New study assess 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 Moderna or Pfizer-BioNTech vaccine. This phase 2 trial is sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
‘New trial will determine whether a third dose of the mRNA COVID-19 vaccines could overcome the suppressed immune response for kidney transplant recipients.’
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Immunosuppressive therapy decreases immune response to both pathogens and vaccines. Many organ transplant recipients usually do not develop antibodies against SARS-CoV-2, the virus that causes COVID-19, after receiving an authorized COVID-19 vaccine regimen.Read More..
The objective of this study is to determine whether a third dose of one of the mRNA COVID-19 vaccines could overcome this problem for at least some kidney transplant recipients.
This population has a high prevalence of conditions that are risk factors for severe COVID-19, such as cardiovascular disease and diabetes.
The pilot study could help distinguish those kidney transplant recipients who would benefit from a third dose of an mRNA vaccine from those who will require a different approach to achieve protection.
The study findings inform a larger phase of the trial that includes strategies to induce a protective immune response against SARS-CoV-2 in solid organ transplant recipients who do not respond to a third dose of an mRNA vaccine.
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The study called COVID Protection After Transplant (CPAT), is being conducted at Johns Hopkins University in Baltimore under the leadership of Dorry Segev, M.D., Ph.D. Dr. Segev is the Marjory K. and Thomas Pozefsky professor of surgery and epidemiology, associate vice chair of the department of surgery, and director of the Epidemiology Research Group in Organ Transplantation at Johns Hopkins University.
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50 and 100 participants will have had no detectable antibody response to two doses of an mRNA COVID-19 vaccine, and 50 to 100 participants will have had a low response. All participants will receive a third dose of the same COVID-19 vaccine that they received previously.
Investigators will measure antibody response to the third dose after three days. They will determine the proportion of participants who achieve a designated antibody response at the 30-day mark.
The study team will follow participants for one year after enrollment. Preliminary results are expected in September 2021.
Source-Medindia