Researchers at Washington University School of Medicine in St. Louis have received a Centers for Disease Control and Prevention (CDC) grant totaling $12.5 million to study the real effectiveness of flu and COVID-19 vaccines and the immune response to infection and vaccination against these two diseases.
Unlike a strictly controlled clinical trial, this research aims to understand how vaccination strategies work for people living and working in the community, where they may not receive vaccines and boosters on a strict schedule or from a single manufacturer. of vaccines.
“We want to understand how these vaccines work in the real world,” said the lead researcher. Stacey L. House, MD, Ph.D., assistant professor of emergency medicine. “These vaccines have proven effective in clinical trials. But we don’t know what it means for the immune response if second doses are delayed, or if boosters are taken at very different times, or if people change vaccine manufacturers for their third or fourth dose, for example. . By enrolling large numbers of patients and gathering many data points about them, we hope to understand how effective vaccines are in a diverse community.
The School of Medicine is one of seven sites recruiting patients in this CDC study. The others are University of Michigan, Baylor Scott & White Health, Kaiser Permanente Washington, University of Pittsburgh, University Hospitals of Cleveland, and Arizona State University. Duke University will serve as the coordinating center for the study.
As part of the Vaccine Effectiveness Project, House and his team will seek to recruit at least 5,000 participants in the St. Louis area over the five years of the grant. Patients — adults and children — who come to Barnes-Jewish Hospital, Missouri Baptist Medical Center and St. Louis Children’s Hospital with respiratory tract infections will be tested for influenza and COVID-19 and may choose to participate in the ‘study. House said investigators will collect data on participants’ vaccination history and general medical history and follow them over time to collect data on complications patients might experience from these viral infections.
“The abundance of data we will collect on these patients should allow us to see how pre-existing conditions, medications, and social determinants of health, such as education and access to health care, may affect the effectiveness of vaccines and how patients recover from these infections,” said House, who is also vice president of clinical research at the Department of Emergency Medicine as well as director of the Center for Urgent Care Research.
Researchers will also perform subtype analysis and viral genome sequencing on viral samples from patients to identify and track new viral variants that emerge over time. These samples and sequences will be made available for further research through a national repository that is part of the CDC’s US Flu Vaccine Effectiveness Network.
A second project will analyze immune responses to various vaccines against COVID-19 and influenza. Led by infectious disease specialists Rachel Presti, MD, Ph.D.associate professor of medicine, and Jane O’Halloran, MD, Ph.D., an associate professor of medicine, researchers will take samples from patients at specific times before and after receiving a COVID-19 or influenza vaccine. The samples will be used to assess antibody levels as well as B-cell and T-cell responses, key components of the body’s immune system, to vaccination.
The study aims to answer key questions about vaccination, including the duration and robustness of the immune response to vaccination; what is the magnitude of the antibody response; and how repeated exposure to different viral variants affects the length and breadth of B cell and T cell responses to viral respiratory infections.
“The CDC has to make vaccine recommendations based on the available information, and we don’t have as much data as we would like on the effectiveness of these vaccines outside of clinical trials,” House said. “If we have the kind of detailed data that we hope to collect during this study, the recommendations may start to be a bit more specific for individual patient populations.”