COVID-19 Protection After Transplant Pilot Study

Summary

Antibodies are an important part of the body's defense against infection. Individuals who have no antibodies or very low antibody levels are considered less well protected from Coronavirus Disease 2019 (COVID-19) than those who have higher antibody levels. What level of antibodies is necessary for protection is currently unknown. Inadequate antibody response to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) vaccination has been described among kidney transplant recipients. The aim of this study is to elicit an antibody response to vaccination against SARS-CoV-2 in kidney transplant recipients who have failed to respond to two doses of either the Moderna COVID-19 vaccine or Pfizer-BioNTech Coronavirus Disease 2019 (COVID-19) vaccine.

Timeline

Start

2021-08-10

Primary completion

2022-11-10

Completion

2023-03-10

Publications

• Background Werbel WA, Boyarsky BJ, Ou MT, Massie AB, Tobian AAR, Garonzik-Wang JM, Segev DL. Safety and Immunogenicity of a Third Dose of SARS-CoV-2 Vaccine in Solid Organ Transplant Recipients: A Case Series. Ann Intern Med. 2021 Sep;174(9):1330-1332. doi: 10.7326/L21-0282. Epub 2021 Jun 15. No abstract available.
• Karaba AH, Morgenlander WR, Johnston TS, Hage C, Pekosz A, Durand CM, Segev DL, Robien MA, Heeger PS, Larsen CP, Blankson JN, Werbel WA, Larman HB, Tobian AAR. Epitope Mapping of SARS-CoV-2 Spike Antibodies in Vaccinated Kidney Transplant Recipients Reveals Poor Spike Coverage Compared to Healthy Controls. J Infect Dis. 2024 May 15;229(5):1366-1371. doi: 10.1093/infdis/jiad534.
• Werbel WA, Karaba AH, Chiang TP, Massie AB, Brown DM, Watson N, Chahoud M, Thompson EA, Johnson AC, Avery RK, Cochran WV, Warren D, Liang T, Fribourg M, Huerta C, Samaha H, Klein SL, Bettinotti MP, Clarke WA, Sitaras I, Rouphael N, Cox AL, Bailey JR, Pekosz A, Tobian AAR, Durand CM, Bridges ND, Larsen CP, Heeger PS, Segev DL; CPAT investigators. Persistent SARS-CoV-2-specific immune defects in kidney transplant recipients following third mRNA vaccine dose. Am J Transplant. 2023 Jun;23(6):744-758. doi: 10.1016/j.ajt.2023.03.014. Epub 2023 Mar 24.

Drugs

Indications