UI to participate in clinical trial of COVID-19 vaccine

University of Iowa is participating in a large-scale, international clinical trial to study the safety, tolerability, immunogenicity, and efficacy of vaccines against COVID-19. The study is testing an experimental RNA vaccine developed by drug companies BioNTech and Pfizer. Overall, the study aims to enroll approximately 30,000 adults. The UI site will start vaccinations July 30 and hopes to enroll 250 participants.

Finding vaccines for COVID-19 that are safe and effective is a crucial step to overcoming this virus. We are excited to be part of this large, phase 2/3 vaccine trial

Participants for the study will be men and nonpregnant women ages 18-85 who are generally healthy or with stable medical conditions and who also have jobs or activities that put them at increased risk of COVID exposure (for example, essential workers in the food industry, or frontline health care workers). Winokur notes that it is important to enroll a diverse population to ensure that the vaccine is equally effective in people of different ages, races, and genders.

All the participants will receive two intramuscular doses of vaccine either 3 weeks or 2 months apart. Half the participants will get the COVID vaccine product and half will get a placebo injection. Over six visits, the participants will be evaluated to learn about the safety of the vaccines as well as any side effects that might occur.

The researchers will analyze blood samples to look for antibodies to the COVID virus proteins, and will ask participants if they have sore arm, fever, or muscle aches from the vaccine. Participants will also get two nasal swabs during the study. If symptoms of COVID develop, additional visits may be required and additional nasal swabs will be performed. Participants will be followed for two years to look for any evidence of COVID infections and the durability of the antibody titers.

The FDA requires that vaccines show the ability to prevent COVID infection. All participants will be followed for up to two years to see if they develop symptoms of COVID and the researchers will perform nasal swabs for new illnesses that might be consistent with COVID.  Because half of subjects will be getting a placebo and half will be getting the active vaccine, the study will compare onset of COVID infection between the two groups. 

“The blood samples collected during the study will help us evaluate the antibody responses, but the true test of the vaccine is the ability to prevent infection,” Winokur says.

The blood samples collected during the study will help us evaluate the antibody responses, but the true test of the vaccine is the ability to prevent infection.