US starts fourth phase Covid-19 vaccine trial
A fourth Phase 3 clinical trial evaluating an investigational Covid-19 vaccine has begun enrolling adult volunteers, the U.S. National Institutes of Health (NIH) announced on Wednesday.
The trial was created to evaluate if the investigational Janssen Covid-19 vaccine JNJ-78436725 can prevent symptomatic COVID-19 after a single dose regimen, the NIH said in a release, reports Xinhua.
Up to 60,000 volunteers will be signed up for the trial at up to practically 215 clinical research sites in america and internationally.
The Janssen Pharmaceutical Companies of Johnson & Johnson developed the investigational vaccine, and is leading the clinical trial as regulatory sponsor.
It's the fourth large-scale phase 3 clinical trials for a Covid-19 vaccine in the United States.
The other three trials are for vaccine candidate AZD1222, co-invented by the University of Oxford and its spin-out company Vaccitech; vaccine candidate mRNA-1273, developed by the U.S. National Institute of Allergy and Infectious Diseases (NIAID) and American biotechnology company Moderna; and vaccine prospect BNT162b2, produced by American biopharmaceutical company Pfizer and German company BioNTech.
As the other vaccine prospects require two doses, the Janssen vaccine prospect will be studied as a single-dose vaccine. It is a recombinant vector vaccine that uses a human adenovirus expressing the SARS-CoV-2 spike protein in cells.
Preclinical findings published in Nature show that the Janssen vaccine induced neutralizing antibody responses in rhesus macaques and provided complete or near-complete protection against virus infection in the lungs and nose following SARS-CoV-2 challenge.
The trial was created mostly to determine if the investigational vaccine can prevent moderate to extreme Covid-19 after an individual dose. In addition, it aims to comprehend if the vaccine can prevent Covid-19 requiring medical intervention and if the vaccine can prevent milder cases of Covid-19 and asymptomatic SARS-CoV-2 infection, according to the NIH.
An unbiased Data and Safety Monitoring Board provides oversight to guarantee the safe and ethical conduct of the analysis.
"Four Covid-19 vaccine candidates are in Phase 3 clinical testing in the United States just over eight months after SARS-CoV-2 was identified. This is an unprecedented feat for the scientific community permitted by decades of progress in vaccine technology and a coordinated, strategic approach across government, industry and academia," said NIAID Director Anthony Fauci.
"It is likely that multiple Covid-19 vaccine regimens will be asked to meet the global need. The Janssen prospect has showed promise in early-stage testing and could be especially useful in controlling the pandemic if demonstrated to be protective after an individual dose," Fauci said.
