The Saint Louis University Center for Vaccine Development (CVD) is a globally renowned leader in the field, with notable discoveries that have contributed to life-saving vaccines for influenza, tuberculosis, hepatitis C and other infectious diseases. The team is now on the frontline of the fight against COVID-19.
Hear researchers and volunteers with the Center for Vaccine Development discuss what it means to participate in a vaccine trial at SLU.
With 76 faculty, scientists and staff in infectious diseases and more than 30 years of experience, the Center for Vaccine Development is home to the region鈥檚 leading experts in vaccine and treatment research. The team has access to state-of-the-art facilities, including more than 7,000 square feet of research and clinical spaces, and approval to work with select agent pathogens under BSL-3 conditions.
The CVD is also home to one of only . The VTEU at SLU has previously participated in vaccine trials for the H1N1 and Zika outbreaks, among other trials. The VTEU team, which is led by Daniel Hoft, M.D., Ph.D., participated in a teleconference on March 6 with the other VTEU sites to begin coordinating a response to this current pandemic.
The Race for a Vaccine
SLU has been an integral part of the global effort to find a vaccine for COVID-19.
In July 2020, SLU and Washington University in St. Louis announced that researchers at the two universities expected to enroll about 3,000 participants in several COVID-19 vaccine trials, with each school participating in different trials. SLU and Washington University are both members of , a newly organized network formed by the National Institute of Allergy and Infectious Diseases (NIAID) to develop and test vaccines and treatments in the fight against COVID-19. SLU researchers are currently recruiting for these large-scale trials that will enroll tens of thousands of participants around the world.
Moderna Trial
The first of these trials began at SLU in August 2020, when the CVD began accepting volunteers to participate in a phase three clinical trial to study the effectiveness, safety and immune response generated by a vaccine co-developed by scientists at Moderna and the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center. Sharon Frey, M.D., clinical director of the Center for Vaccine Development, was the principal investigator on this trial. Those in the study were randomly assigned to receive either the mRNA-1273 vaccine or a placebo, which were given in two injections, 28 days apart. Participants could not contract COVID-19 from the vaccine and were not deliberately exposed to the SARS-CoV-2 virus. The results of the overall study found that the vaccine efficacy against COVID-19 was 94.1% and vaccine efficacy against severe COVID-19 was 100%. The vaccine is now awaiting emergency use authorization from the Food and Drug Administration (FDA).
Janssen Trial
SLU is currently enrolling for a second Phase 3 COVID-19 vaccine trial.
The SLU Center for Vaccine Development will be a testing site for the Janssen Pharmaceutical Companies of Johnson & Johnson鈥檚 Phase 3 clinical research study, ENSEMBLE trial, to evaluate the safety and efficacy of Janssen鈥檚 investigational COVID-19 vaccine candidate, JNJ-78436735, also known as Ad26.COV2.S. The Phase 3 randomized, double-blind, placebo-controlled clinical trial is designed to evaluate the safety and efficacy of a single vaccine dose of the Janssen investigational COVID-19 vaccine candidate versus placebo in adults 18 years old and older, including significant representation from those that are over 60. The trial will include those both with and without comorbidities associated with an increased risk for progression to severe COVID-19. SLU will enroll up to 250 adults aged 18 and up from the St. Louis metropolitan area. Sharon Frey, M.D., clinical director of the Center for Vaccine Development, is principal investigator of the Janssen trial at SLU.
To learn more about participating in the trial at Saint Louis University, please visit vaccine.slu.edu and complete the questionnaire or call 314-977-6333 or 1-866-410-6333.
In addition to these trials, in collaboration with EpiVax and with support from the SLU Research Institute鈥檚 Rapid Response COVID-19 Seed Fund, SLU researchers are working to harness the potent antiviral properties of immune T-cells in a promising and innovative approach.
Testing for Treatments
In March 2020, SLU tested what became one of the first viable treatments for the novel coronavirus. The VTEU at SLU completed a study, the Adaptive COVID-19 Treatment Trial (ACTT), which investigated the safety and effectiveness of remdesivir in treating COVID-19. Sarah George, M.D., associate professor of infectious diseases, was the principal investigator of this St. Louis trial. The CVD has participated in multiple iterations, including the current ACTT-4.
Early data from the trial showed that patients who were hospitalized with COVID-19 recovered faster when they were given remdesivir, cutting recovery time from 15 to 11 days. The study also showed that patient mortality rates dropped from 11.6% to 8% for those given the study medication. On April 29, 2020, Anthony Fauci, M.D., director of the National Institute of Allergy and Infectious Disease (NIAID), called the drug the 鈥渘ew standard-of-care鈥� at a White House press conference.
In October 2020, in adults and pediatric patients 12 years of age and older and weighing at least 40 kg (about 88 pounds) who require hospitalization.
Building Capacity for Care
A New Institute
In April 2020, the Center for Vaccine Development received a generous gift to build upon the momentum of its COVID-19 research. Stephen C. Peiper, M.D. (Med 鈥�77), and his wife, Zi-Xuan 鈥淶oe鈥� Wang, Ph.D., gifted $750,000 to support research aimed at developing new vaccines for COVID-19 and other illnesses.
The gift led to the creation of a new center of excellence, the Stephen C. Peiper and Zi-Xuan Wang Institute for Vaccine Science and Policy. The SARS-CoV-2 pandemic has made it abundantly clear that the connections between vaccine science, public health and policy are of critical importance. This Center will sit at the intersection of these fields, uniting the expertise of more than 35 faculty from SLU鈥檚 School of Medicine, College for Public Health and Social Justice, College of Arts and Sciences and School of Law to address the complex, global challenges to human health.
Improved Infrastructure
In 2018, the Center for Vaccine Development opened an Extended Stay Research Unit (ESRU) that allows for human challenge studies in which volunteers are exposed to a pathogen while researchers test novel treatments, collect samples and better understand the body鈥檚 immune response. In 2020, the ESRU was renovated in order to safely quarantine COVID-19-positive volunteers and monitor their recovery progress.
The CVD is not currently performing challenge studies with COVID-19 patients. However, these renovations better positioned SLU researchers to respond to future challenges related to COVID-19. The facility is now being used to evaluate volunteers enrolled in Phase three vaccine trials that are suspected of having COVID-19.