Media advisory

Tuesday August 10, 2021

The trial will assess the antibody response in people who have not responded to the two-dose regimen.

What

A pilot study has begun to assess the antibody response to a third dose of an approved COVID-19 mRNA vaccine in kidney transplant recipients who have failed to respond to two doses of the Moderna or Pfizer-BioNTech COVID- vaccine. 19. The Phase 2 trial is sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the National Institutes of Health.

Lifelong immunosuppressive therapy that organ transplant recipients must take to prevent organ rejection dulls their immune response to both pathogens and vaccines. Research has shown that many organ transplant recipients do not develop antibodies to SARS-CoV-2, the virus that causes COVID-19, after receiving an approved COVID-19 vaccine regimen. The aim of the new study is to determine whether a third dose of one of the COVID-19 mRNA vaccines could overcome this problem for at least some kidney transplant recipients. This is especially important because 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 also aims to identify characteristics that might help distinguish kidney transplant recipients who would benefit from a third dose of an mRNA vaccine from those who will need a different approach to achieve protection. The results of the pilot study will inform a later, larger phase of the trial that includes higher risk strategies to induce a protective immune response against SARS-CoV-2 in solid organ transplant recipients who do not. not respond to a third dose of an mRNA vaccine.

The third-dose vaccine intervention was chosen because of the demonstrated safety of the two-dose mRNA vaccine regimen in solid organ transplant recipients as well as the efficacy of additional doses of other vaccines, such as than those against hepatitis and influenza, in immunocompromised people.

The pilot study, called COVID Protection After Transplant (CPAT), is being conducted at Johns Hopkins University in Baltimore under the direction of Dorry Segev, MD, Ph.D. Dr. Segev is Professor of Surgery and Epidemiology Marjory K and Thomas Pozefsky, associate vice president of the department of surgery and director of the Organ Transplant Epidemiology Research Group at Johns Hopkins University.

The CPAT study team will recruit up to 200 adults aged 18 years or older who received a kidney transplant one year or more prior to recruitment and have had no recent organ rejection or changes in immunosuppression. Between 50 and 100 participants will have had no detectable antibody response to two doses of a COVID-19 mRNA vaccine, and 50 to 100 participants will have had a poor response. All participants will receive a third dose of the same COVID-19 vaccine that they received previously. Thirty days later, investigators will measure participants’ antibody response to the third dose. The goal is to determine the proportion of participants who achieve a designated antibody response after 30 days. The study team will follow the participants for one year after registration. The first results are expected in September 2021.

Those interested in registering for the CPAT pilot study should contact Johns Hopkins University using the email address [email protected]. More information about the trial is available at ClinicalTrials.gov under study ID NCT04C969263.

Which

NIAID Director Anthony S. Fauci, MD, and Daniel Rotrosen, MD, Director of the Division of Allergy, Immunology and Transplantation at NIAID, are available to discuss the CPAT pilot study.

Contact

To schedule interviews, please contact the NIAID News & Science Writing Branch, (301) 402-1663, [email protected].

NIAID conducts and supports research – at NIH, across the United States, and around the world – to study the causes of infectious and immune diseases, and to develop better ways to prevent, diagnose, and treat these diseases. Press releases, fact sheets and other materials related to NIAID are available on the NIAID website.

About the National Institutes of Health (NIH):The NIH, the national agency for medical research, comprises 27 institutes and centers and is part of the US Department of Health and Human Services. The NIH is the principal federal agency that conducts and supports basic, clinical, and translational medical research, and studies the causes, treatments, and cures for common and rare diseases. For more information about the NIH and its programs, visit www.nih.gov.

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