Johnson & Johnson
Johnson & Johnson’s (NYSE:JNJ) vaccine candidate is the fourth one to reach Phase 3 clinical trials. The trial’s goals include determining whether J&J’s Janssen Pharmaceuticals COVID-19 vaccine candidate (JNJ-78436725) can prevent symptomatic COVID-19 after a single dose regimen.
Up to 60,000 volunteers are slated to be enrolled in the trial, which will take place at nearly 215 clinical research sites in the U.S. and across the globe, according to the NIH. Janssen is leading the trial as a regulatory sponsor with funding from NIAID and BARDA.
Janssen’s candidate is a recombinant vector vaccine using a human adenovirus to express the SARS-CoV-2 spike protein in cells. It uses the same vector in the first dose of its prime-boost vaccine regimen against Ebola, which recently received European commercial approval.
Preclinical findings for the vaccine candidate demonstrated that it induced neutralizing antibody responses in rhesus macaques and offered complete or near-complete protection against the virus infection in the lungs and nose, according to J&J. The candidate’s safety, reactogenicity and immunogenicity are being evaluated in a Phase 1/2a trial in the U.S. and Belgium, with interim results supporting further development, the company said.