The COVID-19 Vaccine and Immune Disorders

April 27, 2021

The NIH will be conducting a clinical trial testing COVID-19 vaccine responses in people with immune deficiencies. These will include primary and secondary immune system disorders. In addition to learning how this population responds to the COVID-19 vaccine, this study aims to fill the gap regarding the clinical presentation of COVID-19 in those with immune deficiencies, “especially those who have inborn conditions involving deficits or dysregulations in antibody or cell-based immune responses to infections.”

Because those with immune disorders were excluded from the COVID-19 vaccine clinical trials prior to emergency authorization, this study will “characterize the features and adequacy of immune responses to COVID-19 vaccination in people with a range of immune deficiencies and dysregulation syndromes.” The study will include 500 participants, 400 of which have primary or secondary immune system disorders and are 16 years of age or older. If participants get vaccinated during the study, blood samples will be taken before and after vaccination and studied for “short-term immunological effects of immunization.”

Participants may voluntarily provide blood samples at different intervals following their last dose of the vaccine. Researchers will then assess the T-cell response and vaccine-induced antibody production in those with immune disorders compared to those without immune system disorders.

For more information regarding the study and enrollment, visit clinicaltrials.gov and use the search code NCT04852276.





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