A phase 1 clinical trial evaluating an investigational vaccine for protection against coronavirus disease 2019 (COVID-19) has been initiated at the Kaiser Permanente Washington Health Research Institute (KPWHRI) in Seattle. The trial is led by Lisa A. Jackson, MD, senior investigator at KPWHRI, and is funded by the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institute of Health (NIH).
mRNA-1273 (Moderna, Inc.) is a novel lipid nanoparticle (LNP)-encapsulated mRNA vaccine that encodes for a prefusion stabilized form of the spike (S) protein of SARS-CoV-2. According to NIH scientists, the vaccine is expected to “direct the body’s cells to express the spike in its prefusion conformation to elicit an immune response.”
The phase 1 trial is assessing the safety and immunogenicity of mRNA-1273 in 45 healthy adults aged 18 to 55 years. Participants will receive 1 of 3 doses of mRNA-1273 (25, 100, or 250mcg) administered intramuscularly on a 2-dose vaccination schedule, given 28 days apart.
Study participants will be followed over the course of 1 year following the second vaccination and monitored for vaccination symptoms. They will also be asked to provide blood samples periodically in order to measure immune responses to the vaccine. Safety and vaccine reactogenicity have been designated as the primary outcome measures of the study; evaluation of immunogenicity to the SARS-CoV-2 protein will be a secondary end point.
“Finding a safe and effective vaccine to prevent infection with SARS-CoV-2 is an urgent public health priority,” said NIAID Director Anthony S. Fauci, MD “This phase 1 study, launched in record speed, is an important first step toward achieving that goal.”
Adults in the Seattle area who are interested in participating in the study can find more information here.
In a press release, Moderna, the company developing the investigational mRNA vaccine for COVID-19, announced that it is actively preparing for a potential phase 2 trial under its own Investigational New Drug Application.