V-01
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V-01
V-01 is a protein subunit COVID-19 vaccine candidate developed by a subsidiary of Livzon Pharmaceutical Group Inc. __TOC__ Preclinical studies A Preclinical development, preclinical study in Rhesus macaque, rhesus macaques was published in July 2021. The vaccine's ability to neutralize several variants of concern has also been tested in mice. Another study in mice tested V-01 as a booster after inactivated Covid vaccine, including neutralization of a range of variants of concern. Clinical studies A phase I clinical trial to assess the safety and immune response was initiated in February 2021. It concluded that the vaccine was well-tolerated. A phase II trial with 880 participants concluded that the vaccine was Immunogenicity, immunogenic and well-tolerated. A second phase II trial tested V-01 and a Bivalent vaccine, bivalent version targeting SARS-CoV-2 Beta variant, Beta and SARS-CoV-2 Delta variant, Delta variants of concern as a booster after primary vaccination with ina ...
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SARS-CoV-2 Omicron Variant
Omicron (B.1.1.529) is a variant of SARS-CoV-2 first reported to the World Health Organization (WHO) by the Network for Genomics Surveillance in South Africa on 24 November 2021. It was first detected in Botswana and has spread to become the predominant variant in circulation around the world. Following the original BA.1 variant, several subvariants of Omicron have emerged: BA.2, BA.3, BA.4, and BA.5. Since October 2022, two subvariants of BA.5 named BQ.1 and BQ.1.1 have spread rapidly. Three doses of a COVID-19 vaccine provide protection against severe disease and hospitalisation caused by BA.1 and BA.2. The immunity effects of BA.2 are similar to those of BA.1. For three-dose vaccinated individuals, the BA.4 and BA.5 variants are more infectious than previous subvariants, making it likely, , for a new peak in COVID-19 infections to occur. __TOC__ Classification On 26 November, the WHO's Technical Advisory Group on SARS-CoV-2 Virus Evolution declared PANGO linea ...
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COVID-19 Vaccine
A COVID19 vaccine is a vaccine intended to provide acquired immunity against severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2), the virus that causes coronavirus disease 2019 ( COVID19). Prior to the COVID19 pandemic, an established body of knowledge existed about the structure and function of coronaviruses causing diseases like severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS). This knowledge accelerated the development of various vaccine platforms during early 2020. The initial focus of SARS-CoV-2 vaccines was on preventing symptomatic, often severe illness. In January 2020, the SARS-CoV-2 genetic sequence data was shared through GISAID, and by March 2020, the global pharmaceutical industry announced a major commitment to address COVID19. In 2020, the first COVID19 vaccines were developed and made available to the public through emergency authorizations and conditional approvals. Initially, most COVID19 vaccines were two ...
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Severe Acute Respiratory Syndrome Coronavirus 2
Severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2) is a strain of coronavirus that causes COVID-19 (coronavirus disease 2019), the respiratory illness responsible for the ongoing COVID-19 pandemic. The virus previously had a Novel coronavirus, provisional name, 2019 novel coronavirus (2019-nCoV), and has also been called the human coronavirus 2019 (HCoV-19 or hCoV-19). First identified in the city of Wuhan, Hubei, China, the World Health Organization declared the outbreak a public health emergency of international concern on January 30, 2020, and a pandemic on March 11, 2020. SARS‑CoV‑2 is a positive-sense single-stranded RNA virus that is Contagious disease, contagious in humans. SARS‑CoV‑2 is a virus of the species ''severe acute respiratory syndrome–related coronavirus'' (SARSr-CoV), related to the Severe acute respiratory syndrome coronavirus 1, SARS-CoV-1 virus that caused the 2002–2004 SARS outbreak. Despite its close relation to SARS-CoV-1, i ...
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Phase III Trial
The phases of clinical research are the stages in which scientists conduct experiments with a health intervention to obtain sufficient evidence for a process considered effective as a medical treatment. For drug development, the clinical phases start with testing for safety in a few human subjects, then expand to many study participants (potentially tens of thousands) to determine if the treatment is effective. Clinical research is conducted on drug candidates, vaccine candidates, new medical devices, and new diagnostic assays. Summary Clinical trials testing potential medical products are commonly classified into four phases. The drug development process will normally proceed through all four phases over many years. If the drug successfully passes through Phases I, II, and III, it will usually be approved by the national regulatory authority for use in the general population. Phase IV trials are 'post-marketing' or 'surveillance' studies conducted to monitor safety over se ...
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Chinese COVID-19 Vaccines
Chinese can refer to: * Something related to China * Chinese people, people of Chinese nationality, citizenship, and/or ethnicity **''Zhonghua minzu'', the supra-ethnic concept of the Chinese nation ** List of ethnic groups in China, people of various ethnicities in contemporary China ** Han Chinese, the largest ethnic group in the world and the majority ethnic group in Mainland China, Hong Kong, Macau, Taiwan, and Singapore ** Ethnic minorities in China, people of non-Han Chinese ethnicities in modern China ** Ethnic groups in Chinese history, people of various ethnicities in historical China ** Nationals of the People's Republic of China ** Nationals of the Republic of China ** Overseas Chinese, Chinese people residing outside the territories of Mainland China, Hong Kong, Macau, and Taiwan * Sinitic languages, the major branch of the Sino-Tibetan language family ** Chinese language, a group of related languages spoken predominantly in China, sharing a written script (Chinese c ...
