The U.S. National Institutes of Health (NIH) said on Tuesday it had launched a new study to assess how patients on immunosuppressive therapy after kidney transplant, who did not respond to the first two doses of COVID-19 vaccine, respond to a third dose.
The study, sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), aims to determine whether a third dose of either Moderna or Pfizer/BioNTech COVID-19 vaccine could help kidney transplant patients overcome the problem of not developing immune response to the coronavirus even after vaccination.
U.S. health regulators have said more scientific evidence was needed to ascertain the need for booster vaccine shots, but have indicated that a third shot may be needed for people with compromised immune systems.
Top U.S. infectious disease expert Dr Anthony Fauci last week said the United States was working to give additional COVID-19 booster shots to Americans with compromised immune systems as quickly as possible.
The pilot study is being conducted at Johns Hopkins University in Baltimore and will enroll up to 200 adults aged 18 years or older who have received a kidney transplant at least a year prior to enrollment.
The study also aims to identify characteristics that could help distinguish those kidney transplant recipients who would benefit from a third dose from those who might require a different approach to achieve protection.
Findings from the study will inform a subsequent, larger phase of the trial that will include other strategies to induce an immune response against the coronavirus, NIH said.