The University of Illinois Chicago will participate in a National Institutes of Health phase two clinical trial evaluating additional COVID-19 booster shots for adults.
The trial aims to understand if different vaccine regimens, including those designed to target specific variants, can broaden immune responses among those who already have received a primary vaccination series and a first booster shot.
-This is an important study in forwarding efforts to develop vaccines in anticipation of future changes in the virus,- said Dr. Richard Novak, the Harry F. Dowling Professor of Medicine and head of the division of infectious diseases at the College of Medicine, who will spearhead the study at UIC.
The study will include prototype and variant vaccines alone and in combinations.
Similar to the way flu vaccines can be updated seasonally for maximum effect against predicted circulating strains, COVID-19 vaccine manufacturers can adjust their prototypes to target specific variants.
In the trial, the prototype vaccine is the approved vaccine developed by Moderna, which is now called Spikevax (mRNA-1273). The variant vaccines are investigational vaccines that target the beta (mRNA-1273.351), delta (mRNA-1273.617.2) and omicron (mRNA-1273.529) variants of SARS-CoV-2.
The trial will test six regimes, and participants will randomly be assigned to receive one of the following:
- One dose (50 mcg) of Spikevax.
- One dose of an omicron targeting vaccine.
- One dose of a Spikevax-omicron combination.
- One dose of a delta-omicron combination.
- One dose of a beta-omicron combination.
- Two doses, given two months apart, of the beta-omicron combination.
Participants will be monitored for symptoms and adverse events following vaccination and will provide blood samples periodically over the course of 12 to 14 months. Investigators will measure and characterize immune responses to SARS-CoV-2 strains by analyzing the samples for antibodies and by tracking any COVID-19 illnesses in participants.
Novak said his team will focus on recruiting people over the age of 65 and people from communities disproportionately affected by COVID-19. Both people who have and have not had COVID-19 can participate.
According to a news release from the National Institute of Allergy and Infectious Diseases , initial findings may be available by August 2022.
The national trial includes 24 sites, such as UIC, where Novak plans to enroll around 40 participants. Anyone willing to enroll in the trial at UIC can call 312’355 -0656 to express their interest or visit ClinicalTrials.gov for more information.
The trial is funded through an NIH contract (75N91019D00024) to Frederick National Laboratory for Cancer Research, operated by Leidos Biomedical Research.