A fourth Phase 3 clinical trial evaluating an investigational vaccine for COVID-19 has begun trials. The trial will evaluate investigational Janssen COVID-19 vaccine (JNJ-78436725) can prevent symptomatic COVID-19 after a single dose regimen. Over 60,000 volunteers will be enrolled in the trial in United States and internationally.
The Janssen Pharmaceutical Companies of Johnson & Johnson developed the investigational COVID vaccine and is leading the clinical trial. U.S. and international trial sites part of the NIAID-supported COVID-19 Prevention Network (CoVPN) will participate in the trial. The CoVPN is composed of existing NIAID-supported clinical research networks with infectious disease expertise and designed for rapid and thorough evaluation of vaccine candidates and monoclonal antibodies for the prevention of COVID-19.
NIAID Director Anthony S. Fauci, M.D said, “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 made possible by decades of progress in vaccine technology and a coordinated, strategic approach across government, industry and academia. It is likely that multiple COVID-19 vaccine regimens will be required to meet the global need. The Janssen candidate has showed promise in early-stage testing and may be especially useful in controlling the pandemic if shown to be protective after a single dose”.
Volunteers will provide informed consent to participate in trial. After providing a baseline nasopharyngeal and blood sample, participants will be assigned either a single dose of the investigational vaccine or a saline placebo. The trial is blinded, that means neither investigators nor participants will know who is receiving the investigational vaccine. For participants’ safety they will be followed closely. Scientists will analyze the blood samples of participants to detect and quantify immune responses to COVID-19.
The trial is aimed to determine if the investigational vaccine can prevent moderate to severe COVID-19 after a single dose. It also aims to understand 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.
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