For more information about NIH and its programs, visit www.nih.gov. The Janssen vaccine candidate is a recombinant vector vaccine that uses a human adenovirus to express the SARS-CoV-2 spike protein in cells. Adults who are interested in joining this study can visit Coronaviruspreventionnetwork.org or ClinicalTrials.gov and search identifier NCT04505722. 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,” said NIAID Director Anthony S. Fauci, M.D. About Operation Warp Speed: OWS is a partnership among components of the Department of Health and Human Services and the Department of Defense, engaging with private firms and other federal agencies, and coordinating among existing HHS-wide efforts to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics. After providing a baseline nasopharyngeal and blood sample, participants will be assigned at random to receive either a single dose of the investigational vaccine or a saline placebo. The Janssen Pharmaceutical Companies of Johnson & Johnson developed the investigational vaccine (also known as Ad.26.COV2.S) and is leading the clinical trial as regulatory sponsor. By continuing to use this website you agree to our use of cookies. Find the Janssen Research & Development Spring House address. The prescribing information included here may not be appropriate for use outside the United States. The trial is blinded, meaning neither investigators nor participants will know who is receiving the investigational vaccine. Janssen, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response, are funding the trial. Within ASPR, BARDA invests in the innovation, advanced research and development, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products needed to combat health security threats. Through the CoVPN, NIAID is leveraging the infectious disease expertise of its existing research networks and global partners to address the pressing need for vaccines and antibodies against SARS-CoV-2. Johnson & Johnson - Janssen Healthcare Innovation (Main Office) 3210 Merryfield Row San Diego, CA 92121 - 1126 (858) 784-3070. The trial is designed primarily to determine if the investigational vaccine can prevent moderate to severe COVID-19 after a single dose. 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. Volunteers must provide informed consent to participate in the trial. The mission of ASPR is to save lives and protect Americans from 21st century health security threats. 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.”. About the National Institutes of Health (NIH): The Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership helped to ensure the protocols of all NIH- and OWS-supported Phase 3 trials of investigational vaccines use the same assays and are designed to evaluate the same primary objective: whether the vaccine can prevent symptomatic COVID-19.