A pilot study called COVID Protection After Transplant (CPAT) to evaluate the antibody response to a third dose of an authorized COVID-19 mRNA vaccine in kidney transplant recipients who did not respond to two doses of the Moderna or Pfizer-BioNTech COVID-19 vaccine has been launched by the National Institutes of Health (NIH).

The study will also attempt to characterise those kidney transplant recipients who would benefit from a third dose of an mRNA vaccine and differentiate them from those who will require a different approach to achieve protection.  The two dose mRNA vaccines have been shown to be safe in solid organ transplant recipients. Efficacy of additional doses of other vaccines, such as those for hepatitis and influenza, in immunocompromised people also influenced the selection of this intervention.

The pilot study is being conducted at Johns Hopkins University in Baltimore. It will enroll up to 200 adults aged ≥ 18 years who received a kidney transplant ≥ 1 year before their recruitment in the study and have had no recent organ rejection or change in immunosuppression. Some participants would have had no detectable antibody response despite both doses of mRNA COVID-19 vaccine, while some would have shown a low response.  The goal is to determine the proportion of participants who achieve a designated antibody response at the 30-day mark. The goal is to determine the proportion of participants who achieve a designated antibody response at the 30-day mark. Patients will be followed up for one year after enrollment. Preliminary results are expected in September 2021.

(Source: NIH, August 10, 2021)