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JNJ-78436735, also known as Ad26. COV2. S, is being investigated in the ENSEMBLE Phase III trial (NCT04505722), which will recruit volunteers at approximately 215 clinical studies sites in the United States and the world.
Janssen is investing the test with the National Institute of Allergy and Infectious Diseases (NIAID) and the Advanced Biomedical Research and Development Authority (BARDA).
BARDA has committed more than $456. 2 million to JNJ-78436735, from progression to certification, approximately part of the $1 billion combined and most committed through BARDA and J
ENSEMBLE is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the protection and efficacy of a single placebo vaccine dose in up to 60,000 adults over the age of 18, adding what J
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ENSEMBLE’s number one endpoint is the number of participants with a moderate to severe/critical COVID-19 shown at the molecular point with HIV-negative prestige up to 2. 1 years after injection.
The trial also measures 3 secondary final results:
“As COVID-19 continues to have an effect on the daily lives of others around the world, our purpose remains the same: to leverage our company’s global success and clinical innovation to help end this pandemic,” Alex Gorsky said. , President and CEO of J
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In the statement, Paul Stoffels, MD, Vice President of J’s Executive Committee and CSO
This would position J’s vaccine
“Four applicants for the COVID-19 vaccine are in a clinical trial in the United States just over 8 months after the identity of SARS-CoV-2. This is an unprecedented achievement for the clinical network that has been made imaginable to through decades of advancements in vaccine generation and a strategic technique across government, industry, and academia, “said NIAID Director Anthony S. Fauci, MD, in a separate NIH document. ” It’s very Multiple COVID-19 vaccination regimens likely to be needed to meet global needs. It showed promise in the early stages of testing and could possibly be helpful in controlling the pandemic if found to be protective after a single dose. “
Janssen initiated the Phase III trial after reporting positive intermediate knowledge of a Phase I/IIa trial (NCT04436276) that showed that the protection profile and immunogenicity after a single JNJ-78436735 vaccination supported the next progression of the vaccine. , but accelerated to July,
Earlier this month, researchers from Janssen, BIDMC, and clinical partners published a study in Nature that showed that Ad26. COV2. S, an exclusive immunization of an Ad26 vector encoding a full-length prefusion stabilized S immunogen (S. PP), opposed a serious clinical disease after a high-dose trial of SARS-CoV-2 in golden hamsters.
JNJ-78436735 is a recombinant vector vaccine that uses a human adenovirus for the complex protein SARS-CoV-2 in cells. JNJ-78436735 is derived from vaccine structures created and tested through J
AdVac is in the progression and production of adenovirus vectors (gene carriers) and can be used with PER technology. Janssen C6 to expand recombinant vaccines against life-threatening infectious diseases.
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Ad26. COV2-S, recombinant, is one of 18 forward-sighted applicants among the approximately three hundred COVID-19 healing products detailed in updating the “COVID-19 DRUG
Together with ENSEMBLE, J
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The staging sites in the ENSEMBLE assay are components of the NIAID-backed COVID-19 prevention network (CoVPN). CoVPN is composed of existing clinical study networks supported through NIAID, experienced in infectious diseases and designed for immediate and in-depth evaluation of vaccine applicants and monoclonal antibodies for COVID-19 prevention.
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