COVID-19 nasal vaccine enters US trials

A nasal vaccine to prevent the effects of the virus that causes the disease known as COVID-19 is to enter a preliminary clinical trial in the United States. The vaccine is based on technology developed at Washington University in St Louis. The National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) will conduct the trial. The FDA’s approval is a pivotal first step in the initiation of the phase 1 trial, scheduled for this spring. Designed to induce robust immunity in the nose and upper respiratory tract, the technology has the potential to stop the transmission of the virus and reduce the risk of serious illness and death. The upcoming trial will assess the safety and effectiveness of the vaccine when administered via two routes: inhalation into the lungs and spray into the nose. The trial will enrol 80 adults aged between 18 and 64. Subjects will be randomly allocated to one of four groups for intranasal or inhaled delivery. While the primary objective of the study is to assess the vaccine safety, the research team will also evaluate the immunogenicity of the vaccine by measuring antibody production. Vaccine efficacy will be determined by the number of breakthrough cases of SARS-CoV-2. The experimental nasal vaccine was developed jointly by scientists at WashU Medicine, the Center for Vaccines & Immunity to Microbial Pathogens, and members of their laboratories.