ATLANTA, GA — Vaccine researchers at Emory University are presently examining booster shots and whether they could become an additional weapon to strengthen vaccine immunity against COVID-19.
In medical terms, a booster shot is an extra administration of a vaccine after an earlier dose. Both Emory Children’s Center and the Hope Clinic of Emory Vaccine Center are participating in a clinical study that assesses the potential for booster shots of COVID-19 vaccines in a format called “mix and match”.
The study is led and supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
The study will be divided into two groups. The first group consists of people who have already received any emergency use authorized (EUA) COVID-19 vaccines. The second one will include a group of people who have never received a COVID-19 vaccine and have not had a prior SARS-CoV-2 infection.
Study participants in the first group will receive a delayed booster vaccine 12-20 weeks after completing EUA approved vaccines, regardless of which COVID-19 vaccine was first administered.
Meanwhile, study participants in the second group will initially receive the Moderna-mRNA-1273 EUA vaccines, followed by a booster vaccine. The study design is adaptive so that vaccines developed to target emerging SARS-CoV-2 variants of concern can be rapidly assessed if necessary.
Srilatha Edupuganti, MD, MPH, associate professor of medicine (infectious diseases) at Emory University School of Medicine and principal investigator at the Hope Clinic site acknowledged obstacles for this study.
“Because of successful COVID-19 vaccination programs in the United States, it is becoming difficult to recruit people who haven’t been vaccinated,” said Edupuganti. “If you haven’t been vaccinated yet, you can both get it done and help researchers prepare for the potential rollout of booster shots against COVID-19.”
“This study will help us to understand if booster shots would be a practical strategy to protect against COVID-19,” says Christina Rostad, MD, assistant professor of pediatrics at Emory University School of Medicine and Children’s Healthcare of Atlanta, and protocol principal investigator at the Emory Children’s Center site.
The Mix & Match study will assess the safety, reactogenicity, and immunogenicity of vaccine combinations in healthy adult volunteers in two age groups: 18 to 55 years old and those over 56 years old. The study is open-label, meaning that no placebos are involved, and organizers and participants will know which vaccine a participant receives.
Participants will be asked to come to the Hope Clinic or Emory Children’s Center to be vaccinated and complete several follow-up visits. People who have not been vaccinated will receive two doses of the Moderna mRNA-1273 vaccine 28 days apart and then a booster shot after a delay of greater than 12 weeks.
Clinic visits include blood draws for safety monitoring and to see whether the booster vaccine resulted in a stronger immune response. Clinical research staff will also be in contact with participants by telephone to keep track of symptoms.
Volunteers should not have a known history of COVID-19 infection. They must not have health conditions associated with an increased risk of severe illness from SARS-CoV-2 infection, such as cancer, heart conditions, type 2 diabetes mellitus, severe obesity, or chronic kidney disease.
Those interested in participating in the trial at the Hope Clinic, located in Decatur, can fill out a volunteer form or contact the Hope Clinic. The Emory Children’s Center vaccine research site’s preferred contact mode is via email: firstname.lastname@example.org.