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.
