A team of clinical investigators at the Icahn School of Medicine at Mount Sinai has announced the launch of a Phase 1, open-label, placebo-controlled study to evaluate the safety and immunogenicity of an egg-based COVID-19 vaccine in healthy, vaccinated adults who have never been infected with COVID-19.
Credit: Mount Sinai Health System
A team of clinical investigators at the Icahn School of Medicine at Mount Sinai has announced the launch of a Phase 1, open-label, placebo-controlled study to evaluate the safety and immunogenicity of an egg-based COVID-19 vaccine in healthy, vaccinated adults who have never been infected with COVID-19.
This egg-based vaccine—called NDV-HXP-S—contains a recombinant Newcastle disease virus that expresses the spike protein of SARS-CoV-2, the virus that causes COVID-19. It does not contain any adjuvants nor any preservatives and may have the potential to provide additional immunity against COVID-19.
Mount Sinai’s COVID Clinical Trials Unit is looking for healthy, vaccinated individuals, aged 18-59, who received their last vaccine dose (primary series or booster) more than six months ago and have never tested positive for COVID-19 infection. Study participants will receive one of two dose levels of the NDV-HXP-S vaccine as an intranasal, intramuscular, or combined intranasal/intramuscular administration, or placebo. Additional study details are available at: https://clinicaltrials.gov/ct2/show/NCT05181709.
The vaccine that will be used in the study was developed by researchers at Icahn Mount Sinai. It has been or is currently being studied in clinical trials in Mexico, Thailand, Brazil, and Vietnam. Phase 1 results from those international trials are published in eClinicalMedicine (March 2022) medRxiv (September 2021) and (January 2022). Importantly, the physicians leading the U.S.-based phase 1 study at Mount Sinai—Sean Liu, MD, PhD, Assistant Professor of Medicine (Infectious Diseases) (Principal Investigator) and Judith Aberg, MD, Dr. George Baehr Professor of Clinical Medicine and Chief of the Division of Infectious Diseases (Co-Investigator)—are not the faculty inventors and have no financial interests related to this vaccine.
“Our microbiology team has a particular and impressive breadth of expertise in the understanding, evaluation, and development of RNA viruses and vaccines,” said Dr. Liu. “Now, our independent clinical research team is eager to do the rigorous, objective scientific work needed to evaluate this investigational vaccine. To that end, multiple safeguards have been implemented in order to protect the research objectivity and oversight of this clinical trial, so we are poised to begin and enrollment is currently open.”
Safeguards that have been put into place include use of an external institutional review board; appointment of clinical investigators without any financial interest with the vaccine or any reporting relationship to the faculty inventors; outsourcing verification of the main study endpoint (which measures anti-spike antibodies) to an expert at a separate institution; use of an independent data safety monitoring board comprising faculty members outside Mount Sinai; and use of an independent medical monitor.
If you are interested in potential participation in the trial, please call 212-824-7714 or email [email protected] to see if you qualify.
Disclosure: the vaccine used in this study was developed by faculty members at the Icahn School of Medicine at Mount Sinai. Mount Sinai is actively seeking to advance this vaccine to be available for commercial use.
About the Mount Sinai Health System
The Mount Sinai Health System is New York City’s largest academic medical system, encompassing eight hospitals, a leading medical school, and a vast network of ambulatory practices throughout the greater New York region. We advance medicine and health through unrivaled education and translational research and discovery to deliver care that is the safest, highest-quality, most accessible and equitable, and the best value of any health system in the nation. The Health System includes approximately 7,300 primary and specialty care physicians; 13 free-standing joint-venture centers; more than 410 ambulatory practices throughout the five boroughs of New York City, Westchester, and Long Island; and more than 30 affiliated community health centers. The Mount Sinai Hospital is ranked in U.S. News & World Report’s “Honor Roll” of the top 20 U.S. hospitals and among the top in the nation by specialty: No. 1 in Geriatrics and top 20 in Cardiology/Heart Surgery, Diabetes/Endocrinology, Gastroenterology/GI Surgery, Neurology/Neurosurgery, Orthopedics, Pulmonology/Lung Surgery, Urology, and Rehabilitation. Mount Sinai Kravis Children’s Hospital is ranked in U.S. News & World Report’s “Best Children’s Hospitals” among the country’s best in four out of 10 pediatric specialties. New York Eye and Ear Infirmary of Mount Sinai is ranked among the Top 20 nationally for ophthalmology. The Icahn School of Medicine at Mount Sinai is one of three medical schools that have earned distinction by multiple indicators: ranked in the top 20 by U.S. News & World Report’s “Best Medical Schools,” aligned with a U.S. News & World Report “Honor Roll” Hospital, and No. 14 in the nation for National Institutes of Health funding. Newsweek’s “The World’s Best Smart Hospitals” ranks The Mount Sinai Hospital as No. 1 in New York and top five globally, and Mount Sinai Morningside as top 20 globally, and “The World’s Best Specialized Hospitals” ranks Mount Sinai Heart as No. 1 in New York and No. 4 globally and the Division of Gastroenterology as No. 3 globally, and the Division of Pulmonary Medicine as No. 6 globally. For more information, visit https://www.mountsinai.org or find Mount Sinai on Facebook, Twitter and YouTube.
###
