Jennifer Haller, a clinical trial volunteer, receives the first-ever injection of an investigational vaccine for the coronavirus. Credit: Ted S. Warren / AP Photos
On March 16, 2020, Kaiser Permanente Washington Health Research Institute (KPWHRI) gave the first-ever injection of an investigational vaccine for the 2019 novel coronavirus, SARS-CoV-2, to 4 volunteers participating in a phase 1 federally sponsored clinical trial.
To date, no other trial has been launched in people of any vaccine for this virus, which causes COVID-19. The KPWHRI trial in Seattle began recruiting participants on March 3.
“We are proud that the National Institute of Allergy and Infectious Diseases (NIAID) selected us to conduct this innovative trial,” said Lisa Jackson, MD, MPH, senior investigator at KPWHRI. “We’re well prepared and focused on helping to address this evolving health situation.” Dr. Jackson is the lead researcher for the study, funded by the U.S. National Institutes of Health.
“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, in a NIAID news release. “This phase 1 study, launched in record speed, is an important first step toward achieving that goal.”
The investigational vaccine is called mRNA-1273 and made by Moderna. The vaccine is made using a new process that is much faster than older methods of making vaccines. It does not contain any part of the actual coronavirus and cannot cause infection. Instead, it includes a short segment of messenger RNA that is made in a lab.
Study participants must be healthy Seattle-area adults age 18 to 55 years. To be eligible, they can’t have certain health conditions that affect the immune system, and they can’t be taking medications that affect the immune system.
The initial trial is a small “phase I” test involving 45 participants—part of a 3-phase process examining the potential vaccine. In this first phase, KPWHRI researchers are testing the safety of various doses and whether these doses produce an immune response. Phase I trials don’t study the effectiveness of the vaccine in preventing coronavirus infection. That work comes at a later phase of the vaccine research.
KPWHRI’s vaccine research team began preparations for the possibility of a trial as soon as they got the call on January 28. The team has expertise in conducting these kinds of trials, including testing other investigational vaccines against “swine” and “bird” flu. KPWHRI became a VTEU site in 2007, and it is the only one of the nation’s 9 VTEU centers not housed at a university medical center. Since 1962, the VTEUs have played a key role in developing new and improved vaccines and therapies against infectious diseases.
Currently there is no vaccine proven to protect against SARS-CoV-2 infection. A vaccine is urgently needed for several important reasons:
Response to study recruitment efforts has been very positive, so the study team no longer needs to identify potential study participants. Online study recruitment is now closed.
Neal Browning becomes the second volunteer to receive the investigational COVID-19 vaccine in the NIH-supported clinical trial in Seattle. Credit: Ted S. Warren / AP Photos
The story is by Rebecca Hughes. It was updated March 19 and March 16 from the original version published March 4.
Seattle Times, Feb 26, 2020
Dr. Lisa A. Jackson leads national trial to explore improving immune responses to the vaccine.
Read it in News and Events.
Sept 26, 2013