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Clinical Trials Related To COVID-19
Clinical may refer to: Healthcare * Of or about a clinic, a healthcare facility * Of or about the practice of medicine Other uses * ''Clinical'' (film), a 2017 American horror thriller See also * * * Clinical chemistry, the analysis of bodily fluids for diagnostic and therapeutic purposes * Clinical death, the cessation of blood circulation and breathing * Clinical formulation, a theoretically-based explanation of information obtained from clinical assessment * Clinical governance, a systematic approach to maintaining and improving the quality of patient care * Clinical linguistics, linguistics applied to speech-language pathology * Clinical psychology, the understanding, preventing, and relieving psychologically-based distress or dysfunction * Clinical research, to determine the safety and effectiveness of medications etc. * Clinical significance, the practical importance of a treatment effect * Clinical trial, experiments or observations done in clinical research * Clinical wa ...
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Booster Dose
A booster dose is an extra administration of a vaccine after an earlier (primer) dose. After initial immunization, a booster provides a re-exposure to the immunizing antigen. It is intended to increase immunity against that antigen back to protective levels after memory against that antigen has declined through time. For example, tetanus shot boosters are often recommended every 10 years, by which point memory cells specific against tetanus lose their function or undergo apoptosis. The need for a booster dose following a primary vaccination is evaluated in several ways. One way is to measure the level of antibodies specific against a disease a few years after the primary dose is given. Anamnestic response, the rapid production of antibodies after a stimulus of an antigen, is a typical way to measure the need for a booster dose of a certain vaccine. If the anamnestic response is high after receiving a primary vaccine many years ago, there is most likely little to no need for a boos ...
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Placebo
A placebo ( ) is a substance or treatment which is designed to have no therapeutic value. Common placebos include inert tablets (like sugar pills), inert injections (like Saline (medicine), saline), sham surgery, and other procedures. In general, placebos can affect how patients perceive their condition and encourage the body's chemical processes for relieving pain and a few other symptoms, but have no impact on the disease itself. Improvements that patients experience after being treated with a placebo can also be due to unrelated factors, such as regression to the mean (a statistical effect where an unusually high or low measurement is likely to be followed by a less extreme one). The use of placebos in clinical medicine raises ethical concerns, especially if they are disguised as an active treatment, as this introduces dishonesty into the doctor–patient relationship and bypasses informed consent. While it was once assumed that this deception was necessary for placebos to have ...
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Randomized Controlled Trial
A randomized controlled trial (or randomized control trial; RCT) is a form of scientific experiment used to control factors not under direct experimental control. Examples of RCTs are clinical trials that compare the effects of drugs, surgical techniques, medical devices, diagnostic procedures or other medical treatments. Participants who enroll in RCTs differ from one another in known and unknown ways that can influence study outcomes, and yet cannot be directly controlled. By Random assignment, randomly allocating participants among compared treatments, an RCT enables ''statistical control'' over these influences. Provided it is designed well, conducted properly, and enrolls enough participants, an RCT may achieve sufficient control over these confounding factors to deliver a useful comparison of the treatments studied. Definition and examples An RCT in clinical research typically compares a proposed new treatment against an existing Standard of care#Medical standard of care, ...
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Inactivated Vaccine
An inactivated vaccine (or killed vaccine) is a vaccine consisting of virus particles, bacteria, or other pathogens that have been grown in culture and then killed to destroy disease-producing capacity. In contrast, live vaccines use pathogens that are still alive (but are almost always attenuated, that is, weakened). Pathogens for inactivated vaccines are grown under controlled conditions and are killed as a means to reduce infectivity and thus prevent infection from the vaccine. Inactivated vaccines were first developed in the late 1800s and early 1900s for cholera, plague, and typhoid. Today, inactivated vaccines exist for many pathogens, including influenza, polio (IPV), rabies, hepatitis A and pertussis. Because inactivated pathogens tend to produce a weaker response by the immune system than live pathogens, immunologic adjuvants and multiple "booster" injections may be required in some vaccines to provide an effective immune response against the pathogen. Attenuated vacci ...
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SARS-CoV-2 Beta Variant
The Beta variant, (B.1.351), was a variant of SARS-CoV-2, the virus that causes COVID-19. One of several SARS-CoV-2 variants initially believed to be of particular importance, it was first detected in the Nelson Mandela Bay metropolitan area of the Eastern Cape province of South Africa in October 2020, which was reported by the country's health department on 18 December 2020. Phylogeographic analysis suggests this variant emerged in the Nelson Mandela Bay area in July or August 2020. The World Health Organization labelled the variant as Beta variant, not to replace the scientific name but as a name for the public to commonly refer to. The WHO considers it to be a variant of concern no longer in circulation. Names The variant is also known as the ''South African variant''. Mutations File:SARS-CoV-2 Beta variant.svg, Amino acid mutations of SARS-CoV-2 Beta variant plotted on a genome map of SARS-CoV-2 with a focus on Spike. There are three mutations of particular interes ...
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SARS-CoV-2 Delta Variant
The Delta variant (B.1.617.2) was a variant of SARS-CoV-2, the virus that causes COVID-19. It was first detected in India in late 2020. The Delta variant was named on 31 May 2021 and had spread to over 179 countries by 22 November 2021. The World Health Organization (WHO) indicated in June 2021 that the Delta variant was becoming the dominant strain globally. It has mutations in the gene encoding the SARS-CoV-2 coronavirus spike protein, spike protein causing the substitutions T478K, Variants of SARS-CoV-2#P681R, P681R and Variants of SARS-CoV-2#L452R, L452R, which are known to affect transmissibility of the virus as well as whether it can be neutralised by antibodies for previously circulating variants of the COVID-19 virus. In August 2021, Public Health England (PHE) reported secondary attack rate in household contacts of non-travel or unknown cases for Delta to be 10.8% ''vis-à-vis'' 10.2% for the SARS-CoV-2 Alpha variant, Alpha variant; the case fatality rate for those ...
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