A fourth clinical trial of a corona vaccine begins in the United States

This is a vaccine based on Jensen's Ebola vaccine. "Four vaccines in clinical trials is an unprecedented achievement by the scientific community made possible by decades of advances in vaccine technology and a coordinated strategic approach between government, industry and academia," said NIAID Director Anthony Fauci.

The article is based on a press release of National Institute of Allergy and Infectious Diseases in the USA, belonging to the NIH.

A fourth phase 3 clinical trial for a vaccine for the corona virus disease (COVID-19) has begun recruiting adult volunteers. The trial was designed to evaluate whether the experimental Janssen COVID-19 vaccine (JNJ-78436725) can prevent symptomatic COVID-19 after a single injection. Up to 60,000 volunteers will be enrolled in the trial at nearly 215 clinical research sites in the United States and around the world

Johnson & Johnson-owned pharmaceutical company Jensen, which developed the experimental vaccine (also known as Ad.26.COV2.S), is leading the clinical trial as a regulatory sponsor. In addition to Jensen, the National Institute of Allergy and Infectious Diseases (NIAID), the National Institutes of Health, the Biomedical Advanced Research and Development Authority (BARDA), and the US Department of Health are partners in the research.

Four potential vaccines for COVID-19 are in Phase 3 clinical trials in the United States just over eight months after the SARS-CoV-2 virus was identified. "This is an unprecedented achievement for the scientific community made possible by decades of advances in vaccine technology and a coordinated strategic approach between government, industry and academia," said NIAID Director Anthony Fauci, who is the US administration's top epidemiologist. for COVID-19 to meet global need. Genso's vaccine showed promise in the early testing phase and if successful it may be particularly useful in controlling the epidemic if it turns out that it protects after just one dose."

The vaccine candidate developed by Jensen is a recombinant vector vaccine that uses a human adenovirus to express the "spikes" proteins of SARS-CoV-2 in cells. Adenoviruses are a group of viruses that cause the common cold. However, the adenovirus vector used in the vaccine is modified so that it can no longer replicate in humans and cause disease. Jensen uses the same vector in the first dose of its vaccine against the Ebola virus disease (Ad26.ZEBOV and MVA-BN-Filo) which was recently approved for marketing by the European Commission.

Preclinical findings published in Nature show that the experimental Janssen COVID-19 vaccine neutralized antibody responses in rhesus macaques and provided full or near-full protection against lung virus infection even following a SARS-CoV-2 challenge. The safety of the experimental vaccine was tested in a phase 1/2a trial in the United States and Belgium in adult volunteers. Positive interim results from the phase 1/2a clinical study showed that the safety and immunization profile after a single vaccination is one that encourages further development.

"Scientific partners from government, industry and academia are working hand in hand to develop safe and effective vaccines to put this epidemic behind us," said NIH Director Francis Collins. "While administrative measures can be effective to speed up the process, attention to safety and efficiency measures is still more rigorous than ever."

The Phase 3 trial is being conducted in partnership with Operation Speed ​​on Space (OWS), a multi-agency collaboration overseen by HHS and the Department of Defense that aims to accelerate the development, production and distribution of medical countermeasures for COVID-19. OWS and CoVPN are also assisting in the development of additional preventive vaccine candidates against COVID-19, including Moderna's mRNA-1273 and UK-based AstraZeneca's AZD1222.

"If we manage to reach one vaccine that has passed the clinical trials (phase 3) less than a year after the first report of the virus, it will be an extraordinary achievement; Four nominees at this stage would be an even more remarkable success,” said HHS Secretary Alex Azar. "By developing a portfolio of potential vaccines, speed on space maximizes the chances that we will have a significant supply of safe and effective vaccine - and possibly multiple vaccine options - by January 2021."

"Volunteers must provide informed consent to participate in the experiment. After administration and blood sampling, participants will be randomly assigned to receive one dose of the vaccine or a saline placebo. The experiment was done in a double-blind manner, meaning that neither the researchers nor the participants knew who was receiving the vaccine. The participants will be closely monitored for the safety of the vaccine and will be asked to provide additional blood samples at specified time points after the injection for over two years. Scientists will analyze the blood samples to detect and quantify immune responses to COVID-19. The system will know how to differentiate between immunity created by natural infection and immunity created by the vaccine.

The trial is primarily designed to determine whether the vaccine can prevent moderate to severe COVID-19 after a single dose. The researchers aim to understand if the vaccine can prevent infection with COVID-19 at a level that requires medical intervention (moderate or higher) and if the vaccine can prevent milder cases of COVID-19 and asymptomatic infection with SARS-CoV-2.

An independent Data and Safety Monitoring Board (DSMB) will be established to ensure the safe and ethical conduct of the study. All Phase 3 clinical trials of vaccine candidates supported through Operation Supervelocity are under common DSMB oversight developed in consultation with ACTIV.

Adults (living in the US) who wish to join this study can go to the website ClinicalTrials.gov Or to coronaviruspreventionnetwork.org. Search ID NCT04505722.

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