Mixed COVID-19 Vaccine Study Launches
The US National Institutes of Health has announced the launch of a Phase 1/2 clinical trial. Adult volunteers who have been fully vaccinated against COVID-19 will receive booster doses of different COVID-19 vaccines to determine the safety and immunogenicity of mixed boosted regimens.
This vaccine study will include approximately 150 individuals who already have received one of the three COVID-19 vaccine regimens currently available under FDA Emergency Use Authorization in the USA.
Twelve to 20 weeks following their initial vaccination regimen, participants will receive a single booster dose of the Moderna COVID-19 vaccine as part of the trial.
People who have not yet received an FDA authorized COVID-19 vaccine can also enroll in the trial in a separate cohort. Initially, these volunteers will receive the two-dose Moderna COVID-19 vaccine regimen and will be assigned to receive a booster dose of a vaccine about 12 to 20 weeks later.
The trial has an adaptive design and may add arms as vaccines are awarded EUA and/or variant lineage vaccines become available for evaluation. All trial participants will be followed for one year after receiving their last vaccination as part of the study.
The trial is led by principal investigators Robert L. Atmar, M.D., at Baylor College of Medicine, Houston, and Kirsten E. Lyke, M.D., at the University of Maryland, College Park.
The National Institute of Allergy and Infectious Diseases, part of NIH, is leading and funding the study through the Infectious Diseases Clinical Research Consortium, a clinical trials network encompassing the Institute’s long-standing Vaccine and Treatment Evaluation Units.
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