In the late 1940s and early 1950s, people in the United States were afraid of contracting polio, a highly contagious, disabling and sometimes deadly disease. It hit children especially hard. At its peak in 1952, the virus infected 60,000 children. Some parents kept their children indoors and isolated during the summer, a season when the virus seemed especially rampant. Only a vaccine could protect people from the disease.
University of Pittsburgh researchers Jonas Salk, MD, Julius Youngner, ScD, and colleagues had been working for years on a polio vaccine. Children in Pittsburgh participated in the first small study of a potential vaccine. In 1955, after a larger, nationwide trial, the vaccine was proved safe and effective. It was widely considered to be a monumental achievement in public health that led to the eventual eradication of new polio cases from the United States.
During the COVID-19 pandemic, we are, again, keeping our distance from each other and waiting for a vaccine. Many different vaccines are in development around the world, including at the University of Pittsburgh. Drs. Alejandro Hoberman and Judith Martin have conducted vaccine research in the region for 20 years through their Clinical Trials Unit. Now Pittsburghers will have another chance to participate in studies that could change lives for the better worldwide. The unit is preparing to conduct a COVID-19 vaccine study in the region. The effort begins with creating a registry of people who may be interested in participating in such a study.
Creating a registry of interested people will lay the groundwork for when a vaccine trial is ready to begin. Research studies are a multi-phase, rigorously monitored process. The first phase of a trial is a safety study, according to Judith Martin, MD, professor of pediatrics, University of Pittsburgh School of Medicine and codirector, Pittsburgh Vaccine Trials Unit.
Judith Martin, MD
“A phase-one study isn’t looking at whether the vaccine works,” she says. “Phase one is when we’re just making sure the vaccine is safe and doesn’t cause harm. Phase two of the study is where we know the vaccine is safe, but we’re trying to figure out the dose and make sure it would be effective. Phase three builds on the findings of the previous phases. We know the vaccine is safe, and we’re fairly confident it’s going to work. Phase three studies are large scale with hundreds, if not thousands, of participants.”
Currently, there are more than 100 vaccines in development around the world. To bring a COVID-19 vaccine trial to the area, the Pittsburgh Vaccine Trials Unit must evaluate each vaccine to see which is the safest and the best fit for the community. The unit is multidisciplinary, with people from internal medicine, pediatrics, family medicine, infectious diseases, vaccine development companies, Pitt’s Clinical and Translational Science Institute and from the community.
“Our job as scientists is to digest what we learn about each of the vaccine options and bring to the community the one we think has the best chance for success,” says Alejandro Hoberman, MD, Jack L. Paradise Professor of Pediatric Research, University of Pittsburgh School of Medicine, professor of clinical and translational medicine and codirector, Pittsburgh Vaccine Trials Unit.
When the vaccines are ready for phase three clinical trials, Drs. Martin and Hoberman want to hit the ground running. To do that, they say they first need to understand the needs of the community and what people’s concerns are. Then, people will be asked to go to the online registry and indicate their interest in being a part of the phase-three study so that the community is prepared for when the study begins.
As with any study, Drs. Martin and Hoberman say it is necessary for the COVID-19 vaccine study to include people of any race, gender, sex or ethnicity. The more diverse a study population is, the better the chance is that the vaccine will be effective for everyone.
Researchers are learning more about COVID-19 every day. Dr. Hoberman says that while we cannot yet know when a vaccine will be available, the different phases of the vaccine trials are progressing quickly. But when it is time to conduct phase-three studies of vaccines, Drs. Martin and Hoberman want Pittsburgh to be in on it.
“We want our community to have the advantages of a COVID-19 vaccine,” says Dr. Martin. “I see it as the best of both worlds: We’re bringing something to the community that’s potentially going to protect them, and they can benefit from it earlier than the rest of the population. This is going to be another opportunity for Pittsburghers to demonstrate that they can contribute to scientific progress.”