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Nih Vaccine Trials

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Last Updated: 02 July 2021

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General | Latest Info

Phase III clinical Trials to evaluate mRNA - 1273, investigational Vaccine against COVID - 19 developed by National Institutes of Health and drug developer Moderna, have enrol 30 000 adult volunteers. It is the largest study of COVID - 19 Vaccine so far, and the vaccine is one of several candidates being studied worldwide. Testing will be conducted at approximately 89 clinical research sit in the US, 24 of which are part of the NIH Coronavirus Prevention Network. Participants will be randomized 1: 1 to receive either two intramuscular injections of mRNA - 1273 100 mcg or two shots of saline placebo, approximately 28 days apart. Randomize, double - blind Trials are designed to evaluate Vaccine safety and to determine whether treatment with mRNA - 1273 can prevent symptomatic COVID - 19 after two doses. Secondary goals include assessing if vaccine can prevent severe COVID - 19 and laboratory - confirm SARS - CoV - 2 Infection with or without symptoms. Researchers also will examine whether a vaccine can prevent death caused by COVID - 19 and whether a single dose can prevent symptomatic infection. This is the first in a series of similar testing phases that will be carried out by COVPN. The Network plans to roll out new studies of leading vaccine candidates every month through fall, each with 30 000 volunteers. Phase III US study of Vaccine developed by Oxford University will begin in August, followed by plans to test candidates from Johnson & Johnson and Novavax in September and October, respectively. These Trials need to be multigenerational, they need to be multiethnic, they need to reflect the diversity of the United States population, says Larry Corey, MD, President and Director Emeritus of Fred Hutchinson Cancer Research Institute, who is co - leading CoVPNs Vaccine efforts.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Organizational and Funding Approaches

The Dale and Betty Bumpers Vaccine Research Center at the National Institutes of Health was established to facilitate Research in Vaccine Development. Vrc is dedicated to improving Global Human Health through rigorous pursuit of effective Vaccines for Human Diseases. Establish by former President Bill Clinton as part of an initiative to develop AIDS Vaccine,s VRC is a unique venture within NIH intramural Research Program. Initially spearheaded by NIAID, National Cancer Institute, and NIH Office of AIDS Research, VRC is now part of the NIAID organization. The mission of the Vaccine Research Center is to conduct research that facilitates development of effective Vaccines for Human Disease. Primary focuses of research include: viewing all research conducted at Vaccine Research Center

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Treatments Clinical Trials

The National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, today launched a study designed to determine whether certain approved therapies or investigational drugs in late - stage Clinical Development show promise against COVID - 19 and merit advancement into larger Clinical Trials. Activ - 5 Big Effect Trial, which will enroll adult volunteers hospitalized with COVID - 19 at as many as 40 US sites, is being conducted in collaboration with NIH public - private partnership Accelerating COVID - 19 Therapeutic Innovations and Vaccines Program. ACTIV - 5 / BET Study aims to streamline the pathway to finding urgently needed COVID - 19 treatments by repurposing either licensed or late - stage - Development medicines and testing them in a way that identifies the most promising agents for larger clinical studies in the most expedient way possible, say NIH Director Francis S. Collins, MD, ph. D Phase 2 Adaptive, randomize, double - blind, placebo - control Trial will compare different investigational therapies to common control arm to determine which experimental treatments have relatively large effects. Approximately 100 hospitalized volunteers will be assigned to each study arm with each of the study sites testing no more than three investigational treatments at once. The goal here is to identify as quickly as possible experimental therapeutics that demonstrate most clinical promise as COVID - 19 treatments and move them into larger - scale testing, said NIAID Director Anthony S. Fauci, MD. This study design is both an efficient way of finding those promising treatments and eliminating those that are not. The trial will test risankizumab, monoclonal antibody developed by Boehringer Ingelheim and AbbVie, in conjunction with Antiviral Drug Remdesivir, compared to placebo Plus Remdesivir. The ACTIV - 5 / BET Trial will also test investigational monoclonal Antibody lenzilumab, developed by Humanigen, with Remdesivir, compared to placebo and Remdesivir. Remdesivir has demonstrated clinical benefit for patients with severe COVID - 19 requiring supplemental oxygen and is considered the standard of care for hospitalized COVID - 19 patients. Monoclonal Antibodies are laboratory - made versions of proteins naturally produced by the immune system in response to invading viruses or other pathogens. Risankizumab was approved in the United States in 2019 for the treatment of severe plaque psoriasis. Lenzilumab is currently being tested separately in Phase 3 COVID - 19 Study and in Phase 1b / 2 Study as sequenced therapy with CAR - T treatments. In the ACTIV - 5 / BET Study, volunteers assigned to receive risankizumab will be administered single intravenous dose on day one of study. Study participants assigned to receive lenzilumab will be given 600 mg intravenous infusion every eight hours for a total of three doses. The primary purpose of the ACTIV - 5 / BET Study is to evaluate Clinical Efficacy of different investigational Therapeutics relative to control arm in hospitalized adults based on volunteer clinical status at day eight. Study secondary point of evaluation is to evaluate the Clinical Efficacy of different investigational Therapeutics as assessed by the amount of time it takes for each volunteer to recover from COVID - 19. Study volunteers will be assessed daily by clinical staff while they are hospitalize.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Immune Response Clinical Trials

