Want to help the fight against COVID-19 crisis? You can volunteer for vaccine trials
If you’ve been wanting to give development of a COVID-19 vaccine a shot in the arm, now’s your chance.
Washington University and St. Louis University need area residents to roll up their sleeves and help them in the search for a safe, effective vaccine against the virus that has killed at least 650,000 worldwide since January.
Over the coming months, researchers at the two schools expect to enroll about 3,000 volunteers in several COVID-19 vaccine trials, with each school participating in different trials. They say it will be critically important to find participants who are likely to be exposed to COVID-19 and those at risk for severe disease from the virus, including those over age 65.
For information about enrolling in trials at the Washington University School of Medicine, you can email idcru@wustl.edu, call 314-454-0058 or go to https://infectiousdiseases.wustl.edu/patient-care/clinical-trials. For more information about trials at St. Louis University’s Center for Vaccine Development, you can email vaccine@slu.edu, call 314-977-6333 or go to vaccine.slu.edu.
“Our long history of working with the HIV community has demonstrated how critically important community support is in conducting successful clinical trials,” said Dr. Rachel Presti, director of Washington University’s Infectious Disease Clinical Research Unit. “We are excited that the St. Louis community will have this opportunity to participate in historic clinical trials aimed at helping to identify the most effective vaccines for preventing COVID-19.”
“St. Louisans will be key to the success of the vaccine trials,” said Dr. Sharon Frey, clinical director of St. Louis University’s Center for Vaccine Development and principal investigator for the center’s trials.”A powerful example of the role the St. Louis community plays in advancing public health was seen in (its) response to the 2009 pandemic influenza vaccine trial.
“We are deeply grateful for the support of the St. Louis community as we launch these trials, which represent our best hope to fight back against the COVID-19 pandemic.”
The two local medical schools are participating in the trials as part of the COVID-19 Prevention Network, which recently was formed by the National Institute of Allergy and Infectious Diseases to develop and test COVID-19 vaccines and treatments.
The network brings together several existing National Institutes of Health networks, including the Infectious Diseases Clinical Research Consortium, the HIV Vaccine Trials Network, the HIV Prevention Trials Network and the AIDS Clinical Trials Group. Presti is principal investigator of the latter two at Washington University.
First Phase 3 trial set to launch soon
The network will participate in large-scale Phase 3 vaccine trials that will enroll thousands of participants from across the nation — or, in some cases, around the world — to determine whether prospective vaccines can prevent COVID-19 disease. Currently, there are 25 potential COVID-19 vaccines in some phase of clinical trials worldwide, according to the World Health Organization.
The first Phase 3 trial in the United States is expected to launch this week and will involve a vaccine being developed by the National Institutes of Health’s Vaccine Research Center in partnership with the biotechnology company Moderna.
It is hoped the vaccine can spur a healthy person’s immune system to produce a strong enough antibody response so it will kill COVID-19 and prevent the disease should the person ever encounter the actual virus. The trial likely will involve 30,000 volunteers and test whether the vaccine protects people against the disease.
Early results from the Phase 1 study showed the vaccine, given at three different doses, did trigger an immune response, according to results published earlier this month in the New England Journal of Medicine. Higher doses triggered more intense immune responses. More than half the participants did report side effects, including fatigue, chills, headache, muscle pain and pain at the injection site. The new trial is expected to involve the middle dose.
Looking for volunteers for clinical trials
To help attract volunteers nationally, the Department of Health and Human Services recently launched a new website — coronaviruspreventionnetwork.org — that allows anyone interested to register for clinical trials for vaccines and monoclonal antibody therapies.
Those interested in joining a vaccine study on the new national website will be asked to complete a short questionnaire that will determine whether they will be accepted or rejected as volunteers.
For example, the researchers say, if you stay home most of the time or are religious about wearing a mask in public, you may not qualify. That’s because the study wants to see if it is the vaccine preventing illness, not just strict adherence to current social behavior guidelines.
As a result, researchers say they’ll be going to communities hardest hit by the virus to recruit volunteers. They’ll also be concentrating on potential hot spots such as factories and meatpacking plants. Researchers also say they will try to have at least 40 percent of volunteers be over age 65 or have underlying conditions, such as high blood pressure, lung disease, diabetes and morbid obesity.
Ready to take the fight to COVID-19
Locally, officials at Washington University and St. Louis University say they are perfectly positioned to conduct COVID-19 vaccine trials because of their long history in infectious disease research.
The St. Louis University Center for Vaccine Development is home to one of 10 Vaccine and Treatment Evaluation Units in the country. As such, the school conducts Phases 1 through 4 vaccine and treatment trials, including clinical studies in collaboration with industry. Washington University has more than 30 years of experience leading vaccine and treatment trials, including work in controlling, preventing and treating HIV and AIDS.
“This is where we begin to really fight back against the scourge of COVID-19,” said Dr. Michael Klebert, the lead research coordinator at Washington University. “We are looking forward to the challenge.”