NIH trial will test reducing medication to boost vaccine response in transplant recipients
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A phase 2 trial will evaluate if temporarily reducing the immunosuppressive medication of transplant recipients in the days before and after they receive an additional dose of COVID-19 vaccine increases their immune response to the vaccine.
The trial, which is sponsored and funded by the National Institute of Allergy and Infectious Diseases, will enroll up to 400 kidney and liver transplant recipients who did not elicit detectable antibody responses following two to four doses of a COVID-19 messenger RNA vaccine.
Currently, all immunocompromised adults who have received either mRNA COVID-19 vaccine are eligible for a fourth dose 6 months following their third shot.
The new trial will be conducted at 15 transplant centers in the U.S. Each participant will have received either a kidney or liver transplant at least a year before enrollment. Participants will be assigned at random into two cohorts — one will receive an additional dose of mRNA COVID-19 vaccine, and the other will take a reduced dose of their immunosuppressants for 5 days before and 2 weeks after receiving the additional dose.
Investigators will assess antibody responses in each participant for 30 days after the additional dose. The goal is to determine the proportion of participants who achieve the predefined antibody response by day 30. All participants will be followed for a year after enrollment.
“Eliciting a protective immune response to COVID-19 vaccines in some organ transplant recipients continues to be a challenge,” NIAID Director Anthony S. Fauci, MD, said in a news release. “We are concerned about protecting everyone from COVID-19 and therefore continue to develop and test new approaches to make vaccination effective for all organ transplant recipients.”
Because they must take lifelong immunosuppressive therapies to prevent organ rejection, transplant recipients do not have optimal immune responses to vaccines. Research has shown that many organ transplant recipients do not develop antibodies against SARS-CoV-2 after two or even three doses, the NIH release noted.
“The lack of robust antibody responses, along with a high prevalence of risk factors such as obesity and diabetes, leaves kidney and liver transplant recipients at a high risk for SARRS-CoV-2 infection and severe COVID-19,” the NIH said.
Research has shown that pausing immunosuppressants in people with an autoimmune disease can safely improve antibody responses to vaccinations for both COVID-19 and influenza, the NIH noted.
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