Investigational Vaccine, mRNA - 1273, designed to protect against SARS - CoV - 2, virus that cause coronavirus disease 2019, was generally well tolerated and prompt neutralizing antibody activity in healthy adults, according to interim results published online today in New England Journal of Medicine. The Ongoing Phase 1 Trial is supported by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. Experimental Vaccine is being co - developed by researchers at NIAID and at Moderna, Inc. Of Cambridge, Massachusetts. Manufacture by Moderna, mRNA - 1273 is designed to induce neutralizing antibodies direct at portion of coronavirus spike protein, which the virus uses to bind to and enter human cells. The trial was led by Lisa. Jackson, MD, MPH, of Kaiser Permanente Washington Health Research Institute in Seattle, where first participant received candidate Vaccine on March 16. This interim report details initial findings from first 45 participants aged 18 to 55 years enrol at study sites in Seattle and at Emory University in Atlanta. Three groups of 15 participants receive two intramuscular injections, 28 days apart, of either 25 100 or 250 micrograms of investigational Vaccine. All participants receive one injection; 42 receive both scheduled injections. In April, trial was expanded to enroll adults older than age 55 years; it now has 120 participants. However, newly published results cover the 18 to 55 - year age group only. Regarding safety, no serious adverse events were report. More than half of participants reported fatigue, headache, chills, myalgia or pain at the injection site. Systemic adverse events were more common following the second vaccination and in those who received the highest vaccine dose. Data on side effects and Immune Responses at various Vaccine dosages inform doses used or planned for use in Phase 2 and 3 Clinical trials of investigational Vaccine. Interim analysis includes results of tests measuring levels of Vaccine - induced neutralizing activity through day 43 after second injection. Two doses of vaccine prompted high levels of neutralizing antibody activity that were above average values seen in convalescent sera obtained from persons with confirmed COVID - 19 disease. The Phase 2 Clinical Trial of mRNA - 1273, sponsored by Moderna, begins enrollment in late May. Plans are underway to launch Phase 3 efficacy Trial in July 2020. Additional information about Phase 1 Clinical Trial design is available at clinicaltrials. Gov uses identifier NCT04283461. This trial was supported in part by NIAID grants M1AI148373, UM1AI148576 and UM1AI148684. Funding for manufacture of mRNA - 1273 Phase 1 material was provided by Coalition for Epidemic Preparedness Innovations. La Jackson et al. Sars - CoV - 2 mRNA Vaccine preliminary report. New England Journal of Medicine. Doi: 10. 1056 / NEJMoa2022483. Niaid Director Anthony S. Fauci, MD, and John Beigel, MD, associate Director for Clinical Research, Division of Microbiology and Infectious Diseases, NIAID, are available to discuss results of this Trial.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Epidemiological Studies

The study at NIH Clinical Center in Bethesda, Maryland aims to determine how many adults in the United States without a confirmed history of infection with SARS - CoV - 2, virus that caused Coronavirus Disease 2019, have antibodies to the virus. Presence of antibodies in blood indicates prior infection. In this Serosurvey, researchers will collect and analyze blood samples from as many as 10 000 volunteers to provide critical data for epidemiological models. Results will help illuminate the extent to which the novel Coronavirus has spread undetected in the United States and provide insights into which communities and populations are most affected.


Epidemiology

Epidemiology pinpoints weak links in chains, sources, and transmission pathways of pathogens so that interventions can be direct. Understanding of epidemiology is required from very early stage of priority - setting for disease burden, understanding the basis of correlates of protection, development of vaccines, evaluating different vaccination strategies including epidemiological and economic modeling, deciding National Vaccination strategies, developing surveillance mechanisms, impact assessment, and designing Vaccine introduction strategies. Term disease burden or burden of disease occupies key place in Epidemiology. Bod could be measured by incidence or prevalence of disease; severity / mortality; disability and quality - adjusted life years]; Economics; and social aspects. Key concepts and study designs to understand Epidemiology are well, documented and thus not described in this article. However, Vaccine probe studies require special mention here, Vaccine probe study is a randomized cluster trial of vaccine in which, usually, Vaccine effectiveness endpoints are used. Differences in incidence of disease between vaccinated and unvaccinated children represent Vaccine - preventable disease burden. These are technically Vaccine - effectiveness Trials and have been used to measure Vaccine - preventable proportion / incidence of clinically defined outcomes. This approach has been used successfully in several countries for studies on Haemophilus influenzae type B conjugate and pneumococcal conjugate vaccines.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

Sources

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions.

* Please keep in mind that all text is machine-generated, we do not bear any responsibility, and you should always get advice from professionals before taking any actions

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