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A phase III clinical trial to evaluate J & J’s COVID-19 vaccine in several countries has enrolled its first patients.
A phase III clinical trial evaluating Johnson & Johnson’s (J&J) investigational vaccine for COVID-19 has begun enrolling adult volunteers. The trial is designed to evaluate whether vaccine candidate JNJ-78436735, or Ad.26.COV2.S, can prevent symptomatic COVID-19 after a single-dose regimen. Up to 60,000 volunteers will be enrolled in the trial at up to nearly 215 clinical research sites.
Participants in the randomized, double-blind trial will be randomly assigned to receive a single dose of the investigational vaccine or a saline placebo. The study will enroll participants in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa and the United States.
Ad.26.COV2.S is a recombinant vector vaccine that uses a human adenovirus to express the SARS-CoV-2 Spike (S) protein in cells. Preclinical findings showed that the potential vaccine induced neutralizing antibody responses in rhesus macaques and provided complete or near complete protection against virus infection in the lungs and nose after exposure to SARS-CoV-2.
The safety, reactogenicity and immunogenicity of the investigational vaccine are being evaluated in a phase I / IIa trial. Interim positive results from this clinical study demonstrated that the safety profile and immunogenicity after a single vaccine supported further development.
“Four COVID-19 vaccine candidates are in phase III clinical trials in the US Just over eight months after SARS-CoV-2 was identified. This is an unprecedented feat for the scientific community, made possible by decades of progress in vaccine technology and a coordinated strategic approach between government, industry, and academia, ”said Dr. Anthony Fauci, director of the National Institute. of Allergy and Infectious Diseases of EE. “Multiple COVID-19 vaccine regimens are likely to be required to meet the global need. Janssen’s candidate has shown promise in early-stage testing and may be especially helpful in controlling the pandemic if it is shown to protect after just one dose. “
“With our candidate vaccine now in our global phase III trial, we are one step closer to finding a solution for COVID-19. We use a highly scientific and evidence-based approach to select this vaccine candidate. We are grateful for the tireless efforts of our researchers and for the vital contributions of those participants who have volunteered to participate in our studies, ”said Dr. Mathai Mammen, Global Director of Research and Development for Janssen at J&J.
