behind only the 2013–2016 Western Africa epidemic. In June 2019, the virus reached Uganda, having infected a 5-year-old Congolese boy who entered Uganda with his family, but was contained.
Ansuvimab, sold under the brand name Ebanga, is a monoclonal antibody medication for the treatment of Zaire ebolavirus (Ebolavirus) infection.
Jean-Jacques Muyembe is a Congolese microbiologist. He is the general director of the Democratic Republic of the Congo Institut National pour la Recherche Biomedicale (INRB). He was part of team at the Yambuku Catholic Mission Hospital that investigated the first Ebola outbreak, and was part of the effort that discovered Ebola as a new disease, although his exact role is still subject to controversy. In 2016, he led the research that designed, along with other researchers at the INRB and the National Institute of Health Vaccine Research Center in the US, one of the most promising treatment for Ebola, mAb114. The treatment was successfully experimented during recent outbreaks in the DRC, on the express decision of the then DRC Minister of Health, Dr Oly Ilunga, despite a prior negative advice from the World Health Organization.
Michael Joseph Ryan is an Irish epidemiologist and former trauma surgeon, specialising in infectious disease and public health. He is executive director of the World Health Organization's Health Emergencies Programme, leading the team responsible for the international containment and treatment of COVID-19. Ryan has held leadership positions and has worked on various outbreak response teams in the field to eradicate the spread of diseases including bacillary dysentery, cholera, Crimean–Congo hemorrhagic fever, Ebola, Marburg virus disease, measles, meningitis, relapsing fever, Rift Valley fever, SARS, and Shigellosis.
Caitlin M. Rivers is an American epidemiologist who as Senior Scholar at the Johns Hopkins Center for Health Security and assistant professor at the Johns Hopkins Bloomberg School of Public Health, specializing on improving epidemic preparedness. Rivers is currently working on the American response to the COVID-19 pandemic with a focus on the incorporation of infectious disease modeling and forecasting into public health decision making.
Science diplomacy is the collaborative efforts by local and global entities to solve global issues using science and technology as a base. In science diplomacy, collaboration takes place to advance science but science can also be used to facilitate diplomatic relations. This allows even conflicting nations to come together through science to find solutions to global issues. Global organizations, researchers, public health officials, countries, government officials, and clinicians have previously worked together to create effective measures of infection control and subsequent treatment. They continue to do so through sharing of resources, research data, ideas, and by putting into effect laws and regulations that can further advance scientific research. Without the collaborative efforts of such entities, the world would not have the vaccines and treatments we now possess for diseases that were once considered deadly such as tuberculosis, tetanus, polio, influenza, etc. Historically, science diplomacy has proved successful in diseases such as SARS, Ebola, Zika and continues to be relevant during the COVID-19 pandemic today.
Atoltivimab/maftivimab/odesivimab, sold under the brand name Inmazeb, is a fixed-dose combination of three monoclonal antibodies for the treatment of Zaire ebolavirus. It contains atoltivimab, maftivimab, and odesivimab-ebgn and was developed by Regeneron Pharmaceuticals.
References
- ↑ World Health Organization (WHO). (2016). Emergency use of unproven interventions outside of research [Chapter 9]. In Guidance for Managing Ethical Issues in Infectious Disease Outbreaks. World Health Organization. https://apps.who.int/iris/handle/10665/250580. alternative DOI: https://doi.org/10.5281/zenodo.3715302
- ↑ "Notes for the record: Consultation on Monitored Emergency Use of Unregistered and Investigational Interventions for Ebola Virus Disease (EVD)" (PDF). World Health Organization. 17 May 2018. Retrieved 26 May 2018.
- ↑ WHO Ethics Working Group (2014). "Ethical issues related to study design for trials on therapeutics for Ebola Virus Disease: WHO Ethics Working Group meeting 20–21 October, summary of discussion". World Health Organization. hdl:10665/137509.
{{cite journal}}: Cite journal requires|journal=(help) - ↑ Calain, Philippe (2018-01-01). "The Ebola clinical trials: a precedent for research ethics in disasters". Journal of Medical Ethics. 44 (1): 3–8. doi:10.1136/medethics-2016-103474. ISSN 0306-6800. PMC 5749307 . PMID 27573153.
- ↑ Richardson, Thomas; Johnston, Andrew McDonald; Draper, Heather (2017-01-17). "A Systematic Review of Ebola Treatment Trials to Assess the Extent to Which They Adhere to Ethical Guidelines". PLOS ONE. 12 (1): e0168975. Bibcode:2017PLoSO..1268975R. doi: 10.1371/journal.pone.0168975 . PMC 5240928 . PMID 28095476.
- ↑ Alirol, Emilie; Kuesel, Annette C.; Guraiib, Maria Magdalena; dela Fuente-Núñez, Vânia; Saxena, Abha; Gomes, Melba F. (2017-06-26). "Ethics review of studies during public health emergencies - the experience of the WHO ethics review committee during the Ebola virus disease epidemic". BMC Medical Ethics. 18 (1): 43. doi: 10.1186/s12910-017-0201-1 . ISSN 1472-6939. PMC 5485606 . PMID 28651650.
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