Study will assess COVID-19 booster dose in kidney transplant recipients
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A phase 2 trial sponsored and funded by the NIH’s National Institute of Allergy and Infectious Diseases will assess the antibody response of a third dose of COVID-19 messenger RNA vaccine in kidney transplant recipients.
Like with other immunizations, there is evidence that patients who have undergone a transplant do not respond optimally to COVID-19 vaccination because of the immunosuppressive therapy they must take to prevent organ rejection, the NIH noted in a press release.
The new trial will attempt to determine whether a third dose of a COVID-19 mRNA vaccine will overcome this problem, and whether there are characteristics that can distinguish transplant recipients who might benefit from a third dose from those who require a different approach, the NIH said.
The pilot study, called COVID Protection After Transplant (CPAT), is being conducted at Johns Hopkins University and will enroll up to 200 people aged 18 years or older who received a kidney transplant 1 year or more before enrollment and have had no recent organ rejection or change in immunosuppression. All participants will have had a low or no detectable antibody response to two doses of an mRNA vaccine.
To mark the announcement of the trial, we compiled a list of six recent stories related to the topic of COVID-19 booster doses and immunocompromised patients.
Q&A: Reduced efficacy of COVID-19 vaccines in transplant recipients
A study of COVID-19 vaccine responses among kidney transplant recipients in Israel suggested that they may remain at high risk for COVID-19 even after vaccination. We spoke with Infectious Disease News Editorial Board Member Peter Chin-Hong, MD, professor of medicine and director of the transplant infectious disease program at the University of California, San Francisco, about the impact of COVID-19 on transplant programs and the efficacy of COVID-19 vaccines in transplant recipients. Read more.
Organ transplant recipients 'should not assume immunity' from COVID-19 vaccine
Only 54% of solid organ transplant recipients demonstrated evidence of antibody development after receiving a COVID-19 vaccine, according to data in a pair of research letters published in JAMA. Read more.
Booster dose could make transplant recipients less vulnerable to COVID-19, study finds
Researchers from Johns Hopkins found that a booster dose could make transplant recipients less vulnerable to infection. In a study published in Annals of Internal Medicine, they reported that a third dose of COVID-19 vaccine increased antibody levels in a third of patients who had negative levels and all patients with low-positive antibody levels after two doses. Read more.
COVID-19 vaccine response varies widely among immunocompromised patients
Approximately 84% of patients with autoimmune diseases develop antibodies from the COVID-19 vaccine, compared with 98.1% of healthy health care workers, according to an interim analysis published in medRxiv. The findings demonstrated a wide heterogeneity regarding COVID-19 vaccine response in immunocompromised patients, with only one in five participants with a lung transplant developing an antibody response, and a nearly complete response in those with well-controlled HIV, the researchers wrote. Read more.
'Limited data' exist for COVID-19 booster in immunocompromised patients
On July 12, Israel’s Ministry of Health began offering a third dose of the Pfizer mRNA vaccine to severely immunocompromised adults, which could herald a similar booster approach in older and vulnerable populations in other parts of the world, including the United States. Read more.
CDC, FDA say booster doses not needed as Pfizer eyes authorization
Pfizer and BioNTech announced positive initial findings from an ongoing trial assessing a booster dose of their COVID-19 vaccine and said they plan to submit the data soon to the FDA. But federal health officials said a booster program for COVID-19 vaccines is not yet necessary, and that fully vaccinated people are protected against serious illness from all SARS-CoV-2 viruses, including variants. Read more.
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